SOLIFENACIN SUCCINATE tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Lannett Company, Inc.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 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 pregna

Περίληψη προϊόντος:

Solifenacin succinate tablets are supplied as round, film-coated tablets, available in bottles as follows:  Each 5 mg tablet is round, yellow coated tablet debossed with “33” on one side and “LCI” on the other side and is available as follows: Bottle of 30                                 NDC 0527-1933-30 Bottle of 90                                 NDC 0527-1933-09 Bottle of 1000                             NDC 0527-1933-10 Each 10 mg tablet is round, beige coated tablet debossed with “34” on one side and “LCI” on the other side and is available as follows: Bottle of 30                                 NDC 0527-1934-30 Bottle of 90                                 NDC 0527-1934-09 Bottle of 1000                             NDC 0527-1934-10 Store at 20º to 25ºC (68° to 77ºF) [See USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

SOLIFENACIN SUCCINATE- SOLIFENACIN SUCCINATE TABLET, FILM COATED
LANNETT COMPANY, 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 tablets 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
tablets are 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 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 succinate
tablets affect them. (5.4)
Cont