Megafil
Generic Name
Tadalafil
Manufacturer
ACI Limited
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| megafil 10 mg tablet | ৳ 35.11 | ৳ 140.44 |
Description
Overview of the medicine
Tadalafil, marketed as Megafil-10 mg Tablet, is a phosphodiesterase-5 (PDE5) inhibitor used to treat erectile dysfunction (ED) and symptoms of benign prostatic hyperplasia (BPH). It helps increase blood flow to the penis during sexual stimulation and relaxes muscles in the prostate and bladder.
Uses & Indications
Dosage
Adults
For ED: As needed, 10 mg orally at least 30 minutes before sexual activity. Dose may be increased to 20 mg or decreased to 5 mg based on efficacy and tolerability. For daily ED/BPH: 2.5 mg to 5 mg once daily.
Elderly
No dosage adjustment required.
Renal_impairment
Moderate (CrCl 30-50 mL/min): Start with 5 mg once daily; max 10 mg every 48 hours. Severe (CrCl <30 mL/min): Maximum 5 mg every 72 hours, or not recommended.
How to Take
Megafil-10 mg Tablet is for oral administration. It can be taken with or without food. Do not chew, crush, or break the tablet; swallow it whole.
Mechanism of Action
Tadalafil selectively inhibits cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sexual stimulation leads to local release of nitric oxide, which activates guanylate cyclase, resulting in increased cGMP levels. This causes smooth muscle relaxation and inflow of blood into the corpus cavernosum, enhancing erectile function. For BPH, it relaxes smooth muscles in the prostate and bladder neck, improving urinary flow.
Pharmacokinetics
Onset
Within 30-60 minutes for erectile dysfunction.
Excretion
Mainly excreted in feces (approximately 61%) and to a lesser extent in urine (approximately 36%) as metabolites.
Half life
Approximately 17.5 hours.
Absorption
Rapidly absorbed after oral administration. Peak plasma concentrations (Tmax) are typically reached within 2 hours.
Metabolism
Primarily metabolized by cytochrome P450 (CYP3A4) to inactive catechol metabolites.
Side Effects
Contraindications
- Concomitant use of any form of organic nitrates or nitric oxide donors.
- Concomitant use of riociguat.
- Hypersensitivity to tadalafil or any excipients.
- Patients with recent myocardial infarction (within 90 days), unstable angina, uncontrolled arrhythmias, uncontrolled hypertension, stroke (within 6 months), severe hepatic impairment.
Drug Interactions
Nitrates
Potentiation of hypotensive effects, potentially life-threatening. Concomitant use is contraindicated.
Riociguat
Contraindicated due to potential for severe hypotension.
Alpha-blockers
Increased risk of symptomatic hypotension.
CYP3A4 Inducers (e.g., Rifampin, Phenytoin)
Decreased exposure to tadalafil.
CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir)
Increased exposure to tadalafil, requiring dose adjustment.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis is not expected to accelerate clearance significantly.
Pregnancy & Lactation
Not indicated for use in women. Pregnancy Category B for Tadalafil. It is not known whether tadalafil is excreted in human milk.
Side Effects
Contraindications
- Concomitant use of any form of organic nitrates or nitric oxide donors.
- Concomitant use of riociguat.
- Hypersensitivity to tadalafil or any excipients.
- Patients with recent myocardial infarction (within 90 days), unstable angina, uncontrolled arrhythmias, uncontrolled hypertension, stroke (within 6 months), severe hepatic impairment.
Drug Interactions
Nitrates
Potentiation of hypotensive effects, potentially life-threatening. Concomitant use is contraindicated.
Riociguat
Contraindicated due to potential for severe hypotension.
Alpha-blockers
Increased risk of symptomatic hypotension.
CYP3A4 Inducers (e.g., Rifampin, Phenytoin)
Decreased exposure to tadalafil.
CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir)
Increased exposure to tadalafil, requiring dose adjustment.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis is not expected to accelerate clearance significantly.
Pregnancy & Lactation
Not indicated for use in women. Pregnancy Category B for Tadalafil. It is not known whether tadalafil is excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24-36 months from manufacturing date.
Availability
Pharmacies, hospitals
Approval Status
Approved (e.g., by FDA, DGDA)
Patent Status
Generic available (patent expired for generic form)
Clinical Trials
Extensive clinical trials have established the efficacy and safety of Tadalafil for the treatment of erectile dysfunction and benign prostatic hyperplasia.
Lab Monitoring
- No specific routine lab monitoring is required. Blood pressure monitoring is advisable, especially in patients concomitantly taking alpha-blockers.
Doctor Notes
- Crucially counsel patients against concomitant use of any form of nitrates due to severe hypotensive risk.
- Assess cardiovascular status prior to prescribing, especially in patients with pre-existing cardiac conditions.
- Educate patients on symptoms of priapism and NAION, advising immediate medical consultation if they occur.
Patient Guidelines
- Do not take Megafil-10 mg Tablet if you are taking any nitrate medicine.
- Seek immediate medical attention if an erection lasts longer than 4 hours.
- Report any sudden decrease or loss of vision or hearing immediately.
- Inform your doctor about all other medications and medical conditions.
Missed Dose Advice
For 'as needed' use, take it when remembered, but do not take more than one dose per day. For daily use, if a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. Do not take two doses at once to make up for a missed one.
Driving Precautions
Megafil-10 mg Tablet may cause dizziness or affect vision. Patients should be aware of how they react to the medicine before driving or operating machinery.
Lifestyle Advice
- Maintain a healthy lifestyle, including regular exercise and a balanced diet.
- Limit alcohol consumption, as it can increase the risk of side effects.
- Quit smoking to improve overall cardiovascular health.
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