kX-50 50 mg (Tablet)

Unit Price: ৳ 30.09 (5's pack: ৳ 150.45)

Medicine Details

Category Details
Generic Sildenafil citrate
Company Kemiko pharmaceuticals ltd
Also available as

Indications

  • Treatment of erectile dysfunction in men
  • Treatment for pulmonary arterial hypertension

Description

  • Selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5)
  • Requires sexual stimulation to be effective
  • Results in smooth muscle relaxation and increased blood flow to the penile tissues

Pharmacology

  • Mechanism of Action: Involves releasing nitric oxide in the corpus cavernosum during sexual stimulation, activation of guanylate cyclase, and increased levels of cGMP
  • Pharmacokinetics and Metabolism: Rapid absorption after oral administration, hepatic metabolism by cytochrome P450 3A4, and conversion to active metabolite with similar properties
  • Absorption and Distribution: Rapidly absorbed, maximum plasma concentrations reached within 30 to 120 minutes
  • Metabolism and Excretion: Cleared by hepatic microsomal isoenzymes, excreted as metabolites predominantly in feces and to a lesser extent in urine
  • Pharmacokinetics in Special Populations: Elderly volunteers (65 years or over) had reduced clearance, resulting in higher plasma AUC values

Dosage & Administration

  • Erectile Dysfunction:
    • Recommended dose is 50 mg taken approximately 1 hour before sexual activity, with possibility of adjustment to 100 mg or decrease to 25 mg based on effectiveness and toleration
    • Max 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
  • Pulmonary Arterial Hypertension:
    • Recommended dose is 20 mg three times a day, taken approximately 4-6 hours apart, with or without food

Interaction

  • Metabolism: Principally mediated by cytochrome P450 (CYP) isoforms 3A4 and 2C9
  • Inhibitors:
    • Cimetidine, erythromycin, saquinavir, ketoconazole, itraconazole, ritonavir, and protease inhibitors can increase kX-50 concentrations
    • Strong CYP3A4 inhibitors expected to have greater effects

Contraindications

  • Hypersensitivity to any component of the medication
  • Concomitant use with organic nitrates

Side Effects

  • Various systemic and specific adverse effects related to different body systems
  • Serious cardiovascular, cerebrovascular, and vascular events reported post-marketing
  • Potential for prolonged erection, priapism, hematuria, and visual disturbances

Pregnancy & Lactation

  • Pregnancy category B with no adequate and well-controlled studies in pregnant women
  • Not indicated for use by women, animal studies show no evidence of teratogenicity or embryotoxicity

Precautions & Warnings

  • General:
    • Evaluation of erectile dysfunction should include determination of potential underlying causes and appropriate treatment following complete medical assessment
  • Vasodilatory Effects:
    • Caution advised when co-administered with alpha-blockers as both are vasodilators with blood-pressure-lowering effects
    • Potential for additive effect on blood pressure
    • Safety of combined use affected by various variables including intravascular volume depletion
  • Cardiac Risk:
    • Potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease
    • Systemic vasodilatory properties should be carefully considered in patients with underlying cardiovascular disease
  • Sensitive Patient Groups:
    • Patients with specific underlying conditions such as left ventricular outflow obstruction, severely impaired autonomic control of blood pressure, and certain cardiovascular disorders
  • Special Groups:
    • Lack of controlled clinical data on safety or efficacy in specific groups including those with recent myocardial infarction, resting hypotension or hypertension, certain heart conditions, retinal disorders, and certain anemias

Storage Conditions

  • Keep in a dry place
  • Away from light and heat
  • Keep out of the reach of children

Therapeutic Class

  • Drugs for Erectile Dysfunction

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