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 of new york llc - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 25 mg - adjunctive therapy lamotrigine orally disintegrating tablets are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial-onset seizures partial-onset seizures - primary generalized tonic-clonic (pgtc) seizures primary generalized tonic-clonic (pgtc) seizures - generalized seizures of lennox-gastaut syndrome generalized seizures of lennox-gastaut syndrome monotherapy lamotrigine orally disintegrating tablets are indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (aed). safety and effectiveness of lamotrigine have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from aeds other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant aeds. lamotrigine orally disintegrating tablets are indicated for the maintenance treatment of bipolar i disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy [see clinical studies (14.1)] . limitations of use treatment of acute manic or mixed episodes is not recommended. effectiveness of lamotrigine in the acute treatment of mood episodes has not been established. lamotrigine orally disintegrating tablets are contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see boxed warning, warnings and precautions (5.1 , 5.2)] . as with other aeds, physiological changes during pregnancy may affect lamotrigine concentrations and/or therapeutic effect. there have been reports of decreased lamotrigine concentrations during pregnancy and restoration of pre-partum concentrations after delivery. dosage adjustments may be necessary to maintain clinical response.  pregnancy category c there are no adequate and well-controlled studies in pregnant women. in animal studies, lamotrigine was developmentally toxic at doses lower than those administered clinically. lamotrigine orally disintegrating tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. when lamotrigine was administered to pregnant mice, rats, or rabbits during the period of organogenesis (oral doses of up to 125, 25, and 30 mg/kg, respectively), reduced fetal body weight and increased incidences of fetal skeletal variations were seen in mice and rats at doses that were also maternally toxic. the no-effect doses for embryofetal developmental toxicity in mice, rats, and rabbits (75, 6.25, and 30 mg/kg, respectively) are similar to (mice and rabbits) or less than (rats) the human dose of 400 mg/day on a body surface area (mg/m2 ) basis. in a study in which pregnant rats were administered lamotrigine (oral doses of 5 or 25 mg/kg) during the period of organogenesis and offspring were evaluated postnatally, behavioral abnormalities were observed in exposed offspring at both doses. the lowest effect dose for developmental neurotoxicity in rats is less than the human dose of 400 mg/day on a mg/m2 basis. maternal toxicity was observed at the higher dose tested. when pregnant rats were administered lamotrigine (oral doses of 5, 10, or 20 mg/kg) during the latter part of gestation, increased offspring mortality (including stillbirths) was seen at all doses. the lowest effect dose for peri/postnatal developmental toxicity in rats is less than the human dose of 400 mg/day on a mg/m2 basis. maternal toxicity was observed at the 2 highest doses tested. lamotrigine decreases fetal folate concentrations in rat, an effect known to be associated with adverse pregnancy outcomes in animals and humans. pregnancy registry to provide information regarding the effects of in utero exposure to lamotrigine, physicians are advised to recommend that pregnant patients taking lamotrigine orally disintegrating tablets enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll-free number 1-888-233-2334 and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org. the effect of lamotrigine on labor and delivery in humans is unknown. lamotrigine is present in milk from lactating women taking lamotrigine. data from multiple small studies indicate that lamotrigine plasma levels in human milk-fed infants have been reported to be as high as 50% of the maternal serum levels. neonates and young infants are at risk for high serum levels because maternal serum and milk levels can rise to high levels postpartum if lamotrigine dosage has been increased during pregnancy but not later reduced to the pre-pregnancy dosage. lamotrigine exposure is further increased due to the immaturity of the infant glucuronidation capacity needed for drug clearance. events including apnea, drowsiness, and poor sucking have been reported in infants who have been human milk-fed by mothers using lamotrigine; whether or not these events were caused by lamotrigine is unknown. human milk-fed infants should be closely monitored for adverse events resulting from lamotrigine. measurement of infant serum levels should be performed to rule out toxicity if concerns arise. human milk-feeding should be discontinued in infants with lamotrigine toxicity. caution should be exercised when lamotrigine orally disintegrating tablets are administered to a nursing woman. epilepsy lamotrigine orally disintegrating tablets are indicated as adjunctive therapy in patients aged 2 years and older for partial-onset seizures, the generalized seizures of lennox-gastaut syndrome, and pgtc seizures. safety and efficacy of lamotrigine used as adjunctive treatment for partial-onset seizures were not demonstrated in a small, randomized, double-blind, placebo-controlled withdrawal trial in very young pediatric patients (aged 1 to 24 months). lamotrigine was associated with an increased risk for infectious adverse reactions (lamotrigine 37%, placebo 5%), and respiratory adverse reactions (lamotrigine 26%, placebo 5%). infectious adverse reactions included bronchiolitis, bronchitis, ear infection, eye infection, otitis externa, pharyngitis, urinary tract infection, and viral infection. respiratory adverse reactions included nasal congestion, cough, and apnea. additional information describing a clinical study in which efficacy was not demonstrated in pediatric patients ages 10 to 17 years is approved for glaxosmithkline llc’s lamictal® (lamotrigine) products. however, due to glaxosmithkline llc’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. juvenile animal data in a juvenile animal study in which lamotrigine (oral doses of 5, 15, or 30 mg/kg) was administered to young rats (postnatal days 7 to 62), decreased viability and growth were seen at the highest dose tested and long-term behavioral abnormalities (decreased locomotor activity, increased reactivity, and learning deficits in animals tested as adults) were observed at the 2 highest doses. the no-effect dose for adverse effects on neurobehavioral development is less than the human dose of 400 mg/day on a mg/m2 basis. clinical trials of lamotrigine for epilepsy and bipolar disorder did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients or exhibit a different safety profile than that of younger patients. in general, dose selection for an elderly patient should be cautious, 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. experience in patients with hepatic impairment is limited. based on a clinical pharmacology study in 24 patients with mild, moderate, and severe liver impairment [see clinical pharmacology (12.3)] , the following general recommendations can be made. no dosage adjustment is needed in patients with mild liver impairment. initial, escalation, and maintenance doses should generally be reduced by approximately 25% in patients with moderate and severe liver impairment without ascites and 50% in patients with severe liver impairment with ascites. escalation and maintenance doses may be adjusted according to clinical response [see dosage and administration (2.1)] . lamotrigine is metabolized mainly by glucuronic acid conjugation, with the majority of the metabolites being recovered in the urine. in a small study comparing a single dose of lamotrigine in subjects with varying degrees of renal impairment with healthy volunteers, the plasma half-life of lamotrigine was approximately twice as long in the subjects with chronic renal failure [see clinical pharmacology (12.3)] . initial doses of lamotrigine orally disintegrating tablets should be based on patients’ aed regimens; reduced maintenance doses may be effective for patients with significant renal impairment. few patients with severe renal impairment have been evaluated during chronic treatment with lamotrigine. because there is inadequate experience in this population, lamotrigine orally disintegrating tablets should be used with caution in these patients [see dosage and administration (2.1)] .

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

amneal pharmaceuticals ny llc - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil for oral suspension is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see clinical studies (14.1)] , heart [see clinical studies (14.2)]  or liver transplants [see clinical studies (14.3)] , in combination with other immunosuppressants.  allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil for oral suspension is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (mmf), mycophenolic acid (mpa) or any component of the drug product.  pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. to report a pregnancy or obtain information about the registry, visit www.mycophenolaterems.com or call 1-800-­617-8191.  risk summary  use of mycophenolate mofetil (mmf) during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems [see human data] . oral administration of mycophenolate to rats and rabbits during the period of organogenesis produced congenital malformations and pregnancy loss at doses less than the recommended clinical dose (0.01 to 0.05 times the recommended clinical doses in kidney and heart transplant patients) [see animal data] .  consider alternative immunosuppressants with less potential for embryofetal toxicity. risks and benefits of mycophenolate mofetil should be discussed with the pregnant woman.  the estimated background risk of pregnancy loss and congenital malformations in organ transplant populations is not clear. 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.  data  a spectrum of congenital malformations (including multiple malformations in individual newborns) has been reported in 23% to 27% of live births in mmf exposed pregnancies, based on published data from pregnancy registries. malformations that have been documented include external ear, eye, and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system.  based on published data from pregnancy registries, the risk of first trimester pregnancy loss has been reported at 45% to 49% following mmf exposure.  in animal reproductive toxicology studies, there were increased rates of fetal resorptions and malformations in the absence of maternal toxicity. oral administration of mmf to pregnant rats from gestational day 7 to day 16 produced increased embryofetal lethality and fetal malformations including anophthalmia, agnathia, and hydrocephaly at doses equivalent to 0.015 and 0.01 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for bsa. oral administration of mmf to pregnant rabbits from gestational day 7 to day 19 produced increased embryofetal lethality and fetal malformations included ectopia cordis, ectopic kidneys, diaphragmatic hernia, and umbilical hernia at dose equivalents as low as 0.05 and 0.03 times the recommended human doses for renal and cardiac transplant patients, respectively, when corrected for bsa.  risk summary  there are no data on the presence of mycophenolate in human milk, or the effects on milk production. there are limited data in the national transplantation pregnancy registry on the effects of mycophenolate on a breastfed child [see data] . studies in rats treated with mmf have shown mycophenolic acid (mpa) to be present in milk. because available data are limited, it is not possible to exclude potential risks to a breastfeeding infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for mycophenolate mofetil and any potential adverse effects on the breastfed infant from mycophenolate mofetil or from the underlying maternal condition.  limited information is available from the national transplantation pregnancy registry. of seven infants reported by the national transplantation pregnancy registry to have been breastfed while the mother was taking mycophenolate, all were born at 34 to 40 weeks gestation, and breastfed for up to 14 months. no adverse events were reported.  females of reproductive potential must be made aware of the increased risk of first trimester pregnancy loss and congenital malformations and must be counseled regarding pregnancy prevention and planning.  pregnancy planning  for patients who are considering pregnancy, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible. risks and benefits of mycophenolate mofetil should be discussed with the patient.  pregnancy testing  to prevent unplanned exposure during pregnancy, all females of reproductive potential should have a serum or urine pregnancy test with a sensitivity of at least 25 miu/ml immediately before starting mycophenolate mofetil. another pregnancy test with the same sensitivity should be done 8 to 10 days later. repeat pregnancy tests should be performed during routine follow-up visits. results of all pregnancy tests should be discussed with the patient. in the event of a positive pregnancy test, consider alternative immunosuppressants with less potential for embryofetal toxicity whenever possible.  contraception  female patients  females of reproductive potential taking mycophenolate mofetil must receive contraceptive counseling and use acceptable contraception (see table 9  for acceptable contraception methods). patients must use acceptable birth control during the entire mycophenolate mofetil therapy, and for 6 weeks after stopping mycophenolate mofetil, unless the patient chooses abstinence.  patients should be aware that mycophenolate mofetil reduces blood levels of the hormones from the oral contraceptive pill and could theoretically reduce its effectiveness [see drug interactions (7.2)] .  table 9 acceptable contraception methods for females of reproductive potential pick from the following birth control options: option 1 methods to use alone - intrauterine devices (iuds) - tubal sterilization - patient’s partner vasectomy or option 2 hormone methods choose 1 barrier methods choose 1 choose one hormone method  and  one barrier method estrogen and progesterone - oral contraceptive pill - transdermal patch - vaginal ring progesterone-only - injection - implant and - diaphragm with spermicide - cervical cap with spermicide - contraceptive sponge - male condom - female condom or option 3 barrier methods choose 1 barrier methods choose 1 choose one barrier method from each column  (must choose two methods) - diaphragm with spermicide - cervical cap with spermicide - contraceptive sponge and - male condom - female condom male patients  genotoxic effects have been observed in animal studies at exposures exceeding the human therapeutic exposures by approximately 1.25 times. thus, the risk of genotoxic effects on sperm cells cannot be excluded. based on this potential risk, sexually active male patients and/or their female partners are recommended to use effective contraception during treatment of the male patient and for at least 90 days after cessation of treatment. also, based on the potential risk of genotoxic effects, male patients should not donate sperm during treatment with mycophenolate mofetil and for at least 90 days after cessation of treatment [see use in special populations (8.1), nonclinical toxicology (13.1), patient counseling information (17.9)] .  safety and effectiveness have been established in pediatric patients 3 months and older for the prophylaxis of organ rejection of allogeneic kidney, heart or liver transplants. kidney transplant use of mycophenolate mofetil in this population is supported by evidence from adequate and well-controlled studies of mycophenolate mofetil in adults with additional data from one open-label, pharmacokinetic and safety study of mycophenolate mofetil in pediatric patients after receiving allogeneic kidney transplant (100 patients, 3 months to 18 years of age) [see dosage and administration (2.2), adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1)] .  heart transplant and liver transplant use of mycophenolate mofetil in pediatric heart transplant and liver transplant patients is supported by adequate and well- controlled studies and pharmacokinetic data in adult heart transplant and liver transplant patients. additional supportive data include pharmacokinetic data in pediatric kidney transplant and pediatric liver transplant patients (8 liver transplant patients, 9 months to 5 years of age, in an open-label, pharmacokinetic and safety study) and published evidence of clinical efficacy and safety in pediatric heart transplant and pediatric liver transplant patients [ see dosage and administration (2.3, 2.4), adverse reactions (6.1), clinical pharmacology (12.3), clinical studies (14.1)] . clinical studies of mycophenolate mofetil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between geriatric and younger patients. in general, dose selection for a geriatric patient should take into consideration the presence of decreased hepatic, renal or cardiac function and of concomitant drug therapies [see adverse reactions (6.1), drug interactions (7)] . patients with kidney transplant  no dosage adjustments are needed in kidney transplant patients experiencing delayed graft function postoperatively but patients should be carefully monitored [see clinical pharmacology (12.3)] . in kidney transplant patients with severe chronic impairment of the graft  (gfr <25 ml/min/1.73 m2 ), no dose adjustments are necessary; however, doses greater than 1 g administered twice a day should be avoided.  patients with heart and liver transplant  no data are available for heart or liver transplant patients with severe chronic renal impairment. mycophenolate mofetil may be used for heart or liver transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks.  patients with kidney transplant  no dosage adjustments are recommended for kidney transplant patients with severe hepatic parenchymal disease. however, it is not known whether dosage adjustments are needed for hepatic disease with other etiologies [see clinical pharmacology (12.3)] .  patients with heart transplant  no data are available for heart transplant patients with severe hepatic parenchymal disease.  mycophenolate mofetil (mye " koe fen ' oh late moe ' fe til) for oral suspension, usp read this instructions for use before you take or give mycophenolate mofetil for oral suspension for the first time and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or treatment. important: - always use the oral dispenser provided with mycophenolate mofetil for oral suspension to make sure you measure the right amount of medicine. if your mycophenolate mofetil for oral suspension does not come with the oral dispenser, contact your pharmacist. - call your pharmacist if your oral dispenser is lost or damaged. - your pharmacist will write the expiration date on your mycophenolate mofetil for oral suspension bottle label. do not use after the expiration date. - ask your doctor or pharmacist if you have any questions or are unsure about how to take or give the right amount of medicine. - the mycophenolate mofetil for oral suspension should not be mixed with any type of liquids before taking or giving the dose. - do not let the mycophenolate mofetil for oral suspension come in contact with the skin. if this happens, wash the skin well with soap and water. if the mycophenolate mofetil for oral suspension gets in the eyes, rinse the eyes with plain water. - if you spill any mycophenolate mofetil for oral suspension, wipe it up using paper towels wet with water. put the child-resistant bottle cap back on the bottle and wipe the outside of the bottle with wet paper towels. supplies needed to take or give a dose of mycophenolate mofetil for oral suspension : to take or give a dose of mycophenolate mofetil for oral suspension, you will need the bottle of medicine and the oral dispenser provided with the medicine (see figure 1 ). your pharmacist will insert the bottle adapter in the mycophenolate mofetil for oral suspension bottle. do not remove the bottle adapter from the bottle. taking or giving a dose of mycophenolate mofetil for oral suspension: step 1:   with the child-resistant cap on the bottle, shake the bottle well for about 5 seconds before each use. step 2:   open the bottle by firmly pressing down on the child-resistant bottle cap and turning it to the left (counter-clockwise). do not throw away the child-resistant bottle cap. step 3:   place the bottle on a flat surface. before inserting the tip of the oral dispenser into the bottle adapter, push the plunger completely down toward the tip of the oral dispenser. use 1 hand to hold the bottle upright. insert the oral dispenser tip firmly into the opening of the bottle adapter. step 4:   carefully turn the bottle upside down with the oral dispenser tip in place. slowly pull the plunger down to withdraw your prescribed dose. do not pull the plunger out of the oral dispenser (see figure 2 ). step 5:   leave the oral dispenser tip in the bottle and turn the bottle to an upright position. slowly remove the oral dispenser tip from the bottle.                if there are air bubbles in the oral dispenser or if you have withdrawn the wrong dose, insert the oral dispenser tip back into the bottle adapter while the bottle is in an upright position. push the plunger gently all the way up so the mycophenolate mofetil for oral suspension flows back into the bottle. repeat step 4 . step 6:   place the tip of the oral dispenser in the mouth directed towards the cheek and slowly push the plunger down until the oral dispenser is empty. step 7:   put the child-resistant bottle cap back on the bottle and turn the cap to the right (clockwise) to close the bottle. keep the bottle tightly closed after each use. step 8:   rinse the oral dispenser under running tap water after each use: - remove the plunger from the oral dispenser. - rinse the oral dispenser and plunger with water only and let them air dry on a paper towel. - when the oral dispenser and plunger are dry, put the plunger back in the oral dispenser for the next use. do not throw away the oral dispenser. store the oral dispenser in a clean, dry place. - do not boil the oral dispenser. do not use solvent-containing wipes to clean the oral dispenser. do not use cloths or wipes to dry the oral dispenser. how should i store mycophenolate mofetil for oral suspension? - store the mycophenolate mofetil for oral suspension at room temperature between 59°f to 86°f (15°c to 30°c), for up to 60 days. you can also store mycophenolate mofetil for oral suspension in the refrigerator between 36°f to 46°f (2°c to 8°c). - do not freeze. keep mycophenolate mofetil for oral suspension and all medicines out of the reach of children. this instructions for use has been approved by the u.s. food and drug administration. distributed by:  amneal pharmaceuticals llc bridgewater, nj  08807 rev. 12-2022-04

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

amneal pharmaceuticals llc - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 50 mg - tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: - have not been tolerated or are not expected to be tolerated. - have not provided adequate analgesia or are not expected to provide adequate analgesia. tramadol hydrochloride is contraindicated for: - all children younger than 12 years of age [see warnings and precautions (5.4)] . - postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see warnings and precautions (5.4)] . tramadol hydrochloride is also contraindicated in patients with: - significant respiratory depression [see warnings and precautio

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

amneal pharmaceuticals llc - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen 250 mg - naproxen tablets are indicated for: the relief of the signs and symptoms of: - rheumatoid arthritis - osteoarthritis - ankylosing spondylitis - polyarticular juvenile idiopathic arthritis - tendonitis - bursitis - acute gout the management of: - pain - primary dysmenorrhea naproxen tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [see warnings and precautions (5.7, 5.9)] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8)] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)] r isk summary use of nsaids, including naproxen, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in

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

amneal pharmaceuticals llc - alprazolam (unii: yu55mq3izy) (alprazolam - unii:yu55mq3izy) - alprazolam 0.5 mg - alprazolam extended-release tablets are indicated for the treatment of panic disorder with or without agoraphobia, in adults. alprazolam extended-release tablets are contraindicated in patients: - with known hypersensitivity to alprazolam or other benzodiazepines. angioedema has been reported [see adverse reactions (6.2)]. - taking strong cytochrome p450 3a (cyp3a) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see dosage and administration (2.5), warnings and precautions (5.5), drug interactions (7.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including alprazolam extended-release tablets during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychiatric medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/. risk summary neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see warnings and precautions (5.8), and clinical considerations)]. available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see data). the 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 risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions benzodiazepines cross the placenta and may produce respiratory depression, hypotonia, and sedation in neonates. monitor neonates exposed to alprazolam extended-release tablets during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems. monitor neonates exposed to alprazolam extended-release tablets during pregnancy for signs of withdrawal. manage these neonates accordingly [see warnings and precautions (5.8)]. data human data published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects. although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. in addition, the majority of recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco, and other medications, have not confirmed these findings. risk summary limited data from published literature reports the presence of alprazolam in human breast milk. there are reports of sedation, poor feeding and poor weight gain in infants exposed to benzodiazepines through breast milk. the effects of alprazolam on lactation are unknown. because of the potential for serious adverse reactions, including sedation and withdrawal symptoms in breastfed infants, advise patients that breastfeeding is not recommended during treatment with alprazolam extended-release tablets. safety and effectiveness of alprazolam extended-release tablets have not been established in pediatric patients. alprazolam extended-release tablets-treated geriatric patients had higher plasma concentrations of alprazolam (due to reduced clearance) compared to younger adults receiving the same doses. therefore, dosage reduction of alprazolam extended-release tablets is recommended in geriatric patients [see dosage and administration (2.3) and clinical pharmacology (12.3)] . patients with alcoholic liver disease exhibit a longer elimination half-life (19.7 hours), compared to healthy subjects (11.4 hours). this may be caused by decreased clearance of alprazolam extended-release tablets in patients with alcoholic liver disease. dosage reduction of alprazolam is recommended in patients with hepatic impairment [see dosage and administration (2.4), clinical pharmacology (12.3)] . alprazolam extended-release tablets contains alprazolam, which is a schedule iv controlled substance. alprazolam extended-release tablets are 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 health care 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 and precautions (5.2)] . 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 alprazolam extended-release tablets 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 and precautions (5.3)] . to reduce the risk of withdrawal reactions, use a gradual taper to discontinue alprazolam extended-release tablets or reduce the dosage [see dosage and administration (2.3), warnings and precautions (5.3)] . 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 associated 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 alprazolam extended-release tablets 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 alprazolam extended-release tablets may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

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amneal pharmaceuticals llc - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 100 mg - gabapentin capsules are indicated for: - management of postherpetic neuralgia in adults - adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin, during pregnancy. encourage women who are taking gabapentin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increas

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

amneal pharmaceuticals ny llc - vigabatrin (unii: gr120krt6k) (vigabatrin - unii:gr120krt6k) - vigabatrin 500 mg - vigabatrin for oral solution is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see warnings and precautions (5.1)] . vigabatrin for oral solution is not indicated as a first line agent for complex partial seizures. vigabatrin for oral solution is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [see warnings and precautions (5.1)] . none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, including vigabatrin, during pregnancy. encourage women who are taking vigabatrin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll-free number 1-888-233-2334 or visiting the website, http://www.aedpregnancyregistry.org/. this must be done by the patient herself. risk summary there are no adequate data on the developmental risk associated with the use of vigabatrin in pregnant women. limited available data from case reports and cohort studies pertaining to vigabatrin use in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. however, based on animal data, vigabatrin use in pregnant women may result in fetal harm. when administered to pregnant animals, vigabatrin produced developmental toxicity, including an increase in fetal malformations and offspring neurobehavioral and neurohistopathological effects, at clinically relevant doses. in addition, developmental neurotoxicity was observed in rats treated with vigabatrin during a period of postnatal development corresponding to the third trimester of human pregnancy (see data) . 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data administration of vigabatrin (oral doses of 50 to 200 mg/kg/day) to pregnant rabbits throughout the period of organogenesis was associated with an increased incidence of malformations (cleft palate) and embryofetal death; these findings were observed in two separate studies. the no-effect dose for adverse effects on embryofetal development in rabbits (100 mg/kg/day) is approximately 1/2 the maximum recommended human dose (mrhd) of 3 g/day on a body surface area (mg/m2 ) basis. in rats, oral administration of vigabatrin (50, 100, or 150 mg/kg/day) throughout organogenesis resulted in decreased fetal body weights and increased incidences of fetal anatomic variations. the no-effect dose for adverse effects on embryo-fetal development in rats (50 mg/kg/day) is approximately 1/5 the mrhd on a mg/m2 basis. oral administration of vigabatrin (50, 100, 150 mg/kg/day) to rats from the latter part of pregnancy through weaning produced long-term neurohistopathological (hippocampal vacuolation) and neurobehavioral (convulsions) abnormalities in the offspring. a no-effect dose for developmental neurotoxicity in rats was not established; the low-effect dose (50 mg/kg/day) is approximately 1/5 the mrhd on a mg/m2 basis. in a published study, vigabatrin (300 or 450 mg/kg) was administered by intraperitoneal injection to a mutant mouse strain on a single day during organogenesis (day 7, 8, 9, 10, 11, or 12). an increase in fetal malformations (including cleft palate) was observed at both doses. oral administration of vigabatrin (5, 15, or 50 mg/kg/day) to young rats during the neonatal and juvenile periods of development (postnatal days 4 to 65) produced neurobehavioral (convulsions, neuromotor impairment, learning deficits) and neurohistopathological (brain vacuolation, decreased myelination, and retinal dysplasia) abnormalities in treated animals. the early postnatal period in rats is generally thought to correspond to late pregnancy in humans in terms of brain development. the no-effect dose for developmental neurotoxicity in juvenile rats (5 mg/kg/day) was associated with plasma vigabatrin exposures (auc) less than 1/30 of those measured in pediatric patients receiving an oral dose of 50 mg/kg. risk summary vigabatrin is excreted in human milk. the effects of vigabatrin on the breastfed infant and on milk production are unknown. because of the potential for serious adverse reactions from vigabatrin in nursing infants, breastfeeding is not recommended. if exposing a breastfed infant to vigabatrin, observe for any potential adverse effects [see warnings and precautions (5.1, 5.3, 5.4, 5.8)] . the safety and effectiveness of vigabatrin as adjunctive treatment of refractory complex partial seizures in pediatric patients 2 to 16 years of age have been established and is supported by three double-blind, placebo-controlled studies in patients 3 to 16 years of age, adequate and well-controlled studies in adult patients, pharmacokinetic data from patients 2 years of age and older, and additional safety information in patients 2 years of age [see clinical pharmacology (12.3) and clinical studies (14.1)] . the dosing recommendation in this population varies according to age group and is weight-based [see dosage and administration (2.2)] . adverse reactions in this pediatric population are similar to those observed in the adult population [see adverse reactions (6.1)] . the safety and effectiveness of vigabatrin as monotherapy for pediatric patients with infantile spasms (1 month to 2 years of age) have been established [see dosage and administration (2.3) and clinical studies (14.2)] . safety and effectiveness as adjunctive treatment of refractory complex partial seizures in pediatric patients below the age of 2 and as monotherapy for the treatment of infantile spasms in pediatric patients below the age of 1 month have not been established. duration of therapy for infantile spasms was evaluated in a post hoc analysis of a canadian pediatric epilepsy network (cpen) study of developmental outcomes in infantile spasms patients. this analysis suggests that a total duration of 6 months of vigabatrin therapy is adequate for the treatment of infantile spasms. however, prescribers must use their clinical judgment as to the most appropriate duration of use [see clinical studies (14.2)] . abnormal mri signal changes and intramyelinic edema (ime) in infants and young children being treated with vigabatrin have been observed [see warnings and precautions (5.3, 5.4)] . juvenile animal toxicity data oral administration of vigabatrin (5, 15, or 50 mg/kg/day) to young rats during the neonatal and juvenile periods of development (postnatal days 4 to 65) produced neurobehavioral (convulsions, neuromotor impairment, learning deficits) and neurohistopathological (brain gray matter vacuolation, decreased myelination, and retinal dysplasia) abnormalities. the no-effect dose for developmental neurotoxicity in juvenile rats (the lowest dose tested) was associated with plasma vigabatrin exposures (auc) substantially less than those measured in pediatric patients at recommended doses. in dogs, oral administration of vigabatrin (30 or 100 mg/kg/day) during selected periods of juvenile development (postnatal days 22 to 112) produced neurohistopathological abnormalities (brain gray matter vacuolation). neurobehavioral effects of vigabatrin were not assessed in the juvenile dog. a no-effect dose for neurohistopathology was not established in juvenile dogs; the lowest effect dose (30 mg/kg/day) was associated with plasma vigabatrin exposures lower than those measured in pediatric patients at recommended doses [see warnings and precautions (5.4)] . clinical studies of vigabatrin did not include sufficient numbers of patients aged 65 and over to determine whether they responded differently from younger patients. vigabatrin is known to be substantially excreted by the kidney, and the risk of toxic 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 monitor renal function. oral administration of a single dose of 1.5 g of vigabatrin to elderly (≥ 65 years) patients with reduced creatinine clearance (< 50 ml/min) was associated with moderate to severe sedation and confusion in 4 of 5 patients, lasting up to 5 days. the renal clearance of vigabatrin was 36% lower in healthy elderly subjects (≥ 65 years) than in young healthy males. adjustment of dose or frequency of administration should be considered. such patients may respond to a lower maintenance dose [see dosage and administration (2.4)  and clinical pharmacology (12.3)] . other reported clinical experience has not identified differences in responses between the elderly and younger patients. dose adjustment, including initiating treatment with a lower dose, is necessary in pediatric patients 2 years of age and older and adults with mild (creatinine clearance > 50 to 80 ml/min), moderate (creatinine clearance > 30 to 50 ml/min) and severe (creatinine clearance > 10 to 30 ml/min) renal impairment [see dosage and administration (2.4)  and clinical pharmacology (12.3)] . vigabatrin is not a controlled substance. vigabatrin did not produce adverse events or overt behaviors associated with abuse when administered to humans or animals. it is not possible to predict the extent to which a cns active drug will be misused, diverted, and/or abused once marketed. consequently, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of vigabatrin (e.g., incrementation of dose, drug-seeking behavior). following chronic administration of vigabatrin to animals, there were no apparent withdrawal signs upon drug discontinuation. however, as with all aeds, vigabatrin should be withdrawn gradually to minimize increased seizure frequency [see warnings and precautions (5.6)] . vigabatrin (vye ga’ ba trin) for oral solution read this instructions for use before your child starts taking vigabatrin for oral solution and each time you get a refill. there may be new information. this information does not take the place of talking with your healthcare provider about your child’s medical condition or treatment. talk to your healthcare provider if you have any questions about the right dose of medicine to give your child or how to mix it. important note:    - vigabatrin for oral solution comes in a packet - each packet contains 500 mg of vigabatrin for oral solution powder - v igabatrin for oral solution powder must be mixed with water only. the water may be cold or at room temperature. - your healthcare provider will tell you: - how many packets of vigabatrin for oral solution you will need for each dose - how many milliliters (ml) of water to use to mix one dose of vigabatrin for oral solution - how many milliliters (ml) of the powder and water mixture you will need for each dose of medicine - vigabatrin for oral solution should be given right away after it is mixed - use the oral syringes, provided by the pharmacy, to measure and give the correct dose. do not use a household teaspoon or tablespoon. supplies you will need to mix 1 dose of v igabatrin for oral solution: - the number of packets of vigabatrin for oral solution needed for each dose - 2 clean cups: 1 for mixing and 1 for water. the cup used for mixing vigabatrin for oral solution should be clear so you can see if the powder is dissolved - water to mix with the vigabatrin for oral solution powder - one small 3 ml oral syringe and one large 10 ml oral syringe which are provided by the pharmacy - small spoon or other clean utensil to stir the mixture - scissors oral syringe detail step 1: start with 1 of the empty cups and the total number of packets you will need for 1 dose. step 2: before you open the packet, tap it to settle all the powder to the bottom of the packet. step 3: use a pair of scissors to cut open the vigabatrin for oral solution packet along the dotted line. step 4: empty the entire contents of the vigabatrin for oral solution packet into 1 of the clean empty cups (see figure a). figure a - repeat steps 2 to 4 above to open all of the packets needed for 1 dose of vigabatrin for oral solution. step 5: take the second cup and fill it half way with water (see figure b). do not mix vigabatrin for oral solution with anything other than water. figure b - you will use the larger oral syringe (10 ml) to draw up the water needed to mix with the powder from the packets. you will need 10 ml of water for each packet of v igabatrin for oral solution. for example: - if you are using 1 packet of vigabatrin for oral solution, you will need to use 10 ml of water (fill the 10 ml oral syringe 1 time) - if you are using 2 packets of vigabatrin for oral solution, you will need to use 20 ml of water (fill the 10 ml oral syringe 2 times) - if you are using 3 packets of vigabatrin for oral solution, you will need to use 30 ml of water (fill the 10 ml oral syringe 3 times) step 6: use the 10 ml oral syringe to draw up 10 ml of water. to do this, put the tip of the oral syringe all the way into the water in your cup. then pull the plunger up towards you until the edge of the white plunger is at the 10 ml line on the barrel of the oral syringe (see figure c). figure c - if you see bubbles of air in the oral syringe after drawing up the water, turn the oral syringe so the tip is pointing up (see figure d). the air will move to the top of the oral syringe. pull the plunger back towards you and then push it back gently into the oral syringe to get rid of the bubbles. tiny bubbles are normal. figure d step 7: check the oral syringe to make sure it is filled with water up to the 10 ml line (see figure e). figure e step 8: get the second cup that contains the vigabatrin for oral solution needed for your dose. step 9: hold the 10 ml oral syringe that is filled with water with the tip pointing down over the vigabatrin for oral solution. step 10: slowly push the oral syringe plunger all the way down to empty the water from the oral syringe straight into the cup containing the vigabatrin for oral solution (see figure f). figure f repeat steps 6 through 10 until all of the water that is needed to mix 1 dose of v igabatrin for oral solution has been added to the cup containing the powder. step 11: stir the mixture with the small spoon or other clean utensil until the solution is clear (see figure g). this means that all of the powder is dissolved and ready for use. figure g - to give a dose of vigabatrin for oral solution to your child, you should use the oral syringe to draw up the total number of mls of the mixture that your healthcare provider tells you to. - if you are giving 3 ml or less of the mixture, use the smaller 3 ml oral syringe. - if you are giving more than 3 ml of the mixture, use the larger 10 ml oral syringe (this is the oral syringe that you just used to add the water). step 12: put the tip of the oral syringe all the way into the mixture. pull the plunger up towards you to draw up the mixture. stop when the edge of the white plunger lines up with markings on the barrel of the oral syringe that matches the number of mls of mixture your healthcare provider told you to give (see figure h). figure h - if you see bubbles of air in the oral syringe after drawing up the mixture, turn the oral syringe so the tip is pointing up (see figure i). the air will move to the top of the oral syringe. pull the plunger back towards you and then gently push it back in the oral syringe in order to get rid of the bubbles. tiny bubbles are normal. figure i step 13: place the tip of the oral syringe into your child’s mouth and point the oral syringe towards either cheek (see figure j). push on the plunger slowly, a small amount at a time, until all of the mixture in the oral syringe is given. figure j - if the dose you are giving your child is more than 10 mls, repeat steps 12 and 13 until you give the total dose of mixture prescribed by your healthcare provider. step 14: throw away any mixture that is left over. do not save or reuse any leftover mixture. step 15: wash the oral syringes and mixing cups in warm water. to clean the oral syringes, remove the plunger by gently pulling it straight out of the barrel. the barrel and plunger can be hand washed with soap and water, rinsed, and allowed to dry. this instructions for use has been approved by the u.s. food and drug administration. distributed by: amneal pharmaceuticals llc bridgewater, nj 08807 rev. 01-2020-03

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amneal pharmaceuticals llc - bosentan anhydrous (unii: xul93r30k2) (bosentan anhydrous - unii:xul93r30k2) - bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1): - in adults to improve exercise ability and to decrease clinical worsening. studies establishing effectiveness included predominantly patients with who functional class ii-iv symptoms and etiologies of idiopathic or heritable pah (60%), pah associated with connective tissue diseases (21%), and pah associated with congenital heart disease with left-to-right shunts (18%) [see clinical studies (14.1)] . use of bosentan is contraindicated in females who are or may become pregnant. to prevent pregnancy, females of reproductive potential must use two reliable forms of contraception during treatment and for one month after stopping bosentan [see boxed warning, warnings and precautions (5.2) , drug interactions (7.2), use in specific populations (8.1)] . co-administration of cyclosporine a and bosentan resulted in markedly increased plasma concentrations of bosentan. therefore, concomitant use of bosentan and cyc

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amneal pharmaceuticals llc - oxymorphone hydrochloride (unii: 5y2ei94nbc) (oxymorphone - unii:9vxa968e0c) - oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of usage - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see warnings and precautions (5.1)] , reserve oxymorphone hydrochloride extended-release tablets 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. - oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. oxymorphone hydrochloride extended-release tablets are contraindicated in patients with: - significant respiratory depression [see warnings and precautions (5.3)] - acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.6)] - hypersensitivity (e.g., anaphylaxis) to oxymorphone, any other ingredients in oxymorphone hydrochloride extended-release tablets [see warnings and precautions (5.7) and adverse reactions (6)]. - moderate and severe hepatic impairment [see warnings and precautions (5.9) and clinical pharmacology (12.3)] - known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings and precautions (5.12)] risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.4)] . available data with oxymorphone hydrochloride extended-release tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. in animal reproduction studies, reduced postnatal survival of pups and an increased incidence of stillborn pups were observed following oral treatment of pregnant rats with oxymorphone during gestation and through lactation at doses 2.4 and 12 times the human daily dose of 20 mg/day (hdd), respectively. reduced fetal weights were observed with oral administration of oxymorphone to pregnant rats and rabbits during organogenesis at exposures up to 4.9 and 48.8 times the hdd, respectively [see 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 clinical recognized pregnancies is 2% to 4% and 14% to 20%, respectively. clinical considerations fetal/neonatal adverse reactions prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes may cause fetal-neonatal physical dependence and neonatal 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 pyscho-physiologic effects in neonates. an opioid antagonist, such as naloxone must be available for reversal of opioid-induced respiratory depression in the neonate. oxymorphone hydrochloride extended-release tablets are not recommended for use in women during and immediately prior to labor, when use of shorter acting analgesics or other analgesic techniques are more appropriate. opioid analgesics, including oxymorphone hydrochloride extended-release tablets, 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 dilatation, which tends to shorten labor. monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression. data animal data pregnant rats were treated with oxymorphone hydrochloride from gestation day 6 to 17 via oral gavage doses of 5, 10, or 25 mg/kg/day (2.4, 4.9, or 12.2 times the hdd based on body surface area, respectively). reduced mean fetal weights were observed at 4.9 times the hdd. maternal toxicity was noted in all treatment groups (reduced food consumption and body weights in all groups and mortality in the high dose group). pregnant rabbits were treated with oxymorphone hydrochloride from gestation day 7 to 20 via oral gavage doses of 10, 25, or 50 mg/kg/day (9.8, 24.4, or 48.8 times the hdd based on body surface area, respectively). decreased mean fetal weights were noted at 48.8 times the hdd. maternal toxicity was noted in all treatment groups (reduced food consumption and body weights). pregnant rats were treated with oxymorphone hydrochloride from gestation day 6 to lactation day 20 via oral gavage doses of 1, 5, 10, or 25 mg/kg/day (0.5, 2.4, 4.9, or 12.2 times the hdd based on body surface area, respectively). increased neonatal death (postnatal day 0 to 1) was noted at 2.4 times the hdd. decreased pup survival over the first week of life, reduced pup birth weight, and reduced postnatal weight gain were noted at 4.9 times the hdd. maternal toxicity was noted in all treatment groups (reduced food consumption and body weights in all groups and mortality in the 10 and 25 mg/kg/day groups). in a published study, neural tube defects (exencephaly and cranioschisis) were noted following subcutaneous administration of 153 mg/kg oxymorphone hydrochloride (62.2 times the hdd) on gestation day 8 to pregnant hamsters. this dose also produced significant maternal toxicity (20% maternal deaths). risk summary there is no information regarding the presence of oxymorphone in human milk, the effects on the breastfed infant, or the effects on milk production. 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 oxymorphone hydrochloride extended-release tablets. clinical considerations monitor infants exposed to oxymorphone through breast milk for excess sedation and respiratory depression. withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast-feeding is stopped. infertility chronic use of opioids may cause reduced fertility in females and males of reproductive potential. it is not known whether these effects on fertility are reversible [clinical pharmacology (12.2) and nonclinical toxicology (13.1)] . the safety and effectiveness of oxymorphone hydrochloride extended-release tablets in patients below the age of 18 years have not been established. two open-label studies were conducted in a total of 42 pediatric patients between the ages of 7 to 17 years requiring continuous, around the clock opioid treatment. the available safety and efficacy data were inconclusive for chronic use of oxymorphone hydrochloride extended-release tablets. limited data from one of the studies suggested that oxymorphone hydrochloride extended-release tablets is not recommended for post-surgical pain. of the total number of subjects in clinical studies of oxymorphone hydrochloride extended-release tablets, 27% were 65 and over, while 9% were 75 and over. no overall differences in effectiveness were observed between these subjects and younger subjects. there were several adverse events that were more frequently observed in subjects 65 and over compared to younger subjects. these adverse events included dizziness, somnolence, confusion, and nausea. on average, age greater than 65 years was associated with an increase in oxymorphone auc and cmax . initiate dosing with oxymorphone hydrochloride extended-release tablets in patients 65 years of age and over using the 5 mg dose and monitor closely for signs of respiratory and central nervous system depression when initiating and titrating oxymorphone hydrochloride extended-release tablets. for patients on prior opioid therapy, start at 50% of the starting dose for a younger patient on prior opioids and titrate slowly. oxymorphone 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 the elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. patients with mild hepatic impairment have an increase in oxymorphone bioavailability compared to the subjects with normal hepatic function. in opioid-naïve patients with mild hepatic impairment, initiate oxymorphone hydrochloride extended-release tablets using the 5 mg dose and monitor closely for respiratory and central nervous system depression. oxymorphone hydrochloride extended-release tablets are contraindicated for patients with moderate and severe hepatic impairment [see dosage and administration (2.6), contraindications (4) , warnings and precautions (5.9), and clinical pharmacology (12.3)] . for patients on prior opioid therapy, start at the 50% of the dose for that a patient with normal hepatic function on prior opioids and titrate slowly. patients with moderate to severe renal impairment were shown to have an increase in oxymorphone bioavailability compared to the subjects with normal renal function [see clinical pharmacology (12.3)] . start opioid-naïve patients with the 5 mg dose of oxymorphone hydrochloride extended-release tablets and titrate slowly while closely monitoring for respiratory and central nervous system depression [see dosage and administration (2.6)] . for patients on prior opioid therapy, start at 50% of the dose for a patient with normal renal function on prior opioids and titrate slowly. oxymorphone hydrochloride extended-release tablets contain oxymorphone, a schedule ii controlled substance. oxymorphone hydrochloride extended-release tablets contains oxymorphone a substance with a high potential for abuse similar to other opioids fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, and tapentadol. oxymorphone hydrochloride extended-release tablets can be abused and is subject to misuse, addiction, and criminal diversion [see warnings and precautions (5.1)] . the high drug content in extended-release formulations adds to the risk of adverse outcomes from abuse and misuse. all patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use. prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. “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 drug abusers and people suffering from untreated addiction. preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control. abuse and addiction are separate and distinct from physical dependence and tolerance. healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. in addition, abuse of opioids can occur in the absence of true addiction. oxymorphone hydrochloride extended-release tablets, like other opioids, can be diverted for non-medical 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 re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to reduce abuse of opioid drugs. risks specific to abuse of oxymorphone hydrochloride extended-release tablets oxymorphone hydrochloride extended-release tablets are for oral use only. abuse of oxymorphone hydrochloride extended-release tablets poses a risk of overdose and death. this risk is increased with concurrent abuse of oxymorphone hydrochloride extended-release tablets with alcohol and other substances. taking cut, broken, chewed, crushed, or dissolved oxymorphone hydrochloride extended-release tablets enhances drug release and increases the risk of over dose and death. parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and hiv. both tolerance and physical dependence can develop during chronic opioid therapy. tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects. physical dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity, (e.g., naloxone, nalmefene), 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 opioid usage. do not abruptly discontinue oxymorphone hydrochloride extended-release tablets in a patient physically dependent on opioids. rapid tapering of oxymorphone hydrochloride extended-release tablets 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 oxymorphone hydrochloride extended-release tablets, gradually taper the dosage using a patient-specific plan that considers the following: the dose of oxymorphone hydrochloride extended-release tablets 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 a long duration 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 (5.14)] . 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 (8.2)].