Enjofil 50 mg (Tablet)
Unit Price: ৳ 30.00 (1 x 4: ৳ 120.00)
Strip Price: ৳ 120.00
Medicine Details
Category | Details |
---|---|
Generic | Sildenafil citrate |
Company | Navana pharmaceuticals ltd |
Also available as |
Product Title
- Enjofil 50mg Tablet
Categories
- Erectile Dysfunction Medication
- Pulmonary Arterial Hypertension Medication
- Phosphodiesterase Type 5 (PDE5) Inhibitor
Indications
- Treatment of erectile dysfunction in men
- Treatment of 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
- Results in smooth muscle relaxation and inflow of blood into the penile tissues
- Has no effect in the absence of sexual stimulation
Mode of Action
- Causes local release of nitric oxide during sexual stimulation
- Inhibition of PDE5 by Enjofil produces increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood
- Rapidly absorbed after oral administration
Pharmacology
- Metabolized predominantly by hepatic metabolism (cytochrome P450 3A4)
- Converted to an active metabolite with properties similar to the parent
- Terminal half lives of about 4 hours
- Maximum observed plasma concentrations reached within 30 to 120 minutes of oral dosing in the fasted state
- Rate of absorption 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
Dosage & Administration
- Recommended dose for erectile dysfunction: 50 mg taken approximately 1 hour before sexual activity
- Dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg based on effectiveness and toleration
- Maximum recommended dosing frequency is once per day
- Recommended dose for pulmonary arterial hypertension: 20 mg three times a day
- Should be taken approximately 4-6 hours apart, with or without food
Interaction
- Metabolism mediated by cytochrome P450 (CYP) isoforms 3A4 and 2C9
- Inhibitors of CYP3A4 and CYP2C9 isoenzymes may reduce Enjofil clearance
- Inducers of CYP3A4 and CYP2C9 isoenzymes may increase Enjofil clearance
- Strong CYP3A4 inhibitors expected to have greater effects on Enjofil
- Concomitant use with nitrates or nitric oxide donors is contraindicated
- No effect on ritonavir pharmacokinetics
- No effect on CYP2C9 inhibitors, CYP2D6 inhibitors, thiazide and related diuretics, ACE inhibitors, and calcium channel blockers
Contraindications
- Hypersensitivity to any component of the medication
- Concomitant use of organic nitrates
- Patients using nitrates regularly or intermittently
Side Effects
- Various body system reactions including cardiovascular, digestive, hemic and lymphatic, metabolic and nutritional, musculoskeletal, nervous, respiratory, skin and appendages, special senses, and urogenital reactions
- Serious cardiovascular, cerebrovascular, and vascular events reported post-marketing
Pregnancy & Lactation
- Pregnancy category B
- Not indicated for use by women
- Animal studies show no evidence of teratogenicity or embryotoxicity
Precautions & Warnings
- Caution advised when PDE5 inhibitors are co-administered with alpha-blockers
- Considerations for patients on alpha-blocker therapy
- Potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease
- Patients with underlying conditions sensitive to vasodilators should use with caution
- No controlled clinical data on the safety or efficacy in certain patient groups
- Prolonged erection and priapism have been reported infrequently
- Caution in patients taking ritonavir
- Potential for adverse events in patients with high systemic levels
Overdose Effects
- In studies with healthy volunteers, adverse events were similar to those seen at lower doses but incidence rates and severities were increased
- Standard supportive measures should be adopted as required
- Renal dialysis not expected to accelerate clearance
Therapeutic Class
- Drugs for Erectile Dysfunction
Storage Conditions
- Keep in a dry place, away from light and heat
- Keep out of the reach of children