Rapilief
Generic Name
Silodosin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| rapilief 8 mg capsule | ৳ 24.00 | ৳ 240.00 |
Description
Overview of the medicine
Silodosin is an alpha1A-adrenoceptor antagonist used for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH). It helps relieve urinary symptoms such as difficulty urinating, weak stream, and frequent urination.
Uses & Indications
Dosage
Adults
8 mg orally once daily with a meal.
Elderly
No specific dose adjustment is required based on age. However, renal function should be assessed before starting treatment.
Renal_impairment
Moderate renal impairment (CrCl 30-50 mL/min): 4 mg orally once daily with a meal. Severe renal impairment (CrCl < 30 mL/min): Contraindicated.
How to Take
Take orally, once daily, with a meal. The capsule should be swallowed whole and not crushed or chewed.
Mechanism of Action
Silodosin selectively blocks alpha1A-adrenoceptors located in the prostate, bladder base, bladder neck, and prostatic capsule. This blockade leads to relaxation of the smooth muscles in these tissues, thereby decreasing urethral resistance and improving urine flow in men with BPH.
Pharmacokinetics
Onset
Symptomatic relief may be observed within a week, but full therapeutic effects can take longer.
Excretion
Primarily via feces (approximately 55%) and urine (approximately 34%) over 7 days.
Half life
Approximately 11 to 13 hours for silodosin; the active metabolite has a longer half-life (around 24 hours).
Absorption
Well absorbed after oral administration; peak plasma concentrations typically occur within 2.5 to 4 hours. Absolute bioavailability is approximately 32%. Absorption is increased when taken with food.
Metabolism
Extensively metabolized, primarily via glucuronidation (UGT2B7) and oxidation (alcohol dehydrogenase and CYP3A4).
Side Effects
Contraindications
- Severe renal impairment (Creatinine Clearance < 30 mL/min)
- Severe hepatic impairment
- Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir)
Drug Interactions
Antihypertensives
Increased risk of orthostatic hypotension.
Other Alpha-blockers
Concomitant use not recommended due to increased risk of orthostatic hypotension.
PDE5 Inhibitors (e.g., sildenafil, tadalafil)
Potential for additive hypotensive effects, use with caution.
Strong P-glycoprotein Inhibitors (e.g., ciclosporin)
Potential for increased silodosin exposure, use with caution.
Strong CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole)
Significantly increase silodosin exposure, contraindicated.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to severe orthostatic hypotension. Treatment should be supportive, focusing on maintaining cardiovascular stability. Intravenous fluids and vasopressors may be necessary.
Pregnancy & Lactation
Silodosin is not indicated for use in women. There are no data on its use in pregnant or lactating women.
Side Effects
Contraindications
- Severe renal impairment (Creatinine Clearance < 30 mL/min)
- Severe hepatic impairment
- Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir)
Drug Interactions
Antihypertensives
Increased risk of orthostatic hypotension.
Other Alpha-blockers
Concomitant use not recommended due to increased risk of orthostatic hypotension.
PDE5 Inhibitors (e.g., sildenafil, tadalafil)
Potential for additive hypotensive effects, use with caution.
Strong P-glycoprotein Inhibitors (e.g., ciclosporin)
Potential for increased silodosin exposure, use with caution.
Strong CYP3A4 Inhibitors (e.g., ketoconazole, itraconazole)
Significantly increase silodosin exposure, contraindicated.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose may lead to severe orthostatic hypotension. Treatment should be supportive, focusing on maintaining cardiovascular stability. Intravenous fluids and vasopressors may be necessary.
Pregnancy & Lactation
Silodosin is not indicated for use in women. There are no data on its use in pregnant or lactating women.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months
Availability
Pharmacies, Hospitals
Approval Status
Approved (DGDA)
Patent Status
Off-patent (Generic available)
Clinical Trials
Extensive clinical trials have demonstrated Silodosin's efficacy and safety in improving BPH symptoms. Key trials showed significant improvements in International Prostate Symptom Score (IPSS) and maximum urinary flow rate (Qmax) compared to placebo.
Lab Monitoring
- No routine laboratory monitoring is typically required.
- Monitor blood pressure periodically, especially at the start of treatment and with dose adjustments.
Doctor Notes
- Emphasize the importance of taking Silodosin with food to minimize orthostatic hypotension.
- Counsel patients on the high incidence of retrograde ejaculation and reassure them it is generally harmless.
- Advise patients to report any symptoms of dizziness, lightheadedness, or syncope, especially when initiating therapy or increasing dose.
Patient Guidelines
- Always take Rapilief 8 mg Capsule with a meal to enhance absorption and minimize orthostatic hypotension.
- Swallow the capsule whole; do not crush, chew, or open it.
- Be aware of the possibility of dizziness upon standing (orthostatic hypotension) and rise slowly from a sitting or lying position.
- Inform your doctor about all other medications you are taking, especially those for BPH or blood pressure.
- Contact your doctor immediately if you experience a painful erection lasting more than 4 hours (priapism).
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten one.
Driving Precautions
Silodosin may cause dizziness, lightheadedness, or fainting, especially when starting treatment or increasing the dose. Patients should be advised to use caution when driving or operating machinery until they are familiar with their response to the medication.
Lifestyle Advice
- Avoid activities requiring mental alertness, such as driving or operating heavy machinery, until you know how this medication affects you.
- Maintain adequate hydration to support overall health.
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