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osmolex er- amantadine tablet, extended release osmolex er- amantadine kit

vertical pharmaceuticals, llc - amantadine (unii: bf4c9z1j53) (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 m 2 ) [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

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

osmolex er- amantadine tablet, extended release

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.