Vegara
Generic Name
Sildenafil Citrate
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
vegara 100 mg tablet | ৳ 50.00 | ৳ 200.00 |
Description
Overview of the medicine
Vegara 100 mg tablet contains Sildenafil Citrate, a phosphodiesterase-5 (PDE5) inhibitor. It is primarily used to treat erectile dysfunction (impotence) in men by increasing blood flow to the penis during sexual stimulation. It helps achieve and maintain an erection suitable for sexual activity.
Uses & Indications
Dosage
Adults
For most patients, the recommended dose is 50 mg taken approximately 1 hour before sexual activity. The dose may be increased to a maximum of 100 mg or decreased to 25 mg, based on efficacy and tolerability. Maximum recommended dosing frequency is once per day.
Elderly
A starting dose of 25 mg should be considered for patients >65 years due to reduced clearance and increased plasma levels.
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
Oral administration. Take approximately 1 hour before sexual activity. It can be taken with or without food, but a high-fat meal may delay the onset of action.
Mechanism of Action
Sildenafil inhibits phosphodiesterase type 5 (PDE5), an enzyme that degrades cyclic guanosine monophosphate (cGMP) in the corpus cavernosum of the penis. When sexual stimulation causes local release of nitric oxide (NO), PDE5 inhibition by sildenafil leads to increased cGMP levels, resulting in smooth muscle relaxation and inflow of blood into the corpus cavernosum, thus facilitating an erection.
Pharmacokinetics
Onset
Typically 30-60 minutes.
Excretion
Excreted predominantly as metabolites in the feces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of administered oral dose).
Half life
Mean terminal half-life of sildenafil and its major circulating N-desmethyl metabolite is about 3-5 hours.
Absorption
Rapidly absorbed after oral administration. Mean absolute bioavailability is about 41%. Peak plasma concentrations (Tmax) are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.
Metabolism
Primarily metabolized by hepatic microsomal isoenzymes CYP3A4 (major route) and CYP2C9 (minor route). The major metabolite, N-desmethyl sildenafil, also has PDE5 inhibitory activity.
Side Effects
Contraindications
- Concomitant use with nitrates (e.g., nitroglycerin, isosorbide dinitrate) due to risk of severe hypotension.
- Concomitant use with riociguat (a guanylate cyclase stimulator).
- Patients with known hypersensitivity to sildenafil or any component of the tablet.
- Patients with severe cardiovascular disease, recent myocardial infarction (within 90 days), or stroke (within 6 months).
- Patients with severe hepatic impairment.
- Patients with retinal disorders (e.g., non-arteritic anterior ischemic optic neuropathy (NAION) history).
Drug Interactions
Alcohol
Excessive alcohol intake may increase the risk of orthostatic hypotension.
Nitrates
Potentiation of hypotensive effects, potentially leading to severe and life-threatening hypotension. Concomitant use is contraindicated.
Riociguat
Synergistic hypotensive effects, concomitant use is contraindicated.
Alpha-blockers
Increased risk of symptomatic hypotension (e.g., doxazosin, tamsulosin). Use with caution, initiate sildenafil at 25 mg.
CYP3A4 Inhibitors (e.g., Ritonavir, Ketoconazole, Erythromycin)
Increased plasma levels of sildenafil. Dose adjustment of sildenafil may be required. For example, a maximum single dose of 25 mg of sildenafil in 48 hours for patients taking ritonavir.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In studies with healthy volunteers, doses up to 800 mg resulted in similar adverse effects to lower doses, but with increased incidence and severity (e.g., headache, flushing, dizziness, dyspepsia, nasal congestion, visual disturbances). In cases of overdose, standard supportive measures should be adopted as clinically indicated.
Pregnancy & Lactation
Sildenafil is not indicated for use in women. There are no adequate and well-controlled studies in pregnant or lactating women.
Side Effects
Contraindications
- Concomitant use with nitrates (e.g., nitroglycerin, isosorbide dinitrate) due to risk of severe hypotension.
- Concomitant use with riociguat (a guanylate cyclase stimulator).
- Patients with known hypersensitivity to sildenafil or any component of the tablet.
- Patients with severe cardiovascular disease, recent myocardial infarction (within 90 days), or stroke (within 6 months).
- Patients with severe hepatic impairment.
- Patients with retinal disorders (e.g., non-arteritic anterior ischemic optic neuropathy (NAION) history).
Drug Interactions
Alcohol
Excessive alcohol intake may increase the risk of orthostatic hypotension.
Nitrates
Potentiation of hypotensive effects, potentially leading to severe and life-threatening hypotension. Concomitant use is contraindicated.
Riociguat
Synergistic hypotensive effects, concomitant use is contraindicated.
Alpha-blockers
Increased risk of symptomatic hypotension (e.g., doxazosin, tamsulosin). Use with caution, initiate sildenafil at 25 mg.
CYP3A4 Inhibitors (e.g., Ritonavir, Ketoconazole, Erythromycin)
Increased plasma levels of sildenafil. Dose adjustment of sildenafil may be required. For example, a maximum single dose of 25 mg of sildenafil in 48 hours for patients taking ritonavir.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In studies with healthy volunteers, doses up to 800 mg resulted in similar adverse effects to lower doses, but with increased incidence and severity (e.g., headache, flushing, dizziness, dyspepsia, nasal congestion, visual disturbances). In cases of overdose, standard supportive measures should be adopted as clinically indicated.
Pregnancy & Lactation
Sildenafil is not indicated for use in women. There are no adequate and well-controlled studies in pregnant or lactating women.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Usually 2-3 years from manufacturing date.
Availability
Pharmacies
Approval Status
Approved
Patent Status
Generic available
Clinical Trials
Sildenafil has undergone extensive clinical trials demonstrating its efficacy and safety for the treatment of erectile dysfunction. Key trials include those comparing sildenafil to placebo in various patient populations, showing significant improvement in erectile function parameters.
Lab Monitoring
- No routine laboratory monitoring is required for Sildenafil use in erectile dysfunction. Pre-treatment cardiovascular assessment is important.
Doctor Notes
- Always assess patient's cardiovascular status before prescribing sildenafil, as sexual activity itself poses cardiac risk.
- Educate patients about the risk of priapism and the need for immediate medical attention if it occurs.
- Advise patients about potential drug interactions, especially with nitrates and alpha-blockers.
- Consider lower starting doses (25 mg) for elderly patients, those with severe renal impairment, or those taking potent CYP3A4 inhibitors.
Patient Guidelines
- Take Vegara about 1 hour before sexual activity.
- Do not take more than one tablet per day.
- Avoid taking with grapefruit juice or excessive alcohol.
- Seek immediate medical attention if you experience a prolonged erection lasting more than 4 hours (priapism) or sudden vision/hearing loss.
- Inform your doctor about all other medications you are taking, especially nitrates or alpha-blockers.
Missed Dose Advice
Vegara is taken as needed for erectile dysfunction, not on a regular schedule. Therefore, a missed dose is not applicable. Do not take more than one dose per day.
Driving Precautions
Sildenafil may cause dizziness or visual disturbances (e.g., blurred vision, blue tinge to vision). Patients should be aware of how they react to Vegara before driving or operating machinery.
Lifestyle Advice
- Maintain a healthy lifestyle, including regular exercise and a balanced diet, to improve overall cardiovascular health which can benefit erectile function.
- Manage underlying conditions like diabetes, hypertension, and high cholesterol.
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