SOLIFENACIN SUCCINATE- solifenacin succinate tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Breckenridge Pharmaceutical, Inc.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Solifenacin Succinate Tablets are a muscarinic antagonist indicated for the treatment of 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) ], - gastric retention [see Warnings and Precautions (5.3) ], - uncontrolled narrow-angle glaucoma [see Warnings and Precautions (5.5) ], and - in patients who have demonstrated hypersensitivity to the drug [see Adverse Reactions (6.2) ]. 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. Administr

Podsumowanie produktu:

Solifenacin Succinate Tablets are supplied as round, film-coated tablets, available in bottles and unit dose blister packages as follows: Each 5 mg tablet is yellow, round, biconvex, film coated tablets debossed with "E5" on one side and plain on other side and is available as follows: Each 10 mg tablet is pink, round, biconvex, film coated tablets debossed with "E7" on one side and plain on other side and is available as follows: Store at 25ºC (77ºF) with excursions permitted from 15ºC to 30ºC (59°F to 86ºF) [see USP Controlled Room Temperature].

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

SOLIFENACIN SUCCINATE- SOLIFENACIN SUCCINATE TABLET
BRECKENRIDGE PHARMACEUTICAL, INC.
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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
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Solifenacin Succinate Tablets are a muscarinic antagonist indicated
for the treatment of overactive bladder with symptoms
of urge urinary incontinence, urgency, and urinary frequency (1)
DOSAGE AND ADMINISTRATION
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:
severe renal impairment [Creatinine Clearance] (CL <30 mL/min) (2.2)
moderate hepatic impairment (Child-Pugh B) (2.3)
concomitant use of potent CYP3A4 inhibitors (2.4)
Use of Solifenacin Succinate Tablets is not recommended in patients
with severe hepatic impairment (Child-Pugh C)
(2.3)
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)
In patients who have demonstrated hypersensitivity to the drug (4,
6.2)
WARNINGS AND PRECAUTIONS
Angioedema and anaphylactic reactions: Reports of angioedema of the
face, lips and/or larynx, in some cases occurring
after the first dose, have been described. Anaphylactic reactions have
been reported rarely (5.1)
Urinary Retention: Administer with caution to patients with clinically
significant bladder outflow obstruction (5.2)
Gastrointestinal Disorders: Use with caution 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 Succinate Tablets affects them (5.4)
Controlled Narrow-Angle Glaucoma: Use with caution in patients bein