Mirovan
Generic Name
Darifenacin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| mirovan 10 mg tablet | ৳ 35.00 | ৳ 350.00 |
Description
Overview of the medicine
Mirovan 10 mg Tablet contains Darifenacin, an anticholinergic medication used to treat symptoms of overactive bladder (OAB), such as urinary urgency, frequency, and urge incontinence. It helps relax the bladder muscles.
Uses & Indications
Dosage
Adults
10 mg once daily. Dosage may be adjusted based on individual response and tolerability, up to a maximum of 15 mg once daily (if available).
Elderly
No specific dose adjustment required, but caution is advised due to potential for increased anticholinergic side effects.
Renal_impairment
No dose adjustment is required for mild to moderate renal impairment. Use with caution in patients with severe renal impairment (creatinine clearance < 30 mL/min).
How to Take
Administer orally once daily with water, with or without food. Tablets should be swallowed whole and not chewed, crushed, or split.
Mechanism of Action
Darifenacin selectively antagonizes M3 muscarinic receptors in the bladder, leading to relaxation of the detrusor muscle, increased bladder capacity, and reduction in involuntary detrusor contractions.
Pharmacokinetics
Onset
Therapeutic effects are typically observed within 2 weeks of starting treatment.
Excretion
Approximately 60% of the dose is excreted in the urine and 35% in the feces, mainly as metabolites.
Half life
The elimination half-life is approximately 13-19 hours at steady state.
Absorption
Well absorbed from the gastrointestinal tract, with a bioavailability of approximately 15-19% due to first-pass metabolism. Peak plasma concentrations (Tmax) are reached around 7 hours.
Metabolism
Extensively metabolized in the liver primarily by cytochrome P450 enzymes CYP2D6 and CYP3A4.
Side Effects
Contraindications
- Urinary retention
- Gastric retention
- Uncontrolled narrow-angle glaucoma
- Severe hepatic impairment (Child-Pugh Class C)
- Hypersensitivity to Darifenacin or any component of the formulation
Drug Interactions
Other anticholinergic agents
Concomitant use may enhance anticholinergic side effects (e.g., dry mouth, constipation, blurred vision).
Potent CYP2D6 inhibitors (e.g., Paroxetine, Fluoxetine, Quinidine)
May increase Darifenacin levels, but the effect is less significant than with CYP3A4 inhibitors.
Potent CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir)
May significantly increase Darifenacin plasma levels. Dose adjustment of Darifenacin may be necessary.
Drugs metabolized by CYP2D6 (e.g., Flecainide, Metoprolol, Nortriptyline)
Darifenacin may inhibit CYP2D6, potentially increasing the levels of these drugs.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include severe anticholinergic effects such as blurred vision, dry mouth, urinary retention, constipation, tachycardia, and hallucinations. Treatment is symptomatic and supportive; gastric lavage may be considered, and physostigmine may be used for severe anticholinergic effects.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Darifenacin is excreted in human milk; therefore, caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from the manufacturing date, as indicated on the packaging.
Availability
Available in retail pharmacies and hospitals
Approval Status
Approved by relevant regulatory authorities (e.g., DGDA, FDA)
Patent Status
Off-patent
Clinical Trials
Clinical trials have demonstrated Darifenacin's efficacy and safety in reducing symptoms of overactive bladder compared to placebo. Studies have also investigated its long-term tolerability and impact on quality of life.
Lab Monitoring
- No specific routine lab monitoring is required for Darifenacin.
- Monitor for signs of urinary retention or decreased renal function in susceptible patients, especially those with pre-existing conditions.
Doctor Notes
- Carefully assess patients for conditions predisposing to urinary retention (e.g., bladder outflow obstruction) or gastric retention before initiating therapy.
- Advise patients about potential CNS effects such as dizziness or blurred vision and their implications for driving or operating machinery.
- Consider dose reduction or alternative treatments for patients with moderate to severe hepatic impairment due to increased Darifenacin exposure.
Patient Guidelines
- Take Mirovan 10 mg Tablet exactly as directed by your doctor.
- Do not crush, chew, or split the tablet; swallow it whole.
- Inform your doctor about all other medications, including over-the-counter drugs and herbal supplements, you are taking.
- Report any severe or persistent side effects to your doctor immediately, especially difficulty urinating or severe constipation.
Missed Dose Advice
If a dose is missed, 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
Mirovan 10 mg Tablet may cause blurred vision, dizziness, or somnolence. Patients should be cautious when driving or operating machinery until they know how Darifenacin affects them.
Lifestyle Advice
- Limit caffeine and alcohol intake, as these can irritate the bladder and worsen OAB symptoms.
- Maintain a healthy weight and engage in regular exercise, which can improve bladder control.
- Practice bladder training techniques as advised by your doctor or therapist.
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