What is the most important information I should know about forzest?

A small number of patients have lost eyesight in one eye after taking forzest. This type of vision loss is called non-arteritic anterior ischemic optic neuropathy (NAION). NAION causes a sudden loss of eyesight because blood flow is blocked to the optic nerve. It is not clear at this time if forzest causes NAION. NAION also happens in patients who do not take this medicine. People who have a higher chance for NAION include those who:

• have heart disease;
• are over 50 years old;
• have diabetes;
• have high blood pressure;
• have high cholesterol;
• smoke; or
• have certain eye problems.

Stop using forzest if you have any loss in your eyesight and seek medical help right away.

Do not take forzest if you are taking any of the following medicines:

• a nitrate such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, Minitran, Deponit, Transderm-Nitro, others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), isosorbide mononitrate (Imdur, ISMO, Monoket), and others;
• nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"); or
• an alpha blocker (other than tamsulosin (Flomax) 0.4 mg once a day) such as doxazosin (Cardura), guanadrel (Hylorel), prazosin (Minipress), terazosin (Hytrin), alfuzosin (Uroxatral), and others.

Taking forzest with any of these medications may cause very low blood pressure, possibly resulting in dizziness, fainting, stroke, or heart attack.

Contact your doctor or seek emergency medical attention for any erection that lasts longer than 4 hours. A sustained erection can damage the penis.

Refrain from further sexual activity and notify your doctor it you develop dizziness, nausea, or angina (pain, tightness, discomfort, numbness, or tingling in the chest, arms, neck, or jaw) during sexual activity.

forzest is usually taken when needed before sexual activity. The effects of forzest may last for up to 36 hours or more. Your doctor will determine how often you can take forzest. Do not take forzest more often than is directed by your doctor.

What is forzest?

forzest relaxes muscles within the penis. This allows increased blood flow into the penis, necessary to achieve and maintain an erection.

forzest is used to treat erectile dysfunction (impotence).

forzest may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking forzest?

A small number of patients have lost eyesight in one eye after taking forzest. This type of vision loss is called non-arteritic anterior ischemic optic neuropathy (NAION). NAION causes a sudden loss of eyesight because blood flow is blocked to the optic nerve. It is not clear at this time if forzest causes NAION. NAION also happens in patients who do not take this medicine. People who have a higher chance for NAION include those who:

• have heart disease;
• are over 50 years old;
• have diabetes;
• have high blood pressure;
• have high cholesterol;
• smoke; or
• have certain eye problems.

Stop using forzest if you have any loss in your eyesight and seek medical help right away.

Do not take forzest if you are taking any of the following medicines:

• a nitrate such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, Minitran, Deponit, Transderm-Nitro, others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), isosorbide mononitrate (Imdur, ISMO, Monoket), and others;
• nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"); or
• an alpha blocker (other than tamsulosin (Flomax) 0.4 mg once a day) such as doxazosin (Cardura), guanadrel (Hylorel), prazosin (Minipress), terazosin (Hytrin), alfuzosin (Uroxatral), and others.

Taking forzest with any of these medications may cause very low blood pressure, possibly resulting in dizziness, fainting, stroke, or heart attack.

Before taking forzest, tell your doctor if you

• have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack;
• have low blood pressure or high blood pressure that is not controlled;
• have had a stroke;
• have liver problems;
• have kidney problems;
• have ever had blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia;
• have a bleeding disorder;
• have a stomach ulcer;
• have retinitis pigmentosa (an inherited condition of the eye);
• have a physical deformity of the penis such as Peyronie's disease;
• had an erection that lasted longer than 4 hours.

You may not be able to take forzest, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Although forzest is not indicated for use by women, it is in the FDA pregnancy category B. This means that forzest is not expected to be harmful to an unborn baby. forzest should not be taken by women.

It is not known whether forzest passes into breast milk. forzest should not be taken by women.

If you are over 65 years of age, you may be more likely to experience side effects from forzest. Your doctor may prescribe a lower dose of this medication.

How should I take forzest?

Take forzest exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

forzest is usually taken when needed before sexual activity. The effects of forzest may last for up to 36 hours or more. Your doctor will determine how often you can take forzest. Do not take forzest more often than is directed by your doctor.

forzest can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill.

forzest can be taken with or without food.

forzest should not be taken with excessive amounts of alcohol (e.g. 5 or more drinks). Excessive alcohol may increase the risk of headache, dizziness, increased heart rate, or low blood pressure when forzest is taken.

If you develop dizziness, nausea, or angina (pain, tightness, discomfort, numbness, or tingling in the chest, arms, neck, or jaw) during sexual activity, refrain from further sexual activity and notify your doctor.

Contact your doctor or seek emergency medical attention for any erection that lasts longer than 4 hours. A sustained erection can damage the penis.

Grapefruit and grapefruit juice may interact with forzest. The interaction could lead to potentially adverse effects. You should discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

forzest is used as needed, so you are not likely to miss a dose.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a forzest overdose are not known.

What should I avoid while taking forzest?

Do not take any other drug used to treat impotence, such as sildenafil (Viagra), vardenafil (Levitra), alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon, Yodoxin, others), without first talking to your doctor.

forzest should not be taken with excessive amounts of alcohol (e.g. 5 or more drinks). Excessive alcohol may increase the risk of headache, dizziness, increased heart rate, or low blood pressure when forzest is taken.

Grapefruit and grapefruit juice may interact with forzest. The interaction could lead to potentially adverse effects. You should discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

What are the possible side effects of forzest?

If you experience any of the following serious side effects, stop taking forzest and seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
• chest pain or irregular heartbeats;
• dizziness, nausea, or angina (pain, tightness, discomfort, numbness, or tingling in the chest, arms, neck, or jaw);
• swelling of the ankles or legs;
• shortness of breath;
• prolonged or severe dizziness; or
• a prolonged (lasting longer than 4 hours) or painful erection.

Other, less serious side effects may be more likely to occur. Continue to take forzest and talk to your doctor if you experience

• headache;
• indigestion;
• back pain;
• muscle aches;
• flushing;
• stuffy or runny nose; or
• temporary blue tint in vision or difficulty telling the difference between the colors blue and green (uncommon).

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect forzest?

Do not take forzest if you are taking any of the following medicines:

• a nitrate such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, Minitran, Deponit, Transderm-Nitro, others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), isosorbide mononitrate (Imdur, ISMO, Monoket), and others;
• nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"); or
• an alpha blocker (other than tamsulosin (Flomax) 0.4 mg once a day) such as doxazosin (Cardura), guanadrel (Hylorel), prazosin (Minipress), terazosin (Hytrin), alfuzosin (Uroxatral), and others.

Taking forzest with any of these medications may cause very low blood pressure, possibly resulting in dizziness, fainting, stroke, or heart attack.

Before taking forzest, tell your doctor if you are taking any of the following medications:

• any other drug used to treat impotence, such as sildenafil (Viagra), vardenafil (Levitra), alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon, Yodoxin, others);
• the antibiotic erythromycin (E-Mycin, Eryc, Ery-Tab, others);
• an antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral); or
• HIV medications such as indinavir (Crixivan), ritonavir (Norvir), and others.

You may not be able to take forzest, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with forzest or affect your condition. Talk to your doctor or pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

Where can I get more information?

Your pharmacist has additional information about forzest written for health professionals that you may read.

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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2003 Cerner Multum, Inc. Version: 2.01. Revision date: 7/13/05.