1 INDICATIONS AND USAGE

Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Renal Dose Adjustments

Your doctor may adjust your dose if needed.Adults 65 years of age and older—25 mg as a single dose no more than once a day, 1 hour before sexual intercourse. Your doctor may adjust your dose if needed.Children—Use is not recommended.For oral dosage form (film):Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse. Your doctor may adjust your dose as needed.Adults 65 years of age and older—25 mg as a single dose no more than once a day, 1 hour before sexual intercourse. Your doctor may adjust your dose as needed.Children—Use is not recommended. For oral dosage form (tablets):Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse.

How is sildenafil supplied (dosage forms)?

Your doctor may adjust your dose if needed.Children—Use is not recommended. Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse. Your doctor may adjust your dose if needed. Adults 65 years of age and older—25 mg as a single dose no more than once a day, 1 hour before sexual intercourse. For oral dosage form (film):Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse.

Alcohol interaction warning

Your doctor may adjust your dose as needed. For treatment of pulmonary arterial hypertension:For oral dosage forms (suspension or tablets):Adults—20 milligrams (mg) 3 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 80 mg 3 times a day.Children 1 year of age and older weighing 45 kilograms (kg) or more—20 mg 3 times a day. However the dose is usually not more than 40 mg 3 times a day.Children 1 year of age and older weighing 20 to 45 kg—20 mg 3 times a day.Children 1 year of age and older weighing 20 kg or less—10 mg 3 times a day.Children younger than 1 year of age—Use and dose must be determined by your doctor. Sildenafil is also available in other brands and other strengths for erectile dysfunction-ED in men. Read the Patient Information Leaflet if available from your pharmacist before you start taking sildenafil and each time you get a refill.

If you have any questions, ask your doctor or pharmacist.

• Sildenafil 20 mg is one of several available dosages.
• Be aware of potential side effects like dizziness and nausea.
• Inform your doctor about any heart history before use.
• Do not take sildenafil if you have recently had a stroke.
• Follow instructions precisely to ensure safe and effective use.

To treat high blood pressure in the lungs, take this medication by mouth with or without food as directed by your doctor, usually 3 times a day.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Children's dosage is also based on weight. Do not increase your dose or take this drug more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Usual Adult Dose for Pulmonary Hypertension

Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. If you already use medicine for high blood pressure (hypertension), sildenafil could make your blood pressure go too low. Call your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly, sweating, or unusual tiredness or weakness. This medicine does not protect you against sexually transmitted diseases (including HIV or AIDS). Use protective measures and ask your doctor if you have any questions about this.

Sildenafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: burning feeling in the chest or stomach burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings decrease in amount of urine or the frequency of urination dizziness or lightheadedness, especially when getting up suddenly from a lying or sitting position dryness, redness, scaling, or peeling of the skin increase in the size of the pupil redness, burning, or swelling of the eyes redness, itching, or tearing of the eyes seeing shades of colors differently than before swelling of the face, hands, feet, or lower legs unusual feeling of burning or stinging of the skin Some side effects may occur that usually do not need medical attention.

What should I know about sildenafil before taking it?

These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: pain or tenderness around the eyes and cheekbones diarrhea or stomach cramps (severe or continuing) numbness or tingling of the hands, legs, or feet redness, soreness, swelling, or bleeding of the gums sensation of motion, usually whirling, either of one's self or of one's surroundings sexual problems in men (continuing), including failure to experience a sexual orgasm sores in the mouth and on the lips Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. Take this medication regularly to get the most benefit from it.

Non-medical use

You may report side effects to the FDA at 1-800-FDA-1088. Generic name:Sildenafil 20 mg (lungs) - oral Generic name:Sildenafil 20 mg (lungs) - oral Sildenafil is used to treat high blood pressure in the lungs (pulmonary hypertension). It works by relaxing and widening the blood vessels in your lungs which allows the blood to flow more easily. Decreasing high blood pressure in the lungs allows your heart and lungs to work better and improves your ability to exercise. This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. To help you remember, take it at the same times each day.

8.1 Pregnancy

Throw away any unused mixed Revatio® oral liquid after 60 days. It is important that you tell all of your doctors that you take sildenafil. If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took sildenafil. Do not use this medicine if you are also using a nitrate medicine, often used to treat angina or high blood pressure. Some illegal ("street") drugs called "poppers" (such as amyl nitrate, butyl nitrate, or nitrite).

Are you currently using Sildenafil (Viagra, Revatio)?

Do not use this medicine if you also use riociguat (Adempas®). If you will be taking this medicine for pulmonary arterial hypertension, your doctor will want to check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. If you take sildenafil for pulmonary arterial hypertension, do not take Viagra®, Vibrique™ or other PDE5 inhibitors, including tadalafil (Cialis®) or vardenafil (Levitra®). If you take too much sildenafil or take it together with these medicines, the chance for side effects will be higher.

Altitude sickness

It is important to tell your doctor about any heart problems you have now or may have had in the past. This medicine can cause serious side effects in patients with heart problems. If you experience a prolonged or painful erection sildenafil tablets 125 for 4 hours or more, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis. If you experience a sudden loss of vision in one or both eyes, contact your doctor immediately. Tell your doctor if your condition does not get better or if it gets worse. Dizziness, lightheadedness, headache, flushing, stomach upset, nosebleeds, trouble sleeping, or swollen hands/ankles/feet (edema) may occur.

Frequently asked questions

For oral dosage forms (suspension or tablets):Adults—20 milligrams (mg) 3 times a day. Adults—20 milligrams (mg) 3 times a day. However, the dose is usually not more than 80 mg 3 times a day. Children 1 year of age and older weighing 45 kilograms (kg) or more—20 mg 3 times a day. However the dose is usually not more than 40 mg 3 times a day.

How should I store sildenafil?

Children 1 year of age and older weighing 20 to 45 kg—20 mg 3 times a day. Children 1 year of age and older weighing 20 kg or less—10 mg 3 times a day. Children younger than 1 year of age—Use and dose must be determined by your doctor. For oral dosage forms (suspension or tablets): If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Serious side effects

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Store mixed oral liquid in the refrigerator. Vision changes such as increased sensitivity to light, blurred vision, or trouble telling blue and green colors apart may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

• Sildenafil 20 mg tablets are supplied in blister packs or bottles.
• Always check the expiration date before use.
• Alcohol may reduce the effectiveness or increase side effects.
• Avoid taking sildenafil with fatty foods for faster absorption.
• Keep out of reach of children to prevent accidental ingestion.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects.

• Sildenafil was originally developed as a treatment for hypertension.
• The 20 mg dose is considered a moderate dosage.
• It can be part of a comprehensive erectile dysfunction treatment plan.
• Regular use should be monitored by a healthcare professional.
• The medication should not be used with other ED drugs simultaneously.

Many people using this medication do not have serious side effects.