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

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