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patrin pharma, inc. - amantadine hydrochloride (unii: m6q1eo9td0) (amantadine - unii:bf4c9z1j53) - amantadine hydrochloride oral solution usp is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza a virus. amantadine hydrochloride oral solution usp is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. amantadine hydrochloride oral solution usp is indicated for chemoprophylaxis against signs and symptoms of influenza a virus infection. because amantadine hydrochloride oral solution usp does 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 oral solution usp prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. amantadine hydrochloride oral solution usp is also indicated in the t

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bryant ranch prepack - amantadine hydrochloride (unii: m6q1eo9td0) (amantadine - unii:bf4c9z1j53) - amantadine hydrochloride capsules, usp are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza a virus. amantadine hydrochloride capsules, usp are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. influenza a prophylaxis:  amantadine hydrochloride capsules, usp are indicated for chemoprophylaxis against signs and symptoms of influenza a virus infection. because amantadine hydrochloride does 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 capsules, usp prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. influenza a treatment:  amantadine hydrochloride capsules, usp are also

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direct_rx - amantadine hydrochloride (unii: m6q1eo9td0) (amantadine - unii:bf4c9z1j53) - amantadine hydrochloride tablets are contraindicated in patients with known hypersensitivity to amantadine hydrochloride or to any of the other ingredients in amantadine hydrochloride tablets. 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. influenza a prophylaxis 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. influenza a treatment amantadine hydrochloride tablets are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza a virus strains especially when administered early in the course of illness. there are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride tablets will avoid the development of influenza a virus pneumonitis or other complications in high risk patients. there is no clinical evidence indicating that amantadine hydrochloride tablets are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza a virus strains. the following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride tablets: • amantadine hydrochloride tablets are not a substitute for early vaccination on an annual basis as recommended by the centers for disease control and prevention advisory committee on immunization practices. • influenza viruses change over time. emergence of resistance mutations could decrease drug effectiveness. other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride tablets. parkinson's disease/syndrome amantadine hydrochloride tablets are indicated in the treatment of idiopathic parkinson's disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication. it is indicated in those elderly patients believed to develop parkinsonism in association with cerebral arteriosclerosis. in the treatment of parkinson's disease, amantadine hydrochloride tablets are less effective than levodopa, (-)-3-(3,4-dihydroxyphenyl)-l-alanine, and its efficacy in comparison with the anticholinergic antiparkinson drugs has not yet been established. drug-induced extrapyramidal reactions amantadine hydrochloride tablets are indicated in the treatment of drug-induced extrapyramidal reactions. although anticholinergic-type side effects have been noted with amantadine hydrochloride tablets when used in patients with drug-induced extrapyramidal reactions, there is a lower incidence of these side effects than that observed with the anticholinergic antiparkinson drugs.

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adamas pharma, llc - amantadine hydrochloride (unii: m6q1eo9td0) (amantadine - unii:bf4c9z1j53) - osmolex er is indicated for the treatment of parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients. osmolex er is contraindicated in patients with end-stage renal disease (i.e., creatinine clearance below 15 ml/min/1.73 m2) [see clinical pharmacology (12.3)] . risk summary there are no adequate data on the developmental risk associated with use of amantadine in pregnant women. animal studies suggest a potential risk for fetal harm with amantadine. in mice and rats, adverse developmental effects (embryolethality, increased incidence of malformations, and reduced fetal body weight) were observed when amantadine was administered to pregnant animals at clinically relevant doses [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 for major birth defects and miscarriage for the indicated populations is unknown. data animal data the effects of amantadine on development have not been tested in studies conducted in animals using currently recommended methodology; however, developmental toxicity studies of amantadine have been reported in the published literature. in mice, oral administration of amantadine (0, 10, or 40 mg/kg/day) to pregnant animals during organogenesis (gestation days 7-12) resulted in embryolethality and reduced fetal body weight at the highest dose tested, which was associated with maternal toxicity. the no-effect dose for developmental toxicity in mice (10 mg/kg/day) is less than the maximum recommended human dose (mrhd) of 322 mg/day, based on body surface area (mg/m 2 ). in rats, oral administration of amantadine (0, 40 or 120 mg/kg/day) to pregnant animals during organogenesis (gestation days 7-12) resulted in embryolethality and reduced fetal body weight at the highest dose. the no-effect dose for developmental toxicity in this study (40 mg/kg/day) is similar to the mrhd on a mg/m 2 basis. in another study in pregnant rats, oral administration of amantadine during organogenesis (gestation days 7-14) resulted in an increase in visceral and skeletal malformations at oral doses of 50 and 100 mg/kg/day. the no-effect dose for teratogenicity in this study (37 mg/kg/day) is similar to the mrhd on a mg/m 2 basis. evaluation of parturition, lactation, and post-natal development in a limited number of litters from the mouse and rat studies described above revealed reductions in live litter size and pup weights at birth at 40 mg/kg/day in mice and 120 mg/kg/day in rats. risk summary amantadine is excreted in human milk, but amounts have not been quantified. there is no information on the risk to a breastfed infant, and there is insufficient information on the effect of amantadine on milk production in nursing mothers. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for osmolex er and any potential adverse effects on the breastfed infant from osmolex er or from the underlying maternal condition. safety and effectiveness of osmolex er in pediatric patients have not been established. no dose adjustment is recommended on the basis of age. osmolex er is known to be substantially excreted by the kidney, and the risk of adverse reactions 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 [see dosage and administration (2.3)] . because amantadine is mainly excreted in the urine, it accumulates in the plasma and in the body when renal function declines [see clinical pharmacology (12.3)] . osmolex er is contraindicated for use in patients with end-stage renal disease (creatinine clearance below 15 ml/min/1.73 m 2 ). for patients with moderate or severe renal impairment, a reduction in dosing frequency is required. closely monitor these patients (creatinine clearance 15 to less than 60 ml/min/1.73 m 2 ) if prescribed the maximum daily dosage of 322 mg [see dosage and administration (2.3)] . also, closely monitor patients with any degree of renal impairment for adverse reactions and potential changes in renal function, which may necessitate further dosage reduction.

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ax pharmaceutical corp - amantadine hydrochloride (unii: m6q1eo9td0) (amantadine - unii:bf4c9z1j53) -

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bluebay shandong co.,ltd - amantadine hydrochloride (unii: m6q1eo9td0) (amantadine hydrochloride - unii:m6q1eo9td0) -

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food and drug administration - amantadine hydrochloride (unii: m6q1eo9td0) (amantadine - unii:bf4c9z1j53) -

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lake erie medical dba quality care products llc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 150 mg - bupropion hydrochloride extended-release tablets usp, (sr) are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies (14)] . the efficacy of bupropion hydrochloride extended-release tablet (sr) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see clinical studies (14)] . - bupropion hydrochloride extended-release tablets (sr) are contraindicated in patients with a seizure disorder. - bupropion hydrochloride extended-release tablets (sr) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with the immediate-releas

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ncs healthcare of ky, inc dba vangard labs - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 75 mg - bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm) . the efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies (14)]. - bupropion hydrochloride tablets are contraindicated in patients with a seizure disorder. - bupropion hydrochloride tablets are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with bupropion hydrochloride tablets [see warnings and precautions (5.3)]. - bupropion hydrochloride tablets are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see warnings and precautions (5.3) and drug interactions (7.3)].  - th

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preferred pharmaceuticals inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 75 mg - bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies (14)]. pregnancy category c risk summary data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. all pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. no clear evidence of teratogenic activity was found in reproductive developmental studies conducted in rats and rabbits; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at doses approximately equal to the maxim