Activa
Generic Name
Sildenafil
Manufacturer
Hypothetical Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| activa 50 mg tablet | ৳ 25.00 | ৳ 100.00 |
Description
Overview of the medicine
Activa 50 mg Tablet contains Sildenafil, a phosphodiesterase-5 (PDE5) inhibitor used to treat erectile dysfunction (ED) by increasing blood flow to the penis during sexual stimulation. It helps achieve and maintain an erection.
Uses & Indications
Dosage
Adults
For most patients, the recommended dose is 50 mg taken approximately 1 hour prior to sexual activity. Based on efficacy and tolerability, the dose may be increased to 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.
Elderly
No dosage adjustment is required for elderly patients (≥65 years of age).
Renal_impairment
For patients with severe renal impairment (creatinine clearance <30 mL/min), a starting dose of 25 mg should be considered.
How to Take
Activa 50 mg Tablet is for oral administration. It can be taken with or without food. However, taking it with a high-fat meal may delay the onset of action.
Mechanism of Action
Sildenafil inhibits phosphodiesterase-5 (PDE5), an enzyme that degrades cyclic guanosine monophosphate (cGMP) in the corpus cavernosum. By inhibiting PDE5, sildenafil increases cGMP levels, leading to smooth muscle relaxation and increased blood flow into the penis, resulting in an erection during sexual stimulation.
Pharmacokinetics
Onset
Approximately 30-60 minutes.
Excretion
Sildenafil and its metabolites are primarily excreted in the feces (approximately 80% of the administered oral dose) and to a lesser extent in the urine (approximately 13% of the administered oral dose).
Half life
The terminal half-life is approximately 3-5 hours.
Absorption
Rapidly absorbed after oral administration. Absolute bioavailability is approximately 41%. Peak plasma concentrations are achieved within 30-120 minutes (median 60 minutes) in the fasted state.
Metabolism
Primarily metabolized by hepatic CYP3A4 (major route) and CYP2C9 (minor route) microsomal isoenzymes. The major circulating metabolite, N-desmethyl sildenafil, has about 50% of the activity of sildenafil.
Side Effects
Contraindications
- Concomitant use of nitrates (e.g., nitroglycerin) in any form, as sildenafil can potentiate the hypotensive effects of nitrates.
- Hypersensitivity to sildenafil or any component of the tablet.
- Patients with severe cardiovascular events (e.g., stroke, myocardial infarction) within the last 6 months.
- Patients with severe hepatic impairment.
- Patients with known hereditary degenerative retinal disorders, like retinitis pigmentosa.
Drug Interactions
Nitrates
Potentiates hypotensive effects of nitrates; contraindicated.
Riociguat
Concomitant use is contraindicated due to risk of symptomatic hypotension.
Alpha-blockers
May lead to symptomatic hypotension in some patients; use with caution.
CYP3A4 inhibitors (e.g., Ritonavir, Ketoconazole, Erythromycin)
Increase sildenafil plasma concentrations; lower initial dose of sildenafil may be considered.
Storage
Store below 30°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.
Overdose
In studies with healthy volunteers, doses up to 800 mg showed similar adverse events to lower doses but with increased incidence and severity. In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly protein bound.
Pregnancy & Lactation
Activa 50 mg Tablet (sildenafil) is not indicated for use in women. There are no adequate and well-controlled studies of sildenafil in pregnant or lactating women.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture.
Availability
Pharmacies
Approval Status
Approved
Patent Status
Generic available
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of sildenafil in treating erectile dysfunction across various patient populations, including those with comorbidities like diabetes and cardiovascular disease (with appropriate precautions).
Lab Monitoring
- No specific routine laboratory monitoring is required for patients taking sildenafil for erectile dysfunction.
Doctor Notes
- Thorough cardiovascular evaluation is essential before initiating sildenafil, especially in patients with pre-existing heart conditions.
- Educate patients strictly about the contraindication with nitrates and the risks of symptomatic hypotension with alpha-blockers.
- Advise patients to report any prolonged erections (>4 hours) or sudden vision/hearing loss immediately.
Patient Guidelines
- Take the tablet approximately 30-60 minutes before sexual activity.
- Do not take more than one tablet per day.
- Do not take with nitrates (e.g., medicines for chest pain).
- Seek immediate medical attention if an erection lasts longer than 4 hours (priapism).
- Inform your doctor about all other medications you are taking.
Missed Dose Advice
Activa 50 mg Tablet is taken on an as-needed basis, not on a regular dosing schedule. Therefore, a missed dose is not applicable.
Driving Precautions
Activa 50 mg Tablet may cause dizziness or visual disturbances (e.g., blurred vision). Patients should be aware of how they react to this medication before driving or operating machinery.
Lifestyle Advice
- Avoid excessive alcohol consumption, as it can temporarily impair the ability to get an erection.
- Maintain a healthy lifestyle, including regular exercise and a balanced diet, which can support overall cardiovascular health and erectile function.
- Smoking cessation can improve overall health and may positively impact erectile dysfunction.
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