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Description

Generic Name

Sildenafil citrate

Active Ingredient

Sildenafil (as sildenafil citrate)

Chemical Name and Composition

Sildenafil citrate is chemically described as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate.

Sildenafil citrate is a white to off-white crystalline powder. It is slightly soluble in water. It has a molecular weight of about 666.7 (as the citrate salt).

Medication Classification

Viagra is a phosphodiesterase type 5 (PDE5) inhibitor. It works by blocking the PDE5 enzyme, which allows a natural chemical called cyclic GMP to build up. During sexual stimulation, this action relaxes the smooth muscle in the blood vessels of the penis and increases blood flow, which helps produce an erection. Viagra works only when a man is sexually stimulated. It does not cause an erection on its own.

Indication

Viagra is indicated for the treatment of erectile dysfunction (ED) in adult men. Erectile dysfunction is the inability to get or keep an erection firm enough for sexual activity.

Note: Sildenafil is also marketed under a different brand name at different strengths for the treatment of pulmonary arterial hypertension. That use is separate from Viagra and is not covered here.

Dosage Form and Available Strengths

• Dosage Form: Oral tablets
• Route of Administration: Oral
• Available Strengths: 25 mg, 50 mg, and 100 mg

Inactive Ingredients

Inactive ingredients may include microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose, triacetin, and FD&C Blue No. 2 aluminum lake, which gives the tablet its blue color. Refer to the specific product packaging or your pharmacist for exact ingredient details, especially if you have allergies or intolerances.

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Dosage & Administration

Important: Take Viagra exactly as prescribed by your healthcare provider. Your provider will set your dose based on how well it works for you and any side effects you have. Do not change your dose on your own.

How to Take Viagra

• Swallow the tablet with water.
• Take Viagra about 1 hour before sexual activity. It may be taken anywhere from 30 minutes to 4 hours before sex.
• The usual starting dose for most men is 50 mg, taken as needed. Depending on your response, your provider may raise the dose to 100 mg or lower it to 25 mg.
• Do not take Viagra more than once a day.
• Viagra works only with sexual stimulation. It will not cause an erection without it.
• Do not take more than prescribed, and do not take it more often than directed.

Food and Alcohol Considerations

• Viagra may be taken with or without food.
• Taking Viagra after a high-fat meal may delay how quickly it starts to work and may reduce its effect. For faster onset, take it on a relatively empty stomach.
• Avoid drinking large amounts of alcohol before taking Viagra. Alcohol can lower blood pressure and may increase the risk of dizziness, fainting, and other side effects. Alcohol may also make it harder to get an erection.
• Avoid grapefruit and grapefruit juice, which may increase sildenafil levels in your body.

Missed Dose Instructions

Viagra is taken only when needed before sexual activity, so a regular dosing schedule usually does not apply. Take it as directed by your provider before you plan to have sex. Do not take more than one dose in a 24-hour period.

Storage

• Store at 25°C (77°F), with brief excursions permitted between 15° to 30°C (59° to 86°F).
• Keep in a tightly closed container, away from moisture, heat, and light.
• Keep out of the reach of children.

Disposal

Dispose of unused or expired medication through a drug take-back program when possible. If no take-back program is available, follow current FDA guidance for safe household disposal. Ask your pharmacist if you have questions about disposal.

Special Instructions

Children: Viagra is not for use in children. It is approved only for adult men with erectile dysfunction. Keep the medication out of the reach of children. If a child swallows this medication, seek emergency care immediately.

Women: Viagra is not indicated for use in women.

Elderly Patients: Men aged 65 and older may clear sildenafil from the body more slowly, which can raise drug levels. A provider may start at a lower dose, such as 25 mg, and monitor the response.

Patients with Liver Problems: Use with caution. Sildenafil is broken down mainly by the liver, so impaired liver function can increase drug levels. A provider may recommend a lower starting dose, such as 25 mg, for patients with liver problems.

Patients with Kidney Problems: Use with caution. For patients with severe kidney problems, drug levels may rise, and a provider may recommend a lower starting dose, such as 25 mg.

Caregivers: Give the medication exactly as prescribed. Watch for chest pain, fainting, a prolonged or painful erection, sudden vision or hearing changes, or signs of a severe allergic reaction, and seek care right away if these occur. Keep the medication secured and out of sight.

Overdose Warning

In studies, single doses higher than recommended did not lead to new types of side effects, but side effects such as headache, flushing, dizziness, indigestion, nasal congestion, and vision changes became more common and more severe.

In case of a suspected overdose, call the Poison Control Center at 1-800-222-1222 or seek emergency medical care immediately. Because sildenafil is highly bound to proteins in the blood and is not removed by dialysis, treatment focuses on supportive care.

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Side Effects

Serious Side Effects Requiring Immediate Medical Attention

Stop taking Viagra and seek emergency care or contact your healthcare provider right away if you experience any of the following:

• Sudden vision loss in one or both eyes. This may be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION).
• Sudden decrease or loss of hearing, sometimes with ringing in the ears or dizziness.
• Priapism: An erection that is painful or lasts more than 4 hours. This requires emergency treatment to prevent lasting damage to the penis.
• Severe low blood pressure (hypotension): Dizziness, lightheadedness, or fainting, especially if you take nitrates or alpha-blockers.
• Cardiovascular events: Chest pain, shortness of breath, an irregular heartbeat, or symptoms of a heart attack or stroke, especially during sexual activity. Seek emergency help if these occur.
• Severe allergic reactions: Rash, hives, swelling of the face, lips, tongue, or throat, or trouble breathing or swallowing.
• Seizures

If you have chest pain during or after sex, do not take nitrates. Tell emergency responders that you have taken Viagra and when.

Common Side Effects

The following side effects may occur and are not always cause for urgent concern. Talk to your healthcare provider if they persist or become bothersome:

• Headache
• Flushing (warmth or redness in the face, neck, or chest)
• Nasal congestion (stuffy or runny nose)
• Indigestion or upset stomach (dyspepsia)
• Dizziness
• Back pain or muscle aches
• Vision changes, such as blurred vision, increased sensitivity to light, or a blue tinge to your vision
• Nausea

This is not a complete list of possible side effects. Contact your healthcare provider for guidance about any symptoms that concern you.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088

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Warnings & Precautions

Conditions to Disclose to Your Healthcare Provider

Before taking Viagra, tell your healthcare provider if you have or have had any of the following:

• Heart problems, including chest pain (angina), heart failure, an irregular heartbeat, or a recent heart attack or stroke
• High or low blood pressure
• Any condition that makes sexual activity risky for your heart
• An eye problem, including retinitis pigmentosa or a history of sudden vision loss (NAION)
• Hearing problems
• Liver or kidney problems
• A blood cell disorder, such as sickle cell anemia, multiple myeloma, or leukemia
• A physical deformity of the penis, such as Peyronie's disease
• A condition that could cause a long-lasting erection (priapism)
• Stomach ulcers or a bleeding problem
• An allergy to sildenafil or any ingredient in Viagra

Contraindications

Do not take Viagra if you:

• Take any medicine that contains nitrates, either regularly or as needed. This includes nitroglycerin, isosorbide, and certain recreational drugs known as "poppers" (amyl or butyl nitrite). Combining Viagra with nitrates can cause a sudden, serious, and possibly fatal drop in blood pressure.
• Take medicines called soluble guanylate cyclase (sGC) stimulators, such as riociguat, used for pulmonary hypertension. This combination can cause a dangerous drop in blood pressure.
• Have a known hypersensitivity to sildenafil or any component of the formulation.

Drug Interactions

Tell your healthcare provider and pharmacist about all medications, supplements, and herbal products you take. Because sildenafil is processed mainly by the CYP3A4 liver enzyme, many drugs can affect its levels. Key interactions include:

• Nitrates: Do not use Viagra with any nitrate medicine. The combination can cause a sudden, dangerous drop in blood pressure. This combination is contraindicated.
• Alpha-blockers: Medicines used for high blood pressure or an enlarged prostate (such as doxazosin or tamsulosin) can add to the blood-pressure-lowering effect of Viagra and cause dizziness or fainting. Your provider may adjust timing or dosing.
• Other blood pressure medicines: Combining Viagra with these may further lower your blood pressure.
• Other PDE5 inhibitors or ED treatments: Do not take Viagra with other PDE5 inhibitors (such as tadalafil or vardenafil) or other ED products. Doing so raises the risk of side effects without added benefit.
• CYP3A4 inhibitors: Drugs such as certain antifungals (for example, ketoconazole, itraconazole), macrolide antibiotics (for example, erythromycin, clarithromycin), and some HIV protease inhibitors (for example, ritonavir) can raise sildenafil levels and increase the risk of side effects. Your provider may lower your dose.
• CYP3A4 inducers: Drugs such as rifampin may lower sildenafil levels and reduce its effect.
• Riociguat and other sGC stimulators: Do not use with Viagra, as this can cause a dangerous drop in blood pressure.
• Grapefruit and grapefruit juice: May increase sildenafil levels in the body.

Monitoring Requirements

Your healthcare provider may monitor:

• Your heart health and whether sexual activity is safe for you
• Your blood pressure, especially if you take other blood-pressure-lowering medicines
• Your response to treatment and any side effects
• Vision or hearing changes, if reported
• The need to adjust your dose based on age, liver, or kidney function

Long-Term Use Considerations

• Viagra is used only as needed and is not taken on a daily schedule for erectile dysfunction.
• If Viagra does not work for you, or if side effects are a problem, tell your provider. Your dose may be adjusted, or another treatment may be considered.
• Erectile dysfunction can sometimes be a sign of an underlying health condition, such as heart disease or diabetes. Your provider may evaluate your overall health.
• Viagra does not protect against sexually transmitted infections, including HIV.

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Patient Counseling Information

Safe Medication Use

• Take Viagra exactly as prescribed. Do not take more than directed or use it more than once a day.
• Take it about 1 hour before sexual activity, and understand that it works only with sexual stimulation.
• Never take Viagra with any nitrate medicine, including "poppers." This combination can be fatal.
• Tell all your healthcare providers, including your dentist and any emergency staff, that you take Viagra, especially if you may need a nitrate medicine.
• Do not share Viagra with anyone else. It is prescribed for you based on your health.
• Keep Viagra in a safe place, away from children.
• Read the FDA-approved patient information provided with your prescription.

Risk Prevention

• Heart safety: Sexual activity can put extra strain on your heart. If you feel chest pain, dizziness, or nausea during sex, stop and tell your provider right away.
• Nitrates: If you have chest pain after taking Viagra, do not use nitrates. Get emergency care and tell responders you have taken Viagra.
• Low blood pressure: Stand up slowly, especially if you take alpha-blockers or other blood pressure medicines, to reduce the risk of dizziness or fainting.
• Alcohol: Avoid drinking large amounts of alcohol with Viagra, as it may increase dizziness and lower blood pressure.
• Vision and hearing: Stop taking Viagra and seek care if you have sudden vision loss or a sudden decrease or loss of hearing.
• Prolonged erection: Get emergency help if you have an erection that lasts more than 4 hours, to prevent lasting damage.
• All medicines: Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Do not start or stop other medicines without talking to your provider first.

When to Contact a Healthcare Provider

Contact your healthcare provider or seek emergency care right away if you:

• Have an erection that is painful or lasts more than 4 hours
• Have sudden vision loss in one or both eyes
• Have a sudden decrease or loss of hearing, with or without ringing in the ears or dizziness
• Have chest pain, shortness of breath, or an irregular heartbeat, especially during sex
• Feel faint, very dizzy, or lightheaded
• Have a severe allergic reaction, such as swelling of the face, lips, tongue, or throat, hives, or trouble breathing
• Find that Viagra does not work or causes bothersome side effects
• Have any symptom that concerns you or does not go away