"The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary di"...
(sildenafil) Tablets, for Oral Use
(sildenafil) for Oral Suspension
(sildenafil) Injection, for Intravenous Use
REVATIO, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction.
Sildenafil citrate is designated chemically as l-[[3-(6,7-dihydro-l-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula:
Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7.
REVATIO Tablets: REVATIO is formulated as white, film-coated round tablets with 20 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose monohydrate, and triacetin.
REVATIO Injection: REVATIO is supplied as a clear, colorless, sterile, ready to use solution containing 10 mg (12.5 mL) of sildenafil. Each mL of solution contains 1.124 mg sildenafil citrate, 50.5 mg dextrose and water for injection.
REVATIO for Oral Suspension: REVATIO is supplied in an amber glass bottle as a white to off-white powder providing a white to off-white grape flavored oral suspension when constituted. Bottles containing 32.27 g powder for oral suspension are intended for constitution with 90 mL water to produce an oral suspension containing 10 mg/mL sildenafil. In addition to the bottle, a press-in bottle adapter and an oral dosing syringe (2 mL) are provided. The inactive ingredients include sorbitol, citric acid anhydrous, sucralose, sodium citrate dihydrate, xanthan gum, titanium dioxide, sodium benzoate, colloidal silicon dioxide anhydrous and grape flavor.
What are the possible side effects of sildenafil (Revatio, Viagra)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of sildenafil.
Stop using sildenafil and call your doctor at once if you have a serious side effect such as:
- sudden vision loss;
- ringing in your ears, or sudden hearing...
What are the precautions when taking sildenafil citrate (Revatio)?
Before taking sildenafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: sickle cell disease, high or low blood pressure, a severe loss of body water (dehydration), history of painful/prolonged erection (priapism), eye problems (such as decreased vision in one or both eyes, retinitis pigmentosa), heart problems (such as heart attack or irregular heartbeat in the past 6 months, heart failure, chest pain/angina, aortic stenosis, idiopathic hypertrophic subaortic stenosis), kidney disease, liver...
Last reviewed on RxList: 9/17/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Revatio Information
Revatio - User Reviews
Revatio User Reviews
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