Drug Name: Staxyn 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 also taking certain antiarrhythmic medicine (e.g., amiodarone, procainamide, quinidine, sotalol), a nitrate (e.g., isosorbide, nitroglycerin) in any form (e.g., capsule, ointment, patch, tablet), nitroprusside, certain azole antifungals (e.g., itraconazole, ketocanazole), HIV protease inhibitors (e.g., indinavir, ritonavir), certain macrolide antibiotics (e.g., clarithromycin, erythromycin), another PDE5 inhibitor (e.g., sildenafil, tadalafil); another medicine that contains vardenafil or any other medicine for ED (e.g., alprostadil). DO NOT TAKE THIS MEDICINE if you use certain recreational drugs called "poppers" (e.g., amyl nitrate or nitrite, butyl nitrate or nitrite). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking alpha-blockers (e.g., doxazosin), azole antifungals(e.g., fluconazole), macrolide antibiotics (e.g., azithromycin), telithromycin, an antiarrhythmic or medicines for high blood pressure. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a deformed penis (e.g., cavernosal fibrosis, Peyronie disease ); blood cell problems (e.g., leukemia, multiple myeloma, sickle cell anemia); any other condition that may increase the risk of a prolonged (more than 4 hours) or painful erection (priapism); allergies; pregnancy or breast-feeding. Tell your doctor if you have a history of priapism, certain eye problems (e.g., macular degeneration, optic neuropathy, retinitis pigmentosa, non-arteritic anterior ischemic optic neuropathy/NAION, sudden vision loss), hearing problems (e.g., ringing in the ears, decreased hearing, hearing loss) ; liver or kidney problems; high or low blood pressure; ulcers; seizures; lung problems (e.g.., pulmonary veno-occlusive disease); bleeding problems; blood vessel problems, heart problems (e.g., angina, aortic stenosis, heart failure), 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 certain heart problems (e.g., severe heart failure, unstable angina), low blood pressure, uncontrolled high blood pressure, moderate to severe liver problems, sever kidney problems that require dialysis, certain hereditary degenerative eye problems (e.g., retinitis pigmentosa), or hereditary problems of fructose intolerance. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have had a heart attack, stroke, life-threatening irregular heartbeat within the past 6 months; if you have a history of a certain type of irregular heartbeat (e.g., congenital QT prolongation); or if you have been advised by your doctor to avoid sexual activity because of heart problems. Use of this medicine in CHILDREN is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
HOW TO USE THIS MEDICINE: Follow the directions for using this medicine provided by your doctor. AN ADDITIONAL PATIENT INFORMATION LEAFLET is available with this medicine. Ask your doctor, nurse or pharmacist any question that you may have about this medicine. TAKE THIS MEDICINE about 30 minutes before sexual activity. Take this medicine may be taken on an empty stomach or with food. Take this medicine without liquid. TAKE THIS MEDICINE ABOUT 1 HOUR BEFORE SEXUAL ACTIVITY. Do not take this medicine more than once daily or as directed by your doctor. BE SURE YOUR HANDS ARE COMPLETELY DRY before you remove this medicine from the blister. Take this medicine immediately after you remove it from the blister. Do not store the removed tablet for future use. DO NOT CRUSH OR SPLIT THIS MEDICINE. Place this medicine on the tongue. Allow it to completely dissolve. AVOID EATING GRAPEFRUIT OR DRINKING GRAPEFRUIT JUICE while taking this medicine. STORE THIS MEDICINE at 77 degrees F (25 degrees C) in the original packaging, away from heat, moisture and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not use if the blister is open, torn or broken. 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 TAKE THIS MEDICINE IF you have had an allergic reaction to it or if you are allergic to any ingredient in this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE OR SURGERY (including care for a heart problem), tell the doctor or dentist that you are taking this medicine. This medicine may cause drowsiness, dizziness, lightheadedness, fainting or blurred vision. Alcohol, hot weather, exercise and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness or weakness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks. 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. DO NOT SWITCH BETWEEN THIS MEDICINE AND VARDENAFIL TABLETS without checking with your doctor. The tablets may not provide the same amount of medicine to your body as the same dose of this medicine. THIS MEDICINE MAY RARELY CAUSE a prolonged (more than 4 hours) or painful erection. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens. 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 (e.g., condoms) 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 MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. DO NOT USE OTHER MEDICINES or treatments for ED while you are taking this medicine without first checking with your doctor. PHENYLKETONURICS: this medicine contains phenylalanine. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be more sensitive to the effects of this medicine. FOR WOMEN: THIS MEDICINE IS NOT APPROVED for use in women. If you become pregnant, discuss with your doctor the benefits and risks of using this medicine during pregnancy. IT IS NOT KNOWN IF THIS MEDICINE IS FOUND in breast milk. If you are or will be breast-feeding while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby.
POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include dizziness, flushing, headache, heartburn, mild back pain, stuffy nose or upset stomach. If these continue or are bothersome, check with your doctor. THIS MEDICINE MAY UNCOMMONLY CAUSE mild, temporary vision changes (e.g., blurred vision, sensitivity to light, blue/green color tint to vision). Contact your doctor if vision changes persist or are severe. 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 has 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. CONTACT YOUR DOCTOR IMMEDIATELY if you experience chest, jaw or left arm pain; fainting; fast, slow or irregular heartbeat; memory loss; numbness of an arm or leg; prolonged, painful erection; ringing in the ears; seizures; severe back or muscle pain; severe or persistent dizziness; 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 erection; severe back or muscle pain; severe dizziness; or sever or persistent vision changes.
ADDITIONAL INFORMATION: DO NOT SHARE THIS MEDICINE with other for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.
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.