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Levitra | Staxyn | Vardenafil 10/20 mg is used to treat male sexual function problems such as impotence or erectile dysfunction-ED. In combination with sexual stimulation, vardenafil works by increasing blood flow to the penis to help a man get and keep an erection.

Therapeutic Class:

Drugs for Erectile Dysfunction

Pharmacology:

Does not directly cause penile erections but affects the response to sexual stimulation. The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation.

NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation and inflow of blood to the corpus cavernosum.

Levitra enhances the effect of NO by inhibiting phosphodiesterase type 5 (PDE-5), which is responsible for degradation of cGMP in the corpus cavernosum; when sexual stimulation causes local release of NO, inhibition of PDE-5 by vardenafil causes increased levels of cGMP in the corpus cavernosum.

Dosage & Administration:

Initial dose: 10 mg orally once a day, as needed, approximately 60 minutes before sexual activity. Increase to 20 mg or decrease to 5 mg based on efficacy and tolerability.

Maximum dose: 20 mg once a day

Usual Geriatric Dose for Erectile Dysfunction (65 years or older): 5 mg orally once a day, as needed, approximately 60 minutes before sexual activity

Patients on stable alpha blocker therapy: 5 mg orally once a day

Interaction:

Increased risk of hypotension with α-blockers. Increased risk of priapism with alprostadil. Increased serum levels of Levitra when used with erythromycin.

Contraindications:

Known prolongation of QT interval (congenital or acquired); men for whom sexual intercourse is inadvisable due to CV risk factors; hypotension (systolic 170 mm Hg or diastolic >110 mm Hg); recent stroke or MI (within last 6 mth); unstable angina; severe heart failure.

Side Effects:

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.

Pregnancy & Lactation:

Pregnancy Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility.

Precautions:

Before using Levitra, tell your doctor or pharmacist your medical history, especially of: heart problems (such as heart attack or life-threatening irregular heartbeat in the past 6 months, chest pain/angina, heart failure), stroke in the past 6 months,

kidney disease (dialysis), liver disease, high or low blood pressure, a severe loss of body water (dehydration), penis conditions (such as angulation, fibrosis/scarring, Peyronie’s disease), history of painful/prolonged erection (priapism).

multiple myeloma), eye problems (such as retinitis pigmentosa, sudden decreased vision, NAION), bleeding disorders, active stomach ulcers.

Levitra may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using Levitra, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using Levitra safely.

Levitra may make you dizzy or cause vision changes. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages.

Levitra may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet, ask your doctor or pharmacist about using this medication safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

Levitra is not usually used in women. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this medication.

Use in Special Population:

Patients stabilized on α-blocker therapy: max daily dose 5 mg and not to be taken within 6 hr of the α-blocker (except tamsulosin).

Patients on erythromycin: Max: 5 mg daily.

Renal Impairment: Haemodialysis: Avoid.

Hepatic Impairment:

·         Child Pugh A-B (mild to moderate) impairment: Initiate with 5 mg.

·         Max dose in moderate impairment: 10 mg.

·         Child-Pugh C (severe impairment): No studies done.

Storage Conditions:

Store between 15-30° C.