Indications |
Oral Erectile dysfunction Adult: Initially, 10 mg taken 60 minutes before sexual activity. Adjust subsequent doses according to response. Max: 20 mg as a single dose. Max frequency: Once daily. Sexual stimulation needed for response to therapy. Elderly: ≥65 yr: Initially 5 mg 60 minutes before sexual activity, increased to 10 mg then 20 mg if needed. Renal impairment: Haemodialysis: Avoid.
Special Populations: Hepatic impairment: Initial dose: 5 mg. Renal Impairment (creatinine clearance <30 mL/min): Initial dose: 5 mg. |
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Contraindications |
Known prolongation of QT interval (congenital or acquired); men for whom sexual intercourse is inadvisable due to CV risk factors; hypotension (systolic <90 mm Hg); hypertension (systolic >170 mm Hg or diastolic >110 mm Hg); recent stroke or MI (within last 6 mth); unstable angina; severe heart failure; end-stage renal disease requiring dialysis; severe hepatic impairment; known degenerative retinal disorders e.g. retinitis pigmentosa. Women, child. | ||||
Warnings / Precautions |
Anatomical deformation of the penis; predisposition to priapism e.g. sickle cell anaemia, multiple myeloma, or leukaemia; bleeding disorders or active peptic ulceration; left ventricular outflow obstruction; elderly (≥ 65 yr). Discontinue and seek medical advice if there is sudden vision loss or decreased vision in one or both eyes or tinnitus, dizziness or sudden loss or decrease in hearing, while taking vardenafil. May cause dizziness or abnormal vision so avoid driving or operating machinery until effects of vardenafil is known. Seek immediate medical advice if erection last > 4 hr. | ||||
Adverse Reactions |
Dyspepsia, vomiting, headache, flushing, dizziness, visual disturbances, colour vision changes, raised intra-ocular pressure, nasal congestion, hypersensitivity reactions, nausea, photosensitivity reactions, hypotension, hypertension, priapism, palpitations, myalgia, increased creatinine kinase, sudden decrease or loss of hearing, tinnitus. | ||||
Drug Interactions |
Increased risk of hypotension with α-blockers. Increased risk of priapism with alprostadil. Increased serum levels of vardenafil when used with erythromycin. Potentially Fatal: Increased risk of hypotension with nitrates, nitrites, and nitric oxide donors, either regularly or intermittently (avoid combination). Increased risk of ventricular arrhythmias with drugs that prolong QT interval e.g. Class IA or Class III antiarrhythmics (avoid combination). Increased vardenafil concentrations with potent CYP 3A4 inhibitors e.g. ketoconazole, itraconazole, HIV-protease inhibitors such as indinavir and ritonavir (avoid combination). See Below for More vardenafil Drug Interactions |
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Food Interactions |
Increased vardenafil concentration levels with grapefruit juice. | ||||
Mechanism of Actions |
Vardenafil is a phosphodiesterase type-5 inhibitor. It manages erectile dysfunction by increasing the amounts of cyclic guanosine monophosphate (cGMP). Absorption: Rapidly absorbed from GI tract with 15% bioavailability. Peak plasma concentration: 30-120 minutes. Rate of absorption decreased with high fat meal. Distribution: Widely distributed. Protein binding: 95%. Metabolism: Metabolised in the liver primarily by cytochrome P450 isoenzymes CYP3A4 (the major route), CYP3A5 and CYP2C. Major metabolite has some activity. Excretion: Excreted as metabolites mainly in faeces (91-95%), and some in urine (2-6%). Terminal half life: 4-5 hr. |
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Administration |
May be taken with or without food. |
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Storage Conditions |
Oral: Store between 59-86°F (15-30°C). | ||||
ATC Classification |
G04BE09 - vardenafil ; Belongs to the class of drugs used in erectile dysfunction. | ||||
Storage |
Oral: Store between 59-86°F (15-30°C). | ||||
Available As |
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Vardenafil
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Vardenafil Containing Brands
Vardenafil is used in following diseases
Drug - Drug Interactions of Vardenafil
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