PRAMIPEXOLE DIHYDROCHLORIDE tablet, extended release PRAMIPEXOLE DIHYDROCHLORIDE- pramipexole dihydrochloride tablet, extended

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Dr. Reddy's Laboratories Limited

INN (Διεθνής Όνομα):

PRAMIPEXOLE DIHYDROCHLORIDE

Σύνθεση:

PRAMIPEXOLE DIHYDROCHLORIDE 0.375 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 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 incidence

Περίληψη προϊόντος:

Pramipexole dihydrochloride extended-release tablets are available as follows:   0. 375 mg: Off white, round shaped, biconvex, uncoated tablet, debossed with 'RDY' on one side and '611' on other side  and are supplied in bottle of 30’s count. Bottles of 30 NDC 55111-611-30  0.75 mg: Off white, round shaped, biconvex, uncoated tablet, debossed with 'RDY' on one side and '612' on other side  and are supplied in bottle of 30’s count. Bottles of 30 NDC 55111-612-30   1.5 mg: Off white, oval shaped, biconvex, uncoated tablet, debossed with 'RDY' on one side and '613' on other side  and are supplied in bottle of 30’s count. Bottles of 30 NDC 55111-613-30  3 mg: Off white, oval shaped, biconvex, uncoated tablet, debossed with 'RDY' on one side and '614' on other side  and are supplied in bottle of 30’s count. Bottles of 30 NDC 55111-614-30  4.5 mg: Off white, oval shaped, biconvex, uncoated tablet, debossed with 'RDY' on one side and '615' on other side  and are supplied in bottle of 30’s count. Bottles of 30 NDC 55111-615-30 ­­Store at 20° to 25°C (68° to 77°F)  [see USP Controlled Room Temperature]. Protect from exposure to high humidity. Store in a safe place out of the reach of children.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

PRAMIPEXOLE DIHYDROCHLORIDE - PRAMIPEXOLE DIHYDROCHLORIDE TABLET,
EXTENDED RELEASE
DR. REDDY'S LABORATORIES LIMITED
----------
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,
Impulse Control/Compulsive Behaviors (5.3) 7/2021
Hallucinations/Psychotic-Like Behavior (5.4) 7/2021
Withdrawal Symptoms (5.11) 7/2021
INDICATIONS AND USAGE
Pramipexole dihydrochloride extended-release tablet is 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 extended-release
pramipexole 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, 3 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: Monitor closely espe