Solifenacin Succinate (3 brand names, 2 dosage forms, 1 route)
Available dosage forms: TABLET, SUSPENSION.
Routes of administration: ORAL.
Brand Names
- SOLIFENACIN SUCCINATE
- VESICARE
- VESICARE LS
Indications and Usage
VESIcare LS® is indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and older.
Contraindications
VESIcare LS is contraindicated in patients: •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 VESIcare LS oral suspension. Reported adverse reactions have included anaphylaxis and angioedema [see Adverse Reactions (6.2)].
Adverse Reactions
•Angioedema and Anaphylactic Reactions [see Warnings and Precautions (5.1)] •Urinary Retention [see Warnings and Precautions (5.2)] •Gastrointestinal Disorders [see Warnings and Precautions (5.3)] •Central Nervous System Effects [see Warnings and Precautions (5.4)] •QT Prolongation in Patients at High Risk of QT Prolongation [see Warnings and Precautions (5.6)]
Mechanism of Action
Solifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle.
Overdosage
Overdosage with VESIcare LS oral suspension 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 in adults. This case was associated with mental status changes. Some cases reported a decrease in the level of consciousness. Intolerable antimuscarinic adverse reactions (fixed and dilated pupils, blurred vision, failure of heel-to-toe exam, tremors, and dry skin) occurred on day 3 in normal adult volunteers taking 50 mg daily (5 times the maximum recommended dosage) and resolved within 7 days following discontinuation of drug. The highest overdose reported in a pediatric patient was the accidental ingestion of 95 mg of solifenacin succinate (9.5 times the maximum recommended dosage). The child experienced severe antimuscarinic adverse reactions and was treated with gastric lavage and supportive measures until all antimuscarinic signs and symptoms reversed. In the event of overdose with VESIcare LS oral suspension, treat with gastric lavage and appropriate supportive measures. ECG monitoring is also recommended.