Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)
American Health Packaging
PRAMIPEXOLE DIHYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE 0.125 mg
ORAL
PRESCRIPTION DRUG
Pramipexole dihydrochloride tablets are indicated for the treatment of Parkinson's disease. Pramipexole dihydrochloride 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 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) t
Pramipexole Dihydrochloride Tablets, 0.125 mg are pink color, capsule-shaped, flat, beveled-edged, uncoated tablets debossed with 'P1' on one side and plain on other side and are supplied are as follows: Unit dose packages of 30 (5 x 6) NDC 68084-793-25 Pramipexole Dihydrochloride Tablets, 0.25 mg are pale blue color, round, flat, beveled-edged, uncoated tablets debossed with 'P2' on one side and break line on other side and are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-440-01 Pramipexole Dihydrochloride Tablets, 0.5 mg are lavender, capsule-shaped, flat, beveled-edged, uncoated tablets debossed with 'P' breakline '3' on one side and plain on other side and are supplied as follows: Unit dose packages of 30 (5 x 6) NDC 68084-974-25 Pramipexole Dihydrochloride Tablets, 1 mg are light peach to peach, round, flat, beveled-edged, uncoated tablets debossed with 'P4' on one side and break line on other side and are supplied as follows: Unit dose packages of 30 (5 x 6) NDC 68084-982-25 Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. FOR YOUR PROTECTION: Do not use if blister is torn or broken. Store in a safe place out of the reach of children.
Abbreviated New Drug Application
PRAMIPEXOLE DIHYDROCHLORIDE- PRAMIPEXOLE DIHYDROCHLORIDE TABLET AMERICAN HEALTH PACKAGING ---------- 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 Warnings and Precautions, Postural Deformity ( 5.6) 5/2018 Warnings and Precautions, Rhabdomyolysis ( 5.8) 5/2018 Warnings and Precautions, Events Reported with Dopaminergic Therapy ( 5.10); Melanoma Removed 5/2018 INDICATIONS AND USAGE Pramipexole dihydrochloride tablets are 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 * 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 * RESTLESS LEG SYNDROME ( 2.3) TITRATION STEP DOSE (MG) 2 TO 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, 1 mg, and 1.5 mg ( 3). CONTRAINDICATIONS None ( 4) WARNINGS AND PRECAUTIONS Doses should not be increased more frequently than every 5 to 7 days. T itrate to effective dose. If used with levodopa, may need to reduce levodopa dose. * Dosing interval is 4 days to 7 days (14 days in patients with CrCl 20 mL/min to 60 mL/min * 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) Symptom Izlasiet visu dokumentu