WARNINGS AND PRECAUTIONS

(5.3)Patients should stop sildenafil and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.4)Caution is advised when sildenafil is co-administered with alpha-blockers or anti-hypertensives.

• The medication is generally well tolerated when used correctly.
• Erectile response to sildenafil varies among individuals.
• Avoid heavy or greasy foods before taking the pill.
• Some side effects are more common in first-time users.
• Notify your doctor if your condition worsens or persists.
• Sildenafil 100 mg may also be prescribed for other health issues.
• Do not take sildenafil if you have recent history of stroke or heart attack.
• Confirm your allergies with your healthcare provider before use.
• Always store medication in a secure location away from children.

Concomitant use may lead to hypotension (5.5)Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.

Other uses for this medicine

However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity (2.1)Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg (2.1)Maximum recommended dosing frequency is once per day (2.1)DOSAGE FORMS AND STRENGTHSTablets: 25 mg, 50 mg, 100 mg (3)CONTRAINDICATIONSAdministration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil tablets was shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2)Known hypersensitivity to sildenafil or any component of tablet ( 4.2)Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3)WARNINGS AND PRECAUTIONSPatients should not use sildenafil if sexual activity is inadvisable due to cardiovascular status (5.1)Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil with caution in patients predisposed to priapism (5.2)Patients should stop sildenafil and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Sildenafil should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a “crowded” optic disc may also be at an increased risk of NAION. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased.

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Decrease in sildenafil dosage is recommended (2.4, 5.6)ADVERSE REACTIONSMost common adverse reactions ( >2%) include headache, flushing, dyspepsia, abnormal

8.2 Lactation

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. 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.

Related treatment guides

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. vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc.

Generic vs Brand

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. 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.

Recreational use

Ask your healthcare professional how you should dispose of any medicine you do not use. Store mixed oral liquid in the refrigerator. 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. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or INTERACTIONSSildenafil can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1, 5.5, 7.1, 7.2, 7.3, 12.2)With concomitant use of alpha blockers, initiate sildenafil

5.2 Prolonged Erection and Priapism

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. 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.

How Sildenafil Works to Treat ED

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. 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. at 25 mg dose ( 2.3)CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil exposure ( 2.4,

Brand names

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). 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.

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

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. 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 for 4 hours or sildenafil citrate tablets 200mg more, contact your doctor immediately. 7.4, 12.3)Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg

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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. 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.

Can I take sildenafil every day?

If you notice any other effects, check with your healthcare professional. If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S. Approval: 1998INDICATIONS AND USAGESildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1)DOSAGE AND ADMINISTRATIONFor most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. ( 2.4, 7.4)Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period ( 2.4, 5.6)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 4/2025 Sildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1) For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.

• Sildenafil was originally developed to treat pulmonary hypertension.
• The 100 mg dosage is often prescribed when lower doses are ineffective.
• It can cause vision changes such as blurred vision or a blue tint.
• Alcohol consumption can enhance side effects and reduce effectiveness.
• Patients with heart conditions should consult a doctor before use.
• The medication is available by prescription only in many countries.
• Use with caution in patients with kidney or liver impairment.
• Report any allergic reactions like rash or difficulty breathing immediately.
• Sildenafil may cause dizziness; avoid operating heavy machinery after intake.

However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity (2.1) Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg (2.1)

Condition	Details	Rationale
Temperature	Store below 25°C (77°F)	Preserves chemical stability
Humidity	Keep in a dry place	Prevents clumping and degradation
Light	Protect from direct sunlight	Prevents breakdown of active ingredient
Container	Original blister or tightly closed bottle	Maintains stability and prevents contamination

Maximum recommended dosing frequency is once per day (2.1) Tablets: 25 mg, 50 mg, 100 mg (3) Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form.

• Sildenafil 100 mg tablets are primarily used to treat erectile dysfunction.
• The medication works by increasing blood flow to the penis.
• It is usually taken 30-60 minutes before sexual activity.
• Do not take more than one tablet per 24 hours to avoid overdose.
• Common side effects include headache, flushing, and nasal congestion.
• Sildenafil 100 mg should be used only under medical supervision.
• Avoid consuming high-fat meals close to the time of intake.
• It may interact with nitrates, leading to dangerous blood pressure drops.
• Store in a cool, dry place away from children and pets.

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