Vesinac
Generic Name
Solifenacin Succinate
Manufacturer
Drug International Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| vesinac 10 mg tablet | ৳ 30.00 | ৳ 300.00 |
Description
Overview of the medicine
Vesinac 10 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 dose is 5 mg once daily. If needed, the dose may be increased to 10 mg once daily based on individual patient response and tolerability.
Elderly
No dosage adjustment is required for elderly patients.
Renal_impairment
For patients with severe renal impairment (CrCl < 30 mL/min), a maximum dose of 5 mg once daily is recommended. Not recommended in patients undergoing hemodialysis.
Hepatic_impairment
For patients with moderate hepatic impairment (Child-Pugh B), a maximum dose of 5 mg once daily is recommended. Not recommended in patients with severe hepatic impairment (Child-Pugh C).
How to Take
Vesinac tablets should be taken orally once daily with water, with or without food. The tablet should be swallowed whole and not chewed, crushed, or split.
Mechanism of Action
Solifenacin is a competitive muscarinic receptor antagonist. It has a high affinity for M3 muscarinic receptors, which are predominantly involved in bladder contraction. By blocking these receptors, Solifenacin inhibits involuntary contractions of the detrusor muscle in the bladder, thereby increasing bladder capacity and reducing symptoms of OAB.
Pharmacokinetics
Onset
Within 1 week of treatment, full effect observed within 2-4 weeks.
Excretion
Approximately 69% excreted in urine (11% as unchanged drug) and 23% in feces over 26 days.
Half life
Approximately 45-68 hours.
Absorption
Well absorbed from the gastrointestinal tract; Tmax is 3-8 hours. Bioavailability is approximately 90%.
Metabolism
Extensively metabolized in the liver, primarily by CYP3A4, with minor contributions from CYP1A1, 2C9, 2C19, and 2D6. Major active metabolite is 4R-hydroxy solifenacin.
Side Effects
Contraindications
- Urinary retention
- Gastric retention
- Uncontrolled narrow-angle glaucoma
- Myasthenia gravis
- Severe hepatic impairment (Child-Pugh C)
- Severe renal impairment on hemodialysis
- Hypersensitivity to the active substance or to any of the excipients
Drug Interactions
Other anticholinergic agents
May lead to increased frequency and severity of anticholinergic side effects.
Cholinergic receptor agonists
May reduce the effect of cholinergic agonists.
CYP3A4 inducers (e.g., Rifampicin, Phenytoin)
May decrease Solifenacin plasma concentrations, potentially reducing its efficacy.
Strong CYP3A4 inhibitors (e.g., Ketoconazole)
Coadministration with strong CYP3A4 inhibitors can significantly increase Solifenacin exposure. The dose of Solifenacin should not exceed 5 mg when co-administered with strong CYP3A4 inhibitors.
Drugs that affect gastrointestinal motility (e.g., Metoclopramide, Cisapride)
Solifenacin may antagonize the effect of prokinetic agents.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe anticholinergic effects such as dry mouth, constipation, blurred vision, tachycardia, urinary retention, and mydriasis. Treatment should be symptomatic and supportive. Gastric lavage and activated charcoal may be considered. ECG monitoring is recommended.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether Solifenacin is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
Contraindications
- Urinary retention
- Gastric retention
- Uncontrolled narrow-angle glaucoma
- Myasthenia gravis
- Severe hepatic impairment (Child-Pugh C)
- Severe renal impairment on hemodialysis
- Hypersensitivity to the active substance or to any of the excipients
Drug Interactions
Other anticholinergic agents
May lead to increased frequency and severity of anticholinergic side effects.
Cholinergic receptor agonists
May reduce the effect of cholinergic agonists.
CYP3A4 inducers (e.g., Rifampicin, Phenytoin)
May decrease Solifenacin plasma concentrations, potentially reducing its efficacy.
Strong CYP3A4 inhibitors (e.g., Ketoconazole)
Coadministration with strong CYP3A4 inhibitors can significantly increase Solifenacin exposure. The dose of Solifenacin should not exceed 5 mg when co-administered with strong CYP3A4 inhibitors.
Drugs that affect gastrointestinal motility (e.g., Metoclopramide, Cisapride)
Solifenacin may antagonize the effect of prokinetic agents.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe anticholinergic effects such as dry mouth, constipation, blurred vision, tachycardia, urinary retention, and mydriasis. Treatment should be symptomatic and supportive. Gastric lavage and activated charcoal may be considered. ECG monitoring is recommended.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown whether Solifenacin is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture.
Availability
Available in pharmacies nationwide
Approval Status
Approved (e.g., by US FDA and DGDA in Bangladesh)
Patent Status
Patent expired for generic Solifenacin
Clinical Trials
Solifenacin has been extensively studied in various randomized, double-blind, placebo-controlled clinical trials for its efficacy and safety in treating overactive bladder symptoms.
Lab Monitoring
- Routine liver and kidney function tests for patients with pre-existing impairment or those on high doses.
- Monitoring for anticholinergic side effects.
Doctor Notes
- Educate patients on proper administration and potential side effects.
- Monitor renal and hepatic function, especially in patients with pre-existing conditions.
- Advise patients to report any signs of urinary retention or severe constipation promptly.
Patient Guidelines
- Take the tablet whole with water, do not chew or crush it.
- Do not stop taking the medicine abruptly without consulting your doctor.
- Inform your doctor about all other medications you are taking, including herbal supplements and over-the-counter drugs.
- Report any severe side effects like blurred vision, difficulty urinating, or severe constipation to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Solifenacin may cause blurred vision, dizziness, and 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
- Maintain a healthy diet and regular exercise.
- Avoid excessive caffeine and alcohol, as they can irritate the bladder.
- Practice bladder training techniques as advised by your healthcare provider.
- Drink adequate fluids throughout the day, but avoid large amounts before bedtime.
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