SOLIFENACIN SUCCINATE- solifenacin succiate tablet, film coated SOLIFENACIN SUCCINATE tablet, film coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Proficient Rx LP

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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: 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 the period of organogenesis at a dose resulting in 1.2 times the systemic exposure at the maximum recommended human dose (MRHD) of 10 mg/day. However, administration of doses 3.6 times and greater than the MRHD during organogenesis produced maternal toxicity in the pregnant mice and resulted in developmental toxicity and reduced fetal body weights in offspring [see Data] . In the U.S. general population, the estimated

Резиме производа:

Solifenacin Succinate Tablets are supplied as round, film-coated tablets, biconvex, available in bottles as follows: Each 5 mg tablet is yellow, debossed with ‘AP28’ on one side and plain on the other side and is available as follows: Bottle of 30                 NDC 71205-933-30 Bottle of 60                 NDC 71205-933-60 Bottle of 90                 NDC 71205-933-90 Each 10 mg tablet is yellow, debossed with ‘AP29’ on one side and plain on the other side and is available as follows: Bottle of 30                 NDC 71205-934-30 Bottle of 60                 NDC 71205-934-60 Bottle of 90                 NDC 71205-934-90 Store at 25ºC (77ºF) with excursions permitted from 15ºC to 30ºC (59°F to 86ºF) [see USP Controlled Room Temperature].

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

SOLIFENACIN SUCCINATE- SOLIFENACIN SUCCIATE TABLET, FILM COATED
PROFICIENT RX LP
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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 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
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DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 10 mg ( 3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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:
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•
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Severe renal impairment creatinine clearance < 30 mL/min/1.73 m
. ( 2.2, 8.6)
2
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)
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)
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 heav