FULL PRESCRIBING INFORMATION: CONTENTS*

Use sildenafil citrate with caution in patients predisposed to priapism ( 5.2)Patients should stop sildenafil tablets 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).

Top 20 FAQs

Do not change your dose or stop taking this medicine on your own. Take sildenafil tablet or oral suspension 3 times a day, about 4 to 6 hours apart. Take at approximately the same times every day. Sildenafil oral suspension will be mixed for you by your pharmacist. Do not mix with other medicines or flavorings.

Regional issues

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). When sildenafil is used for ED, it is used as needed, so you are not likely to miss a dose. If you are taking sildenafil for PAH and you miss a dose, take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time. Sildenafil tablets 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.

• Sildenafil citrate tablets 50mg are commonly used in erectile dysfunction treatment.
• They help relax blood vessels in the penis for improved blood flow.
• Taking the medication on an empty stomach may result in quicker action.
• Do not use if you are taking other medications containing nitrates.
• Side effects like flushing or indigestion are usually mild.
• Discontinue use and seek medical help if an erection lasts longer than 4 hours.
• Sildenafil should be used only as prescribed by a healthcare practitioner.
• Consult your doctor if you experience adverse or unexpected effects.

( 5.3)Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4)Caution is advised when Sildenafil citrate is co-administered with alpha- blockers or anti-hypertensives. Concomitant use may lead to hypotension ( 5.5)Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.

In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in Sildenafil citrate dosage is recommended ( 2.4, 5.6)ADVERSE REACTIONSMost common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash ( 6.1).To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or INTERACTIONSSildenafil citrate 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 citrate at 25 mg dose ( 2.3)CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase Sildenafil citrate exposure ( 2.4, 7.4, 12.3)Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period ( 2.4, 5.6)Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg ( 2.4, 7.4)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 12/2024 Warnings and Precautions, Effects on the Eye ( 5.3) 08/2017 Sildenafil citrate is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED).

Composition, Action & Use

In some patients, the use of sildenafil with alpha-blockers can lead to a drop in blood pressure or fainting Other drugs to treat high blood pressure or a prostate disorder Medicines to treat HIV, such as protease inhibitors, such as ritonavir and saquinavir Some types of oral antifungal medicines, such as ketoconazole and itraconazole Some types of antibiotics, such as erythromycin Other medicines that treat high blood pressure Medicines or treatments for ED, such as avanafil (Stendra), tadalafil (Cialis), or vardenafil (Levitra). Tell your doctor about all other medications you use for erectile dysfunction. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. Other drugs may interact with sildenafil, including prescription and over-the-counter medicines, vitamins, and herbal products.

Revatio for Oral Suspension

Not all possible drug interactions are listed here. Store sildenafil tablets and oral film at room temperature, between 20°C and 25°C (68°F and 77°F). Store sildenafil reconstituted oral suspension below 30°C (86°F) or in a refrigerator between 2°C to 8°C (36°F to 46°F). Throw away the reconstituted oral suspension sildenafil tablet manforce 50 mg after 60 days. Active ingredient: sildenafil citrateInactive ingredients: dextrose and water for injection. For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.

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) Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form.

7.4 Ritonavir and other CYP3A4 inhibitors

If you take too much sildenafil, call your doctor or go to the nearest hospital emergency room. Drinking alcohol with sildenafil can cause side effects. Grapefruit juice and products may interact with sildenafil, leading to unwanted side effects. Avoid using any other medicines to treat impotence, such as alprostadil or yohimbine, without first talking to your doctor. Tell your healthcare provider about all the medicines you take, including prescription and over-the-countermedicines, vitamins, and herbal supplements.

Can I take sildenafil every day?

Sildenafil may affect the way other medicines work, and other medicines may affect the way sildenafil works, causing side effects. Especially tell your healthcare provider if you take: Nitrates for chest pain or heart problems. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking sildenafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure Alpha-blockers are sometimes prescribed for prostate problems orhigh blood pressure. Sildenafil citrate 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) Patients should not use sildenafil citrate if sexual activity is inadvisable due to cardiovascular status ( 5.1) Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil citrate with caution in patients predisposed to priapism ( 5.2) Patients should stop sildenafil tablets 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). Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4) Caution is advised when Sildenafil citrate is co-administered with alpha- blockers or anti-hypertensives.

• Sildenafil citrate tablets 50mg are used to treat erectile dysfunction.
• These tablets work by increasing blood flow to the penis.
• Take sildenafil 50mg approximately 30 minutes before activity.
• Do not exceed one dose in a 24-hour period.
• Common side effects include headache and flushing.
• Sildenafil can interact with nitrates, causing dangerous drops in blood pressure.
• Store tablets in a cool, dry place away from direct sunlight.
• Consult a doctor before use, especially if you have heart conditions.

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

How to take Avarante 10mg Tablets

Contains no ingredients made from gluten-containing grain (eg, wheat, barley, or rye). Revatio is distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017. Viagra is distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017. It is distributed by: IBSA Pharma Inc, Parsippany, NJ 07054 USA. Cialis vs Viagra - What's the difference between them?

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Do you know these 11 amazing facts about Viagra? Is generic Viagra available in the U.S.? Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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. Decrease in Sildenafil citrate dosage is recommended ( 2.4, 5.6) Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash ( 6.1).

5.6 Adverse Reactions with the Concomitant Use of Ritonavir

See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S. Approval:1998RECENT MAJOR CHANGESWarnings and Precautions, Effects on the Eye ( 5.3) 08/2017INDICATIONS AND USAGESildenafil citrate 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. 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: 50 mg ( 3)CONTRAINDICATIONSAdministration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil citrate 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 citrate if sexual activity is inadvisable due to cardiovascular status ( 5.1)Patients should seek emergency treatment if an erection lasts >4 hours. To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or Sildenafil citrate 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 citrate at 25 mg dose ( 2.3) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase Sildenafil citrate exposure ( 2.4, 7.4, 12.3) Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period ( 2.4, 5.6) Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg ( 2.4, 7.4) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.