Vesocal
Generic Name
Solifenacin Succinate
Manufacturer
Aci Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| vesocal 5 mg tablet | ৳ 5.02 | ৳ 50.20 |
Description
Overview of the medicine
Vesocal 5 mg Tablet contains Solifenacin Succinate, an antimuscarinic agent used to treat symptoms of overactive bladder (OAB), such as urinary urgency, frequency, and urge incontinence.
Uses & Indications
Dosage
Adults
The recommended starting dose is 5 mg once daily. If needed, the dose may be increased to 10 mg once daily based on patient response and tolerability.
Elderly
No dose adjustment is generally required in elderly patients. However, caution should be exercised in very elderly patients due to potential increased susceptibility to anticholinergic side effects.
Renal_impairment
For patients with moderate renal impairment (creatinine clearance 30-59 mL/min), a maximum dose of 5 mg once daily is recommended. Not recommended for severe renal impairment (creatinine clearance <30 mL/min).
Hepatic_impairment
For patients with moderate hepatic impairment (Child-Pugh B), a maximum dose of 5 mg once daily is recommended. Not recommended for severe hepatic impairment (Child-Pugh C).
How to Take
Vesocal tablets should be taken orally once daily, with or without food. The tablet should be swallowed whole with water and should not be crushed, chewed, or split.
Mechanism of Action
Solifenacin succinate is a competitive muscarinic receptor antagonist. It specifically binds to M3 muscarinic receptors found in the bladder, inhibiting involuntary contractions of the detrusor muscle, thereby increasing bladder capacity and reducing OAB symptoms.
Pharmacokinetics
Onset
Clinical effects are typically observed within one week of starting treatment.
Excretion
Approximately 70% excreted in urine (11% as unchanged drug) and 30% in feces.
Half life
Approximately 45-68 hours.
Absorption
Well absorbed from the gastrointestinal tract, reaching peak plasma concentrations (Cmax) in 3-8 hours. Bioavailability is approximately 90%.
Metabolism
Extensively metabolized in the liver, primarily by the cytochrome P450 3A4 (CYP3A4) enzyme system. Multiple metabolites exist, some active.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma.
- Patients undergoing hemodialysis.
- Patients with severe hepatic impairment (Child-Pugh C).
- Patients with severe renal impairment (creatinine clearance <30 mL/min) or moderate hepatic impairment (Child-Pugh B) who are also being treated with a potent CYP3A4 inhibitor, such as ketoconazole.
Drug Interactions
Metoclopramide, Cisapride
Solifenacin may reduce the prokinetic effect of these drugs.
Other Anticholinergic Agents
Concomitant use may potentiate anticholinergic side effects.
Cholinergic Receptor Agonists
May reduce the effect of cholinergic agents.
Drugs that Prolong QT Interval
Use with caution due to theoretical risk of QT prolongation, although not clinically significant with solifenacin alone.
CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir)
Concomitant use with potent CYP3A4 inhibitors can increase solifenacin exposure. A maximum dose of 5 mg solifenacin should be used.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose with solifenacin may include severe anticholinergic effects such as dry mouth, blurred vision, urinary retention, tachycardia, and hallucinations. Management involves symptomatic and supportive treatment. Gastric lavage and activated charcoal may be considered. A parasympathomimetic agent (e.g., physostigmine) may be used for severe anticholinergic symptoms.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether solifenacin is excreted in human milk, so caution should be exercised when administered to a nursing mother. A decision should be made whether to discontinue nursing or to discontinue the drug.
Side Effects
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
- Patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma.
- Patients undergoing hemodialysis.
- Patients with severe hepatic impairment (Child-Pugh C).
- Patients with severe renal impairment (creatinine clearance <30 mL/min) or moderate hepatic impairment (Child-Pugh B) who are also being treated with a potent CYP3A4 inhibitor, such as ketoconazole.
Drug Interactions
Metoclopramide, Cisapride
Solifenacin may reduce the prokinetic effect of these drugs.
Other Anticholinergic Agents
Concomitant use may potentiate anticholinergic side effects.
Cholinergic Receptor Agonists
May reduce the effect of cholinergic agents.
Drugs that Prolong QT Interval
Use with caution due to theoretical risk of QT prolongation, although not clinically significant with solifenacin alone.
CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir)
Concomitant use with potent CYP3A4 inhibitors can increase solifenacin exposure. A maximum dose of 5 mg solifenacin should be used.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose with solifenacin may include severe anticholinergic effects such as dry mouth, blurred vision, urinary retention, tachycardia, and hallucinations. Management involves symptomatic and supportive treatment. Gastric lavage and activated charcoal may be considered. A parasympathomimetic agent (e.g., physostigmine) may be used for severe anticholinergic symptoms.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether solifenacin is excreted in human milk, so caution should be exercised when administered to a nursing mother. A decision should be made whether to discontinue nursing or to discontinue the drug.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Generic available, original patent expired
Clinical Trials
Solifenacin has undergone extensive clinical trials demonstrating its efficacy and safety in treating symptoms of overactive bladder across various patient populations.
Lab Monitoring
- Routine laboratory monitoring is generally not required for patients taking solifenacin. However, liver and kidney function tests may be considered in patients with pre-existing impairment.
Doctor Notes
- Assess for urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma prior to initiating treatment.
- Monitor for anticholinergic side effects, particularly in elderly patients.
- Adjust dose in patients with moderate renal or hepatic impairment.
- Caution with concomitant use of potent CYP3A4 inhibitors.
Patient Guidelines
- Take Vesocal exactly as prescribed by your doctor.
- Do not crush, chew, or split the tablet; swallow it whole with water.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
- Be aware of potential side effects like dry mouth, constipation, and blurred vision.
- Do not stop taking the medicine suddenly without consulting your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time to make up for a missed dose.
Driving Precautions
Vesocal may cause blurred vision, dizziness, or somnolence. Patients should be cautioned about engaging in activities requiring mental alertness, such as driving or operating machinery, until they know how the drug affects them.
Lifestyle Advice
- Limit caffeine and alcohol intake, as they can irritate the bladder and worsen OAB symptoms.
- Maintain adequate fluid intake throughout the day, but avoid excessive drinking right before bedtime.
- Practice bladder training techniques, such as delaying urination gradually and scheduled voiding.
- Perform pelvic floor exercises (Kegel exercises) to strengthen bladder control.
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