Vigorex 50 mg (Tablet)
Unit Price: ৳ 30.10 (2 x 5: ৳ 301.00)
Strip Price: ৳ 150.50
Medicine Details
| Category | Details |
|---|---|
| Generic | Sildenafil citrate |
| Company | Square pharmaceuticals plc |
| Also available as |
Product Title
- Vigorex
Therapeutic Class
- Drugs for Erectile Dysfunction
Indications
- Treatment of erectile dysfunction in men
- Indicated in pulmonary arterial hypertension
Description
- Selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5)
- Produces increased levels of cGMP in the corpus cavernosum when sexual stimulation causes the local release of nitric oxide
Mechanism of Action
- Involves the release of nitric oxide in the corpus cavernosum during sexual stimulation
- Activates the enzyme guanylate cyclase, resulting in increased levels of cGMP and producing smooth muscle relaxation
- Enhances the effect of nitric oxide by inhibiting phosphodiesterase type 5 (PDE5) responsible for degradation of cGMP
Pharmacokinetics
- Rapidly absorbed after oral administration
- Mean absolute bioavailability of 41%
- Eliminated predominantly by hepatic metabolism, mainly cytochrome P450 3A4
- Metabolized to an active metabolite with properties similar to the parent compound
- Maximum observed plasma concentrations reached within 30 to 120 minutes of oral dosing
- Plasma levels are reduced when taken with a high-fat meal
- Cleared by hepatic microsomal isoenzymes
- Excreted as metabolites predominantly in the feces and to a lesser extent in the urine
- Reduced clearance and higher plasma AUC values in healthy elderly volunteers
- Age, hepatic impairment, severe renal impairment, and concurrent use of potent cytochrome P450 3A4 inhibitors associated with increased plasma levels
Dosage & Administration
- Recommended dose for erectile dysfunction is 50 mg taken approximately 1 hour before sexual activity
- May be taken anywhere from 4 hours to 0.5 hour before activity
- Dose may be increased to a maximum of 100 mg or decreased to 25 mg based on effectiveness and toleration
- Recommended dosing frequency is once per day
- Factors associated with increased plasma levels include age >65, hepatic impairment, severe renal impairment, and concomitant use of potent cytochrome P450 3A4 inhibitors
Interaction
- Metabolism principally mediated by cytochrome P450 isoforms 3A4 and 2C9
- Inhibitors of these isoenzymes may reduce clearance and inducers may increase clearance
- Strong CYP3A4 inhibitors expected to have greater effects
- Concomitant use of CYP3A4 inhibitors may reduce clearance
- Co-administration with HIV protease inhibitors resulted in increased plasma levels
- Moderate CYP3A4 inducers may decrease plasma levels
- No effect on plasma levels by CYP2C9 inhibitors, CYP2D6 inhibitors, thiazide and related diuretics, ACE inhibitors, and calcium channel blockers
- Effects on the active metabolite observed with loop and potassium-sparing diuretics and nonspecific beta-blockers
Contraindications
- Hypersensitivity to any component of this medication
- Concurrent use with organic nitrates, either regularly or intermittently
Side Effects
- Various side effects including body edema, photosensitivity reaction, shock, asthenia, chest pain, allergic reaction, abdominal pain, anemia, thrombocytopenia, and leukopenia
- Common cardiovascular and cerebrovascular side effects reported
- Digestive system related side effects such as vomiting, glossitis, colitis, dysphagia, gastritis, and abdominal pain
- Metabolic and nutritional side effects including hyperglycemia, hypernatremia, and hyperuricemia
- Musculoskeletal side effects such as arthritis, myalgia, tendon rupture, and bone pain
- Nervous system related side effects like ataxia, neuralgia, neuropathy, tremor, depression, and somnolence
- Respiratory system related side effects including asthma, dyspnea, and cough
- Skin and appendages related side effects such as urticaria, pruritus, and skin ulcer
- Urogenital system related side effects including cystitis, urinary frequency, and abnormal ejaculation
Pregnancy & Lactation
- Pregnancy category B
- Not indicated for use by women
- No evidence of teratogenicity or embryotoxicity in animal studies
Precautions & Warnings
- Caution advised when co-administered with alpha-blockers
- Potential for additive effect on blood pressure when used in combination with vasodilators
- Patients with hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use
- Use with caution in patients with anatomical deformation of the penis or conditions predisposing to priapism
- Not generally recommended in men for whom sexual activity is inadvisable due to underlying cardiovascular status
- Particular sensitivity to vasodilators in patients with left ventricular outflow obstruction and severely impaired autonomic control of blood pressure
- No controlled clinical data on safety or efficacy in specific groups including those with recent myocardial infarction, stroke, resting hypotension or hypertension, cardiac failure, coronary artery disease, and retinitis pigmentosa or related anemias
- Risk of prolonged erection greater than 4 hours and priapism
- Caution with concurrent use of ritonavir, decreased dosage recommended to decrease adverse events
Overdose Effects
- Adverse events similar to lower doses, but with increased incidence rates and severities
- Standard supportive measures should be adopted as required
- Renal dialysis not expected to accelerate clearance, as Vigorex is highly bound to plasma proteins and not eliminated in the urine
Storage Conditions
- Keep in a dry place, away from light and heat
- Keep out of the reach of children