LEVITRA

Other names for this medication: Vardenafilum, Vivanza

Active Ingredient: Vardenafil

Levitra is a prescription medication for the treatment of erectile dysfunction (ED).

Qualitative and quantitative composition

Each tablet contains 5 mg, 10 mg or 20 mg of vardenafil (as hydrochloride).

Tablet core:

  • Crospovidone
  • Magnesium stearate
  • Microcrystalline cellulose
  • Silica, colloidal anhydrous

Film coat:

  • Macrogol 400
  • Hypromellose
  • Titanium dioxide (E171)
  • Ferric oxide yellow (E172)
  • Ferric oxide red (E172)

Therapeutic indications

Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

In order for Levitra to be effective, sexual stimulation is required.

Posology and method of administration

Posology

Use in adult men

The recommended dose is 10 mg taken as needed approximately 25 to 60 minutes before sexual activity. Based on efficacy and tolerability the dose may be increased to 20 mg or decreased to 5 mg. The maximum recommended dose is 20 mg. The maximum recommended dosing frequency is once per day. Levitra can be taken with or without food. The onset of activity may be delayed if taken with a high fat meal.

Special populations

Elderly (>65 years old)

Dose adjustments are not required in elderly patients. However, an increase to a maximum 20 mg dose should be carefully considered depending on the individual tolerability (see sections 4.4 and 4.8).

Hepatic impairment

A starting dose of 5 mg should be considered in patients with mild and moderate hepatic impairment (Child-Pugh A-B). Based on tolerability and efficacy, the dose may subsequently be increased. The maximum dose recommended in patients with moderate hepatic impairment (Child-Pugh B) is 10 mg.

Renal impairment

No dose adjustment is required in patients with mild to moderate renal impairment.

In patients with severe renal impairment (creatinine clearance < 30 ml/min), a starting dose of 5 mg should be considered. Based on tolerability and efficacy the dose may be increased to 10 mg and 20 mg.

Paediatric population

Levitra is not indicated for individuals below 18 years of age. There is no relevant indication for use of Levitra in children.

Use in patients using other medicinal products

Concomitant use of CYP3A4 inhibitors

When used in combination with the CYP3A4 inhibitors such as erythromycin or clarithromycin, the dose of vardenafil should not exceed 5 mg.

Method of administration

For oral use.

INSTRUCTIONS

Use Levitra as directed by your doctor.

Take Levitra by mouth with or without food.

Take Levitra about 1 hour before sexual activity.

Do not take 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 Levitra.

If you miss a dose of 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.

DOSAGE

For most patients, the recommended starting dose of Levitra is 10 mg, taken orally 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.

Some men can only take a low dose of 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 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 Levitra.

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

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

STORAGE

Store Levitra at 25 degrees C (77 degrees F); excursions permitted to 15-30 degrees C (59-86 degrees F). Keep Levitra out of the reach of children.

Inactive Ingredients: Microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, yellow ferric oxide, and red ferric oxide.