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:

Golden State Medical Supply, Inc.

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Solifenacin succinate is 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 ingredients in solifenacin succinate tablets. Reported adverse reactions have included anaphylaxis and angioedema

Vörulýsing:

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: NDC 51407-254-30 bottles of 30 NDC 51407-254-90 bottles of 90 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: NDC 51407-255-30 bottles of 30 NDC 51407-255-90 bottles of 90 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].

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

SOLIFENACIN SUCCINATE- SOLIFENACIN SUCCINATE TABLET, FILM COATED
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
SOLIFENACIN SUCCINATE TABLETS.
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 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 m
. ( 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 succinate 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
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 opera