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:

ScieGen 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 pramipexo

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 50228-126-90, bottle of 90 tablets NDC 50228-126-10, bottle 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 50228-127-90, bottle of 90 tablets NDC 50228-127-10, bottle 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 50228-128-90, bottle of 90 tablets NDC 50228-128-10, bottle 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 50228-129-90, bottle of 90 tablets NDC 50228-129-10, bottle 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 50228-130-90, bottle of 90 tablets NDC 50228-130-10, bottle 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 50228-131-90, bottle of 90 tablets NDC 50228-131-10, bottle 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
SCIEGEN 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, Withdrawal Symptoms ( 5.11)
7/2021
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
BEDTIME
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
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 Contr