Utal
Generic Name
Tadalafil
Manufacturer
General Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
utal 5 mg tablet | ৳ 54.50 | ৳ 545.00 |
Description
Overview of the medicine
Tadalafil is a phosphodiesterase type 5 (PDE5) inhibitor used to treat erectile dysfunction (ED) and the symptoms of benign prostatic hyperplasia (BPH). It works by increasing blood flow to the penis during sexual stimulation and by relaxing smooth muscles in the prostate and bladder.
Uses & Indications
Dosage
Adults
For ED, as needed: 10 mg or 20 mg at least 30 minutes before sexual activity. For ED, once daily: 2.5 mg or 5 mg, taken at approximately the same time each day. For BPH, once daily: 5 mg, taken at approximately the same time each day.
Elderly
No dosage adjustment required based on age alone.
Renal_impairment
Mild to moderate (CrCl 30-80 mL/min): No adjustment needed for once-daily use. Severe (CrCl <30 mL/min) or ESRD on hemodialysis: Max 5 mg/day. Use with caution.
How to Take
Take orally, with or without food. For once-daily dosing, take at approximately the same time each day.
Mechanism of Action
Tadalafil selectively inhibits cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), which is responsible for the degradation of cGMP in the corpus cavernosum. This leads to increased cGMP levels, smooth muscle relaxation, and enhanced blood flow into the penis, resulting in an erection. For BPH, it relaxes smooth muscle in the prostate and bladder, improving urinary symptoms.
Pharmacokinetics
Onset
Erectile Dysfunction: 30-60 minutes. Benign Prostatic Hyperplasia: Symptomatic improvement over several days to weeks.
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 are achieved within 0.5 to 6 hours (median 2 hours). Food does not affect the rate or extent of absorption.
Metabolism
Primarily metabolized by cytochrome P450 3A4 (CYP3A4) to inactive catechol metabolite.
Side Effects
Contraindications
- Concomitant use of nitrates (e.g., nitroglycerin) due to severe hypotension risk.
- Concomitant use of guanylate cyclase stimulators (e.g., riociguat).
- Hypersensitivity to tadalafil or any component of the formulation.
- Patients with cardiovascular disease for whom sexual activity is inadvisable.
Drug Interactions
Nitrates
Potentiates hypotensive effects, potentially life-threatening.
Antihypertensives
Additive hypotensive effects.
CYP3A4 inducers (e.g., rifampin)
Decreased tadalafil exposure.
Alpha-blockers (e.g., doxazosin, tamsulosin)
Increased risk of symptomatic hypotension.
CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
Increased tadalafil exposure, adjust dose if needed.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance of tadalafil.
Pregnancy & Lactation
Tadalafil is not indicated for use in women. For pregnant/lactating women, consult a healthcare provider; animal studies showed no direct harmful effects, but human data are lacking. Benefits must outweigh risks.
Side Effects
Contraindications
- Concomitant use of nitrates (e.g., nitroglycerin) due to severe hypotension risk.
- Concomitant use of guanylate cyclase stimulators (e.g., riociguat).
- Hypersensitivity to tadalafil or any component of the formulation.
- Patients with cardiovascular disease for whom sexual activity is inadvisable.
Drug Interactions
Nitrates
Potentiates hypotensive effects, potentially life-threatening.
Antihypertensives
Additive hypotensive effects.
CYP3A4 inducers (e.g., rifampin)
Decreased tadalafil exposure.
Alpha-blockers (e.g., doxazosin, tamsulosin)
Increased risk of symptomatic hypotension.
CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
Increased tadalafil exposure, adjust dose if needed.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance of tadalafil.
Pregnancy & Lactation
Tadalafil is not indicated for use in women. For pregnant/lactating women, consult a healthcare provider; animal studies showed no direct harmful effects, but human data are lacking. Benefits must outweigh risks.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date.
Availability
Pharmacies
Approval Status
Approved
Patent Status
Generically available
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of Tadalafil for treating erectile dysfunction and benign prostatic hyperplasia.
Lab Monitoring
- No specific routine lab monitoring required.
- Monitor blood pressure for patients on alpha-blockers or antihypertensives.
Doctor Notes
- Counsel patients on the absolute contraindication with nitrate medications due to severe hypotensive risk.
- Assess patient's cardiovascular status before initiating therapy.
- Advise immediate medical consultation if priapism or sudden vision/hearing changes occur.
Patient Guidelines
- Do not take tadalafil with any nitrate medication (e.g., nitroglycerin) due to risk of severe drop in blood pressure.
- Seek immediate medical attention if erection lasts longer than 4 hours (priapism).
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
- Do not exceed the prescribed dose.
Missed Dose Advice
If taking once daily and 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 resume your regular dosing schedule. Do not take two doses at once.
Driving Precautions
May cause dizziness or visual disturbances. Advise caution when driving or operating machinery until individual response is known.
Lifestyle Advice
- Maintain a healthy diet and regular exercise to improve overall cardiovascular health.
- Avoid excessive alcohol consumption as it may increase the risk of orthostatic hypotension.
- Quit smoking for better overall health.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.