PRAMIPEXOLE DIHYDROCHLORIDE tablet
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
05-07-2023
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Active ingredient:
PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)
Available from:
Torrent Pharmaceuticals Limited
INN (International Name):
PRAMIPEXOLE DIHYDROCHLORIDE
Composition:
PRAMIPEXOLE DIHYDROCHLORIDE 0.125 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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 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, o
Product summary:
Pramipexole Dihydrochloride Tablets are available as follows: Pramipexole Dihydrochloride Tablets 0.125 mg are white to off white, round, flat, bevel edged, uncoated tablets with "91" debossed on one side and plain on other side. Bottles of 30 NDC 13668-091-30 Bottles of 90 NDC 13668-091-90 Bottles of 500 NDC 13668-091-05 Bottles of 6,000 NDC 13668-091-42 Pramipexole Dihydrochloride Tablets 0.25 mg are peach colored, round, flat, bevel edged, uncoated tablets with "9/2" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-092-30 Bottles of 90 NDC 13668-092-90 Bottles of 500 NDC 13668-092-05 Bottles of 5,500 NDC 13668-092-41 Pramipexole Dihydrochloride Tablets 0.5 mg are reddish brown colored, round, biconvex, uncoated tablets with "9/3" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-093-30 Bottles of 90 NDC 13668-093-90 Bottles of 500 NDC 13668-093-05 Bottles of 4,000 NDC 13668-093-40 Pramipexole Dihydrochloride Tablets 0.75 mg are yellow colored, round, flat, bevel edged, uncoated tablets with "84" debossed on one side and plain on other side. Bottles of 30 NDC 13668-184-30 Bottles of 90 NDC 13668-184-90 Bottles of 500 NDC 13668-184-05 Bottles of 2,500 NDC 13668-184-31 Pramipexole Dihydrochloride Tablets 1 mg are light pink colored, round, flat, bevel edged, uncoated tablets with "9/4" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-094-30 Bottles of 90 NDC 13668-094-90 Bottles of 500 NDC 13668-094-05 Bottles of 2,500 NDC 13668-094-31 Pramipexole Dihydrochloride Tablets 1.5 mg are white to off white, round, flat, bevel edged, uncoated tablets with "9/5" debossed on one side and breakline on other side. Bottles of 30 NDC 13668-095-30 Bottles of 90 NDC 13668-095-90 Bottles of 500 NDC 13668-095-05 Bottles of 1,500 NDC 13668-095-15 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light. Store in a safe place out of the reach of children.
Authorization status:
Abbreviated New Drug Application
Summary of Product characteristics
PRAMIPEXOLE DIHYDROCHLORIDE- PRAMIPEXOLE DIHYDROCHLORIDE TABLET
TORRENT PHARMACEUTICALS LIMITED
----------
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,Withdrawal symptoms (5.11) 7/2021
INDICATIONS AND USAGE
Pramipexole dihydrochloride tablets are 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
* Doses should not be increased more frequently than every 5 to 7
days. Titrate to effective dose. If used
with levodopa, may need to reduce levodopa dose.
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 LEGS 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
* Dosing interval is 4 to 7 days (14 days in patients with CrCl 20 to
60 mL/min)
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
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