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:

Sunshine Lake Pharma Co., Ltd.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Solifenacin succinate is a muscarinic antagonist indicated for the treatment of 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)] , - 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-solifena

Περίληψη προϊόντος:

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 white or almost white and debossed with “C2” on one side and blank on the other side, and is available as follows: Bottle of 30 NDC 48792-7909-1 Bottle of 90 NDC 48792-7909-2 Each 10 mg tablet is white or almost white and debossed with “C77” on one side and blank on the other side, and is available as follows: Bottle of 30 NDC 48792-7910-1 Bottle of 90 NDC 48792-7910-2 Store at 20ºC to 25ºC (68ºF-77ºF) with excursions permitted from 15ºC to 30ºC (59°F-86ºF) [see USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

SOLIFENACIN SUCCINATE- SOLIFENACIN SUCCINATE TABLET, FILM COATED
SUNSHINE LAKE PHARMA CO., LTD.
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Solifenacin succinate is 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 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. Advise patients not to
drive or operate heavy machinery until they know how solifenacin
succinate affects them ( 5.4).
Controlled Narrow-Angle Glaucoma: Use with ca