Revatio Injection Generic Name: Sildenafil
Revatio Injection is used for:
Treating high blood pressure in the lungs (pulmonary arterial hypertension [PAH]). It may also be used for other conditions as determined by your doctor.
Revatio Injection is a phosphodiesterase type 5 (PDE5) inhibitor. It works by relaxing and dilating the blood vessels in the lungs. This lowers the blood pressure in the lungs and helps to improve your ability to exercise.
Do NOT use Revatio Injection if:
- you are allergic to any ingredient in Revatio Injection
- you have pulmonary veno-occlusive disease (PVOD)
- you are taking nitrates (eg, isosorbide, nitroglycerin) in any form (eg, tablet, capsule, spray, patch, ointment), or nitroprusside
- you take another medicine that contains sildenafil, another PDE5 inhibitor (eg, tadalafil, vardenafil), or ritonavir
- you use certain recreational drugs called "poppers" (eg, amyl nitrate or nitrite, butyl nitrate or nitrite)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Revatio Injection :
Some medical conditions may interact with Revatio Injection . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of a prolonged (more than 4 hours) or painful erection (priapism)
- if you have a deformed penis (eg, cavernosal fibrosis, Peyronie disease), certain blood cell problems (eg, leukemia, multiple myeloma, sickle cell anemia), or any other condition that may increase the risk of a prolonged or painful erection (priapism)
- if you have a history of certain eye problems (eg, macular degeneration, optic neuropathy, retinitis pigmentosa, sudden vision loss in one or both eyes) or hearing problems (eg, ringing in the ears, decreased hearing, hearing loss)
- if you are dehydrated or have a history of liver or kidney problems, high or low blood pressure, ulcers, bleeding problems, heart problems (eg, aortic stenosis, angina, irregular heartbeat, heart failure), blood vessel problems, or nervous system problems
- if you have a history of heart attack, stroke, or life-threatening irregular heartbeat, especially within the past 6 months
- if you are taking bosentan or medicine for erectile dysfunction (ED)
Some MEDICINES MAY INTERACT with Revatio Injection . Tell your health care provider if you are taking any other medicines, especially any of the following:
- Alpha-blockers (eg, doxazosin), medicines for high blood pressure, nitrates (eg, isosorbide, nitroglycerin), or nitroprusside because severe low blood pressure with dizziness, lightheadedness, and fainting may occur
- Azole antifungals (eg, itraconazole, ketoconazole), H2 antagonists (eg, cimetidine), HIV protease inhibitors (eg, ritonavir, saquinavir), macrolide antibiotics (eg, erythromycin), or telithromycin because they may increase the risk of Revatio Injection 's side effects
- Barbiturates (eg, phenobarbital), bosentan, carbamazepine, efavirenz, nevirapine, phenytoin, rifabutin, or rifampin because they may decrease Revatio Injection 's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Revatio Injection may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Revatio Injection :
Use Revatio Injection as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Revatio Injection is usually given as an injection at your doctor's office, hospital, or clinic.
- Do not use Revatio Injection if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Use Revatio Injection on a regular schedule to get the most benefit from it. Use it at the same times each day.
- Continue to use Revatio Injection even if you feel well. Do not miss any doses.
- Do not suddenly stop using Revatio Injection or change your dose without talking to your doctor.
- If you miss a dose of Revatio Injection , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Revatio Injection .
Important safety information:
- Revatio Injection may cause dizziness, drowsiness, fainting, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Revatio Injection with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Revatio Injection may cause dizziness, lightheadedness, or fainting; 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.
- Patients with heart problems who take Revatio Injection 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.
- Revatio Injection may rarely cause a prolonged (more than 4 hours) or painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if you have an erection that lasts more than 4 hours.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
- Revatio Injection may uncommonly cause mild, temporary vision changes (eg, 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 nonarteritic anterior ischemic optic neuropathy (NAION) has been reported in patients who took Revatio Injection . 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 Revatio Injection . Sometimes they also noticed ringing in the ears or dizziness. If you notice a sudden decrease or loss of hearing, contact your doctor right away.
- Do not use medicines or treatments for ED while you are taking Revatio Injection without first checking with your doctor.
- Use Revatio Injection with caution in the ELDERLY; they may be more sensitive to its effects.
- Revatio Injection should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Revatio Injection while you are pregnant. It is not known if Revatio Injection is found in breast milk. If you are or will be breast-feeding while you use Revatio Injection , check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Revatio Injection :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; dizziness; flushing; headache; mild pain, redness, or swelling at the injection site; muscle aches; nausea; nosebleed; numb or tingling skin; stuffy or runny nose; trouble sleeping; upset stomach.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; fast or irregular heartbeat; fever; memory loss; numbness of an arm or leg; one-sided weakness; painful or prolonged erection; persistent or severe pain, redness, or swelling at the injection site; ringing in the ears; seizure; severe or persistent dizziness or nosebleed; severe or persistent vision changes; shortness of breath; speech problems; sudden decrease or loss of hearing; sudden decrease or loss of vision in one or both eyes.
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. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include fainting; prolonged erection; severe dizziness.Proper storage of Revatio Injection :
Revatio Injection is usually handled and stored by a health care provider. If you are using Revatio Injection at home, store Revatio Injection as directed by your pharmacist or health care provider. Keep Revatio Injection out of the reach of children and away from pets.
- If you have any questions about Revatio Injection , please talk with your doctor, pharmacist, or other health care provider.
- Revatio Injection is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Revatio Injection . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
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