X-Fil 50 mg (Tablet)

Indications

• Erectile dysfunction treatment
• Pulmonary arterial hypertension

Description

• Selective inhibitor of cGMP-specific phosphodiesterase type 5
• Causes smooth muscle relaxation
• Increases blood flow into penile tissues
• No effect in the absence of sexual stimulation

Mechanism of Action

• Involves release of nitric oxide in corpus cavernosum
• Activation of guanylate cyclase
• Increased levels of cGMP
• Enhancement of nitric oxide effect by inhibiting PDE5

Pharmacokinetics

• Rapid absorption after oral administration
• Mean absolute bioavailability of 41%
• Elimination predominantly by hepatic metabolism
• Converted to active metabolite with similar properties
• Terminal half lives of about 4 hours

Dosage & Administration

• Recommended initial dose of 50 mg
• May be adjusted based on effectiveness and toleration
• Maximum recommended dosing frequency once per day
• Considerations for increased plasma levels in specific patient groups
• Recommended dosage for pulmonary arterial hypertension

Interaction

• Metabolism mediated by CYP isoforms 3A4 and 2C9
• Effects of inhibitors and inducers on X-Fil clearance
• Examples of inhibitors and their impact on X-Fil concentrations
• Effects of ritonavir, a highly potent P450 inhibitor
• Expectations of CYP3A4 inducers on X-Fil plasma levels
• Limited effect on X-Fil bioavailability by certain drugs

Contraindications

• Hypersensitivity to any component of the medication
• Contraindicated in patients using organic nitrates

Side Effects

• Wide range of potential side effects on various body systems
• Serious cardiovascular, cerebrovascular, and vascular events reported post-marketing

Pregnancy & Lactation

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

Precautions & Warnings

• Importance of evaluating potential underlying causes of erectile dysfunction
• Caution with concomitant use of alpha-blockers
• Considerations for patients with preexisting cardiovascular disease
• Potential cardiac risk of sexual activity for patients with underlying cardiovascular status
• Potential sensitivity to vasodilators for patients with specific conditions

Overdose Effects

• Adverse events similar to lower doses but with increased incidence rates and severities
• Standard supportive measures recommended in cases of overdose
• 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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