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

lake erie medical dba quality care products llc - selegiline hydrochloride (unii: 6w731x367q) (selegiline - unii:2k1v7gp655) - selegiline hydrochloride 5 mg

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

proficient rx lp - selegiline hydrochloride (unii: 6w731x367q) (selegiline - unii:2k1v7gp655) - selegiline capsules, usp are indicated as an adjunct in the management of parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. there is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy. evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa. selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of ‘off’ time, and patient self-rating of treatment success. beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and co

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

rising pharma holdings, inc. - selegiline hydrochloride (unii: 6w731x367q) (selegiline - unii:2k1v7gp655) - selegiline capsules, usp are indicated as an adjunct in the management of parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. there is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy. evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa. selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of ‘off’ time, and patient self-rating of treatment success. beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and co

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

bausch health us, llc - selegiline hydrochloride (unii: 6w731x367q) (selegiline - unii:2k1v7gp655) - selegiline hydrochloride 1.25 mg - zelapar is indicated as an adjunct in the management of patients with parkinson’s disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. there is no evidence from controlled studies that zelapar has any beneficial effect in the absence of concurrent levodopa therapy [see clinical studies (14) ]. zelapar is contraindicated in patients with: risk summary there are no adequate data on the developmental risk associated with the use of zelapar in pregnant women. in animal studies, administration of selegiline during pregnancy was associated with developmental toxicity (decreased embryofetal and postnatal offspring growth and survival) at doses greater than those used clinically. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage in the indicated population is u

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

sandoz inc - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - methylphenidate hydrochloride 5 mg - methylphenidate hydrochloride and methylphenidate hydrochloride sustained-release are indicated for the treatment of: • attention deficit hyperactivity disorders (adhd) in pediatric patients 6 years and older and adults • narcolepsy pregnancy category c in studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. teratogenic effects (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 40 times the maximum recommended human dose (mrhd) on a mg/m2 basis. the no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (11 times the mrhd on a mg/m2 basis). there was no evidence of specific teratogenic activity in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (7 times the mrhd on a mg/m2 basis), which was also maternally toxic. the no effect level for embryo-fetal development

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

a-s medication solutions - selegiline hydrochloride (unii: 6w731x367q) (selegiline - unii:2k1v7gp655) - selegiline hydrochloride tablets usp are indicated as an adjunct in the management of parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. there is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy. evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa. selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of 'off' time, and patient self-rating of treatment success. beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking

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

a2a integrated pharmaceuticals - selegiline hydrochloride (unii: 6w731x367q) (selegiline - unii:2k1v7gp655) - selegiline hydrochloride tablets, usp are indicated as an adjunct in the management of parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. there is no evidence from controlled studies that selegiline has any beneficial effect in the absence of concurrent levodopa therapy. evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa. selegiline was significantly superior to placebo on all three principal outcome measures employed: change from baseline in daily levodopa/carbidopa dose, the amount of ‘off’ time and patient self-rating of treatment success. beneficial effects were also observed on other measures of treatment success (e.g., measures of reduced end of dose akinesia, decreased tremor and sialorrhea, improved speech and dressing ability and improved overall disability as assessed by walking and comparison to previous state). selegiline hydrochloride is contraindicated in patients with a known hypersensitivity to this drug. selegiline is contraindicated for use with meperidine. this contraindication is often extended to other opioids. (see drug interactions .)

Australia - English - Department of Health (Therapeutic Goods Administration)

orion pharma (aus) pty limited - selegiline hydrochloride, quantity: 5 mg - tablet, uncoated - excipient ingredients: magnesium stearate; povidone; maize starch; microcrystalline cellulose; mannitol - as an adjunct in the management of late stage parkinson's disease in patients being treated with levodopa and/or a peripheral decarboxylase inhibitor, who exhibit deterioration in the quality of their response to the therapy. indications as approved 22 january 1999 - eldepryl is indicated for the treatment of patients with parkinson's disease. it can be used as monotherapy in the early phases of the disease and as adjunctive therapy with levodopa (with/without a peripheral decarboxylase inhibitor) as an adjunct in the management of late stage parkinson's disease in patients being treated with levodopa and/or a peripheral decarboxylase inhibitor, who exhibit deterioration in the quality of their response to the therapy. indications as approved 22 january 1999 - eldepryl is indicated for the treatment of patients with parkinson's disease. it can be used as monotherapy in the early phases of the disease and as adjunctive therapy with levodopa (with/without a peripheral decarboxylase inhibitor)

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - selegiline hydrochloride -

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

zoetis inc. - selegiline hydrochloride (unii: 6w731x367q) (selegiline - unii:2k1v7gp655) - selegiline hydrochloride 2 mg - anipryl tablets are indicated for the control of clinical signs associated with canine cognitive dysfunction syndrome (cds) and control of clinical signs associated with uncomplicated canine pituitary dependent hyperadrenocorticism (pdh). anipryl is contraindicated in patients with known hypersensitivity to this drug.  in humans, selegiline is contraindicated for use with meperidine and this contraindication is often extended to other opioids.