Canada - English - Health Canada

avanstra inc - pramipexole dihydrochloride monohydrate - tablet - 0.25mg - pramipexole dihydrochloride monohydrate 0.25mg - nonergot-derivative dopamine receptor agonists

Canada - English - Health Canada

avanstra inc - pramipexole dihydrochloride monohydrate - tablet - 0.5mg - pramipexole dihydrochloride monohydrate 0.5mg - nonergot-derivative dopamine receptor agonists

Canada - English - Health Canada

avanstra inc - pramipexole dihydrochloride monohydrate - tablet - 1.0mg - pramipexole dihydrochloride monohydrate 1.0mg - nonergot-derivative dopamine receptor agonists

Canada - English - Health Canada

avanstra inc - pramipexole dihydrochloride monohydrate - tablet - 1.5mg - pramipexole dihydrochloride monohydrate 1.5mg - nonergot-derivative dopamine receptor agonists

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

southern cross pharma pty ltd - pramipexole dihydrochloride monohydrate -

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

southern cross pharma pty ltd - pramipexole dihydrochloride monohydrate -

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

alembic pharmaceuticals limited - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride tablets are indicated for the treatment of  parkinson’s disease. none.    pregnancy category c   risk summary there are no adequate data on the developmental risk associated with the use of pramipexole dihydrochloride tablets 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 to 4% and 15 to 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. this increase in embryolethality is thought to result from the prolactin-lowering effect of pramipexole; prolactin is necessary for implantation and maintenance of early pregnancy in rats but not rabbits or humans. because of pregnancy disruption and early embryonic loss in this study, the teratogenic potential of pramipexole could not be adequately assessed in rats. the highest no-effect dose for embryolethality in rats was associated with maternal plasma drug exposures (auc) approximately equal to those in humans receiving the maximum recommended human dose (mrhd) of 4.5 mg/day. there were no adverse effects on embryo-fetal development following oral administration of pramipexole (0.1, 1, and 10 mg/kg/day) to pregnant rabbits during organogenesis (plasma auc up to approximately 70 times that in humans at the mrhd). postnatal growth was inhibited in the offspring of rats treated with pramipexole (0.1, 0.5, or 1.5 mg/kg/day) during the latter part of pregnancy and throughout lactation. the no-effect dose for adverse effects on offspring growth (0.1 mg/kg/day) was associated with maternal plasma drug exposures lower than that in humans at the mrhd. risk summary there are no data on the presence of pramipexole in human milk, the effects of pramipexole on the breastfed infant, or the effects of pramipexole on milk production. however, inhibition of lactation is expected because pramipexole inhibits secretion of prolactin in humans. pramipexole or metabolites, or both, are present in rat milk [see data] . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for pramipexole dihydrochloride tablets and any potential adverse effects on the breastfed infant from pramipexole dihydrochloride tablets or from the underlying maternal condition. data in a study of radio-labeled pramipexole, pramipexole or metabolites, or both, were present in rat milk at concentrations three to six times higher than those in maternal plasma. safety and effectiveness of pramipexole dihydrochloride tablets in pediatric patients has not been established. pramipexole total oral clearance is approximately 30% lower in subjects older than 65 years compared with younger subjects, because of a decline in pramipexole renal clearance due to an age-related reduction in renal function. this resulted in an increase in elimination half-life from approximately 8.5 hours to 12 hours. in clinical studies with parkinson’s disease patients, 38.7% of patients were older than 65 years. there were no apparent differences in efficacy or safety between older and younger patients, except that the relative risk of hallucination associated with the use of pramipexole dihydrochloride tablets was increased in the elderly. the elimination of pramipexole is dependent on renal function. pramipexole clearance is extremely low in dialysis patients, as a negligible amount of pramipexole is removed by dialysis. caution should be exercised when administering pramipexole dihydrochloride tablets to patients with renal disease [see dosage and administration (2.2), warnings and precautions (5.6), and clinical pharmacology (12.3) ].

Canada - English - Health Canada

pharmascience inc - pramipexole dihydrochloride monohydrate - tablet - 0.25mg - pramipexole dihydrochloride monohydrate 0.25mg - nonergot-derivative dopamine receptor agonists

Canada - English - Health Canada

pharmascience inc - pramipexole dihydrochloride monohydrate - tablet - 0.50mg - pramipexole dihydrochloride monohydrate 0.50mg - nonergot-derivative dopamine receptor agonists

Canada - English - Health Canada

pharmascience inc - pramipexole dihydrochloride monohydrate - tablet - 1.0mg - pramipexole dihydrochloride monohydrate 1.0mg - nonergot-derivative dopamine receptor agonists