solifenacin succinate


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Related to solifenacin succinate: Tamsulosin, Vesicare

solifenacin succinate

VESIcare, Vesicare (UK)

Pharmacologic class: Anticholinergic

Therapeutic class: Renal and genitourinary agent

Pregnancy risk category C

Action

Antagonizes muscarinic receptors, reducing urinary bladder smooth-muscle contractions

Availability

Tablets: 5 mg, 10 mg

Indications and dosages

Overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency

Adults: 5 mg P.O. daily initially; may increase to 10 mg P.O. daily if well tolerated

Dosage adjustment

• Moderate hepatic impairment
• Severe renal impairment
• Concurrent use of potent CYP3A4 inhibitors (such as ketoconazole)

Contraindications

• Hypersensitivity to drug or its components
• Urinary retention
• Gastric retention
• Uncontrolled angle-closure glaucoma

Precautions

Use cautiously in:
• hepatic or renal impairment, bladder outflow obstruction, decreased GI motility, GI obstructive disorder, controlled angle-closure glaucoma, congenital or acquired QT interval prolongation
• increased risk of urinary retention or heat prostration
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

• Give with liquids, with or without food. Make sure patient swallows tablet whole.

Adverse reactions

CNS: dizziness, depression, fatigue, asthenia

CV: hypertension

EENT: dry eyes, blurred vision, dry throat, pharyngitis

GI: nausea, vomiting, constipation, upper abdominal pain, dyspepsia, dry mouth

GU: urinary tract infection, urinary retention

Respiratory: cough

Skin: dry skin, rash, pruritus

Other: influenza, leg or foot edema

Interactions

Drug-drug.Anticholinergics: increased frequency or severity of adverse reactions

CYP3A4 inhibitors (such as ketoconazole): increased solifenacin blood level

Patient monitoring

• Monitor GI, renal, and hepatic function frequently.
• Monitor patient for ophthalmic disorders, especially angle-closure glaucoma. If present, stop drug until condition stabilizes.

Patient teaching

• Instruct patient to take drug with liquids, with or without food, and to swallow tablet whole.
• Advise patient to contact prescriber if severe abdominal pain or constipation lasting 3 or more days occurs.
• Caution patient to avoid driving and other hazardous activities until drug effects are known.
• Advise patient of risk for heat prostration; describe symptoms.
• Instruct patient to consult prescriber before taking over-the-counter products such as antihistamines because these may increase risk of side effects.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs mentioned above.

References in periodicals archive ?
Pharmaceutical company Astellas Pharma Inc (TSE:4503) stated on Thursday that it has filed its supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) seeking approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB), a urine storage problem of urgency, with or without urge urinary incontinence (leakage), often with urinary frequency and nocturia.
The company is seeking approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.
These studies, which included more than 5,000 patients with OAB, evaluated combination therapy with mirabegron and solifenacin succinate compared with each drug as monotherapy and placebo.
According to the company, the Phase 3 SYNERGY I trial evaluated the efficacy and safety of combinations of mirabegron and solifenacin succinate compared with each drug as monotherapy and placebo in patients who had experienced symptoms of "wet" OAB for at least three months.
Mirabegron and solifenacin succinate are already marketed in the United States as Myrbetriq and VESIcare, respectively.
Tenders are invited for Supply of Solifenacin succinate 10 mg tab
Randomized, double-blind placebo controlled trial of the once daily antimuscarinic agent solifenacin succinate in patients with overactive bladder.