United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - ipratropium bromide (unii: j697uz2a9j) (ipratropium - unii:gr88g0i6ul) - ipratropium bromide nasal solution 0.03% is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. ipratropium bromide nasal solution 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis. ipratropium bromide nasal solution 0.03% is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients. ipratropium bromide nasal solution 0.03%, nasal spray, 21 mcg/spray read complete instructions carefully before using. in order to ensure proper dosing, do not attempt to change the size of the spray opening. ipratropium bromide nasal solution 0.03% is indicated for the symptomatic relief of rhinorrhea (runny nose) associated with allergic and nonallergic perennial rhinitis in adults and children age 6 years and older. ipratropium bromide nasal solution 0.03% does not relieve nasal congestion, sneezing, or postnasal drip associated with allergic or nonallergic perennial rhinitis. read complete instructions carefully and use only as directed. to use: 1. remove the clear plastic dust cap and the green safety clip from the nasal spray pump (figure 1). the safety clip prevents the accidental discharge of the spray in your pocket or purse. 2. the nasal spray pump must be primed before ipratropium bromide nasal solution 0.03% is used for the first time. to prime the pump, hold the bottle with your thumb at the base and your index and middle fingers on the white shoulder area. make sure the bottle points upright and away from your eyes. press your thumb firmly and quickly against the bottle seven times (figure 2). the pump is now primed and can be used. your pump should not have to be reprimed unless you have not used the medication for more than 24 hours; repriming the pump will only require two sprays. if you have not used your nasal spray for more than seven days, repriming the pump will require seven sprays. 3. before using ipratropium bromide nasal solution 0.03%, blow your nose gently to clear your nostrils if necessary. 4. close one nostril by gently placing your finger against the side of your nose, tilt your head slightly forward and, keeping the bottle upright, insert the nasal tip into the other nostril (figure 3). point the tip toward the back  and outer  side of the nose. 5. press firmly and quickly upwards with the thumb at the base while holding the white shoulder portion of the pump between your index and middle fingers. following each spray, sniff deeply and breathe out through your mouth. 6. after spraying the nostril and removing the unit, tilt your head backwards for a few seconds to let the spray spread over the back of the nose. 7. repeat steps 4 through 6 in the same nostril. 8. repeat steps 4 through 7 in the other nostril (i.e., two sprays per nostril). 9. replace the clear plastic dust cap and safety clip. 10. at some time before the medication is completely used up, you should consult your physician or pharmacist to determine whether a refill is needed. you should not take extra doses or stop using ipratropium bromide nasal solution 0.03% without consulting your physician. to clean: if the nasal tip becomes clogged, remove the clear plastic dust cap and safety clip. hold the nasal tip under running, warm tap water (figure 4) for about a minute. dry the nasal tip, reprime the nasal spray pump (step 2 above), and replace the plastic dust cap and safety clip. caution: ipratropium bromide nasal solution 0.03% is intended to relieve your rhinorrhea (runny nose) with regular use. it is therefore important that you use ipratropium bromide nasal solution 0.03% as prescribed by your physician. for most patients, some improvement in runny nose is usually apparent during the first full day of treatment with ipratropium bromide nasal solution 0.03%. some patients may require up to two weeks of treatment to obtain maximum benefit. do not spray ipratropium bromide nasal solution 0.03% in your eyes. should this occur, immediately flush your eye with cool tap water for several minutes. if you accidentally spray ipratropium bromide nasal solution 0.03% in your eyes, you may experience a temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion, development or worsening of narrow-angle glaucoma, pupil dilation, or acute eye pain/discomfort, and increased sensitivity to light, which may last a few hours. should acute eye pain or blurred vision occur, contact your doctor. should you experience excessive nasal dryness or episodes of nasal bleeding contact your doctor. if you have glaucoma or difficulty urinating due to an enlargement of the prostate, be sure to tell your physician prior to using ipratropium bromide nasal solution 0.03%. if you are pregnant or you are breast feeding your baby, be sure to tell your physician prior to using ipratropium bromide nasal solution 0.03%. address medical inquiries to: www.amneal.com or 1-877-835-5472. store tightly closed at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. avoid freezing. keep out of reach of children. distributed by: amneal pharmaceuticals llc bridgewater, nj 08807 rev. 04-2022-01

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals ny llc - ipratropium bromide (unii: j697uz2a9j) (ipratropium - unii:gr88g0i6ul) - ipratropium bromide nasal solution 0.06% is indicated for the symptomatic relief of rhinorrhea associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. ipratropium bromide nasal solution 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. the safety and effectiveness of the use of ipratropium bromide nasal solution 0.06% beyond four days in patients with the common cold or beyond three weeks in patients with seasonal allergic rhinitis has not been established. ipratropium bromide nasal solution 0.06% is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, or to any of the other ingredients. ipratropium bromide nasal solution 0.06%  nasal spray 42 mcg/spray   read complete instructions carefully before using.   in order to ensure proper dosing, do not attempt to change the size of the spray opening. ipratropium bromide nasal solution 0.06% is indicated for the symptomatic relief of rhinorrhea (runny nose) associated with the common cold or seasonal allergic rhinitis for adults and children age 5 years and older. ipratropium bromide nasal solution 0.06% does not relieve nasal congestion or sneezing associated with the common cold or seasonal allergic rhinitis. do not use ipratropium bromide nasal solution 0.06% for longer than four days for a common cold or three weeks for seasonal allergic rhinitis unless instructed by your physician. read complete instructions carefully and use only as directed. to use: 1. remove the clear plastic dust cap and the green safety clip from the nasal spray pump (figure 1). the safety clip prevents the accidental discharge of the spray in your pocket or purse. 2. the nasal spray pump must be primed before ipratropium bromide nasal solution 0.06% is used for the first time. to prime the pump, hold the bottle with your thumb at the base and your index and middle fingers on the white shoulder area. make sure the bottle points upright and away from your eyes. press your thumb firmly and quickly against the bottle seven times (figure 2). the pump is now primed and can be used. your pump should not have to be reprimed unless you have not used the medication for more than 24 hours; repriming the pump will only require two sprays. if you have not used your nasal spray for more than seven days, repriming the pump will require seven sprays. 3. before using ipratropium bromide nasal solution 0.06%, blow your nose gently to clear your nostrils if necessary. 4. close one nostril by gently placing your finger against the side of your nose, tilt your head slightly forward and, keeping the bottle upright, insert the nasal tip into the other nostril (figure 3). point the tip toward the back  and outer  side of the nose. 5. press firmly and quickly upwards with the thumb at the base while holding the white shoulder portion of the pump between your index and middle fingers. following each spray, sniff deeply and breathe out through your mouth. 6. after spraying the nostril and removing the unit, tilt your head backwards for a few seconds to let the spray spread over the back of the nose. 7. repeat steps 4 through 6 in the same nostril. 8. repeat steps 4 through 7 in the other nostril (i.e., two sprays per nostril). 9. replace the clear plastic dust cap and safety clip. 10. at some time before the medication is completely used up, you should consult your physician or pharmacist to determine whether a refill is needed. you should not take extra doses or stop using ipratropium bromide nasal solution 0.06% without consulting your physician. to clean: if the nasal tip becomes clogged, remove the clear plastic dust cap and safety clip. hold the nasal tip under running, warm tap water (figure 4) for about a minute. dry the nasal tip, reprime the nasal spray pump (step 2 above), and replace the plastic dust cap and safety clip. caution: ipratropium bromide nasal spray 0.06% is intended to relieve your rhinorrhea (runny nose) with regular use. it is therefore important that you use ipratropium bromide nasal solution 0.06% as prescribed by your physician. for most patients, some improvement in runny nose is apparent following the first dose of treatment with ipratropium bromide nasal solution 0.06%. do not use ipratropium bromide nasal solution 0.06% for longer than four days for your cold or three weeks for seasonal allergic rhinitis unless instructed by your physician. do not spray ipratropium bromide nasal solution 0.06% in your eyes.  should this occur, immediately flush your eye with cool tap water for several minutes. if you accidentally spray ipratropium bromide nasal solution 0.06% in your eyes, you may experience a temporary blurring of vision, visual halos or colored images in association with red eyes from conjunctival and corneal congestion, development or worsening of narrow-angle glaucoma, pupil dilation , or acute eye pain/discomfort, and increased sensitivity to light, which may last a few hours. should acute eye pain or blurred vision occur, contact your doctor. should you experience excessive nasal dryness or episodes of nasal bleeding contact your doctor. if you have glaucoma or difficulty urinating due to an enlargement of the prostate, be sure to tell your physician prior to using ipratropium bromide nasal solution 0.06%. if you are pregnant or you are breast feeding your baby, be sure to tell your physician prior to using ipratropium bromide nasal solution 0.06%. address medical inquiries to: www.amneal.com or 1-877- 835-5472. storage: store tightly closed at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. avoid freezing. keep out of reach of children. distributed by: amneal pharmaceuticals llc  bridgewater, nj 08807 rev. 04-2021-00

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals llc - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - lioresal intrathecal (baclofen injection) is indicated for use in the management of severe spasticity. patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. for spasticity of spinal cord origin, chronic infusion of lioresal intrathecal via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable cns side effects at effective doses. patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. lioresal intrathecal is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only in implantable pumps approved by the fda specifically for the administration of lioresal intrathecal into the intrathecal space. spasticity of spinal cord origin: evidence supporting the efficacy of lioresal intrathecal was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of lioresal intrathecal to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis. lioresal intrathecal was superior to placebo on both principal outcome measures employed: change from baseline in the ashworth rating of spasticity and the frequency of spasms. spasticity of cerebral origin: the efficacy of lioresal intrathecal was investigated in three controlled clinical trials; two enrolled patients with cerebral palsy and one enrolled patients with spasticity due to previous brain injury. the first study, a randomized controlled cross-over trial of 51 patients with cerebral palsy, provided strong, statistically significant results; lioresal intrathecal was superior to placebo in reducing spasticity as measured by the ashworth scale. a second cross-over study was conducted in 11 patients with spasticity arising from brain injury. despite the small sample size, the study yielded a nearly significant test statistic (p= 0.066) and provided directionally favorable results. the last study, however, did not provide data that could be reliably analyzed. lioresal intrathecal therapy may be considered an alternative to destructive neurosurgical procedures. prior to implantation of a device for chronic intrathecal infusion of lioresal intrathecal, patients must show a response to lioresal intrathecal in a screening trial (see dosage and administration). hypersensitivity to baclofen. lioresal intrathecal is not recommended for intravenous, intramuscular, subcutaneous or epidural administration. drug preparation kit for use with medtronic ® synchromed implantable programmable infusion pumps instructions for use the lioresal® intrathecal (baclofen injection) drug preparation kit is used for kit models 8561, 8562, 8564, 8565 and 8566 to draw the drug from the ampule(s). the appropriate ampule(s) is/are placed within the corresponding kit. in addition, each kit contains: -syringe cap(s) -filter straw® tube(s) -ampule opener(s) -syringe label(s) -plastic bag -four gauze pads -20 ml syringe -lioresal® intrathecal (baclofen injection) prescribing information -drug preparation kit instructions for use indications the lioresal® intrathecal (baclofen injection) drug preparation kit is intended for use with medtronic synchromed implantable programmable infusion pumps. it is not for use with the medtronic minimed® infusion pumps. refer to the lioresal® lntrathecal (baclofen injection) drug prescribing information for indications, contraindications, warnings, precautions, dosage and administration information, and screening procedures.  contraindications refer to the contraindications listed in the appropriate pump technical manual, 856x refill kit instructions for use, and drug labeling. precautions if dilution of the drug is required, refer to the drug labeling for proper diluent and procedures. for emergency procedures, refer to the refill kit 856x instructions for use that are packaged with the refill kit. sterilization all components of the drug preparation kit are sterile. do not resterilize. should sterility be in question, discard and use a new kit. the outside of the ampule is sterile. if sterile technique is broken, the contents of the ampule are still sterile. instructions for use use sterile technique throughout the procedure to prevent contamination of the components and drug. note: the drug ampule is not sterile. 1. remove the drug ampule from the box. confirm drug ampule concentration prior to drug administration. 2. open the ampule as follows: note: the entire neck of the ampule is scored. an ampule opener has been provided to ease the opening of the ampule; always exercise caution when opening a glass ampule note: if the ampule opener is not used, use gauze pads to hold the top of the ampule when opening. figure 1.   a. hold the ampule in one hand and place opener (fins first) over the neck until it rests on the base portion of the ampule. grasp opener with forefinger and thumb while holding the ampule base. hold ampule upright and snap. dispose of opener and ampule top to prevent potential contamination (figure 1).  3. assemble the syringe and filter straw® tube (figure 2), making sure the syringe connection is snug to avoid leakage. figure 2. assemble syringe and filter straw® tube 4.withdraw the drug from the ampule(s) (figure 3). figure 3. withdraw drug from ampule 5.remove the filter straw® tube from the syringe. appropriately discard filter straw® tube. 6.purge the air from the syringe. 7. if drug syringe is to be transferred prior to procedure a syringe cap has been provided. attach the syringe cap, making sure the cap is snug to avoid leakage. 8. for convenience, a syringe label has been provided to capture patient's name, drug name, drug concentration, and date. 9. peel the backing from the label and attach the label to the syringe, making sure not to cover the volume indicators on the syringe (figure 4). figure 4. syringe with cap and label 10.  if the drug needs to be transported, place the syringe(s) in the plastic bag. 11.  if applicable, repeat steps 1 – 10 with the second syringe, filter straw® tube, syringe cap, and syringe label supplied in the model 8562, 8565 and 8566 kits. 12. refer to the 856x refill kit instructions for use for pump refill instructions. note: purge air from syringe prior to drug administration. rx only medtronic® and minimed® are trademarks of medtronic® and are registered in the u.s. and possibly other countries. lioresal® is a registered trademark of amneal filter straw® is a registered trademark of b.braun medical inc. amneal pharmaceuticals llc bridgewater, nj  08807 rev. 03-2023-00 amneal refill kit 856x for use with medtronic synchromed® implantable programmable infusion pumps instructions for use rx only explanation of symbols on product or package labeling refer to the appropriate product for symbols that apply. open here table of contents   introduction 7 package contents 7 indications 7 contraindications 7 warnings 7 precautions 11 adverse events 12 instructions for use 12 sterilization 12 preliminary procedures 12 emptying the synchromed pump 13 refilling the synchromed pump 16 programming the synchromed pump 19 after the refill procedure 19 reservoir rinse procedure 19 performing a reservoir rinse 19 technical support 20 emergency procedures 20 lioresal intrathecal (baclofen injection) overdose 20 lioresal intrathecal (baclofen injection) underdose/withdrawal 21 emergency procedure to empty pump reservoir 22 special notice 23 limited warranty 24 amneal model 856x refill kit limited warranty 24 refer to the indications, drug stability, and emergency procedures reference manual1 for indications and related information. refer to the appropriate information for prescribers booklet for contraindications, warnings, precautions, adverse events summary, individualization of treatment, patient selection, use in specific populations, and component disposal. refer to the lioresal intrathecal (baclofen injection) drug labeling for indications, contraindications, warnings, precautions, dosage and administration information, and screening procedures. 1 the referenced manual is available from the medtronic website. to view, download, print, or order the manual, go to www.medtronic.com/manual or contact your medtronic representative. introduction these instructions include only the procedure for refilling the pump reservoir with lioresal intrathecal (baclofen injection). refer to the appropriate technical manuals, provided by the manufacturer for instructions on implanting and/or programming of the pump. package contents the model 856x refill kit contains the following sterile components that are not made with natural rubber latex: - two 22-gauge noncoring needles - extension set with a clamp - 0.2-micron filter - 20-ml syringe - template - fenestrated drape with adhesive strips - accessories (adhesive bandage, sharps plug, four gauze pads, two alcohol wipes, gloves, povidone iodine swab sticks) - refill kit instructions for use - sterile drape indications the model 856x refill kit is intended for use in refilling medtronic synchromed implantable programmable infusion pumps. it is not for use with the medtronic minimed infusion pumps. contraindications amneal refill kits are contraindicated for all catheter access port procedures. warnings withdrawal - abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death. prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. special attention should be given to patients at apparent risk (e.g. spinal cord injuries at t-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information. user instructions - comply with all product instructions for initial preparation and filling, implantation, programming, refilling, and accessing the catheter access port (if present) of the pump. failure to comply with all instructions can lead to technical errors or improper use of implanted infusion pumps and result in additional surgical procedures, a return of underlying symptoms, drug withdrawal symptoms, or a clinically significant or fatal drug underdose or overdose. implantation and system management - implantation and ongoing system management must be performed by individuals trained in the operation and handling of the infusion system and must be in compliance with procedures described in the appropriate technical instructions. inadequate training or failure to follow instructions can require surgical revision or replacement, and result in a clinically significant or fatal drug underdose or overdose. overinfusion – overinfusion is defined as the delivery of more drug volume than the programmed rate, exceeding the pump’s flow rate accuracy specification. pump reservoir contents aspirated during a refill procedure that are less than expected may indicate that the pump has overinfused. overinfusion may or may not be associated with clinically relevant symptoms. when the pump delivers more drug volume than the programmed rate, patients may experience overdose symptoms, and the pump reservoir will deplete more quickly than expected. patients may experience underdose or withdrawal symptoms if the drug is depleted prior to the scheduled refill date from an overinfusing pump. at each refill visit, question and examine the patient for signs and symptoms of overdose, underdose, and withdrawal. the low reservoir alarm of an overinfusing pump will not sound if the pump reservoir is prematurely depleted. the low reservoir alarm is calculated from the pump’s programmed delivery rate and is not a direct measurement of the actual drug volume in the pump reservoir. multiple factors may increase the likelihood of overinfusion, including: nonindicated drug formulations, overfilling of the pump reservoir, operation of the pump with no fluid in the reservoir, catheter occlusion, and pump stops or motor stalls lasting more than 48 hours. refer to the appropriate drug labeling for specific drug underdose or overdose symptoms and methods of management. if overinfusion is strongly suspected, contact medtronic. reducing the dose and/or concentration is not recommended as a solution for overinfusion. if immediate discontinuation of therapy is clinically appropriate for the patient, program the pump to minimum rate mode, and aspirate any remaining drug from the reservoir. five occurrences of overinfusion have been identified in medtronic’s prospective, long-term multi-center registry study (product surveillance registry) as of january 2016, resulting in a rate estimate of less than 0.14% (approximately 1 in 700). calculating catheter volume - use the catheter length recorded at implant or catheter revision when calculating catheter volume. the actual implanted catheter length and catheter model number are required to accurately calculate catheter volume. a universal value does not exist that can be used as a substitute for this knowledge. an inaccurate catheter volume calculation can result in a clinically significant or fatal drug underdose or overdose. contrast medium (pumps with a catheter access port) - do not inject any contrast medium into the pump reservoir. injecting contrast medium into the pump reservoir can impair pump operation. refill - patients must return to the clinic for refills at the prescribed times. failure to return to the clinic for refills at the prescribed times can result in the actual flow rate of the pump being less than expected, resulting in a loss of or change in therapy, which may lead to a return of underlying symptoms, drug withdrawal symptoms, or a clinically significant or fatal drug underdose. failure to return at the prescribed times can also damage the pump, requiring surgical replacement. refill kit components - use the appropriate amneal refill kit during all lioresal refill procedures using medtronic implantable infusion pumps. using components other than amneal components or a kit other than the appropriate refill kit can damage medtronic pump components, requiring surgical revision or replacement, and allow drug leakage into surrounding tissue, resulting in loss of or change in therapy, which may lead to a return of underlying symptoms, drug withdrawal symptoms, or a clinically significant or fatal drug underdose or overdose. injection error during a pump refill procedure - be certain you are accessing the reservoir fill port when injecting fluids into an implanted pump. always: - identify the pump model and reservoir volume. - identify the location of the reservoir fill port. – avoid pocket fill, ie, improper injection of medication into the subcutaneous tissue (see below). – avoid inadvertent injection into the catheter access port (see below). - use the instructions, noncoring needles, appropriate template edge, and other accessories provided in the appropriate kit. - verify the location of the reservoir fill port during needle insertion according to the instructions provided and using other medical procedures as appropriate. - refer to the drug labeling for indications, contraindications, warnings, precautions, adverse events, and dosage and administration information. pocket fill is the improper injection of refill medication into the subcutaneous tissue, which includes the pump pocket. the injection of drug into the subcutaneous tissue can lead to an acute systemic overdose, which can be fatal. after a pocket fill, the pump reservoir will become empty sooner than anticipated, and this may cause underdose symptoms and/or baclofen withdrawal syndrome, which can be fatal. if it is suspected or known that all or part of the drug was injected into the pocket during the refill procedure, monitor the patient closely for signs and symptoms of overdose in an appropriate facility for a sufficient amount of time or until the symptoms have resolved. refer to the refill kit manual or the indications, drug stability, and emergency procedures reference manual1 for emergency procedures associated with drug underdose and overdose. refer to the drug product information label for specific drug underdose and overdose symptoms and methods of management. inadvertent injection into the catheter access port may result in a clinically significant or fatal drug overdose. if it is suspected or known that all or part of the drug was injected into the catheter access port during the refill procedure, monitor the patient closely for signs and symptoms of overdose in an appropriate facility for a sufficient amount of time or until the symptoms have resolved. refer to the catheter access port kit manual or the indications, drug stability, and emergency procedures reference manual1 for emergency procedures associated with drug overdose. refer to the drug labeling for specific drug overdose symptoms and methods of management. changing drug or decreasing drug concentrations - rinse the reservoir twice between solutions when changing drug or decreasing drug concentrations in the pump reservoir. a significant amount of drug may be present in the pump reservoir after emptying the pump. this residual volume cannot be removed by emptying the pump. rinsing the reservoir between solutions minimizes the amount of drug in this residual volume but does not eliminate it. failure to account for residual drug in the pump reservoir can result in a concentration that is different than intended and a clinically significant or fatal drug underdose or overdose. program a bridge bolus after rinsing the reservoir twice.the bridge bolus advances the remaining old drug (the drug left in the pump tubing, catheter access port, and catheter after emptying and refilling the pump) to the catheter tip at the specified flow rate. refer to "performing a reservoir rinse" on page 18 of this manual. refer to the programming guide for bridge bolus procedures. connections - firmly secure all connections. failure to secure connections can allow drug to leak onto the surrounding skin and may result in inadequate therapy or infection. reservoir fill port injections - do not use excessive force when accessing the reservoir fill port. excessive force can result in damage to the needle or pump requiring surgical revision or replacement, and leakage into surrounding tissue, resulting in loss of or change in therapy, which may lead to a return of underlying symptoms, drug withdrawal symptoms, or a clinically significant or fatal drug underdose or overdose. intrathecal therapy - for intrathecal therapy, use only a preservative-free sterile solution indicated for intrathecal use. nonindicated fluids containing preservatives or endotoxins can be neurotoxic in intrathecal applications. using nonindicated fluids can result in adverse events including, but not limited to, extreme pain, cramps, seizures, and death. drug information - refer to the drug labeling for indications, contraindications, warnings, precautions, dosage and administration information, and screening procedures. refer to the drug labeling for specific drug underdose or overdose symptoms and methods of management. failure to refer to the drug labeling can result in inappropriate patient selection and management, inadequate therapy, intolerable side effects, or a clinically significant or fatal drug underdose or overdose. consider the possibility of a drug error if the patient experiences unusual side effects. failure to do so can result in misdiagnosis of patient symptoms. mixing drugs - the effects that drug mixtures have on pump operation are unknown. drugs can precipitate when mixed. these precipitates can inhibit pump flow or block the catheter, resulting in loss of therapy or a clinically significant or fatal drug underdose. drug interaction and side effects - inform patients of the appropriate warnings and precautions regarding drug interactions, potential side effects, and signs and symptoms that require medical attention, including prodromal signs and symptoms of inflammatory mass. failure to recognize the signs and symptoms and to seek appropriate medical intervention can result in serious patient injury or death. drug overdose symptoms and management - refer to the emergency procedures included at the end of this manual and the drug labeling for specific drug overdose symptoms and methods of management. drug underdose/overdose - inform patients and caregivers of the signs and symptoms of a drug underdose and overdose. inform patients and caregivers: - to be aware and report any unusual signs or symptoms at anytime during or after a refill or catheter access port procedure. - to be alert for any burning sensations in the area of the pump pocket during their refill or catheter access port procedure. - to especially watch for signs of underdose and overdose. - to stay alert for signs or symptoms that may indicate changes to their prescribed drug concentration or programmed dose. - to seek emergency assistance as necessary. refer to the refill kit or catheter access port kit manual or the indications, drug stability and emergency procedures reference manual1 for emergency procedures associated with drug underdose and overdose. failure to recognize these signs and symptoms and to seek appropriate medical intervention can result in serious patient injury or death. patient travel – patients should notify their clinicians of any travel plans. clinicians need this information to coordinate patient care and pump refills and help prevent a loss of or change in therapy, which may lead to a return of underlying symptoms, drug withdrawal symptoms, or a clinically significant or fatal drug underdose. precautions compatibility, all components - follow these guidelines when selecting system components: - amneal components: for proper therapy, use only components that are compatible with the appropriate indication. - non-amneal components: no claims of safety, efficacy, or compatibility are made with regard to the use of non-amneal components. refer to the non-amneal component documentation for information. component packaging - before shipment the components in the sterile package were sterilized by the process indicated on the package label. do not use or implant a component if the following circumstances have occurred: - the storage package or sterile seal has been pierced or altered because component sterility cannot be guaranteed and infection may occur. - the component shows signs of damage because the component may not function properly. - the use-by date has expired because component sterility cannot be guaranteed and infection may occur; also, device battery longevity may be reduced and may require early replacement. storage temperature: kits and accessories - do not store or transport the kit device components or accessories above 57 °c (135 °f) or below –34 °c (–30 °f). temperatures outside this range can damage device components. aseptic technique - use strict aseptic technique when accessing the reservoir fill port or the catheter access port of an implanted pump. failure to use aseptic technique can contaminate fluids or tissues and result in local or systemic infection. infection - use extreme caution when accessing the reservoir fill port or catheter access port of the implanted pump if local or systemic infection is suspected. avoid contaminating the system or further spreading the infection. local or systemic infection may require pump revision or removal. therapy discontinuance - if therapy is discontinued for an extended period, fill the pump reservoir with preservative-free saline. program the pump to infuse at the minimum flow rate. refill the pump as needed to ensure the pump always contains fluid in the reservoir and fluid pathway. stopping the pump for extended periods or allowing the pump reservoir to empty completely can damage the system and require surgical replacement. single use only - do not reuse any component. components are intended for single use only. reusing components can result in inadequate therapy and an increased risk of infection. reservoir valve activation - do not prematurely activate the pump reservoir valve. activation of the pump reservoir valve seals the pump reservoir valve closed. unusual resistance or the inability to inject the entire fill volume may indicate activation of the pump reservoir valve. if the valve closes, a portion of the reservoir contents must be delivered or removed before filling can be completed, and procedural delays can occur. activation of the pump reservoir valve before the pump is filled can be resolved by the following actions: - completely aspirating all contents of the pump reservoir before filling - not allowing air into the pump reservoir through an open needle in the septum or an unclamped extension - not exceeding the maximum reservoir volume indicated in the pump labeling - if the patient has a fever, waiting for the patient’s fever to reduce to 38°c or below adverse events the adverse events associated with the use of this device may include, but may not be limited to, the following: - meningitis - infection - reservoir contamination - overpressurization of the reservoir - injection into pocket or subcutaneous tissue - activation of reservoir valve instructions for use become thoroughly familiar with all product literature before using this refill kit. sterilization all components of the kit are sterile. do not resterilize. should sterility of the kit be in question, discard and use a new kit. note: the outside of the ampule is sterile. if sterile technique is broken, the contents of the ampule are still sterile. preliminary procedures - open the lioresal refill kit - prepare the sterile field. the sterile drape can be used to prepare the sterile field. - gather the following sterile equipment: - drug prep kit containing correct concentration and volume of lioresal intrathecal (baclofen injections) - sterile drape from the refill kit: - 20-ml empty syringe - extension set with a clamp - template - 0.2-micron filter - two 22-gauge noncoring needle (2", 1.5") - fenestrated drape with adhesive strips - two alcohol wipes -  latex-free sterile gloves - adhesive bandage, optional - *note: the sharps plug should remain in the kit tray to receive the used sharps, if desired 4. refer to the drug labeling for indications, contraindications, warnings, precautions, dosage and administration information, and screening procedures. 5. prepare the programmer for use. refer to the appropriate programming guide for instructions. 6. confirm the: - pump model - reservoir volume (i.e., expected volume) - location of the pump note: the model and reservoir volume can be confirmed by the programmer. alternatively, a radiopaque identifier in the pump shows the pump model and identifies medtronic as the pump manufacturer on a standard x-ray (figure 1). a three-letter code designates the pump model. figure 1. a radiopaque identifier on a synchromed ii pump.     5. confirm that the volume of the prescribed fluid does not exceed the reservoir volume of the pump. emptying the synchromed pump - prepare the injection site by cleansing the area. - open the kit. put on sterile gloves. - place the drape, exposing the pump site. - using sterile procedures, assemble the needle, extension set, and empty syringe as follows: a. connect the empty syringe to the extension set. b. connect the needle to the extension set. 5. palpate the pump and identify the location of the catheter access port and the edges of pump. factors that may make it difficult to locate the pump include, but are not limited to: - deep implant - patient position (eg, a seated patient) - scar tissue at the pump implant site - seroma - the pump is tilted in the pocket - ·obesity - pump movement within the pocket - weight gain after implant - weight loss after implant if you have difficulty identifying the pump features, you may seek assistance from another clinician. if deemed necessary by the clinician, x-ray and fluoroscopy can be used to assist in locating or determining the orientation of the pump. 6. place the template on the skin over the pump, and align the refill template. align the right edge of the template with the right edge of the pump (figure 2). use the center circle of the template to insert the needle into the reservoir fill port. figure 2. aligning the refill template. 7. close the clamp. 8. gently insert the 22-gauge needle perpendicular to the surface of the pump through the center of the template and into the center of the reservoir fill port until the needle touches the bottom of the reservoir fill port (figures: 3 – 4). note: the pump may be tilted within the pocket and therefore the needle angle may not be perpendicular to the patient's body. during proper needle insertion, you will feel the needle: - pass through the patient's skin and subcutaneous tissue, - hit the silicone septum, (scar tissue, if present, can feel similar to the septum.) - pass through the septum, and - hit the metal bottom of the reservoir fill port. (the top of the pump is metal and hitting the top of the pump can feel similar to hitting the bottom of the reservoir fill port.) if excessive resistance is encountered during needle insertion, reassess placement. do not force the needle. the feel of abnormal resistance during the procedure may be an indication that the needle is not in the center of the reservoir fill port. figure 3. view inside of a synchromed programmable pump while the needle is fully and properly inserted. figure 4. close the clamp and insert the needle into the reservoir fill port.   note: at any point during the procedure, if in doubt about the needle location, reassess its position. factors that may contribute to difficulty inserting the needle into the reservoir fill port include, but are not limited to: - the pump is flipped in the pocket - deep implant - patient position (eg, a seated patient) - patient movement (eg, spasticity, difficulty hold still) - localized muscle spasms at the pump implant site - scar tissue at the pump implant site - seroma - the pump is tilted in the pocket - obesity - pump movement within the pocket - weight gain after implant - weight loss after implant 9. open the clamp and slowly withdraw the fluid from the reservoir into the empty syringe. note: if the withdrawn fluid has an unexpected appearance (eg, evidence of blood), this may indicate that the needle is not properly inserted into the pump. 10. if the syringe maximum capacity is reached before the reservoir is completely empty, more than one syringe will be needed to empty the pump. a. close the clamp. b. remove the full syringe. c. attach an empty syringe. d. verify that the needle is in the pump reservoir fill port. e. repeat step 9, then continue to step 11. 11. completely empty the pump. when the pump is empty, the bubbles will stop forming, and negative pressure in the syringe can be felt. 12. close the clamp and remove the syringe from the extension set. note: keep the needle in the reservoir fill port and the clamp closed for the pump refill procedure that follows. 13. note the amount withdrawn from the pump for entry in the patient's record. 14. compare the amount withdrawn from the pump to the expected volume. see the pump programmer for the expected volume. the amount withdrawn should approximately equal the expected volume. if a less than expected volume is observed, potential causes of the volume discrepancy could include: inaccurate volume measurements, incomplete pump aspiration, incorrect volume entry into clinician programmer at refills, unrecognized partial pocket fill, aspiration of pump medication by patient or caregiver, or overinfusion. note: immediately following the refill procedure: − record the amount withdrawn and the expected volume in the patient’s record − record any volume discrepancy and compare volume discrepancies from visit to visit. 15. discard the fluid and syringe as appropriate for the fluid content in accordance with institutional policies and applicable regulations. refilling the synchromed pump warning: overinfusion is defined as the delivery of more drug volume than the programmed rate, exceeding the pump’s flow rate accuracy specification. pump reservoir contents aspirated during a refill procedure that are less than expected may indicate that the pump has overinfused. overinfusion may or may not be associated with clinically relevant symptoms. when the pump delivers more drug volume than the programmed rate, patients may experience overdose symptoms, and the pump reservoir will deplete more quickly than expected. patients may experience underdose or withdrawal symptoms if the drug is depleted prior to the scheduled refill date from an overinfusing pump. at each refill visit, question and examine the patient for signs and symptoms of overdose, underdose, and withdrawal. the low reservoir alarm of an overinfusing pump will not sound if the pump reservoir is prematurely depleted. the low reservoir alarm is calculated from the pump’s programmed delivery rate and is not a direct measurement of the actual drug volume in the pump reservoir. multiple factors may increase the likelihood of overinfusion, including: nonindicated drug formulations, overfilling of the pump reservoir, operation of the pump with no fluid in the reservoir, catheter occlusion, and pump stops or motor stalls lasting more than 48 hours. refer to the appropriate drug labeling for specific drug underdose or overdose symptoms and methods of management. if overinfusion is strongly suspected, contact medtronic. reducing the dose and/or concentration is not recommended as a solution for overinfusion. if immediate discontinuation of therapy is clinically appropriate for the patient, program the pump to minimum rate mode, and aspirate any remaining drug from the reservoir. five occurrences of overinfusion have been identified in medtronic’s prospective, long-term multi-center registry study (product surveillance registry) as of january 2016, resulting in a rate estimate of less than 0.14% (approximately 1 in 700). warning: pocket fill is the improper injection into the subcutaneous tissue, which includes the pump pocket. pocket fill can result in a loss of or change in symptom control, drug withdrawal symptoms, or a clinically significant or fatal drug underdose or overdose. observe the patient after the pump refill procedure for any signs or symptoms that could indicate a pocket fill or any other drug-related adverse event due to the refill procedure. inadvertent injection into the catheter access port may result in a clinically significant or fatal drug overdose. observe the patient after the pump refill procedure for any signs or symptoms that could indicate a drug-related adverse event due to the pump refill procedure. warning: if it is suspected or known that all or part of the drug was inadvertently injected into the pocket or the catheter access port during the refill procedure, monitor the patient closely for signs and symptoms of overdose in an appropriate facility for a sufficient amount of time or until the symptoms have resolved. refer to the kit manual or the indications, drug stability, and emergency procedures reference manual1 for emergency procedures associated with drug underdose and overdose. refer to the drug product information label for specific drug underdose and overdose symptoms and methods of management. warning: swelling at the injection site may indicate that the needle tip is not properly located within the pump reservoir, and the result could be pocket fill. pocket fill can result in a loss of or change in symptom control, drug withdrawal symptoms, or a clinically significant or fatal drug underdose or overdose. absence of swelling does not in all cases demonstrate that the needle tip is properly located. if swelling is present, stop injecting and observe the patient for any signs or symptoms that could indicate a pocket fill or any other drug-related adverse event. - if changing drug or drug concentrations, refer to "performing a reservoir rinse" on page 18. otherwise, proceed to the next step. - confirm that the refill volume of the prescribed fluid does not exceed the reservoir volume of the pump. - purge the air from the syringe containing the prescribed fluid. - attach the filter to the syringe with the prescribed fluid. - purge all air from the filter. - attach the syringe with the prescribed fluid and filter to the extension set (figure 5). - before and during injection, verify that the needle remains fully inserted to the bottom of the reservoir fill port. do not apply tension to the extension tubing because the needle may be pulled out from the reservoir. - open the clamp and as the clamp is opened, observe the following indications that the needle continues to be properly positioned: the bubbles in the extension set are immediately drawn into the pump. the plunger may move slightly when the drug is initially drawn into the pump. - the bubbles in the extension set are immediately drawn into the pump. - the plunger may move slightly when the drug is initially drawn into the pump. - slowly depress the plunger on the syringe to inject the prescribed fluid into the pump reservoir. while injecting the prescribed fluid, verify that the needle remains properly located within the reservoir (figure 5). a. periodically withdraw and observe a portion of the drug to confirm that the drug has the expected appearance. b. after confirming that the needle remains in the reservoir, resume injecting fluid. figure 5. open the clamp and inject into the pump reservoir.   caution: if you encounter unusual resistance before the maximum reservoir volume is injected or you are unable to inject fluid, the reservoir valve may have been activated. activation of the pump reservoir valve seals the pump reservoir valve closed. if the valve closes, a portion of the reservoir contents must be delivered or removed before filling can be completed, and procedural delays can occur. to prevent activation of the pump reservoir valve during emptying and filling procedures: - completely aspirate all contents of the pump reservoir before filling; - do not allow air into the pump reservoir through an open needle in the septum or an unclamped extension; and - do not exceed the maximum reservoir volume indicated in the pump labeling. 10. if you have activated the reservoir valve, complete steps a – g below. otherwise, proceed to step 11. a. discontinue injection. b. close the clamp. c. remove the syringe with prescribed fluid and attached filter. d. attach an empty 20-ml syringe to the extension set. e. open the clamp, and aspirate until all fluid/air is removed. f. close the clamp and remove the syringe containing the aspirate from the extension set and discard the syringe. g. repeat steps 2 – 10. note:  for pumps with a reservoir valve, the amount of time before the valve will release is dependent on the duration and the amount of pressure applied after the valve is first activated. the more pressure exerted, the longer it may take to release the valve. 11. if more than one syringe of prescribed fluid is needed to fill the pump reservoir, complete steps a – d below. otherwise, proceed to step 12. a. close the clamp. b. keep the filter from the extension set in place, and remove the first syringe from the filter. caution: do not remove the filter from the extension set. removal of the filter could compromise the sterile barrier, which could result in an infection for the patient. c. purge the air from the second syringe, and attach the second syringe to the filter (figure 5). d. with the second syringe in a vertical position, open the clamp and slowly depress the plunger on the syringe to inject the prescribed fluid into the pump reservoir. 12. when filling is complete, close the clamp and carefully remove the needle from the reservoir fill port. note: if you are unsure whether drug was injected correctly into the pump, completely aspirate the pump to verify that all of the injected drug can be removed. 13. remove the cleansing agent from the patient’s skin using an alcohol pad. 14. apply an adhesive bandage, if desired. 15. discard all components of the kit. programming the synchromed pump - if the drug concentration or drug has been changed, program a bridge bolus. refer to the programming guide for the pump software. - if any prescription information has changed, enter the changed information into the clinician programmer: for example drug name, drug concentration, infusion information, or volume of prescribed fluid in the pump reservoir. - update the pump. after the refill procedure - record the amount withdrawn and the expected volume in the patient’s record. - record any volume discrepancy and compare volume discrepancies from visit to visit. - print out the desired refill-related reports, and place the final pump settings in the patient file. - determine the refill date from the printout, and schedule a refill appointment reservoir rinse procedure   performing a reservoir rinse to prevent drug overdose or underdose when changing concentrations or changing solutions in the pump reservoir, always rinse the reservoir twice between solutions to remove the drug that remains in the reservoir after emptying the pump. this remaining volume is known as the residual volume. the procedure for performing a reservoir rinse is outlined below. use the components of the appropriate refill kit to perform the rinse and follow the applicable empty and refill procedures for that kit. - empty the pump completely. - fill the pump with 10 ml of sterile preservative-free sodium chloride injection, usp. - empty the pump completely. - repeat steps 2 and 3. - fill the pump to capacity with the prescribed fluid. - program a bridge bolus. refer to the programming guide for the pump software. technical support   a toll-free technical support service is available 24 hours a day for clinicians managing patients with medtronic implantable infusion pumps. telephone customer service at: 1-800-707-0933. emergency procedures lioresal intrathecal (baclofen injection) overdose consult the patient's medical record or with the patient's physician to confirm the drug or drug concentration within the pump reservoir. symptoms drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, hypothermia, seizures, rostral progression of hypotonia, and loss of consciousness progressing to coma. there is no specific antidote for treating overdoses of intrathecal baclofen injection.   actions   see table 1. table 1. lioresal intrathecal (baclofen injection) overdose emergency procedures   maintain airway/breathing/circulation. intubation and respiratory support may be necessary. ↓ empty pump reservoir to stop drug flow. record amount withdrawn. ↓ ↓ ↓ if not contraindicated, withdraw 30 – 40 ml csf by lumbar puncture or through the catheter access port to reduce the concentration of baclofen in the csf. use only a 24-gauge or smaller, 1.5- or 2.0-inch (3.8- or 5.1-cm), needle for withdrawal from the catheter access port.a proceed immediately to the next step. ↓ ↓ notify patient's physician managing intrathecal baclofen injection therapy. ↓ continue to monitor closely for symptom recurrence. ↓ report incident to amneal a use a 24- or 25-gauge needle for withdrawal from a synchromed ii catheter access port. lioresal intrathecal (baclofen injection) underdose/ withdrawal   consult the patient's medical record or with the patient's physician to confirm the drug or drug concentration within the pump reservoir. symptoms of underdose pruritus without rash, hypotension, paresthesia, fever, and altered mental state. priapism may develop or recur if treatment with intrathecal baclofen is interrupted. symptoms of withdrawal exaggerated rebound spasticity and muscle rigidity, rhabdomyolysis, and multiple organ failure. the condition may resemble autonomic dysreflexia, infection (sepsis), malignant hyperthermia, and neuroleptic- malignant syndrome. actions see table 2. table 2. lioresal intrathecal (baclofen injection) underdose/withdrawal emergency procedures initiate life-sustaining measures if indicated. ↓ if a patient receiving intrathecal baclofen injection presents with the signs and symptoms suggestive of withdrawal, the following is consistent with that suggested by a panel of therapy-experienced clinicians convened to explore this issue. a,b - immediately contact a physician experienced in intrathecal baclofen injection, preferably the physician managing the therapy for the patient in question; follow the recommendations of this physician. this step is important even if the patient’s signs and symptoms seem mild. - if a physician experienced in intrathecal baclofen injection is unavailable, consider instituting one or more of the following options, unless otherwise contraindicated: - high-dose oral* or enteral baclofen - restoration of intrathecal baclofen injection infusion - intravenous benzodiazepines by continuous or intermittent infusion, titrating the dosage until the desired therapeutic effect is achieved * note: oral baclofen should not be relied upon as the sole treatment for intrathecal baclofen injection withdrawal syndrome. ↓ report incident to amneal a refer to the drug manufacturer’s package insert for a complete list of indications, contraindications, warnings, precautions, adverse events, and dosage and administration information. b coffey rj, edgar ts, francisco ge, et al. abrupt withdrawal from the intrathecal baclofen: recognition and management of a potentially life- threatening syndrome. arch phys med rehabil. 2002;83:735-741. emergency procedure to empty pump reservoir   equipment   - 22-gauge noncoring needle - 20-ml syringe - 3-way stopcock or extension set with clamp - antiseptic agent - assemble the needle, syringe, and stopcock or extension set. - locate the pump by palpation. the reservoir fill port is located in the center of the pump. if you have difficulty identifying the pump features, you may seek assistance from another clinician. if deemed necessary by the clinician, x-ray and fluoroscopy can be used to assist in locating or determining the orientation of the pump. 3. prepare the injection site by cleansing the area using an antiseptic agent. 4. gently insert the 22-gauge noncoring needle into the center of the reservoir fill port until the needle touches the bottom of the reservoir fill port (figure 6). during proper needle insertion, you will feel the needle: - pass through the patient's skin and subcutaneous tissue, - hit the silicone septum, (scar tissue, if present, can feel similar to the septum.) (scar tissue, if present, can feel similar to the septum.) - pass through the septum, and - hit the metal bottom of the reservoir fill port. (the top of the pump is metal and hitting the top of the pump can feel similar to hitting the bottom of the reservoir fill port.) if excessive resistance is encountered during needle insertion, reassess placement. do not force the needle. the feel of abnormal resistance during the procedure may be an indication that the needle is not in the center of the reservoir fill port. figure 6. view inside of a synchromed programmable pump while the needle is fully and properly inserted. 5. open the clamp or stopcock and slowly withdraw the fluid from the reservoir into the empty syringe. 6. depending on pump reservoir volume, more than one syringe may be needed to empty the pump. close the clamp or stopcock when changing syringes. 7. completely empty the pump. when the pump is empty, the bubbles will stop forming, and negative pressure in the syringe can be felt. 8. remove the needle from the reservoir fill port. 9. record in patient chart the amount of fluid emptied from the pump reservoir. special notice the amneal model 856x refill kit is designed to be used for refilling medtronic implantable programmable infusion pumps with the exception of medtronic minimed infusion pumps. amneal cannot warrant or guarantee the refill kit because, despite the exercise of all due care in design, component selection, manufacture, and testing prior to sale, the components of the refill kit may be easily damaged before or during use by improper handling or other intervening acts. amneal model 856x refill kit limited warranty1 a. this limited warranty provides the following assurance to the purchaser of the amneal model 856x packaged herein, hereafter referred to as the “product”: - should the product fail to function within normal tolerances due to a defect in materials or workmanship prior to its "use by" date, amneal will at its option: (a) issue a credit to the purchaser equal to the purchase price, as defined in subsection a(2), against the purchase of the replacement product or provide a functionally comparable replacement product at no charge. - as used herein, purchase price shall mean the lesser of the net invoiced price of the original, or current functionally comparable, or replacement product. b. to qualify for the limited warranty set forth in section a(1), the following conditions must be met: - the product must be used prior to its "use by" date. - the unused portion of the product must be returned to amneal within thirty (30) days after discovery of the defect and shall be the property of amneal. - the product must not have been altered or subjected to misuse, abuse or accident. - the product must be used in accordance with the labeling and instructions for use provided with the product. c. this limited warranty is limited to its express terms. in particular: - except as expressly provided by this limited warranty, amneal is not responsible for any direct, incidental or consequential damages based on any defect, failure or malfunction of the product, whether the claim is based on warranty, contract, tort or otherwise. - this limited warranty is made only to the purchaser who uses the product. as to all others, amneal makes no warranty, express or implied, including, but not limited to, any implied warranty of merchantability or fitness for a particular purposewhether arising from statute, common law, custom or otherwise. no express or impliedwarranty to the patient shall extend beyond the period specified in a(1) above. this limitedwarranty shall be the exclusive remedy available to any person. - the exclusions and limitations set out above are not intended to, and should not be construed so as to contravene mandatory provisions of applicable law. if any part or term of this limited warranty is held to be illegal, unenforceable or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of the limited warranty shall not be affected, and all rights and obligations shall be construed and enforced as if this limited warranty did not contain the particular part or term held to be invalid. this limited warranty gives the patient specific legal rights. the patient may also have other rights which vary from state to state. - no person has any authority to bind amneal to any representation, condition or warranty except this limited warranty. 1 this limited warranty is provided by amneal. it applies only in the united states. medtronic® , isomed® , synchromed® , and medtronic logo are trademarks of medtronic. minimed® is a registered trademark of medtronic minimed, inc. lioresal® is a registered trademark of amneal amneal pharmaceuticals llc bridgewater, nj  08807 rev. 03-2023-00

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals llc - temazepam (unii: chb1qd2qss) (temazepam - unii:chb1qd2qss) - temazepam 7.5 mg - temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). for patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). the clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. temazepam capsules contain temazepam, a schedule iv controlled substance. temazepam is a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - temazepam (unii: chb1qd2qss) (temazepam - unii:chb1qd2qss) - temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). for patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). the clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. temazepam capsules contain temazepam, a schedule iv controlled substance. temazepam is a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. abuse and misuse of benzodiazepines may lead to addiction. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see warnings, abuse, misuse, and addiction ). the following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. the following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. death is more often associated with polysubstance use (especially benzodiazepines with other cns depressants such as opioids and alcohol). physical dependence temazepam may produce physical dependence from continued therapy. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see warnings, dependence and withdrawal reactions ). to reduce the risk of withdrawal reactions, use a gradual taper to discontinue temazepam or reduce the dosage (see dosage and administration, discontinuation or dosage reduction of temazepam and warnings, dependence and withdrawal reactions ). acute withdrawal signs and symptoms acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. more severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality. protracted withdrawal syndrome protracted withdrawal syndrome with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. protracted withdrawal symptoms may last weeks to more than 12 months. as a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. tolerance tolerance to temazepam may develop from continued therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). tolerance to the therapeutic effect of temazepam may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 20 mg - morphine sulfate extended-release capsules are indicated for the management of severe and persistent pain, that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. limitations of use: - because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-release opioid formulations/long-acting opioid formulations, [see warnings and precautions (5.1)], reserve morphine sulfate extended-release capsules for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - morphine sulfate extended-release capsules are not indicated as an as-needed (prn) analgesic. morphine sulfate extended-release capsules are contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.2)] -   acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.7)] -   concurrent use of monoamine oxidase inhibitors (maois) or use of maois within the last 14 days [see warnings and precautions (5.8),  drug interactions (7)] -   known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings and precautions (5.12)] -   hypersensitivity (e.g., anaphylaxis) to morphine [see adverse reactions (6.2)] risk summary use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.4)]. there are no available data with morphine sulfate extended-release capsules in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. published studies with morphine use during pregnancy have not reported a clear association with morphine and major birth defects [see human data] . in published animal reproduction studies, morphine administered subcutaneously during the early gestational period produced neural tube defects (i.e., exencephaly and cranioschisis) at 5 and 16 times the human daily dose of 60 mg based on body surface area (hdd) in hamsters and mice, respectively, lower fetal body weight and increased incidence of abortion at 0.4 times the hdd in the rabbit, growth retardation at 6 times the hdd in the rat, and axial skeletal fusion and cryptorchidism at 16 times the hdd in the mouse. administration of morphine sulfate to pregnant rats during organogenesis and through lactation resulted in cyanosis, hypothermia, decreased brain weights, pup mortality, decreased pup body weights, and adverse effects on reproductive tissues at 3 to 4 times the hdd; and long-term neurochemical changes in the brain of offspring which correlate with altered behavioral responses that persist through adulthood at exposures comparable to and less than the hdd [see animal data] . based on animal data, advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. the onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see warnings and precautions (5.4)]. labor or delivery opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. an opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. morphine sulfate extended-release capsules are not recommended for use in pregnant women during or immediately prior to labor, when use of shorter-acting analgesics or other analgesic techniques are more appropriate. opioid analgesics, including morphine sulfate extended-release capsules, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. however, this effect is not consistent and may be offset by an increased rate of cervical dilation, which tends to shorten labor. monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. data human data the results from a population-based prospective cohort, including 70 women exposed to morphine during the first trimester of pregnancy and 448 women exposed to morphine at any time during pregnancy, indicate no increased risk for congenital malformations. however, these studies cannot definitely establish the absence of any risk because of methodological limitations, including small sample size and non-randomized study design. animal data formal reproductive and developmental toxicology studies for morphine have not been conducted. exposure margins for the following published study reports are based on human daily dose of 60 mg morphine using a body surface area comparison (hdd). neural tube defects (exencephaly and cranioschisis) were noted following subcutaneous administration of morphine sulfate (35 to 322 mg/kg) on gestation day 8 to pregnant hamsters (4.7 to 43.5 times the hdd). a no adverse effect level was not defined in this study and the findings cannot be clearly attributed to maternal toxicity. neural tube defects (exencephaly), axial skeletal fusions, and cryptorchidism were reported following a single subcutaneous (sc) injection of morphine sulfate to pregnant mice (100 to 500 mg/kg) on gestation day 8 or 9 at 200 mg/kg or greater (16 times the hdd) and fetal resorption at 400 mg/kg or higher (32 times the hdd). no adverse effects were noted following 100 mg/kg morphine in this model (8 times the hdd). in one study, following continuous subcutaneous infusion of doses greater than or equal to 2.72 mg/kg to mice (0.2 times the hdd), exencephaly, hydronephrosis, intestinal hemorrhage, split supraoccipital, malformed sternebrae, and malformed xiphoid were noted. the effects were reduced with increasing daily dose; possibly due to rapid induction of tolerance under these infusion conditions. the clinical significance of this report is not clear. decreased fetal weights were observed in pregnant rats treated with 20 mg/kg/day morphine sulfate (3.2 times the hdd) from gestation day 7 to 9. there was no evidence of malformations despite maternal toxicity (10% mortality). in a second rat study, decreased fetal weight and increased incidences of growth retardation were noted at 35 mg/kg/day (5.7 times the hdd) and there was a reduced number of fetuses at 70 mg/kg/day (11.4 times the hdd) when pregnant rats were treated with 10, 35, or 70 mg/kg/day morphine sulfate via continuous infusion from gestation day 5 to 20. there was no evidence of fetal malformations or maternal toxicity. an increased incidence of abortion was noted in a study in which pregnant rabbits were treated with 2.5 (0.8 times the hdd) to 10 mg/kg morphine sulfate via subcutaneous injection from gestation day 6 to 10. in a second study, decreased fetal body weights were reported following treatment of pregnant rabbits with increasing doses of morphine (10 to 50 mg/kg/day) during the pre-mating period and 50 mg/kg/day (16 times the hdd) throughout the gestation period. no overt malformations were reported in either publication; although only limited endpoints were evaluated. in published studies in rats, exposure to morphine during gestation and/or lactation periods is associated with: decreased pup viability at 12.5 mg/kg/day or greater (2 times the hdd); decreased pup body weights at 15 mg/kg/day or greater (2.4 times the hdd); decreased litter size, decreased absolute brain and cerebellar weights, cyanosis, and hypothermia at 20 mg/kg/day (3.2 times the hdd); alteration of behavioral responses (play, social-interaction) at 1 mg/kg/day or greater (0.2 times the hdd); alteration of maternal behaviors (e.g., decreased nursing and pup retrievals) in mice at 1 mg/kg or higher (0.08 times the hdd) and rats at 1.5 mg/kg/day or higher (0.2 times the hdd); and a host of behavioral abnormalities in the offspring of rats, including altered responsiveness to opioids at 4 mg/kg/day (0.7 times the hdd) or greater. fetal and/or postnatal exposure to morphine in mice and rats has been shown to result in morphological changes in fetal and neonatal brain and neuronal cell loss, alteration of a number of neurotransmitter and neuromodulator systems, including opioid and non-opioid systems, and impairment in various learning and memory tests that appear to persist into adulthood. these studies were conducted with morphine treatment usually in the range of 4 to 20 mg/kg/day (0.7 to 3.2 times the hdd). additionally, delayed sexual maturation and decreased sexual behaviors in female offspring at 20 mg/kg/day (3.2 times the hdd), and decreased plasma and testicular levels of luteinizing hormone and testosterone, decreased testes weights, seminiferous tubule shrinkage, germinal cell aplasia, and decreased spermatogenesis in male offspring were also observed at 20 mg/kg/day (3.2 times the hdd). decreased litter size and viability were observed in the offspring of male rats that were intraperitoneally administered morphine sulfate for 1 day prior to mating at 25 mg/kg/day (4.1 times the hdd) and mated to untreated females. decreased viability and body weight and/or movement deficits in both first and second generation offspring were reported when male mice were treated for 5 days with escalating doses of 120 to 240 mg/kg/day morphine sulfate (9.7 to 19.5 times the hdd) or when female mice treated with escalating doses of 60 to 240 mg/kg/day (4.9 to 19.5 times the hdd) followed by a 5-day treatment-free recovery period prior to mating. similar multigenerational findings were also seen in female rats pre-gestationally treated with escalating doses of 10 to 22 mg/kg/day morphine (1.6 to 3.6 times the hdd). risk summary morphine is present in breast milk. published lactation studies report variable concentrations of morphine in breast milk with administration of immediate-release morphine to nursing mothers in the early postpartum period with a milk-to-plasma morphine auc ratio of 2.5:1 measured in one lactation study. however, there is insufficient information to determine the effects of morphine on the breastfed infant and the effects of morphine on milk production. lactation studies have not been conducted with extended–release morphine, including morphine sulfate extended-release capsules. because of the potential for serious adverse reactions, including excess sedation and respiratory depression in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with morphine sulfate extended-release capsules. clinical considerations monitor infants exposed to morphine sulfate extended-release capsules through breast milk for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of morphine is stopped, or when breastfeeding is stopped. infertility use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible [see adverse reactions (6.2), clinical pharmacology (12.2)]. in published animal studies, morphine administration adversely effected fertility and reproductive endpoints in male rats and prolonged estrus cycle in female rats [see nonclinical toxicology (13)] . the safety and efficacy of morphine sulfate extended-release capsules in patients less than 18 years have not been established. clinical studies of morphine sulfate extended-release capsules did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. elderly patients (aged 65 years or older) may have increased sensitivity to morphine. in general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy. respiratory depression is the chief risk for elderly patients treated with opioids, and has occurred after large initial doses were administered to patients who were not opioid-tolerant or when opioids were co-administered with other agents that depress respiration. titrate the dosage of morphine sulfate extended-release capsules slowly in geriatric patients and frequently reevaluate the patient for signs of central nervous system and respiratory depression [see warnings and precautions (5.7)] . this drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to regularly evaluate renal function. morphine pharmacokinetics have been reported to be significantly altered in patients with cirrhosis. start these patients with a lower than usual dosage of morphine sulfate extended-release capsules and titrate slowly while regularly evaluate for signs of respiratory depression, sedation, and hypotension [see clinical pharmacology (12.3)]. morphine pharmacokinetics are altered in patients with renal failure. start these patients with a lower than usual dosage of morphine sulfate extended-release capsules and titrate slowly while regularly evaluate for signs of respiratory depression, sedation, and hypotension [see clinical pharmacology (12.3)]. morphine sulfate extended-release capsules contain morphine, a schedule ii controlled substance. morphine sulfate extended-release capsules contains morphine, a substance with high potential for misuse and abuse, which can lead to the development of substance use disorder, including addiction [see warnings and precautions (5.1)] . misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. misuse and abuse of morphine sulfate extended-release capsules increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death. the risk is increased with concurrent abuse of morphine sulfate extended-release capsules with alcohol and other cns depressants. abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. in addition, abuse of opioids can occur in the absence of addiction. all patients treated with opioids require careful and frequent reevaluation for signs of misuse, abuse, and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use. patients at high risk of morphine sulfate extended-release capsules abuse include those with a history of prolonged use of any opioid, including products containing morphine, those with a history of drug or alcohol abuse, or those who use morphine sulfate extended-release capsules in combination with other abused drugs. “drug-seeking” behavior is very common in persons with substance use disorders. drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among people who abuse drugs and people with substance use disorder. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with inadequate pain control. morphine sulfate extended-release capsules, like other opioids, can be diverted for nonmedical use into illicit channels of distribution. careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised. proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs. risks specific to abuse of morphine sulfate extended-release capsules abuse of morphine sulfate extended-release capsules poses a risk of overdose and death. this risk is increased with concurrent use of morphine sulfate extended-release capsules with alcohol and/or other cns depressants. taking cut, broken chewed, crushed, or dissolved morphine sulfate extended-release capsules enhances drug release and increases the risk of overdose and death. morphine sulfate extended-release capsules are approved for oral use only. inappropriate intravenous, intramuscular, or subcutaneous use of morphine sulfate extended-release capsules can result in death, local tissue necrosis, infection, pulmonary granulomas, increased risk of endocarditis, and valvular heart injury, and embolism. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during use of opioid therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). physical dependence is a state that develops as a result of a physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. withdrawal may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). physical dependence may not occur to a clinically significant degree until after several days to weeks of continued use. do not abruptly discontinue morphine sulfate extended-release capsules in a patient physically dependent on opioids. rapid tapering of morphine sulfate extended-release capsules in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. when discontinuing morphine sulfate extended-release capsules, gradually taper the dosage using a patient-specific plan that considers the following: the dose of morphine sulfate extended-release capsules the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. to improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. in patients taking opioids for an extended period of time at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see dosage and administration (2.5), and warnings and precautions (5.15)] . infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see use in specific populations (8.1)] . morphine sulfate (mor’ feen sul’ fate) extended-release capsules, usp, cii if you cannot swallow morphine sulfate extended-release capsules, tell your healthcare provider. there may be another way to take morphine sulfate extended-release capsules that may be right for you. if your healthcare provider tells you that you can take morphine sulfate extended-release capsules using this other way, follow these steps: morphine sulfate extended-release capsules can be opened and the pellets inside the capsule can be sprinkled over applesauce, as follows: figure 1 - open the morphine sulfate extended-release capsule and sprinkle the pellets over about one tablespoon of applesauce. (see figure 1) figure 2 - swallow all of the applesauce and pellets right away. do not save any of the applesauce and pellets for another dose. (see figure 2) figure 3 - rinse your mouth to make sure you have swallowed all of the pellets. do not chew the pellets. (see figure 3) figure 4 - flush the empty capsule down the toilet right away. (see figure 4) you should not receive morphine sulfate extended-release capsules through a nasogastric tube. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: amneal pharmaceuticals of ny, llc brookhaven, ny 11719 distributed by: amneal pharmaceuticals llc bridgewater, nj 08807 rev. 12-2021-03 dispense with medication guide available at: documents.amneal.com/mg/morphine-sulfate-er-cap.pdf

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amneal pharmaceuticals of new york llc - acebutolol hydrochloride (unii: b025y34c54) (acebutolol - unii:67p356d8gh) - hypertension acebutolol hcl capsules are indicated for the management of hypertension in adults. it may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. ventricular arrhythmias acebutolol hcl capsules are indicated in the management of ventricular premature beats; it reduces the total number of premature beats, as well as the number of paired and multiform ventricular ectopic beats, and r-on-t beats. acebutolol hcl is contraindicated in: 1) persistently severe bradycardia; 2) second- and third-degree heart block; 3) overt cardiac failure; and 4) cardiogenic shock (see warnings ).

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amneal pharmaceuticals llc - carboprost tromethamine (unii: u4526f86fj) (carboprost - unii:7b5032xt6o) - carboprost tromethamine injection is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: 1.   failure of expulsion of the fetus during the course of treatment by another method; 2.   premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; 3.   requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; 4.   inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. carboprost tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations. studies have shown that in such cases, the use of carboprost tromethamine injection has resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome. in a high proportion of cases, carboprost tromethamine injection used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention. 1.   hypersensitivity (including anaphylaxis and angioedema) to carboprost tromethamine injection [see adverse reactions, post-marketing experience ]. 2.   acute pelvic inflammatory disease. 3.   patients with active cardiac, pulmonary, renal or hepatic disease. warnings carboprost tromethamine, like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. carboprost tromethamine should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities. carboprost tromethamine does not appear to directly affect the fetoplacental unit. therefore, the possibility does exist that the previable fetus aborted by carboprost tromethamine could exhibit transient life signs. carboprost tromethamine is not indicated if the fetus in utero has reached the stage of viability. carboprost tromethamine should not be considered a feticidal agent. evidence from animal studies has suggested that certain other prostaglandins have some teratogenic potential. although these studies do not indicate that carboprost tromethamine is teratogenic, any pregnancy termination with carboprost tromethamine that fails should be completed by some other means. this product contains benzyl alcohol. benzyl alcohol has been reported to be associated with a fatal "gasping syndrome" in premature infants.

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amneal pharmaceuticals llc - ranitidine hydrochloride (unii: bk76465ihm) (ranitidine - unii:884kt10yb7) - ranitidine 150 mg - ranitidine tablets are indicated in: 1.   short-term treatment of active duodenal ulcer. most patients heal within 4 weeks. studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. 2.   maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. no placebo-controlled comparative studies have been carried out for periods of longer than 1 year. 3.   the treatment of pathological hypersecretory conditions (e.g., zollinger-ellison syndrome and systemic mastocytosis). 4.   short-term treatment of active, benign gastric ulcer. most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks. 5.   maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. placebo-controlled studies have been carried out for 1 year. 6.   treatment of gerd. symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine tablets 150 mg twice daily. 7.   treatment of endoscopically diagnosed erosive esophagitis. symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine tablets 150 mg 4 times daily. 8.   maintenance of healing of erosive esophagitis. placebo-controlled trials have been carried out for 48 weeks. concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; gerd; and erosive esophagitis. ranitidine tablets are contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see precautions ).

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amneal pharmaceuticals llc - furosemide (unii: 7lxu5n7zo5) (furosemide - unii:7lxu5n7zo5) - parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. edema: furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver and renal disease, including the nephrotic syndrome. furosemide is particularly useful when an agent with greater diuretic potential is desired. furosemide is indicated as adjunctive therapy in acute pulmonary edema. the intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. if gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. parenteral use should be replaced with oral furosemide as soon as practical. furosemide is contraindicated in patients with anuria and in patients with a history of hypersensitivity to furosemide.