מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)
Sandoz Inc
PRAMIPEXOLE DIHYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE 0.125 mg
ORAL
PRESCRIPTION DRUG
Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease. None. Pregnancy: Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Pramipexole dihydrochloride tablets 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
Pramipexole dihydrochloride tablets are available as follows: 0.125 mg, white to off-white, uncoated, round shaped tablets, one side debossed with ‘SZ’ and other side debossed with ‘173’. NDC 0781-5248-92, bottle of 90 tablets NDC 0781-5248-13, in unit-of-use pack of 100 tablets (10 blister cards, each containing 10 tablets) 0.25 mg, white to off-white, uncoated, oval shaped tablets, one side debossed with ‘S’ & ‘Z’ on either side of scoreline and other side debossed with ‘17’& ‘4’ on either side of scoreline. NDC 0781-5249-31, bottle of 30 tablets NDC 0781-5249-60, bottle of 60 tablets NDC 0781-5249-92, bottle of 90 tablets NDC 0781-5249-13, in unit-of-use pack of 100 tablets (10 blister cards, each containing 10 tablets) 0.5 mg, white to off-white, uncoated, oval shaped tablets, one side debossed with ‘S’ & ‘Z’ on either side of scoreline and other side debossed with ‘17’ & ‘5’ on either side of scoreline. NDC 0781-5250-31, bottle of 30 tablets NDC 0781-5250-60, bottle of 60 tablets NDC 0781-5250-92, bottle of 90 tablets NDC 0781-5250-13, in unit-of-use pack of 100 tablets (10 blister cards, each containing 10 tablets) 0.75 mg, white to off-white, uncoated, oval shaped tablets, one side debossed with ‘SZ’ and other side debossed with ‘178’. NDC 0781-5281-31, bottle of 30 tablets NDC 0781-5281-60, bottle of 60 tablets NDC 0781-5281-92, bottle of 90 tablets NDC 0781-5281-13, in unit-of-use pack of 100 tablets (10 blister card, containing 10 tablets) 1 mg, white to off-white, uncoated, round shaped tablets, one side debossed with ‘S’ & ‘Z’ on either side of scoreline and other side side debossed with ‘17’ & ‘6’ on either side of scoreline. NDC 0781-5251-31, bottle of 30 tablets NDC 0781-5251-60, bottle of 60 tablets NDC 0781-5251-92, bottle of 90 tablets NDC 0781-5251-13, in unit-of-use pack of 100 tablets (10 blister cards, each containing 10 tablets) 1.5 mg, white of off-white, uncoated, round shaped tablets, one side debossed with ‘S’ & ‘Z’ on either side of scoreline and other side debossed with ‘17’ & ‘7’ on either side of scoreline. NDC 0781-5252-31, bottle of 30 tablets NDC 0781-5252-60, bottle of 60 tablets NDC 0781-5252-92, bottle of 90 tablets NDC 0781-5252-13, in unit-of-use pack of 100 tablets (10 blister cards, each containing 10 tablets) Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from light. Store in a safe place out of the reach of children.
Abbreviated New Drug Application
PRAMIPEXOLE DIHYDROCHLORIDE- PRAMIPEXOLE DIHYDROCHLORIDE TABLET SANDOZ INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PRAMIPEXOLE DIHYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PRAMIPEXOLE DIHYDROCHLORIDE TABLETS . PRAMIPEXOLE DIHYDROCHLORIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1997 RECENT MAJOR CHANGES Warning and Precautions, Hallucinations and Psychotic-like Behavior (5.4) 03/2015 Warning and Precautions, Events Reported with Dopaminergic Therapy (5.9) 03/2015 INDICATIONS AND USAGE Pramipexole dihydrochloride tablets are non-ergot dopamine agonist indicated for the treatment of: • DOSAGE AND ADMINISTRATION Doses should not be increased more frequently than every 5-7 days. Titrate to effective dose. If used with levodopa, may need to reduce levodopa dose. PARKINSON’S DISEASE-NORMAL RENAL FUNCTION* (2.2) WEEK DOSAGE (MG) TOTAL DAILY DOSE (MG) 1 0.125 TID 0.375 2 0.25 TID 0.75 3 0.5 TID 1.5 4 0.75 TID 2.25 5 1 TID 3 6 1.25 TID 3.75 7 1.5 TID 4.5 PARKINSON’S DISEASE-IMPAIRED RENAL FUNCTION (2.2) CREATININE CLEARANCE STARTING DOSE (MG) MAXIMUM DOSE (MG) > 50 mL/min 0.125 TID 1.5 TID 30 to 50 mL/min 0.125 BID 0.75 TID 15 to 30 mL/min 0.125 QD 1.5 QD < 15 mL/min and hemodialysis patients Data not available DOSAGE FORMS AND STRENGTHS Tablets: 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.5 mg (3). CONTRAINDICATIONS None (4) WARNINGS AND PRECAUTIONS • • • • • • ADVERSE REACTIONS Most common adverse reactions (incidence >5% and greater than placebo): Parkinson’s disease (PD) (1.1) * Falling asleep during activities of daily living: Sudden onset of sleep may occur without warning; advise patients to report symptoms (5.1) Symptomatic orthostatic hypotension. Monitor during dose escalation (5.2) Impulse control/Compulsive behaviors: Patients may experience compulsive behaviors and other intense urges (5.3) Hallucinations and Psychotic-like Behavior: May occur; risk increases with age. קרא את המסמך השלם