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

carilion materials management - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 1.5 mg - pramipexole dihydrochloride tablets are indicated for the treatment of parkinson's disease. none. pregnancy category c there are no adequate and well-controlled studies in pregnant women. pramipexole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. when pramipexole was given to female rats throughout pregnancy, implantation was inhibited at a dose of 2.5 mg/kg/day (5 times the maximum recommended human dose (mrhd) for parkinson's disease of 4.5 mg/day on a body surface area (mg/m2 ) basis). administration of 1.5 mg/kg/day of pramipexole to pregnant rats during the period of organogenesis (gestation days 7 through 16) resulted in a high incidence of total resorption of embryos. the plasma auc in rats at this dose was 4 times the auc in humans at the mrhd. these findings are thought to be due to the prolactin-lowering effect of pramipexole, since prolactin is necessary for implantation and maintenance of early pregnancy in rats (but not rabbits or humans).

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

a-s medication solutions - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride tablets are indicated for the treatment of parkinson's disease. none. risk summary there are no adequate data on the developmental risk associated with the use of pramipexole in pregnant women. no adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see data]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of pramipexole (0.1, 0.5, or 1.5 mg/kg/day) to pregnant rats during the period of organogenesis resulted in a high incidence of total resorption of embryos at the highest dose tested. thi

New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - pramipexole hydrochloride monohydrate 0.125mg - tablet - 0.125 mg - active: pramipexole hydrochloride monohydrate 0.125mg excipient: magnesium stearate maize starch microcrystalline cellulose - · the symptomatic treatment of primary (idiopathic) restless legs syndrome.

New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - pramipexole hydrochloride monohydrate 0.25mg - tablet - 0.25 mg - active: pramipexole hydrochloride monohydrate 0.25mg excipient: magnesium stearate maize starch microcrystalline cellulose - · the symptomatic treatment of primary (idiopathic) restless legs syndrome.

New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - pramipexole hydrochloride monohydrate 0.5mg - tablet - 0.5 mg - active: pramipexole hydrochloride monohydrate 0.5mg excipient: magnesium stearate maize starch microcrystalline cellulose - · the symptomatic treatment of primary (idiopathic) restless legs syndrome.

New Zealand - English - Medsafe (Medicines Safety Authority)

apotex nz ltd - pramipexole hydrochloride monohydrate 1mg - tablet - 1 mg - active: pramipexole hydrochloride monohydrate 1mg excipient: magnesium stearate maize starch microcrystalline cellulose - · the symptomatic treatment of primary (idiopathic) restless legs syndrome.

Canada - English - Health Canada

sivem pharmaceuticals ulc - pramipexole dihydrochloride monohydrate - tablet - 0.25mg - pramipexole dihydrochloride monohydrate 0.25mg - nonergot-derivative dopamine receptor agonists

Canada - English - Health Canada

sivem pharmaceuticals ulc - pramipexole dihydrochloride monohydrate - tablet - 0.5mg - pramipexole dihydrochloride monohydrate 0.5mg - nonergot-derivative dopamine receptor agonists

Canada - English - Health Canada

sivem pharmaceuticals ulc - pramipexole dihydrochloride monohydrate - tablet - 1mg - pramipexole dihydrochloride monohydrate 1mg - nonergot-derivative dopamine receptor agonists

Canada - English - Health Canada

sivem pharmaceuticals ulc - pramipexole dihydrochloride monohydrate - tablet - 1.5mg - pramipexole dihydrochloride monohydrate 1.5mg - nonergot-derivative dopamine receptor agonists