Aggra 100 mg (Tablet)

Therapeutic Class

• Drugs for Erectile Dysfunction

Indications

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

Description

• Selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5)
• Causes smooth muscle relaxation and inflow of blood into penile tissues

Pharmacology

• Mechanism of action involving release of nitric oxide (NO) during sexual stimulation
• Activates guanylate cyclase resulting in increased levels of cGMP
• Rapid absorption and hepatic metabolism
• Mainly metabolized by cytochrome P450 3A4

Dosage & Administration

• Recommended dose: 50 mg taken approximately 1 hour before sexual activity
• Dosage may be adjusted 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

Interaction

• Metabolism mediated by cytochrome P450 isoforms 3A4 and 2C9
• Potential interaction with inhibitors or inducers of these isoenzymes

Contraindications

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

Side Effects

• Various systemic, cardiovascular, digestive, hemic and lymphatic, metabolic and nutritional, musculoskeletal, nervous, respiratory, skin and appendages, special senses, and urogenital effects

Pregnancy & Lactation

• Pregnancy category B
• Not indicated for use by women
• No evidence of teratogenicity or embryotoxicity in animal studies

Precautions & Warnings

• Evaluation of erectile dysfunction should include determination of potential underlying causes
• Caution advised when co-administered with alpha-blockers due to potential for additive blood-pressure-lowering effects
• Considerations for patients with hemodynamic instability, bleeding disorders, peptic ulceration, anatomical deformation of the penis, and conditions predisposing to priapism
• Not generally recommended for men for whom sexual activity is inadvisable due to underlying cardiovascular status
• Caution in patients with preexisting cardiovascular disease, left ventricular outflow obstruction, severely impaired autonomic control of blood pressure
• No controlled clinical data on safety or efficacy for certain patient groups

Overdose Effects

• In studies with healthy volunteers, adverse events increased with higher doses
• Standard supportive measures recommended in cases of overdose
• Renal dialysis not expected to accelerate clearance

Storage Conditions

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

Related Brands

• Aggra 50 mg (Tablet) - eskayef-pharmaceuticals-ltd
• Adegra 100 mg (Tablet) - aci-limited
• Adegra 50 mg (Tablet) - aci-limited