ADVERSE REACTIONS

For most men, the recommended starting dose is 10 mg. Take LEVITRA no more than once a day.

• Some users may experience mild flickering vision episodes.
• The efficacy of vardenafil varies between individuals.
• The medication is available in various dosage forms.
• Always follow the specific instructions provided.
• Avoid taking vardenafil with high-fat meals to speed absorption.
• Do not take vardenafil if allergic to its ingredients.
• The drug may cause a temporary burning sensation.
• Use caution in patients with a history of priapism.
• Avoid combining vardenafil with certain herbal supplements.
• Consult your doctor about any ongoing health treatments.

Some men can only take a low dose of

Why is a prescription required for erectile dysfunction medicines?

Geriatrics: A starting dose of 5 mg LEVITRA should be considered in patients ≥65 years of age (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Special Populations and PRECAUTIONS). Hepatic Impairment: For patients with mild hepatic impairment (Child-Pugh A), no dose adjustment of LEVITRA is required. Vardenafil clearance is reduced in patients with moderate hepatic impairment (Child-Pugh B), and a starting dose of 5 mg LEVITRA is recommended. The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. LEVITRA has not been evaluated in patients with severe hepatic impairment (Child-Pugh C) (see CLINICAL PHARMACOLOGY, Metabolism and ExcretionWARNINGS and PRECAUTIONS).

Medications & Supplements

Renal Impairment: For patients with mild (CLcr = 50-80 ml/min), moderate (CLcr = 30-50 ml/min), or severe (CLcr<30 ml/min) renal impairment, no dose adjustment is required. LEVITRA has not been evaluated in patients on renal dialysis (see CLINICAL PHARMACOLOGY, Metabolism and Excretion and PRECAUTIONS). Concomitant Medications: The dosage of LEVITRA may require adjustment in patients receiving potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, atazanavir, and clarithromycin as well as in other patients receiving moderate CYP3A4 inhibitors such as erythromycin (see WARNINGS, PRECAUTIONS, Drug Interactions). For ritonavir, a single dose of 2.5 mg LEVITRA should not be ed tablets exceeded in a 72-hour period. For indinavir, saquinavir, atazanavir, ketoconazole 400 mg daily, itraconazole 400 mg daily, and clarithromycin, a single dose of 2.5 mg LEVITRA should not be exceeded in a 24-hour period.

Report Problems to the Food and Drug Administration

For ketoconazole 200 mg daily, itraconazole 200 mg daily, and erythromycin, a single dose of 5 mg LEVITRA should not be exceeded in a 24-hour period. For alpha-blockers, caution is advised when PDE5 inhibitors, including LEVITRA, are used concomitantly with alpha-blockers because of the potential for an additive effect on blood pressure. In some patients, concomitant use of these two drug classes can lower blood pressure significantly (see PRECAUTIONS,Alpha-blockers and Drug Interactions) leading to symptomatic hypotension (e.g., fainting). Concomitant treatment should be initiated only if the patient is stable on his alpha blocker therapy. In those patients who are stable on alpha-blocker therapy, LEVITRA should be initiated at a dose of 5 mg (2.5 mg when used concomitantly with certain CYP3A4 inhibitors - see Drug Interactions). LEVITRA because of medical conditions or medicines they take.

Your doctor will prescribe the dose that is right for you.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

The active ingredient in LEVITRA is called vardenafil. See the end of this leaflet for a complete list of ingredients. WHAT SHOULD YOU DISCUSS WITH YOUR DOCTOR BEFORE TAKING LEVITRA? Before taking LEVITRA, tell your doctor about all your medical problems, including if you: have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. have low blood pressure or have high blood pressure that is not controlled or any family members have a rare heart condition known as prolongation of the QT interval (long QT syndrome) have retinitis pigmentosa, a rare genetic (runs in families) eye disease have ever had severe vision loss, or if you have an eye condition called non-arteritic anterior ischemic optic neuropathy (NAION) have a deformed penis shape or Peyronie’s disease have had an erection that lasted more than 4 hours have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. If you are older than 65 or have liver problems,

your doctor may start you on a lower dose of LEVITRA.

• Vardenafil 10 mg may be used by men over 18 years.
• The medication is not approved for use in women or children.
• May be contraindicated in patients with certain eye conditions.
• Use caution if you have a history of stroke.
• The drug’s chemical action involves improving blood flow.
• It is important to distinguish ED causes before treatment.
• Use only medications prescribed by a healthcare professional.
• Avoid combining with other erectile dysfunction medications.
• Keep medication out of sunlight and moisture.
• Seek emergency medical help for severe side effects.

If you have prostate problems or

• Vardenafil is generally safe when used as prescribed.
• The tablet is typically taken around 30 minutes before sex.
• Alcohol may enhance side effects like dizziness.
• Do not use vardenafil if you are taking nitrates.
• Keep a schedule of your medication use.
• Inform your doctor about other medications you are taking.
• Use only prescribed dosage to prevent adverse effects.
• Avoid certain foods that may interfere with absorption.
• Healthcare providers may adjust doses based on response.
• Proper storage extends the shelf life of the medication.

high blood pressure, for which you take

Side Effects

The following section identifies additional, less frequent events (<2%) reported during the clinical development of LEVITRA. Excluded from this list are those events that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient’s underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors (see PRECAUTIONS, Information for Patients). Visual disturbances including vision loss (temporary or permanent), such as visual field defect, retinal vein occlusion, and reduced visual acuity, have also been reported rarely in post-marketing experience.

What are the side effects of vardenafil?

It is not possible to determine whether these events are related directly to the use of LEVITRA. Seizure, seizure recurrence and transient global amnesia have been reported post-marketing in temporal association with LEVITRA. Cases of sudden decrease or loss of hearing have been reported post-marketing in temporal association with the use of PDE5 inhibitors, including LEVITRA. It is not possible to determine whether these reported events are related directly to the use of LEVITRA, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors (see PRECAUTIONS, Information for Patients). The maximum dose of LEVITRA for which human data are available is a single 120 mg dose administered to eight healthy male volunteers.

What should I know about vardenafil before taking it?

The majority of these subjects experienced reversible back pain/myalgia and/or “abnormal vision.” In cases of overdose, standard supportive measures should be taken as required. 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. LEVITRA can be taken with or without food. medicines called alpha-blockers, your doctor may start

you on a lower dose of LEVITRA.

Further information

LEVITRA and other medicines may affect each other. Especially tell your doctor if you take any of the following: medicines called nitrates (See “What important information should you know about LEVITRA?”) These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl) or Uroxatral® (alfuzosin HCl). In some patients the use of PDE5 inhibitor drugs, including LEVITRA, with alpha-blockers can lower blood pressure significantly leading to fainting. You should contact the prescribing physician if alpha-blockers or other drugs that lower blood pressure are prescribed by another healthcare provider. LEVITRA comes in different doses (2.5 mg, 5 mg, 10 mg, and 20 mg). If you are taking certain other medicines

How does the online consultation work?

LEVITRA cheapest ed pills (vardenafil HCl) is formulated as orange, film-coated round tablets with debossed “BAYER” cross on one side and “10” and “20” on the other side equivalent to 10 mg and 20 mg of vardenafil, respectively. Vardenafil HCl (Levitra) 10mg tablets are supplied in bottles of 2, 4, 6, 12 and 18 tablets per bottle.Vardenafil HCl (Levitra) 20mg tablets are supplied in bottles of 2, 3, 4, 6, 12 and 18 tablets per bottle. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Bayer HealthCare Pharmaceuticals Inc.Wayne, NJ 07470 LEVITRA is a registered trademark of Bayer Aktiengesellschaft and is used under license by GlaxoSmithKline and Schering Corporation. ©2008 Bayer HealthCare Pharmaceuticals Inc.Printed in U.S.A.

Other Medical Problems

Repackaged by: APHENA PHARMA SOLUTIONS - TN Cookeville, TN 3850620111027AW Read the Patient Information about LEVITRA before you start taking it and again each time you get a refill. You and your doctor should talk about LEVITRA when you start taking it and at regular checkups. WHAT IMPORTANT INFORMATION SHOULD YOU KNOW ABOUT LEVITRA? LEVITRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. use recreational drugs called “poppers” like amyl nitrate and butyl nitrate.

How is vardenafil supplied (dosage forms)?

Tell all your healthcare providers that you take LEVITRA. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took LEVITRA. LEVITRA is a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men. LEVITRA may help a man with ED get and keep an erection when he is sexually excited. protect a man or his partner from sexually transmitted diseases, including HIV. your doctor may prescribe a lower starting

14.1 Other Vardenafil Clinical Trials Using Film-Coated Tablets

serve as a male form of birth control LEVITRA is only for men with ED. LEVITRA is not for women or children. LEVITRA must be used only under a doctor’s care. LEVITRA helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. Talk to your doctor to decide if LEVITRA is right for you.

Visual disturbances

LEVITRA has been shown to be effective in men over the age of 18 years who have erectile dysfunction, including men with diabetes or who have undergone prostatectomy. take any medicines called “nitrates” (See “What important information should you know about LEVITRA?”). Do not use LEVITRA if you are sex tablet 100mg using these drugs. you have been told by your healthcare provider to not have sexual activity because of health problems. are allergic to LEVITRA or any of its ingredients. dose and limit you to one dose of LEVITRA in a 72-hour (3 days) period.

• The onset of vardenafil 10 mg is typically 30-60 minutes.
• It can last up to 4-5 hours in some users.
• Vardenafil is contraindicated with certain heart medications.
• Use caution if you have a history of hypotension.
• The tablet may cause mild gastrointestinal upset.
• Do not consume large amounts of alcohol when taking vardenafil.
• Inform your doctor if you experience sudden hearing loss.
• Use only as directed by your healthcare provider.
• Discontinue if you experience persistent erection issues.
• The medication does not increase sexual desire.

Take 1 LEVITRA tablet about 1 hour (60 minutes) before sexual activity.