PRECAUTIONS:

Before taking sildenafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Before using this medication, tell your doctor or pharmacist your medical history, especially of: penis conditions (e.g., angulation, fibrosis/scarring, Peyronie's disease), history of painful/prolonged erection (priapism), sickle cell anemia, blood system cancers (e.g., leukemia or myeloma), eye problems (e.g., retina diseases like retinitis pigmentosa), kidney disease, liver disease, bleeding disorders, active stomach ulcers, heart problems (e.g., recent heart attack or serious arrhythmia within past 6 months, heart failure, coronary artery disease with unstable angina, aortic stenosis, idiopathic hypertrophic subaortic stenosis), recent stroke within past 6 months, very high or low blood pressure. This drug may make you dizzy or cause vision changes; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug. This drug is not indicated for use in women or children.

HOW TO USE:

This drug is taken by mouth as needed, at least 30 minutes, but no more than 4 hours, before sexual activity (1 hour before is the most effective). Do not take more often than once daily, and take as directed. A high fat meal may delay the time of onset of this drug. Avoid eating grapefruit or drinking grapefruit juice while you are being treated with this medication unless your doctor instructs you otherwise. The dosage is based on your medical condition, response to therapy, and other medications you may be taking (see also Drug Interactions section). Consult your doctor or pharmacist for more details.

SIDE EFFECTS:

Approximately 15% of persons taking sildenafil experience side effects. The most common side effects are facial flushing (1 in 10), headaches (1 in 6), stomach pain, nasal congestion, nausea, diarrhea, and an inability to differentiate between the colors green and blue. Rare cases of sudden loss of hearing have been reported with phosphodiesterase inhibitors such as sildenafil, sometimes with ringing in the ears and dizziness. If changes in hearing occur, patients should discontinue their sildenafil and seek immediate medical attention.

DRUG INTERACTIONS:

Sildenafil increases the effects of the blood pressure lowering medications. It also increases the blood pressure lowering effects of nitrates, e.g. isosorbide dinitrate (Isordil), isosorbide mononitrate (Imdur, Ismo, Monoket), nitroglycerin (Nitro-Dur, Transderm-Nitro) that are used primarily for treating angina. Patients taking nitrates should not receive sildenafil.

Cimetidine (Tagamet), erythromycin, ketoconazole (Nizoral), itraconazole (Sporanox) and mibefradil (Posicor) can cause marked increases in the amount of sildenafil in the body. Patients taking these medications should be observed carefully if sildenafil is used.

It is expected that rifampin will decrease blood levels of sildenafil and probably reduce its effectiveness.

STORAGE:

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59 and 86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.