PRAMIPEXOLE DIHYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PRAMIPEXOLE DIHYDROCHLORIDE (UNII: 3D867NP06J) (PRAMIPEXOLE - UNII:83619PEU5T)

Available from:

Vensun Pharmaceuticals, Inc.

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 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)

Product summary:

Pramipexole dihydrochloride tablets are available as follows: 0.125 mg, white to off-white, round, flat, beveled edge uncoated tablets, debossed with ‘SG’ on one side ‘126’ on other side. NDC 42543-704-90: Bottles of 90 tablets NDC 42543-704-05: Bottles of 500 tablets NDC 42543-704-10: Bottles of 1000 tablets 0.25 mg, white to off white, oval, flat, beveled edge uncoated functional scored tablets debossed on one side with ‘S’ on the left side of bisect and ‘G’ on the right side of bisect and other side ‘1’ on the left side and ‘27’ on the right side of the bisect. NDC 42543-705-90: Bottles of 90 tablets NDC 42543-705-05: Bottles of 500 tablets NDC 42543-705-10: Bottles of 1000 tablets 0.5 mg, white to off white, oval, flat, beveled edge uncoated functional scored tablets debossed on one side with ‘S’ on the left side of bisect and ‘G’ on the right side of bisect and other side ‘1’ on the left side and ‘28’ on the right side of the bisect. NDC 42543-706-90: Bottles of 90 tablets NDC 42543-706-05: Bottles of 500 tablets NDC 42543-706-10: Bottles of 1000 tablets 0.75 mg, white to off white, oval, flat, beveled edge uncoated tablets, debossed with ‘SG’ on one side ‘129’ on other side. NDC 42543-707-90: Bottles of 90 tablets NDC 42543-707-05: Bottles of 500 tablets NDC 42543-707-10: Bottles of 1000 tablets 1.0 mg, white to off white, oval, flat, beveled edge uncoated functional scored tablets debossed on one side with ‘S’ on the left side of bisect and ‘G’ on the right side of bisect and other side ‘1’ on the left side and ‘30’ on the right side of the bisect. NDC 42543-708-90: Bottles of 90 tablets NDC 42543-708-05: Bottles of 500 tablets NDC 42543-708-10: Bottles of 1000 tablets 1.5 mg, white to off white, oval, flat, beveled edge uncoated functional scored tablets debossed on one side with ‘S’ on the left side of bisect and ‘G’ on the right side of bisect and other side ‘1’ on the left side and ‘31’ on the right side of the bisect. NDC 42543-709-90: Bottles of 90 tablets NDC 42543-709-05: Bottles of 500 tablets NDC 42543-709-10: Bottles of 1000 tablets Store at 20 ºC to 25ºC (68 ºF to 77ºF); (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
VENSUN PHARMACEUTICALS, 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
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
* 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-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) 2-3 HOURS BEFORE
BE DTIME
1
0.125
2 (if needed)
0.25
3 (if needed)
0.5
*Dosing interval is 4-7 days (14 days in patients with CrCl 20-60
mL/min)
DOSAGE FORMS AND STRENGTHS
Tablets: 0.125 mg, 0.25 mg (functional scored tablets), 0.5 mg
(functional scored tablets), 0.75 mg, 1 mg (functional scored
tablets), and 1.5 mg (functional scored tablets) (3).
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
*
WARNINGS AND PRECAUTIONS
Falling asleep during activities of daily living: Sudden