Four Star
Concise Prescribing Info
Vardenafil HCl trihydrate
Dosage/Direction for Use
Adult men 10 mg as needed approx 25-60 min before sexual activity, may be increased to 20 mg or decreased to 5 mg. Max: 20 mg/day. Mild & moderate hepatic impairment Initially 5 mg. Max: 10 mg for patients w/ moderate hepatic impairment. Severe renal impairment (CrCl <30 mL/min) Initially 5 mg, may be increased to 10 & 20 mg.
May be taken with or without food.
Hypersensitivity. Co-administration w/ nitrates or nitric oxide donors. Patients who have loss of vision in 1 eye because of non-arteritic anterior ischemic optic neuropathy. Men for whom sexual activity is inadvisable (eg, patients w/ severe CV disorders). Patients w/ severe hepatic impairment, end stage renal disease requiring dialysis, hypotension (BP <90/50 mmHg), recent history of stroke or MI (w/in the last 6 mth), unstable angina, known hereditary retinal degenerative disorders eg, retinitis pigmentosa. Concomitant use w/ potent CYP3A4 inhibitors ketoconazole & itraconazole (oral form) in men >75 yr. Concomitant use w/ HIV PIs (eg, ritonavir, indinavir); guanylate cyclase stimulators (eg, riociguat).
Special Precautions
Consider CV status prior to initiating treatment. Use w/ caution in patients w/ pre-existing CV risk factors; patients w/ anatomical deformation of the penis (eg, angulation, cavernosal fibrosis or Peyronie's disease) or in patients who have conditions which may predispose them to priapism (eg, sickle cell anaemia, multiple myeloma, leukaemia); patients w/ bleeding disorders or active peptic ulceration. Risk of QTc interval prolongation. Reports of visual defects & non-arteritic anterior ischaemic optic neuropathy. Not recommended in combination w/ other treatments for erectile dysfunction. Concomitant use of α-blockers & vardenafil should only be initiated if patient has been stabilised on α-blocker therapy. Vardenafil dose adjustment might be necessary w/ concomitant moderate CYP3A4 inhibitors. Avoid combination w/ grapefruit or grapefruit juice. May impair ability to drive & use machines. Not indicated for use by women & individuals <18 yr. Elderly.
Adverse Reactions
Headache. Dizziness, flushing, nasal congestion, dyspepsia.
Drug Interactions
Increased plasma levels w/ CYP3A4 inhibitors (eg, indinavir, ritonavir, ketoconazole & itraconazole in oral form, erythromycin, grapefruit juice). Possible potentiation of hypotensive effects of nitrates (eg, nitroglycerin, nicorandil). Additive BP-lowering effect w/ α-blockers; riociguat.
MIMS Class
Drugs for Erectile Dysfunction & Ejaculatory Disorders
ATC Classification
G04BE09 - vardenafil ; Belongs to the class of drugs used in erectile dysfunction.
Levitra film-coated tab 20 mg
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