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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Solifenacin Succinate Tablets is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin 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-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. Administration of solifenacin succinate to pregnant mice at 3.6 times and greater (100 mg/kg/day and greater) the exposure at the MRHD, during the major period of organ development resulted in reduced fetal body weights. Administration of 7.9 times (250 mg/kg/day) the MRHD to pregnant mice resulted in an increased incidence of cleft palate. In utero and lactational exposures to maternal doses of solifenacin succinate of 3.6 times (100 mg/kg/day) the MRHD resulted in reduced peripartum and postnatal survival, reductions in body weight gain, and delayed physical development (eye opening and vaginal patency). An increase in the percentage of male offspring was also observed in litters from offspring exposed to maternal doses of 250 mg/kg/day. No embryotoxic effects were observed in rats at up to 50 mg/kg/day (<1 times the exposure at the MRHD) or in rabbits at up to 1.8 times (50 mg/kg/day) the exposure at the MRHD. Because animal reproduction studies are not always predictive of human response, Solifenacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The effect of Solifenacin on labor and delivery in humans has not been studied. There were no effects on natural delivery in mice treated with 1.2 times (30 mg/kg/day) the expected exposure at the maximum recommended human dose [MRHD] of 10 mg. Administration of solifenacin succinate at 3.6 times (100 mg/kg/day) the exposure at the MRHD or greater increased peripartum pup mortality. After oral administration of 14 C-solifenacin succinate to lactating mice, radioactivity was detected in maternal milk. There were no adverse observations in mice treated with 1.2 times (30 mg/kg/day) the expected exposure at the maximum recommended human dose [MRHD]. Pups of female mice treated with 3.6 times (100 mg/kg/day) the exposure at the MRHD or greater revealed reduced body weights, postpartum pup mortality or delays in the onset of reflex and physical development during the lactation period. It is not known whether solifenacin is excreted in human milk. Because many drugs are excreted in human milk, Solifenacin should not be administered during nursing. A decision should be made whether to discontinue nursing or to discontinue Solifenacin in nursing mothers. The safety and effectiveness of Solifenacin in pediatric patients have not been established. In placebo-controlled clinical studies, similar safety and effectiveness were observed between older (623 patients ≥ 65 years and 189 patients ≥ 75 years) and younger patients (1188 patients < 65 years) treated with Solifenacin. Multiple dose studies of Solifenacin in elderly volunteers (65 to 80 years) showed that C max , AUC and t 1/2 values were 20-25% higher as compared to the younger volunteers (18 to 55 years). Solifenacin should be used with caution in patients with renal impairment. There is a 2.1-fold increase in AUC and 1.6-fold increase in t 1/2 of solifenacin in patients with severe renal impairment. Doses of Solifenacin greater than 5 mg are not recommended in patients with severe renal impairment (CL cr < 30 mL/min) [ see Warnings and Precautions ( 5.7); Dosage and Administration ( 2.2) ]. Solifenacin should be used with caution in patients with reduced hepatic function. There is a 2-fold increase in the t 1/2 and 35% increase in AUC of solifenacin in patients with moderate hepatic impairment. Doses of Solifenacin greater than 5 mg are not recommended in patients with moderate hepatic impairment (Child-Pugh B). Solifenacin is not recommended for patients with severe hepatic impairment (Child-Pugh C) [ see Warnings and Precautions ( 5.6); Dosage and Administration ( 2.3) ]. The pharmacokinetics of solifenacin is not significantly influenced by gender.

Product summary:

Solifenacin Succinate Tablets is supplied as round film-coated tablets, biconvex, debossed on the obverse and reverse sides as follows: NDC 42291-740-30 NDC 42291-740-90 *Reverse sides are plain for all three strengths. Store at 25ºC (77ºF) with excursions permitted from 15ºC to 30ºC (59°F-86ºF) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SOLIFENACIN SUCCINATE- SOLIFENACIN SUCCIATE TABLET, FILM COATED
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
SOLIFENACIN SUCCINATE TABLETS
RX ONLY
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.
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
Solifenacin Succinate Tablets 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:
o severe renal impairment [Creatinine Clearance] (CLcr <30 ml/min) (
2.2)
o moderate hepatic impairment (Child-Pugh B) ( 2.3)
o 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) (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. Advise patients not
to drive or operate heavy machinery until they know how Solifenacin
affects them ( 5.4)
Controlled Narrow-Angle Glaucoma: Use with caution in patients being
treated for narro