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stat rx usa llc - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570) - oxycodone hydrochloride 80 mg - oxycontin tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time. oxycontin is not intended for use as a prn analgesic. physicians should individualize treatment in every case, initiating therapy at the appropriate point along a progression from non-opioid analgesics, such as non-steroidal anti-inflammatory drugs and acetaminophen to opioids in a plan of pain management such as outlined by the world health organization, the agency for healthcare research and quality (formerly known as the agency for healthcare policy and research), the federation of state medical boards model guidelines, or the american pain society. oxycontin is not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild, or not expected to persist for an extended period of time. oxycontin is only indicated for

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amneal pharmaceuticals llc - azelastine hydrochloride (unii: 0l591qr10i) (azelastine - unii:zqi909440x) - azelastine hydrochloride 1 mg in 1 ml - azelastine hydrochloride (hcl) nasal spray, 0.1% is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. none. risk summary   limited data from post-marketing experience over decades of use with azelastine hcl nasal spray, 0.1% in pregnant women have not identified any drug associated risks of miscarriage, birth defects, or other adverse maternal or fetal outcomes. in animal reproduction studies, there was no evidence of fetal harm at oral doses approximately 5 times the clinical daily dose. oral administration of azelastine hcl to pregnant mice, rats, and rabbits, during the period of organogenesis, produced developmental toxicity that included structural abnormalities, decreased embryo-fetal survival, and decreased fetal body weights at doses 270 times and higher than the maximum recommended human daily intranasal dose (mrhdid) of 1.096 mg. however, the relevance of these findings in animals to pregnant women was considered questionable based upon the high animal to human dose multiple. the estimated background risk of major birth defects and miscarriage for the indicated populations 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. data animal data in an embryo-fetal development study in mice dosed during the period of organogenesis, azelastine hcl caused embryo-fetal death, structural abnormalities (cleft palate; short or absent tail; fused, absent or branched ribs), delayed ossification, and decreased fetal weight at approximately 300 times the maximum recommended human daily intranasal dose (mrhdid) in adults (on a mg/m2 basis at a maternal oral dose of 68.6 mg/kg/day), which also caused maternal toxicity as evidenced by decreased maternal body weight. neither fetal nor maternal effects occurred in mice at approximately 15 times the mrhdid in adults (on a mg/m2 basis at a maternal oral dose of 3 mg/kg/day). in an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 7 to 17, azelastine hcl caused structural abnormalities (oligo-and brachydactylia), delayed ossification, and skeletal variations, in the absence of maternal toxicity, at approximately 270 times the mrhdid in adults (on a mg/m2 basis at a maternal oral dose of 30 mg/kg/day). azelastine hcl caused embryo-fetal death and decreased fetal weight and severe maternal toxicity at approximately 610 times the mrhdid (on a mg/m2 basis at a maternal oral dose of 68.6 mg/kg/day). neither fetal nor maternal effects occurred at approximately 20 times the mrhdid (on a mg/m2 basis at a maternal oral dose of 2 mg/kg/day). in an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6 to 18, azelastine hcl caused abortion, delayed ossification and decreased fetal weight and severe maternal toxicity at approximately 530 times the mrhdid in adults (on a mg/m2 basis at a maternal oral dose of 30 mg/kg/day). neither fetal nor maternal effects occurred at approximately 5 times the mrhdid (on a mg/m2 basis at a maternal oral dose of 0.3 mg/kg/day). in a prenatal and postnatal development study in pregnant rats dosed from late in the gestation period and through the lactation period from gestation day 17 through lactation day 21, azelastine hcl produced no adverse developmental effects on pups at maternal doses up to approximately 270 times the mrhdid (on mg/m2 basis at a maternal dose of 30 mg/kg/day). risk summary there are no data on the presence of azelastine hcl in human milk, the effects on the breastfed infant, or the effects on milk production. breastfed infants should be monitored for signs of milk rejection during azelastine hcl use by lactating women (see clinical considerations) .the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for azelastine hcl nasal spray, 0.1% and any potential adverse effects on the breastfed infant from azelastine hcl nasal spray, 0.1% or from the underlying maternal condition. clinical considerations monitoring for adverse reactions breastfed infants of lactating women treated with azelastine hcl nasal spray, 0.1% should be monitored for possible signs of milk rejection related to the bitter taste of azelastine hcl. the safety and effectiveness of azelastine hcl nasal spray, 0.1% for the treatment of symptoms of seasonal allergic rhinitis have been established for patients 5 years and older [see adverse reactions (6.1) and clinical studies (14.1)] . the safety and effectiveness of azelastine hcl nasal spray, 0.1% for the treatment of vasomotor rhinitis have been established for patients 12 years and older [see adverse reactions (6.1) and clinical studies (14.2)] . the safety and effectiveness of azelastine hcl nasal spray, 0.1% in pediatric patients below the age of 5 years with seasonal allergic rhinitis and in pediatric patients below the age of 12 years with vasomotor rhinitis have not been established. clinical trials of azelastine hcl nasal spray, 0.1% did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between the elderly and 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. azelastine hydrochloride (ay” ze las’ teen hye” droe klor’ ide) nasal spray, 0.1% for the correct dose of medicine: - keep your head tilted downward when spraying into your nostril. - change nostrils each time you use the spray. - breathe gently and do not tip your head back after using the spray. this will keep the medicine from running down into your throat. you may get a bitter taste in your mouth. figure a identifies the parts of your azelastine hcl nasal spray, 0.1% pump before you use azelastine hcl nasal spray, 0.1% for the first time, you will need to prime the bottle. priming your azelastine hcl nasal spray, 0.1% remove the dust cover over the tip of the pump and the white safety clip just under the “shoulders” of the pump (see figure b) . hold the bottle upright with 2 fingers on the shoulders of the spray pump unit and - put your thumb on the bottom of the bottle. press upward with your thumb and release for the pumping action. repeat this until you see a fine mist (see figure c) . - to get a fine mist you must pump the spray fast and use firm pressure against the bottom of the bottle. if you see a stream of liquid, the pump is not working correctly and you may have nasal discomfort. - this should happen in 4 sprays or less. now your pump is primed and ready to use. - do not use azelastine hcl nasal spray, 0.1% unless you see a fine mist after you do the priming sprays. if you do not see a fine mist, clean the tip of the spray nozzle. see the “cleaning the spray tip of your azelastine hcl nasal spray, 0.1%” section below. do not use azelastine hcl nasal spray, 0.1% unless you see a fine mist after you do the priming sprays. if you do not see a fine mist, clean the tip of the spray nozzle. see the “cleaning the spray tip of your azelastine hcl nasal spray, 0.1%” section below. - if you do not use azelastine hcl nasal spray, 0.1% for 3 or more days, you will need to prime the pump with 2 sprays or until you see a fine mist. using your azelastine hcl nasal spray, 0.1% if you do not use azelastine hcl nasal spray, 0.1% for 3 or more days, you will need to prime the pump with 2 sprays or until you see a fine mist. using your azelastine hcl nasal spray, 0.1% step 1. blow your nose to clear your nostrils. step 2. keep your head tilted downward toward your toes. step 3. place the spray tip about ¼ inch to ½ inch into 1 nostril. hold bottle upright and aim the spray tip toward the back of your nose (see figure d) . step 4. close your other nostril with a finger. press the pump 1 time and sniff gently at the same time, keeping your head tilted forward and down (see figure e) . step 5. repeat step 3 and step 4 in your other nostril. step 6. if your healthcare provider tells you to use 2 sprays in each nostril, repeat steps 2 through 4 above for the second spray in each nostril. step 7. breathe in gently, and do not tilt your head back after using azelastine hcl nasal spray, 0.1%. this will help to keep the medicine from going into your throat. step 8. when you finish using your azelastine hcl nasal spray, 0.1%, wipe the spray tip with a clean tissue or cloth. put the safety clip and dust cover back on the bottle. cleaning the spray tip of your azelastine hcl nasal spray, 0.1% - the spray tip opening is clogged, do not use a pin or pointed object to unclog the tip. unscrew the spray pump unit from the bottle by turning it to the left (counter-clockwise) (see figure f) . - soak only the spray pump unit in warm water. squirt the spray unit several times while holding it under water. use the pumping action to clear the opening in the tip (see figure g) . - let the spray pump unit air dry. make sure it is dry before you put it back onto the bottle. - put the spray pump unit back into the open bottle and tighten it by turning clockwise (to the right). - to keep the medicine from leaking out, use firm pressure when you put the pump back onto the bottle. - after cleaning, follow the instructions for priming. this patient information and instructions for use has been approved by the u.s. food and drug administration. distributed by: amneal pharmaceuticals llc bridgewater, nj  08807 rev. 10-2018-02

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newgen pharmaceuticals llc - amantadine hydrochloride (unii: m6q1eo9td0) (amantadine - unii:bf4c9z1j53) - amantadine hydrochloride 100 mg - amantadine hydrochloride tablets are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza a virus. amantadine hydrochloride tablets are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. amantadine hydrochloride tablets are indicated for chemoprophylaxis against signs and symptoms of influenza a virus infection. because amantadine hydrochloride tablets do not completely prevent the host immune response to influenza a infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses. following vaccination during an influenza a outbreak, amantadine hydrochloride tablets prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. amantadine hydrochloride tablets are also indicated in the treatment of uncomplicated respiratory tract illness caused

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

legacy pharmaceutical packaging, llc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride 500 mg - metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. metformin hydrochloride tablets are contraindicated in patients with: - severe renal impairment (egfr below 30 ml/min/1.73 m2) [see warnings and precautions (5.1)]. - hypersensitivity to metformin. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary limited data with metformin hydrochloride tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see data]. there are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see clinical considerations ]. no adverse developmental effects were observed when met

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direct rx - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 50 mg - tramadol hydrochloride tablets, usp are indicated for the management of moderate to moderately severe pain in adults. tramadol hydrochloride tablets, usp should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. tramadol hydrochloride tablets, usp are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. tramadol hydrochloride tablets, usp may worsen central nervous system and respiratory depression in these patients. abuse tramadol has mu-opioid agonist activity. tramadol hydrochloride tablets can be abused and may be subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. drug addiction is characterized by behaviors that include

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

northwind pharmaceuticals, llc - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - promethazine hydrochloride 25 mg - promethazine hydrochloride tablets are useful for:      perennial and seasonal allergic rhinitis.           vasomotor rhinitis.      allergic conjunctivitis due to inhalant allergens and foods.    mild, uncomplicated allergic skin manifestations of urticaria and angioedema.          amelioration of allergic reactions to blood or plasma.            dermographism.        anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled.      preoperative, postoperative and obstetric sedation.     prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.               therapy adjunctive to meperidine or other analgesics for control of postoperative pain.      sedation in both children and adults as well as relief of apprehens

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apotheca, inc - promethazine hydrochloride (unii: r61zeh7i1i) (promethazine - unii:ff28ejq494) - promethazine hydrochloride 25 mg - promethazine hydrochloride tablets are useful for:    perennial and seasonal allergic rhinitis.    vasomotor rhinitis.    allergic conjunctivitis due to inhalant allergens and foods.    mild, uncomplicated allergic skin manifestations of urticaria and angioedema.    amelioration of allergic reactions to blood or plasma.    dermographism.    anaphylactic reactions as adjunctive therapy to epinephrine and other standard measures after the acute manifestations have been controlled.    preoperative, postoperative and obstetric sedation.    prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.    therapy adjunctive to meperidine or other analgesics for control of postoperative pain.    sedation in both children and adults as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.    active and prophylactic treatment of motion sickness.    antiemetic therapy in postoperative pat

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aphena pharma solutions - tennessee, llc - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 50 mg - tramadol hydrochloride tablets, usp are indicated for the management of moderate to moderately severe pain in adults. tramadol hydrochloride tablets, usp should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. tramadol hydrochloride tablets, usp are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. tramadol hydrochloride tablets, usp may worsen central nervous system and respiratory depression in these patients. abuse tramadol has mu-opioid agonist activity. tramadol hydrochloride tablets can be abused and may be subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. drug addiction is characterized by behaviors that include

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

apotheca, inc - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 50 mg - tramadol hydrochloride tablets, usp are indicated for the management of moderate to moderately severe pain in adults. tramadol hydrochloride tablets, usp should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. tramadol hydrochloride tablets, usp are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. tramadol hydrochloride tablets, usp may worsen central nervous system and respiratory depression in these patients. abuse tramadol has mu-opioid agonist activity. tramadol hydrochloride tablets can be abused and may be subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. drug addiction is characterized by behaviors that include

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

aidarex pharmaceuticals llc - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 50 mg - tramadol hydrochloride tablets, usp are indicated for the management of moderate to moderately severe pain in adults. tramadol hydrochloride tablets, usp should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids. tramadol hydrochloride tablets, usp are contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. tramadol hydrochloride tablets, usp may worsen central nervous system and respiratory depression in these patients. abuse tramadol has mu-opioid agonist activity. tramadol hydrochloride tablets can be abused and may be subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. drug addiction is characterized by behaviors that include