Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
pramipexole dihydrochloride (UNII: 3D867NP06J) (pramipexole - UNII:83619PEU5T)
Boehringer Ingelheim Pharmaceuticals, Inc.
pramipexole dihydrochloride
pramipexole dihydrochloride 0.125 mg
ORAL
PRESCRIPTION DRUG
MIRAPEX tablets are indicated for the treatment of Parkinson's disease. MIRAPEX tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). None. Risk Summary There are no adequate data on the developmental risk associated with the use of MIRAPEX 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 organogen
MIRAPEX tablets are available as follows: 0.125 mg: white, round, tablet with “BI” on one side and “83” on the reverse side. Bottles of 90 NDC 0597-0183-90 0.25 mg: white, oval, scored tablet with “BI BI” on one side and “84 84” on the reverse side. Bottles of 90 NDC 0597-0184-90 Unit dose packages of 100 NDC 0597-0184-61 0.5 mg: white, oval, scored tablet with “BI BI” on one side and “85 85” on the reverse side. Bottles of 90 NDC 0597-0185-90 Unit dose packages of 100 NDC 0597-0185-61 0.75 mg: white, oval, debossed tablet with “BI” on one side and “101” on the reverse side. Bottles of 90 NDC 0597-0101-90 1 mg: white, round, scored tablet with “BI BI” on one side and “90 90” on the reverse side. Bottles of 90 NDC 0597-0190-90 Unit dose packages of 100 NDC 0597-0190-61 1.5 mg: white, round, scored tablet with “BI BI” on one side and “91 91” on the reverse side. Bottles of 90 NDC 0597-0191-90 Unit dose packages of 100 NDC 0597-0191-61 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Store in a safe place out of the reach of children.
New Drug Application
MIRAPEX- PRAMIPEXOLE DIHYDROCHLORIDE TABLET BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MIRAPEX SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MIRAPEX. MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE TABLETS), FOR ORAL USE INITIAL U.S. APPROVAL: 1997 RECENT MAJOR CHANGES Warnings and Precautions, Withdrawal Symptoms (5.11) 7/2021 INDICATIONS AND USAGE MIRAPEX is a non-ergot dopamine agonist indicated for the treatment of: Parkinson’s disease (PD) (1.1) Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2) 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 Dosing interval is 4-7 days (14 days in patients with CrCl 20-60 mL/min) RESTLESS LEGS SYNDROME (2.3) TITRATION STEP DOSE (MG) 2-3 HOURS BEFORE BEDTIME 1 0.125 2 (if needed) 0.25 3 (if needed) 0.5 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 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 (5.4) Dyskinesia: Ma Læs hele dokumentet