SOLIFENACIN SUCCINATE tablet, film coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

SOLIFENACIN SUCCINATE (UNII: KKA5DLD701) (SOLIFENACIN - UNII:A8910SQJ1U)

Fáanlegur frá:

Unichem Pharmaceuticals (USA), Inc.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate is contraindicated in patients: • With urinary retention [see Warnings and Precautions (5.2) ], • With gastric retention [see Warnings and Precautions (5.3) ], • With uncontrolled narrow-angle glaucoma [see Warnings and Precautions (5.5) ], and • Who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingradients in solifenacin succinate. Reported adverse reactions have included anaphylaxis and angioedema [see Adverse Reactions (6.2) ]. Risk Summary There are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. No adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during the period o

Vörulýsing:

Solifenacin succinate tablets are supplied as round, biconvex, film-coated tablets, available in bottle packages as follows: Each 5 mg tablet is light yellow and debossed with "U" on one side and "328" on the other side and is available as follows: Bottle of 30                                                NDC 29300-328-13 Bottle of 90                                                NDC 29300-328-19 Bottle of 500                                              NDC 29300-328-05 Each 10 mg tablet is light pink and debossed with "U" on one side and "329" on the other side and is available as follows: Bottle of 30                                                NDC 29300-329-13 Bottle of 90                                                NDC 29300-329-19 Bottle of 500                                              NDC 29300-329-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

SOLIFENACIN SUCCINATE - SOLIFENACIN SUCCINATE TABLET, FILM COATED
UNICHEM PHARMACEUTICALS (USA), INC.
----------
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 tablets are a muscarinic antagonist indicated
for the treatment of adults with
overactive bladder with symptoms of urge urinary incontinence,
urgency, and urinary frequency. (1)
DOSAGE AND ADMINISTRATION
• 5 mg tablet taken orally once daily, and if well tolerated may be
increased to 10 mg once daily. (2.1)
• Do not exceed the 5 mg dose of solifenacin succinate in patients
with:
• Severe renal impairment creatinine clearance< 30 mL/min/1.73 m2.
(2.2, 8.6)
• Moderate hepatic impairment (Child-Pugh B). Solifenacin succinate
is not recommended in patients with
severe hepatic impairment (Child-Pugh C). (2.3, 8.7)
• Concomitant use of strong CYP3A4 inhibitors. (2.4, 7.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 10 mg (3).
CONTRAINDICATIONS
• Urinary retention. (4, 5.2)
• Gastric retention. (4, 5.3)
• Uncontrolled narrow-angle glaucoma. (4, 5.5)
• Hypersensitivity to this product or any of its components. (4,
5.1, 6.2)
WARNINGS AND PRECAUTIONS
● Angioedema and Anaphylactic Reactions: Promptly discontinue
solifenacin and provide appropriate
therapy. (5.1)
● Urinary Retention: Solifenacin succinate is not recommended for
use in patients with clinically significant
bladder outlet obstruction. (5.2)
● Gastrointestinal Disorders: Solifenacin succinate is not
recommended for use in patients with decreased
gastrointestinal motility. (5.3)
● Central Nervous System Effects: Somnolence has been reported with
solifenacin succinate. Advise
patients not to drive or operate heavy machinery until they know how
solifenacin succinate affects them.
(5.4)
● Con