Classifications: impotence agent; phosphodiesterase (pde) inhibitor; Therapeutic: impotence
Pregnancy Category: B
20 mg, 25 mg, 50 mg, 100 mg tablets
Enhances vasodilation effect of nitric oxide in the corpus cavernosus of the penis, thus sustaining an erection.
Oral treatment for erectile dysfunction, whether organic or psychogenic in origin.
Erectile dysfunction, pulmonary arterial hypertension.
Hypersensitivity to sildenafil; concurrent administration of organic nitrates and nitroglycerin; lactation, children, infants.
CAD, heart failure, MI, cardiac arrhythmias, stroke within 6 mo of starting drug; nitrate therapy; hypotension and hypertension;
risk factors for CVA; aortic stenosis; anatomic deformity of the penis; sickle cell anemia, polycythemia; multiple myeloma;
leukemia; active bleeding or a peptic ulcer, GERD, hiatal hernia; coagulopathy; retinitis pigmentosa; hepatic disease, hepatitis,
cirrhosis; severe renal impairment (Clcr <30 mL/min); older adults; concurrent use with other medicines for penile dysfunction; pregnancy (category B).
Route & Dosage
Adult: PO 50 mg 0.54 h before sexual activity (dose range: 25 to 100 mg once/d); max dose: 25 mg/d with itraconazole or ketoconazole;
max dose: 25 mg/48 h with ritonavir
Geriatric: PO 25 mg approximately 1 h before sexual activity
Pulmonary Arterial Hypertension
Adult: PO 20 mg t.i.d. (46 h apart)
Hepatic or Severe Renal Impairment
Adult: PO 25 mg approximately 1 h before sexual activity
- For erectile dysfunction: Dose 1 h prior to sexual activity (effective range is 0.54 h).
- Do not give within 24 h of taking any medication with nitrates (i.e., nitroglycerin).
- Store at 15°30° C (59°86° F) in a tightly closed container; protect from light.
Adverse Effects (≥1%)Body as a Whole:
Face edema, photosensitivity, shock, asthenia, pain, chills, fall, allergic reaction, arthritis
, myalgia. CNS: Headache,
dizziness, migraine, syncope, cerebral thrombosis, ataxia, neuralgia, paresthesias, tremor, vertigo, depression
somnolence, abnormal dreams. CV:
Flushing, chest pain, MI,
angina, AV block, tachycardia, palpitation, hypotension, postural hypotension, cardiac arrest, sudden cardiac death,
heart failure, cardiomyopathy, abnormal ECG, edema. GI:
Dyspepsia, diarrhea, abdominal pain, vomiting, colitis
, dysphagia, gastritis
, gastroenteritis, esophagitis, stomatitis,
dry mouth, abnormal liver function tests, thirst. Respiratory:
Nasal congestion, asthma
, dyspnea, laryngitis, pharyngitis, sinusitis
, cough. Skin:
Rash, urticaria, pruritus, sweating, exfoliative dermatitis. Urogenital:
UTI. Special Senses:
Abnormal vision (color changes, photosensitivity, blurred vision, sudden vision loss). Hematologic:
Anemia, leukopenia. Metabolic: Gout
, hyperglycemia, hyperuricemia, hypoglycemia
increase risk of serious hypotension; if used within 4 h of doxazosin, prazosin, terazosin, tamsulosin; cimetidine, erythromycin, ketoconazole, itraconazole, protease inhibitors
increase sildenafil levels; rifampin
can decrease sildenafil levels. Food: Grapefruit juice
(>1 qt/d) may increase plasma
concentrations and adverse effects.
Rapidly from GI tract. Peak:
30120 min. Distribution:
96% protein bound. Metabolism:
In liver (CYP3A4 and 2C9). Elimination:
80% in feces, 12% in urine. Half-Life:
Assessment & Drug Effects
- Monitor carefully for and immediately report S&S of cardiac distress.
Patient & Family Education
- Do not take sildenafil within 4 h of taking doxazosin, prazosin, terazosin, or tamsulosin.
- Consuming a high-fat meal before taking drug may cause delay in drug action.
- Report to physician: Headaches, flushing, chest pain, indigestion, blurred vision, sensitivity to light, changes in color