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Drug Name: LEVITRA 10MG
Generic Name: vardenafil
COMMON USES: This medicine is a phosphodiesterase-5 (PDE5) inhibitor used for treating erectile dysfunction (ED). It may also be used for other conditions as determined by your doctor.
BEFORE USING THIS MEDICINE: Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine you are taking. DO NOT TAKE THIS MEDICINE IF you are taking nitrates (e.g., nitroglycerin, isosorbide) in any form (e.g., tablet, capsule, patch, ointment); nitroprusside; certain antiarrhythmics (e.g., quinidine, procainamide, sotalol, amiodarone); other PDE5 inhibitors (e.g., sildenafil, tadalafil); other medicines that contain vardenafil or if you use certain recreational drugs called "poppers" (e.g., amyl nitrate, butyl nitrate). DO NOT USE OTHER MEDICINES OR TREATMENTS FOR ED while you are taking this medicine without first checking with your doctor. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking alpha-blockers (e.g., doxazosin), medicines for high blood pressure, azole antifungals (e.g., itraconazole), HIV protease inhibitors (e.g.,indinavir, ritonavir), macrolide antibiotics (e.g., erythromycin), telithryomycin, or rifampin. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including if you have a deformed penis (e.g., Peyronie disease, cavernosal fibrosis), blood cell problems (e.g., sickle cell anemia, leukemia, multiple myeloma), any condition that may increase the risk of priapism (prolonged painful erection), allergies, pregnancy or breast-feeding. Tell your doctor if you have a history of prolonged (more than 4 hours) or painful erection (priapism), certain eye problems (e.g., sudden vision loss, optic neuropathy, macular degeneration, retinitis pigmentosa), hearing problems (e.g., ringing in the ears, decreased hearing, hearing loss), liver or kidney problems, dialysis, high or low blood pressure, ulcers, seizures, lung problems (e.g., pulmonary veno-occlusive disease), bleeding problems, blood vessel problems, heart problems (e.g., heart failure, aortic stenosis, angina), heart attack, stroke, a certain type of irregular heartbeat (long QT syndrome), or a family history of long QT syndrome. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have been told by your healthcare provider to avoid sexual activity because of certain health problems, especially heart problems. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have certain heart problems (e.g., angina, severe heart failure), a certain type of irregular heartbeat (e.g., congenital QT prolongation), low or high blood pressure, certain hereditary degenerative eye problems (e.g., retinitis pigmentosa), severe liver problems, severe kidney problems that require dialysis, or if you have had a heart attack, stroke or life-threatening irregular heartbeat within the past 6 months. Use of this medicine in children is not recommended. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
HOW TO USE THIS MEDICINE: Follow the directions for taking this medicine provided by your doctor. An additional patient leaflet is available with this medicine. Read it carefully. Ask your doctor, nurse or pharmacist any questions that you may have about this medicine. This medicine may be taken on an empty stomach or with food. TAKE THIS MEDICINE by mouth about 1 hour before sexual activity. DO NOT TAKE THIS MEDICINE 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 this medicine. STORE THIS MEDICINE at 77 degrees F (25 degrees C) in a tightly closed container, away from heat, moisture and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE 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.
CAUTIONS: DO NOT USE THIS MEDICINE IF you are allergic to any ingredient in this medicine. THIS MEDICINE MAY CAUSE DIZZINESS, DROWSINESS, LIGHTHEADEDNESS, FAINTING OR BLURRED VISION; alcohol, hot weather, exercise or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. These effects may be worse if you take it with alcohol or certain medicines. Use this medicine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. PATIENTS WITH HEART PROBLEMS who take this medicine may be at increased risk for heart-related side effects, including heart attack or stroke. Symptoms of a heart attack may include chest, shoulder, neck or jaw pain; numbness of an arm or leg; severe dizziness, headache, nausea, stomach pain or vomiting; fainting; or vision changes. Symptoms of a stroke may include confusion, vision or speech changes, one-sided weakness, or fainting. Contact your doctor or seek medical attention right away if you experience these symptoms. THIS MEDICINE MAY RARELY CAUSE A PROLONGED OR PAINFUL ERECTION. If this is not treated right away, it could lead to permanent sexual problems such as impotence. THIS MEDICINE MAY UNCOMMONLY CAUSE mild, temporary vision changes (e.g., blurred vision, sensitivity to light, blue/green color tint to vision). Rarely, an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION) has been recorded in patients who took this medicine. This may lead to decreased vision or permanent loss of vision in some cases. If you notice a sudden decrease in vision or loss of vision in one or both eyes, contact your doctor right away. SUDDEN DECREASES IN HEARING AND LOSS OF HEARING have been reported in some patients who have taken this medicine. Sometimes they also notice ringing in the ears or dizziness. If you notice a sudden decrease or loss of hearing, contact your doctor right away. THIS MEDICINE DOES NOT STOP THE SPREAD OF HIV or other sexually transmitted diseases (STDs) to others through sexual contact. Use barrier methods of birth control if you have HIV infection or an STD. THIS MEDICINE WILL NOT PREVENT PREGNANCY. If your partner may become pregnant and you wish to avoid pregnancy, be sure to use an effective form of birth control. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. Use this medicine with caution in the ELDERLY; they may be more sensitive to the effects. FOR WOMEN: This medicine is not approved for use in women. IF YOU BECOME PREGNANT, contact your doctor. You will need to discuss the benefits and risks of using this medicine while you are pregnant. IT IS NOT KNOWN IF THIS MEDICINE IS FOUND in breast milk. IF YOU ARE OR WILL BE BREAST-FEEDING while you use this medicine, check with your doctor. Discuss any possible risks to your baby.
POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include diarrhea; dizziness; flushing; headache; heartburn; nausea; stuffy or runny nose; or upset stomach. If these continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience chest pain; fainting; fast, slow or irregular heartbeat; memory loss; numbness of an arm or leg; one-sided weakness; painful or prolonged erection; ringing in the ears; seizures; severe back or muscle pain; severe or persistent dizziness; severe or persistent vision changes; sudden decrease or loss of vision in one or both eyes; sudden decrease in hearing or hearing loss; or sudden severe headache or vomiting. AN ALLERGIC REACTION to this medicine is unlikely but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; or swelling of the mouth, face, lips or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include chest pain; fainting; prolonged erections; or severe dizziness.
ADDITIONAL INFORMATION: If your symptoms do not improve or they become worse, check with your doctor. DO NOT SHARE THIS MEDICINE with other for whom it was not prescribed, since they may have a problem that is not effectively treated with this medicine, or they may have a condition that is complicated by this medicine. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children and pets. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.
This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warning, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using this medicine.