SOLIFENACIN SUCCINATE tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

Solifenacin Succinate (UNII: KKA5DLD701) (Solifenacin - UNII:A8910SQJ1U)

Verfügbar ab:

Proficient Rx LP

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Solifenacin succinate is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate is contraindicated in patients with: Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Reproduction studies have been performed in mice, rats and rabbits. After oral administration of 14 C-solifenacin succinate to pregnant mice, drug-related material was shown to cross the placental barrier. No embryotoxicity or teratogenicity was observed in mice treated with 1.2 times (30 mg/kg/day) the expected exposure at the maximum recommended human dose [MRHD] of 10 mg. Administration of solifenacin succinate to pregnant mice at 3.6 times and greater (100 mg/kg/day and greater) the exposure at the MRHD, during the major period of organ development resulted in reduced fetal body weights. Administration of 7.9 times (250 mg/kg/day) the MRHD to pregnant mice resulted in an increased incide

Produktbesonderheiten:

Solifenacin succinate tablets, 5 mg, are light yellow, round, film coated tablets debossed with 'SG' on one side and '427' on other side. They are supplied as follows: Solifenacin succinate tablets, 10 mg, are light pink, round, film coated tablets debossed with 'SG' on one side and '428' on other side. They are supplied as follows: Store at 25°C (77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Protect from moisture.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

SOLIFENACIN SUCCINATE- SOLIFENACIN SUCCINATE TABLET, FILM COATED
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SOLIFENACIN SUCCINATE TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SOLIFENACIN
SUCCINATE TABLETS.
SOLIFENACIN SUCCINATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Solifenacin succinate is a muscarinic antagonist indicated for the
treatment of overactive bladder with symptoms of urge
urinary incontinence, urgency, and urinary frequency (1).
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 10 mg (3).
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions (> 4% and > placebo) were dry mouth,
and constipation at both 5 mg and 10 mg
doses; and urinary tract infection, and blurred vision at the 10 mg
dose (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WESTMINSTER
PHARMACEUTICALS, LLC AT 1-844-221-7294
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
_Pregnancy and Nursing Mothers:_ Solifenacin succinate should be used
during pregnancy only if the potential benefit for the
mother justifies the potential risk to the fetus. Solifenacin
succinate should not be administered during nursing (8.1, 8.3).
_Pediatric Use:_ The safety and effectiveness of solifenacin succinate
in pediatric patients have not been established (8.4).
5 mg tablet taken once daily, and if well tolerated may be increased
to 10 mg once daily (2.1).
Do not exceed 5 mg tablet once daily in patients with:
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severe renal impairment [Creatinine Clearance] (CL < 30 mL/min) (2.2).
cr
moderate hepatic impairment (Child-Pugh B) (2.3).
concomitant use of potent CYP3A4 inhibitors (2.4).
Use of solifenacin succinate is not recommended in patients with
severe hepatic impairment (Child-Pugh C) (2.3).
Urinary retention (4, 5.2).
Gastric rete