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Sildenafil tablets (Revatio™)

What are sildenafil tablets?

SILDENAFIL (Revatio™) is used to treat a rare lung condition called pulmonary arterial hypertension or PAH. People with PAH have high blood pressure in the blood vessels that lead from the heart to the lungs. Sildenafil (Revatio™) helps to lower the blood pressure in these blood vessels. Generic sildenafil tablets are not yet available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• anatomical deformity of the penis, Peyronie's disease, or ever had an erection that lasted more than 4 hours
• benign prostatic hypertrophy (BPH)
• bleeding disorder
• cancer
• diabetes
• frequent heartburn or gastroesophageal reflux disease (GERD)
• heart disease, angina, high or low blood pressure, a history of heart attack, or other heart problems
• high cholesterol
• kidney disease
• liver disease
• sickle cell disease
• stomach or intestinal ulcer
• stroke
• eye or vision problems, including a rare inherited eye disease called retinitis pigmentosa
• an unusual or allergic reaction to sildenafil, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Follow the directions on the prescription label. Take sildenafil tablets by mouth. Doses should be taken about 4—6 hours apart, with or without food. Swallow the tablets with a drink of water. Do not take double or extra doses.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, skip the missed dose and take your next tablet at the regular time. Do not take double or extra doses.

What drug(s) may interact with sildenafil?

Do not take sildenafil if you are taking the following medications:

• nitroglycerin-type drugs for the heart or chest pain such as amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin, even if these are only taken occasionally

Sildenafil may also interact with the following medications:

• alpha blockers, used for high blood pressure or an enlarged prostate. NOTE: Do not take doses of sildenafil higher than 25 mg within 4 hours of taking alpha blockers, such as alfuzosin (UroXatral®), doxazosin (Cardura®), prazosin (Minipress®), or terazosin (Hytrin®).
• bosentan
• certain drugs used for seizures such as carbamazepine, phenytoin, and phenobarbital
• certain drugs used for fungal or yeast infections, such as fluconazole, ketoconazole, and voriconazole
• certain drugs for the treatment of HIV infection or AIDS
• cimetidine
• cisapride
• clarithromycin
• diltiazem
• erythromycin
• grapefruit juice
• mibefradil
• monoamine oxidase inhibitors (Azilect®, Eldepryl®, Emsam®, Marplan®, Nardil®, Parnate®, Zelapar™)
• nitroprusside
• rifabutin
• rifampin
• quinidine
• some drugs for treating depression, anxiety or other mood problems (examples: fluoxetine, fluvoxamine, nefazodone)
• verapamil

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What side effects may I notice from taking sildenafil?

Side effects that you should report to your prescriber or health care professional as soon as possible:

• changes in hearing such as loss of hearing or ringing in ears
• changes in vision such as blurred vision, eyes being more sensitive to light, or trouble telling the difference between blue and green objects or objects having a blue color tinge to them
• difficulty breathing, shortness of breath
• chest pain or palpitations
• prolonged erection (lasting longer than 4 hours)
• skin rash, itching

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• diarrhea
• dizziness
• flushing
• headache
• indigestion
• nasal congestion

What should I watch for while taking sildenafil?

Do not change the dose of your medication. Please call your prescriber or health care professional if your medication is not working for you. This may indicate a worsening of your condition.

If you experience symptoms of nausea, dizziness, chest pain, or arm pain after sildenafil use, you should refrain from further activity and should discuss the episode with your prescriber or health care professional as soon as possible.

If you notice any changes in your vision while taking this drug, notify your prescriber or health care professional as soon as possible.

Contact you physician immediately if you have an erection lasts longer than 4 hours or if it becomes painful. This may be a sign of priapism and must be treated immediately to prevent permanent damage.