Classifications: impotence agent; phosphodiesterase (pde) inhibitor; vasodilator; Therapeutic:impotence; pde inhibitor; vasodilator
Pregnancy Category: B
2.5 mg, 5 mg, 10 mg, 20 mg tablets
Phosphodiesterases-5 (PDE5) is an enzyme that speeds up the degradation of cyclic guanosine monophosphate (cGMP), an enzyme
needed to cause and maintain increased blood flow into the penis necessary for an erection. Vardenafil is a PDE5 inhibitor.
It enhances erectile function by increasing the amount of cGMP in the penis.
Treatment of erectile dysfunction.
Hypersensitivity to vardenafil or sildenafil; concurrent administration of nitrates or nitroglycerin; QT prolongation, renal
failure, severe renal impairment; retinitis pigmentosa; not recommended for women or children; lactation.
CAD, MI, or stroke within 6 mo; hypotension, or hypertension; risk factors for CVA; anatomic deformity of the penis; subaortic
stenosis; sickle cell anemia, leukemia; multiple myeloma; leukemia; coagulopathy; active bleeding or a peptic ulcer; coagulopathy;
GERD; hepatitis, cirrhosis; older adults; concurrent use with other medicines for penile dysfunction; pregnancy (category
Route & Dosage
Adult: PO 10 mg approximately 60 min before sexual activity. May increase to max 20 mg/d if needed. If taking ritonavir, max dose
is 2.5 mg/72 h. If taking erythromycin, indinavir, itraconazole, ketoconazole, max dose is 2.55 mg/24 h.
Geriatric: PO Start with 5 mg 60 min before sexual activity (max: 20 mg/d)
Moderate impairment: reduce dose to 5 mg (max: 10 mg/d)
- Take approximately 1 h before expected intercourse, but preferably not after a heavy or high-fat meal.
- Store at 15°30° C (59°86° F).
Adverse Effects (≥1%)Body as a Whole: Flushing,
, back pain, anaphylactoid reactions, asthenia, facial edema, pain, paresthesias. CNS: Headache,
, somnolence, vertigo. CV:
Angina, hypertension, hypotension, MI, orthostatic hypotension, palpitations, syncope, sinus tachycardia. GI:
Dyspepsia, nausea, vomiting, abdominal pain, abnormal liver function tests, diarrhea
, dysphagia, esophagitis, gastritis
GERD, xerostomia. Metabolic:
Increased creatine kinase. Musculoskeletal: Arthralgia
, myalgia, hypertonia, hyperesthesia. Respiratory:
, epistaxis, pharyngitis. Skin:
Photosensitivity, rash, pruritus, sweating. Special Senses:
Tinnitus, sudden vision loss, blurred vision, changes in color vision. Urogenital:
May potentiate hypotensive effects of nitrates
, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin; amiodarone, dofetilide, procainamide, quinidine, sotalol
may increase QTc
interval leading to arrhythmias; erythromycin
(and other macrolides
), indinavir, itraconazole, ketoconazole, PROTEASE INHIBITORS
, ritonavir, voriconazole
may increase level and toxicity
Rapidly absorbed, 15% reaches systemic circulation. Onset:
Within 1 h. Peak:
0.52 h. Metabolism:
In liver by CYP3A4. Elimination:
Primarily in feces (9095%). Half-Life:
Assessment & Drug Effects
- Monitor CV status and report angina or other S&S of cardiac dysfunction.
- Lab tests: Baseline and periodic LFTs.
Patient & Family Education
- Do not take more than once a day and never take more than the prescribed dose.
- Do not take this drug without consulting physician if you are taking drugs called "alpha blockers" or "nitrates"
or any other drugs for high blood pressure, chest pain, or enlarged prostate.
- Report promptly any of the following: palpitations, chest pain, back pain, difficulty breathing, or shortness of breath;
dizziness or fainting; changes in vision; dizziness; swollen eyelids; muscle aches; painful or prolonged erection (lasting
longer than 4 h); skin rash, or itching.