Important Safety Information — Compounded Sildenafil

What is this?

This Important Safety Information summarizes key warnings, precautions, contraindications, and possible side effects for compounded sildenafil, a prescription medication used in certain patients when a licensed healthcare provider determines that sildenafil therapy is medically appropriate.

This page does not include all possible information about compounded sildenafil. Always follow your prescription label, pharmacy instructions, and the instructions provided by your healthcare provider.

Compounded sildenafil is not FDA-approved. The FDA does not review compounded medications for safety, effectiveness, or quality before they are dispensed. Compounded medications may be prescribed when a licensed healthcare provider determines that a compounded preparation is medically appropriate for a specific patient.

Who should not use compounded sildenafil?

Do not use compounded sildenafil if you take any medicines called nitrates, such as nitroglycerin, or if you use recreational drugs called “poppers,” such as amyl nitrate, amyl nitrite, or butyl nitrate. Taking sildenafil with nitrates can cause blood pressure to drop suddenly to an unsafe level.

Do not use compounded sildenafil if you take medicines called guanylate cyclase stimulators, such as riociguat.

Do not use compounded sildenafil if you are allergic to sildenafil or any ingredient in your compounded medication.

Cardiovascular Warnings

Sexual activity can put extra strain on the heart, especially in patients with preexisting heart disease. Compounded sildenafil should not be used if sexual activity is inadvisable because of cardiovascular status.

Before using compounded sildenafil, tell your healthcare provider if you have or have had heart problems, heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve, heart failure, heart surgery within the last 6 months, pulmonary hypertension, stroke, low blood pressure, or uncontrolled high blood pressure.

Seek emergency medical care if you experience chest pain, dizziness, nausea, fainting, symptoms of a heart attack or stroke, sudden vision loss, sudden hearing decrease or hearing loss, or an erection lasting more than four hours.

Prolonged Erection and Priapism

Compounded sildenafil can rarely cause an erection that will not go away. If you have an erection lasting more than four hours, seek medical help right away.

If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

Tell your healthcare provider before using compounded sildenafil if you have a deformed penis shape, Peyronie’s disease, sickle cell anemia, multiple myeloma, leukemia, or if you have ever had an erection lasting more than four hours.

Vision Warnings

Stop using compounded sildenafil and seek medical attention right away if you experience sudden vision loss in one or both eyes.

Sudden vision loss may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a serious eye condition that can cause decreased vision or permanent vision loss.

Tell your healthcare provider before using compounded sildenafil if you have retinitis pigmentosa or have ever had severe vision loss, including NAION.

Hearing Warnings

Stop using compounded sildenafil and seek prompt medical attention if you experience sudden hearing decrease or hearing loss.

Sudden hearing changes may be accompanied by ringing in the ears or dizziness.

Blood Pressure and Drug Interaction Warnings

Compounded sildenafil can lower blood pressure. This effect may be stronger when sildenafil is used with alpha-blockers, medications for high blood pressure, or certain other medicines.

Tell your healthcare provider about all medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

Sildenafil may interact with nitrates, guanylate cyclase stimulators, alpha-blockers, HIV protease inhibitors, certain antifungal medicines, certain antibiotics, blood pressure medications, and other treatments for erectile dysfunction.

Do not use compounded sildenafil with Revatio® or with other pulmonary arterial hypertension treatments containing sildenafil or other PDE5 inhibitors.

Other Medical Conditions to Discuss Before Use

Before using compounded sildenafil, tell your healthcare provider if you have bleeding problems, stomach ulcers, liver problems, kidney problems, are receiving kidney dialysis, or have any other medical condition.

Possible Side Effects

The most common side effects of sildenafil include headache, flushing, upset stomach or dyspepsia, abnormal vision, nasal congestion, back pain, muscle pain, nausea, dizziness, and rash.

Abnormal vision may include changes in color vision, such as a blue color tinge, increased sensitivity to light, or blurred vision.

Tell your healthcare provider if you experience side effects that bother you or do not go away.

Sexually Transmitted Diseases

Compounded sildenafil does not protect against sexually transmitted diseases, including HIV.

Talk to your healthcare provider about protective measures to reduce the risk of sexually transmitted infections.

Use in Women and Children

Sildenafil for erectile dysfunction is not indicated for use in women or children.

How to Use Compounded Sildenafil

Use compounded sildenafil exactly as prescribed by your healthcare provider.

Sildenafil is commonly taken about 1 hour before sexual activity, but it may be taken between 30 minutes and 4 hours before sexual activity when directed by a healthcare provider.

Do not use compounded sildenafil more than one time per day unless specifically instructed by your healthcare provider.

Sildenafil may be taken with or without food. A high-fat meal may delay how quickly sildenafil starts working.

Missed Dose

Compounded sildenafil is typically used as needed before sexual activity and is not usually taken on a fixed daily schedule.

Do not use extra compounded sildenafil to make up for a missed dose. Do not change your dosing instructions without medical direction.

Overdose

In case of overdose or accidental exposure, seek medical attention immediately or contact Poison Control at 1-800-222-1222.

If you accidentally use too much compounded sildenafil, call your healthcare provider or go to the nearest hospital emergency room right away.

Storage

Follow the storage instructions provided by your pharmacy.

Unless your prescription label or pharmacy instructions state otherwise, store medication at controlled room temperature, generally 20°C to 25°C / 68°F to 77°F, away from excessive heat, moisture, and direct light.

In general:

• Store medication at the temperature listed on the prescription label.
• Keep away from excessive heat, moisture, and direct light.
• Keep out of reach of children and pets.
• Do not use medication that appears contaminated, discolored, damaged, crystallized, cloudy, leaking, or otherwise unusual.

Medication Disposal

Do not flush unused medication down the toilet or pour it into a sink or drain unless specifically instructed.

If you have unused compounded sildenafil, follow local disposal guidance or ask your pharmacist for instructions.

Reporting Side Effects

Tell your healthcare provider if you experience side effects or symptoms that concern you.

You may report suspected adverse reactions or product quality concerns to the FDA through MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch.

Telemedicine Disclosure

This prescription may be issued through telemedicine after review by a licensed healthcare provider. If you experience concerning symptoms, contact your provider or seek emergency medical care.

Withholding or providing inaccurate information about your symptoms, medical history, medications, substance use, allergies, prior reactions, lab results, or other relevant health information may result in serious harm.

Disclaimer

This information is not comprehensive and does not include all possible risks, side effects, interactions, warnings, or precautions associated with compounded sildenafil.

This page does not provide medical advice, diagnosis, or treatment. For questions about compounded sildenafil, dosing, side effects, or whether this medication is appropriate for you, contact your healthcare provider or pharmacist.

Compounded sildenafil is prescribed only when a licensed healthcare provider determines that it is medically appropriate. Compounded medications are not FDA-approved and are not reviewed by the FDA for safety, effectiveness, or quality before dispensing.