EXTRA SUPER LEVITRA

Active Ingredient: Vardenafil Dapoxetine

Extra Super Levitra is used in the treatment of Erectile Dysfunction with Premature Ejaculation. Extra Super Levitra 100 mg contains Vardenafil 40 mg and Dapoxetine 60 mg.

INSTRUCTIONS

Use Extra Super Levitra as directed by your doctor.

Take Extra Super Levitra by mouth with or without food.

Take Extra Super Levitra about 1 hour before sexual activity.

Do not take Extra Super Levitra more often than once daily, or as directed by your doctor.

Check with your doctor before you eat grapefruit or drink grapefruit juice while you use Extra Super Levitra.

If you miss a dose of Extra Super Levitra and you still intend to engage in sexual activity, take it as soon as you remember. Continue to take it as directed by your doctor.

INDICATIONS

EXTRA SUPER LEVITRA is indicated for the treatment of erectile dysfunction.

DOSAGE AND ADMINISTRATION

General Dose Information

For most patients, the recommended starting dose of EXTRA SUPER LEVITRA is 10 mg, taken orally, as needed, approximately 60 minutes before sexual activity. The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. Sexual stimulation is required for a response to treatment.

Use With Food

EXTRA SUPER LEVITRA can be taken with or without food.

Use In Specific Populations

Geriatrics

A starting dose of 5 mg EXTRA SUPER LEVITRA should be considered in patients ≥ 65 years of age

DOSAGE

Please take the medication exactly as prescribed by a doctor.

Some men can only take a low dose of Extra Super Levitra because of medical conditions or medicines they take. Your doctor will prescribe the dose that is right for you.

If you are older than 65 or have liver problems, your doctor may start you on a lower dose of Extra Super Levitra.

If you have prostate problems or high blood pressure, for which you take medicines called alpha-blockers, your doctor may start you on a lower dose of Extra Super Levitra.

If you are taking certain other medicines your doctor may prescribe a lower starting dose and limit you to one dose of Extra Super Levitra in a 72-hour (3 days) period.

Ask your health care provider any questions you may have about how to use Extra Super Levitra.

OVERDOSE

The maximum dose of LEVITRA for which human data are available is a single 120 mg dose administered to healthy male volunteers. The majority of these subjects experienced reversible back pain/myalgia and/or “abnormal vision.” Single doses up to 80 mg vardenafil and multiple doses up to 40 mg vardenafil administered once daily over 4 weeks were tolerated without producing serious adverse side effects.

When 40 mg of vardenafil was administered twice daily, cases of severe back pain were observed. No muscle or neurological toxicity was identified.

In cases of overdose, standard supportive measures should be taken as required. Renal dialysis is not expected to accelerate clearance as vardenafil is highly bound to plasma proteins and not significantly eliminated in the urine.

CLINICAL PHARMACOLOGY

Mechanism Of Action

Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells in the corpus cavernosum. Nitric oxide activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum. The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in erection. The tissue concentration of cGMP is regulated by both the rates of synthesis and degradation via phosphodiesterases (PDEs). The most abundant PDE in the human corpus cavernosum is the cGMP-specific phosphodiesterase type 5 (PDE5); therefore, the inhibition of PDE5 enhances erectile function by increasing the amount of cGMP. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation.

In vitro studies have shown that vardenafil is a selective inhibitor of PDE5. The inhibitory effect of vardenafil is more selective on PDE5 than for other known phosphodiesterases (>15-fold relative to PDE6, >130-fold relative to PDE1, >300-fold relative to PDE11, and >1,000-fold relative to PDE2, 3, 4, 7, 8, 9, and 10).

Pharmacodynamics

Effects On Blood Pressure

In a clinical pharmacology study of patients with erectile dysfunction, single doses of vardenafil 20 mg caused a mean maximum decrease in supine blood pressure of 7 mmHg systolic and 8 mmHg diastolic (compared to placebo), accompanied by a mean maximum increase of heart rate of 4 beats per minute. The maximum decrease in blood pressure occurred between 1 and 4 hours after dosing. Following multiple dosing for 31 days, similar blood pressure responses were observed on Day 31 as on Day 1. Vardenafil may add to the blood pressure lowering effects of antihypertensive agents.