PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE- pramipexole tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Par Pharmaceutical, Inc.

INN (International Name):

PRAMIPEXOLE DIHYDROCHLORIDE

Composition:

PRAMIPEXOLE DIHYDROCHLORIDE 0.375 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Pramipexole Dihydrochloride Extended-Release Tablets are indicated for the treatment of Parkinson's disease. None. Risk Summary There are no adequate data on the developmental risk associated with the use of pramipexole dihydrochloride extended-release 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, or 1.5 mg/kg/day) to pregnant rats during the period of organogenesis resulted in a high inciden

Product summary:

Pramipexole Dihydrochloride Extended-Release Tablets are available as follows: 0.375 mg : white to off-white round film-coated tablets engraved with “251” on one side and plain on the other side. Bottles of 30….NDC 10370-251-11 0.75 mg : white to off-white round film-coated tablets engraved with “252” on one side and plain on the other side. Bottles of 30….NDC 10370-252-11 1.5 mg : white to off-white oval film-coated tablets engraved with “253” on one side and plain on the other side. Bottles of 30….NDC 10370-253-11 2.25 mg : white to off-white oval film-coated tablets engraved with “305” on one side and plain on the other side Bottles of 30….NDC 10370-305-11 3 mg : white to off-white oval film-coated tablets engraved with “254” on one side and plain on the other side. Bottles of 30….NDC 10370-254-11 3.75 mg : white to off-white oval film-coated tablets engraved with “306” on one side and plain on the other side. Bottles of 30….NDC 10370-306-11 4.5 mg : white to off-white oval film-coated tablets engraved with “255” on one side and plain on the other side. Bottles of 30….NDC 10370-255-11 Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Protect from exposure to high humidity. Store in a safe place out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE- PRAMIPEXOLE TABLET,
EXTENDED RELEASE
PAR PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PRAMIPEXOLE
DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS.
PRAMIPEXOLE DIHYDROCHLORIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Warnings and Precautions, Postural Deformity (5.6)
5/2018
Warnings and Precautions,
Events Reported with Dopaminergic Therapy (5.10);
Melanoma
Removed 5/2018
INDICATIONS AND USAGE
Pramipexole dihydrochloride extended-release tablets are a non-ergot
dopamine agonist indicated for the
treatment of Parkinson’s disease (PD) (1)
DOSAGE AND ADMINISTRATION
Pramipexole Dihydrochloride Extended-Release Tablets are taken once
daily, with or without food (2.1)
Tablets must be swallowed whole and must not be chewed, crushed, or
divided (2.1)
Starting dose is 0.375 mg given once daily (2.2)
Dose may be increased gradually, not more frequently than every 5 to 7
days, first to 0.75 mg per day
and then by 0.75 mg increments up to a maximum recommended dose of 4.5
mg per day. Assess
therapeutic response and tolerability at a minimal interval of 5 days
or longer after each dose
increment (2.2)
Patients may be switched overnight from immediate-release pramipexole
tablets to pramipexole
dihydrochloride extended-release tablets at the same daily dose. Dose
adjustment may be needed in
some patients (2.3)
Pramipexole dihydrochloride extended-release tablets should be
discontinued gradually (2.2)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg,
3.75 mg, and 4.5 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: