Vesicare ( Solifenacin )

Buy Vesicare (Solifenacin) without prescription in Canada

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Vesicare (solifenacin succinate) is a competitive muscarinic receptor antagonist used to treat the symptoms of overactive bladder (OAB), including urinary urgency, frequency, and urge incontinence. It works by selectively blocking the M3 muscarinic receptors in the detrusor muscle of the bladder, reducing involuntary bladder contractions and increasing the bladder's storage capacity without affecting the strength of voluntary voiding. This helps to decrease the number of trips to the bathroom, control sudden urges to urinate, and reduce episodes of leakage.

Usual adult dose: The recommended starting dose is 5 mg taken orally once daily, swallowed whole with a glass of water, and may be taken with or without food. If the 5 mg dose is well tolerated but provides insufficient symptom control after at least 4 weeks, the dose may be increased to 10 mg once daily. The maximum dose is 10 mg per day. For patients with moderate hepatic impairment (Child-Pugh B) or those taking strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir), the dose should not exceed 5 mg once daily. Solifenacin is contraindicated in patients with severe hepatic impairment.

Dosage form: Oral film-coated tablets: 5 mg and 10 mg (as solifenacin succinate). The 5 mg tablet is typically round, light yellow, and debossed with a logo and "5"; the 10 mg tablet is round, light pink, and debossed with a logo and "10".

Onset of action: Some improvement in urinary symptoms may be noticed within the first week of treatment, but the full therapeutic effect typically requires 4 weeks of continuous daily therapy. Patients should be counselled that maximum benefit is often achieved after 4 to 12 weeks.

Duration of action: The elimination half-life of solifenacin is approximately 45 to 68 hours, allowing once-daily dosing. Steady-state plasma concentrations are reached after about 7 days of regular administration. The clinical effect persists for the 24-hour dosing interval as long as the medication is continued.

Alcohol recommendation: Alcohol consumption should be limited during treatment with Vesicare. Alcohol can worsen the dizziness, drowsiness, and blurred vision that solifenacin may cause, and it may increase the risk of falls and accidents. Heavy drinking can also irritate the bladder and counteract the therapeutic benefits of the medication.

Most common side effects: Dry mouth (up to 30% of patients), constipation (up to 15%), and blurred vision. Other common effects include nausea, dyspepsia, urinary tract infection, and fatigue. Due to its anticholinergic properties, Vesicare can also cause heat prostration (decreased sweating in hot environments), dizziness, and drowsiness. Rare but serious side effects include acute urinary retention, severe constipation or intestinal obstruction, and angioedema. The 10 mg dose is associated with a higher incidence of anticholinergic adverse effects than the 5 mg dose.

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General Information about Vesicare (Solifenacin)

• INN (International Nonproprietary Name): Solifenacin (as solifenacin succinate).
• Brand names available in Canada: Vesicare® (Astellas Pharma Canada Inc.) is the original brand-name product. Generic versions are available and include APO-Solifenacin (Apotex Inc.), TEVA-Solifenacin (Teva Canada Limited), Sandoz Solifenacin (Sandoz Canada Inc.), PMS-Solifenacin (Pharmascience Inc.), and others.
• ATC code: G04BD08 (solifenacin; urinary antispasmodics).
• Dosage forms and strengths: Oral film-coated tablets: 5 mg and 10 mg of solifenacin succinate.
• Manufacturers in Canada: Astellas Pharma Canada Inc. (Vesicare), Apotex Inc., Teva Canada Limited, Sandoz Canada Inc., Pharmascience Inc., and other generic manufacturers.
• Registration status in Canada: Approved by Health Canada. Marketed. DINs: 02280421 (Vesicare 5 mg), 02280422 (Vesicare 10 mg), and generic DINs. First approved in Canada in 2005.
• OTC / Rx classification: Prescription only (Rx). Schedule I drug under the Controlled Drugs and Substances Act. A valid prescription from a licensed Canadian healthcare professional is required.

Mechanism of Action and Pharmacology

Solifenacin is a competitive, specific muscarinic receptor antagonist. In the urinary bladder, muscarinic receptors (primarily the M3 subtype) mediate the contraction of the detrusor smooth muscle. By blocking these receptors, solifenacin reduces the frequency and amplitude of involuntary bladder contractions that cause the urgency, frequency, and urge incontinence characteristic of overactive bladder. Solifenacin also blocks M2 receptors but is somewhat selective for M3, which may contribute to its clinical effect while minimising certain side effects. Unlike some other antimuscarinics, solifenacin has a low propensity to cross the blood-brain barrier and therefore has a relatively low risk of central nervous system side effects such as cognitive impairment, drowsiness, and confusion—making it potentially safer for elderly patients.

After oral administration, solifenacin is well absorbed, with peak plasma concentrations reached 3 to 8 hours after dosing. The absolute bioavailability is approximately 90%, and food does not significantly affect absorption. Solifenacin is approximately 98% bound to plasma proteins, primarily to alpha-1-acid glycoprotein. It is extensively metabolised in the liver, primarily by cytochrome P450 3A4 (CYP3A4), to an active metabolite (4R-hydroxy solifenacin) and other inactive metabolites. The elimination half-life of solifenacin is approximately 45 to 68 hours, which supports once-daily dosing. Steady-state concentrations are achieved after about 7 days. The drug and its metabolites are excreted in the urine (about 70%) and faeces (about 23%). In patients with moderate hepatic impairment (Child-Pugh B), the half-life is prolonged and exposure is increased by about 60%; therefore, the dose should not exceed 5 mg daily. In severe hepatic impairment, solifenacin is contraindicated. In renal impairment, exposure is increased, but no dose adjustment is required for mild to moderate renal impairment; in severe renal impairment (creatinine clearance < 30 mL/min), the maximum dose is 5 mg daily.

Indications

• Symptomatic treatment of overactive bladder (OAB) in adults, to reduce urinary urgency, frequency, and urge incontinence. Vesicare may be used in patients who have not responded adequately to or cannot tolerate non-pharmacological measures (e.g., bladder training, pelvic floor muscle exercises).
• Not indicated for use in children and adolescents under 18 years of age; safety and efficacy have not been established in this population.

Important Warnings and Precautions

At-risk groups

• Pregnancy: There are limited data from the use of solifenacin in pregnant women. Animal studies have not demonstrated teratogenic effects, but safety in human pregnancy has not been established. Vesicare should be used during pregnancy only if the potential benefit clearly outweighs the potential risk. Women of childbearing potential should use effective contraception during treatment.
• Breastfeeding: Solifenacin is excreted in the breast milk of lactating animals; it is not known whether it is excreted in human breast milk. Because of the potential for serious adverse reactions in a nursing infant, breastfeeding is not recommended during treatment. A decision must be made whether to discontinue breastfeeding or to discontinue the drug.
• Paediatrics (< 18 years): Safety and efficacy have not been established in children. Vesicare is not indicated for use in paediatric patients.
• Elderly: No specific dose adjustment is required based on age alone. However, elderly patients are more susceptible to anticholinergic adverse effects such as dry mouth, constipation, urinary retention, confusion, and dizziness. The 5 mg starting dose is generally recommended, and the need for dose escalation to 10 mg should be carefully assessed. Vesicare may cause or exacerbate cognitive impairment in the elderly; consider the risk of anticholinergic burden.
• Hepatic impairment: In patients with moderate hepatic impairment (Child-Pugh B), the maximum dose is 5 mg once daily. Solifenacin is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Use with caution in patients with mild hepatic impairment; no dose adjustment is required but monitor for side effects.
• Renal impairment: For patients with mild to moderate renal impairment (creatinine clearance > 30 mL/min), no dose adjustment is required. In severe renal impairment (CrCl < 30 mL/min), the maximum recommended dose is 5 mg once daily. Solifenacin has not been studied in patients with end-stage renal disease on dialysis; use with caution.
• Urinary retention and bladder outlet obstruction: Solifenacin can cause or worsen urinary retention, particularly in patients with clinically significant bladder outlet obstruction (e.g., benign prostatic hyperplasia). It should be used with caution in such patients, and a lower dose (5 mg) should be considered. In patients at risk of urinary retention, a post-void residual volume should be assessed before and during treatment.
• Gastrointestinal obstructive disorders: Anticholinergics can decrease gastrointestinal motility and should be used with caution in patients with conditions such as severe constipation, ulcerative colitis, intestinal atony, or myasthenia gravis. Vesicare is contraindicated in patients with severe gastrointestinal obstruction, including toxic megacolon.
• Narrow-angle glaucoma: Anticholinergics can precipitate acute angle-closure glaucoma in susceptible individuals. Vesicare is contraindicated in patients with uncontrolled narrow-angle glaucoma. Patients with a history of glaucoma should be monitored.
• QT prolongation: Solifenacin may cause modest QT prolongation at higher-than-therapeutic doses, but at recommended doses (5-10 mg), this effect is small and not considered clinically significant in patients without additional risk factors. Use with caution in patients with a history of QT prolongation, those taking other QT-prolonging drugs, or those with electrolyte imbalances.
• Heat prostration: In the presence of high environmental temperatures, anticholinergics can reduce sweating and lead to heat prostration (fever, heat stroke). Patients should be advised to stay cool and hydrated, particularly during exercise or in hot weather.
• Allergy: Do not take Vesicare if you have a known hypersensitivity to solifenacin succinate or any excipient in the tablet formulation. Angioedema and anaphylactic reactions have been reported.

Driving and alcohol

Solifenacin may cause blurred vision, dizziness, and drowsiness, which can impair the ability to drive or operate hazardous machinery. Patients should not drive or engage in potentially dangerous activities until they have determined how the medication affects them. Alcohol consumption should be limited because it can intensify these central nervous system depressant effects and increase the risk of falls and accidents.

Dosage Instructions

• Standard adult dose: The recommended starting dose is 5 mg taken orally once daily, with or without food. Swallow the tablet whole with a glass of water; do not crush, chew, or split the tablet. If the 5 mg dose is well tolerated but provides inadequate symptom relief after at least 4 weeks, the dose may be increased to 10 mg once daily.
• Patients with moderate hepatic impairment (Child-Pugh B) or taking strong CYP3A4 inhibitors: The maximum dose is 5 mg once daily.
• Patients with severe renal impairment (CrCl < 30 mL/min): The maximum dose is 5 mg once daily.
• Administration: Take the tablet at the same time each day to establish a routine. It may be taken with or without food. A consistent daily regimen helps maintain steady blood levels.
• Missed dose: If a dose is missed, take it as soon as remembered on the same day. If it is close to the time of the next scheduled dose, skip the missed dose and resume the regular once-daily schedule. Do not double the dose.
• Duration of therapy: Vesicare is intended for long-term management of OAB symptoms. The need for continued therapy should be reassessed periodically, and attempts to reduce the dose or discontinue the drug may be made if symptoms are well controlled.

Side Effects and Contraindications

• Very common side effects (≥ 10%): Dry mouth (up to 30%), constipation (up to 15%).
• Common side effects (1-10%): Blurred vision, nausea, dyspepsia, abdominal pain, urinary tract infection, and fatigue. Dizziness and drowsiness also occur.
• Less common but serious side effects: Acute urinary retention (particularly in men with BPH), severe constipation or faecal impaction, intestinal obstruction, and angioedema (swelling of the face, lips, tongue, or throat). QT interval prolongation may occur, although at recommended doses the effect is small. Heat prostration due to decreased sweating has been reported. Cognitive impairment and confusion, especially in the elderly, can occur.
• Contraindications: Hypersensitivity to solifenacin or any excipient. Urinary retention (complete or partial). Severe gastrointestinal obstruction (including paralytic ileus, toxic megacolon). Myasthenia gravis. Uncontrolled narrow-angle glaucoma. Severe hepatic impairment (Child-Pugh C). Patients undergoing haemodialysis with severe renal impairment should use with caution (maximum 5 mg).

Drug Interactions

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, atazanavir, nefazodone): These drugs can significantly increase solifenacin plasma concentrations. The dose of Vesicare should not exceed 5 mg once daily when co-administered with strong CYP3A4 inhibitors.
• Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem, verapamil): May increase solifenacin exposure. While no specific dose adjustment is recommended, the 10 mg dose should be used with caution, and patients should be monitored for anticholinergic side effects.
• Other anticholinergic agents (e.g., antihistamines, tricyclic antidepressants, antipsychotics, oxybutynin, tolterodine): Additive anticholinergic effects, including dry mouth, constipation, blurred vision, urinary retention, and confusion. Concomitant use should be avoided or undertaken with careful monitoring, particularly in the elderly.
• Metoclopramide and other prokinetic drugs: Anticholinergics may antagonise the gastrointestinal motility effects of prokinetic agents.
• Potassium supplements and drugs that can cause oesophageal irritation: Because solifenacin can reduce saliva and oesophageal clearance, solid oral dosage forms of potassium chloride and bisphosphonates should be taken with caution and adequate water to avoid oesophageal ulceration.
• Alcohol: Additive central nervous system depressant effects; limit alcohol intake.

Practical Advice

• Administration: Take Vesicare at the same time each day, with or without food. Swallow the tablet whole; do not crush or chew. If you experience dry mouth, sipping water, chewing sugarless gum, or using saliva substitutes can help. Maintain adequate fluid intake, but avoid drinking large amounts right before bedtime to reduce nighttime urination.
• Monitoring: No routine laboratory monitoring is required. Patients should be periodically assessed for improvement in urinary symptoms (frequency, urgency, incontinence episodes). In patients with obstructive symptoms or risk of urinary retention, a post-void residual measurement may be considered. In the elderly, monitor for confusion, memory impairment, or other anticholinergic effects.
• Storage: Store at room temperature (15-30 °C) in a dry place, protected from moisture and light. Keep the container tightly closed and out of the reach and sight of children.
• Lifestyle: Vesicare works best when combined with behavioural techniques for OAB, such as bladder training, scheduled voiding, pelvic floor muscle exercises, and limiting caffeine and alcohol. Avoid overheating; this medication can reduce sweating. If you become constipated, increase dietary fibre, drink more water, and discuss with your doctor if a stool softener is needed. Do not drive or operate heavy machinery if you experience blurred vision or dizziness.
• When to seek medical review: Contact your doctor if you experience severe constipation, difficulty urinating, eye pain or sudden blurred vision, signs of an allergic reaction (rash, hives, swelling of the face or throat), or confusion. Discontinue the medication and seek emergency care for angioedema or anaphylaxis.
• Disposal: Return unused or expired medication to a pharmacy for safe disposal. Do not flush down the toilet or discard in household waste.

Alternative Medications

• Other antimuscarinics for OAB: Oxybutynin (Ditropan®) is available in immediate-release and extended-release forms, as well as a transdermal patch (Oxytrol®). Tolterodine (Detrol®) and darifenacin (Enablex®) are other muscarinic antagonists with varying selectivity. Trospium (Trosec®) is a quaternary ammonium antimuscarinic that does not cross the blood-brain barrier and may be preferred in patients at risk of cognitive side effects.
• Beta-3 adrenergic agonists: Mirabegron (Myrbetriq®) works through a different mechanism, relaxing the detrusor muscle by stimulating beta-3 receptors. It is an alternative for patients who cannot tolerate or do not respond to anticholinergics, and it carries a lower risk of dry mouth and constipation. It is also approved in Canada for OAB.
• Combination therapy: Solifenacin and mirabegron may be used together for patients with inadequate response to either agent alone, under specialist supervision.
• Non-pharmacological approaches: Bladder training, pelvic floor muscle exercises (Kegels), scheduled voiding, fluid management, and avoidance of bladder irritants (caffeine, alcohol, spicy foods) are first-line therapies and are recommended for all patients with OAB. They can be used alone or in combination with medication.

Clinical Efficacy

The efficacy of solifenacin in the treatment of overactive bladder was established in four randomised, double-blind, placebo-controlled Phase III trials involving over 3,000 patients. In these studies, solifenacin 5 mg and 10 mg once daily produced statistically significant reductions in the number of micturitions per 24 hours (by about 2-3 voids), episodes of urinary urgency (by about 50-70%), and episodes of urge incontinence (by about 70-90%) compared with placebo. The 10 mg dose provided additional improvement over the 5 mg dose in reducing incontinence and urgency, but was associated with a higher incidence of dry mouth and constipation. The onset of action was observed within the first week of treatment, and maximal benefit was achieved by 12 weeks. Solifenacin has also been shown to improve quality-of-life scores in patients with OAB. In Canada, Vesicare is a well-established second-line therapy for OAB when non-pharmacological measures are insufficient. The 5 mg dose provides a good balance of efficacy and tolerability, while the 10 mg dose is reserved for patients who need additional symptom control.

Important:

Vesicare (solifenacin) is a prescription medication that should be used only under the supervision of a qualified healthcare professional. It can cause blurred vision, dizziness, and drowsiness; do not drive or operate heavy machinery until you know how it affects you. Alcohol may worsen these effects. This medication can cause heat prostration in hot environments; avoid overheating and stay hydrated. Serious allergic reactions including angioedema have been reported; if you experience swelling of the face, lips, tongue, or throat, or difficulty breathing, discontinue use and seek emergency medical attention immediately. Solifenacin is contraindicated in patients with severe liver disease, severe gastrointestinal obstruction, uncontrolled narrow-angle glaucoma, and urinary retention. If you have difficulty emptying your bladder, severe constipation, or are taking strong CYP3A4 inhibitors, the dose should not exceed 5 mg. This information is not a substitute for professional medical advice, diagnosis, or treatment.

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