SOLIFENACIN SUCCINATE tablet, coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Alembic Pharmaceuticals Inc.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Solifenacin succinate tablet is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate tablets are 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 [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

Produktbesonderheiten:

Solifenacin succinate tablets 5 mg are creamish to light yellow, round, film-coated tablets, debossed with “L” on one side and “431” on other side. They are supplied as follows: NDC 62332-192-30                   Bottle of 30                                  NDC 62332-192-90                   Bottle of 90                                          NDC 62332-192-91                   Bottle of 1000                                                     NDC 62332-192-08                    Carton of 80 (10 x 8) unit-dose tablets Solifenacin succinate tablets 10 mg are light pink, round, film-coated tablets, debossed with “L” on one side and “432” on other side. They are supplied as follows: NDC 62332-193-30                   Bottle of 30                                  NDC 62332-193-90                   Bottle of 90                                          NDC 62332-193-91                   Bottle of 1000                                                     NDC 62332-193-08                    Carton of 80 (10 x 8) unit-dose tablets Store at 25ºC (77ºF) with excursions permitted from 15ºC to 30ºC (59°F to 86ºF) [see USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

SOLIFENACIN SUCCINATE - SOLIFENACIN SUCCINATE TABLET, COATED
ALEMBIC PHARMACEUTICALS 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 muscarinic antagonist indicated for
the treatment of adults with
overactive bladder with symptoms of urge urinary incontinence,
urgency, and urinary frequency. (1) (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)
(2)
● Do not exceed the 5 mg dose of solifenacin succinate tablets in
patients with: (2)
o Severe renal impairment creatinine clearance <30 mL/min/1.73 m (2.2,
8.6). (2)
o Moderate hepatic impairment (Child-Pugh B). Solifenacin succinate
tablets are not recommended
in patient with severe hepatic impairment (Child-Pugh C). (2.3, 8.7).
(2)
o Concomitant use of strong CYP3A4 inhibitors. (2.4, 7.1) (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 10 mg. (3) (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 tablets and
provide appropriate therapy. (5.1)
Urinary Retention: Solifenacin succinate tablets are not recommended
for use in patients with clinically
significant bladder outlet obstruction. (5.2)
Gastrointestinal Disorders: Solifenacin succinate tablets are not
recommended for use in patients
with decreased gastrointestinal motility. (5.3)
Central Nervous System Effects: Somnolence has been reported with
solifenacin succinate tablets.
Advise patients not to drive or operate heavy machinery until they
know how solifenacin