GOAB 10 Tablets

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 a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency ( 1 ).

• 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

The 5 mg tablets are yellow colored, round, biconvex, film-coated tablets with ‘G’ debossed on one side and ‘51’ debossed on the other side. The 10 mg tablets are pink colored, round, biconvex, film-coated tablets with ‘G’ debossed on one side and ‘52’ debossed on the other side. Tablets: 5 mg and 10 mg ( 3 ).

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Angioedema and Anaphylactic Reactions Inform patients that angioedema and anaphylactic reactions have been reported in patients treated with solifenacin succinate tablets
• Angioedema and anaphylactic reactions may be life-threatening
• Advise patients to promptly discontinue solifenacin succinate tablets therapy and seek immediate attention if they experience edema of the tongue or laryngopharynx, or difficulty breathing [see Contraindications and Warnings and Precautions ] . …

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. …

CYP3A4 Inhibitors : Do not exceed the 5 mg dose of solifenacin succinate with concomitant use of strong CYP3A4 inhibitors ( 7.1 ). 7.1 Strong CYP3A4 Inhibitors Solifenacin is a substrate of CYP3A4. Concomitant use of ketoconazole, a strong CYP3A4 inhibitor, significantly increased the exposure of solifenacin [ see Clinical Pharmacology ( 12.3 ) ]. The dosage of solifenacin succinate greater than 5 mg once daily is not recommended when concomitantly used with strong CYP3A4 inhibitors [ see Dosage and Administration ( 2.4 ) ].

• Angioedema and Anaphylactic Reactions : Promptly discontinue solifenacin succinate and provide appropriate therapy ( 5.1 ) • Urinary Retention : Solifenacin succinate is not recommended for use in patients with clinically significant bladder outlet obstruction ( 5.2 ). • Gastrointestinal Disorders : Solifenacin succinate is not recommended for use 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 ). …

The most common adverse reactions (> 4% in solifenacin succinate-treated patients and > placebo-treated patients) were dry mouth and constipation at both 5 mg and 10 mg doses; and urinary tract infection and blurred vision at the 10 mg dose ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch . …

8.1 Pregnancy 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 …

Overdosage with solifenacin succinate can potentially result in severe antimuscarinic effects and should be treated accordingly. The highest dose ingested in an accidental overdose of solifenacin succinate was 280 mg (28 times the maximum dosage) in a 5-hour period. This case was associated with mental status changes. Some cases reported a decrease in the level of consciousness. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.