Sildenafil GPO

Sildenafil GPO

sildenafil

Manufacturer:

GPO

Distributor:

GPO
Concise Prescribing Info
Contents
Sildenafil citrate
Indications/Uses
Dosage/Direction for Use
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ organic nitrates (eg, nitroglycerin, isosorbide dinitrate).
Special Precautions
Risk for nonarteritic anterior ischemic optic neuropathy may be increased. Hearing loss. Patients w/ retinitis pigmentosa, left ventricular outflow obstruction (aortic stenosis, hypertrophic obstructive cardiomyopathy), receiving antihypertensive therapy, w/ resting hypotension (BP <90/50 mmHg), fluid depletion, or autonomic dysfunction, bleeding disorders, active PUD. Patients should be hemodynamically stable prior to initiating therapy at the lowest possible dose. Prolonged erections (>4 hr) & priapism; conditions which may predispose to priapism (eg, sickle cell anemia, multiple myeloma, leukemia). Patients w/ anatomical deformation of the penis (angulation, cavernosal fibrosis or Peyronie's disease). Uncontrolled HTN (>170/110 mmHg), life-threatening arrhythmias, stroke or MI w/in the last 6 mth, cardiac failure or CAD causing unstable angina. Consider the CV status of patients prior to initiating treatment. Concomitant use w/ α-blockers, ritonavir & other potent CYP3A4 inhibitors, PDE5 inhibitors. Hepatic & renal impairment. May affect ability to drive or operate machinery. Pregnancy & lactation. Childn. Elderly.
Adverse Reactions
Headache, flushing, diarrhea, dyspepsia, pain in extremity. Influenza, insomnia, visual disturbance, blurred vision, epistaxis, cough, nasal congestion, myalgia, back pain, pyrexia.
Drug Interactions
Conc may be increased by CYP3A4 (ketoconazole, itraconazole, macrolides eg, erythromycin) & CYP2C9 inhibitors, & decreased by CYP3A4 & CYP2C9 inducers (eg, carbamazepine, phenytoin, phenobarb). Decreased BP, postural dizziness & orthostatic hypotension may occur w/ alcohol. May cause decreased BP w/ α-blockers (doxazosin, terazosin), amlodipine. Decreased AUC & Cmax w/ bosentan. Increased plasma conc w/ cimetidine, PIs (eg, ritonavir, indinavir, saquinavir), serotonin reuptake inhibitors (eg, fluvoxamine), tacrolimus. Increased plasma levels w/ ciprofloxacin, delavirdine. May potentiate vasodilatory effect of circulating nitric oxide; nitrates (eg, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin). Increased clearance w/ rifampin & other CYP3A4 inducers. Increased incidence of bleeding w/ anticoagulants (vit K dependent). Increased serum levels/toxicity w/ grapefruit juice. Decreased levels w/ St. John's wort.
ATC Classification
G04BE03 - sildenafil ; Belongs to the class of drugs used in erectile dysfunction.
Presentation/Packing
Form
Sildenafil GPO tab 20 mg
Packing/Price
10 × 10's
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