See full prescribing information for SILDENAFIL TABLETSSILDENAFIL tablets, for oral useInitial U.S.
- Use of sildenafil under medical supervision helps prevent adverse effects.
- Seek immediate medical help if you experience chest pain while using.
- The drug is not a cure but helps manage erectile dysfunction symptoms.
- Notify your doctor if you experience any allergic reactions.
Approval: 1998RECENT MAJOR CHANGESWarnings and Precautions, Effects on the Eye ( 5.3)INDICATIONS AND USAGESildenafil tablets are 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: 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 tablets if sexual activity is inadvisable due to cardiovascular status ( 5.1)Patients should seek emergency treatment if an erection lasts >4 hours.
Why is a prescription required for erectile dysfunction medicines?
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.
What should I tell my healthcare provider before taking sildenafil?
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 after 60 days. Active ingredient: sildenafil citrateInactive ingredients: dextrose and water for injection.
When and How to Take Sildenafil for Best Results
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Patients with a "crowded" optic disc may also be at an increased risk of NAION.
- Consult your doctor if you experience vision changes or ringing in ears.
- Sildenafil can interact with nitrates, causing dangerous hypotension.
- Use with caution if you have heart problems or low blood pressure.
- Report any persistent or painful erections lasting over 4 hours.
( 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 tablets is co-administered with alpha-blockers or anti- hypertensives.
Should someone take it directly or consult a doctor?
Your healthcare provider will tell you how much sildenafil to take and when to take it. Take sildenafil by mouth about 1 hour before sexual activity. You may take sildenafil between 30 minutes and 4 hours before sexual activity if needed. Do not take more than once a day. If you take too much sildenafil, call your healthcare provider or go to the nearest hospital emergency room right away.
What’s the best sildenafil dosage for beginners?
Do not remove the film from the pouch unless ready for immediate use. Do not handle the oral film with wet hands. See the Vybrique Prescribing Information for more information about how to take sildenafil oral film. Take sildenafil exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets.
Is 20 or 25mg Sildenafil Enough for ED?
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. Concomitant use may lead to hypotension ( 5.5)Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.
Sildenafil Working Time (And How Long Does it Last)
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.
If you were to talk to a doctor about sildenafil, what would you ask first?
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.
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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 sildenafil price ireland sudden and serious decrease in blood pressure Alpha-blockers are sometimes prescribed for prostate problems orhigh blood pressure. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased.
Before taking this medicine
Women with pulmonary arterial hypertension should not stop taking sildenafil without talking to their doctor if they discover they are pregnant. It is not known whether sildenafil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breastfeeding a baby. Women with pulmonary arterial hypertension should not stop taking sildenafil without talking to their doctor. Take sildenafil oral tablets exactly as your healthcare provider tells you to take it.
Can I take sildenafil every day?
Your healthcare provider will tell you how much to take and when to take it. Your healthcare provider may change your dose if needed. You may take sildenafil between 30 minutes to 4 hours before sexual activity if needed. If you take sildenafil after a high-fat meal (such as a cheeseburger and fries), sildenafil may take a little longer to start working. If you accidentally take too much sildenafil, call your doctor or go to the nearest hospital emergency room right away.
Raynaud's phenomenon
Sildenafil can help you have an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of sildenafil. Take sildenafil oral film (Vybrique) exactly as your healthcare provider tells you to take it. Decrease in sildenafil tablets 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 at Rubicon Research Private Limited, Ambernath at 00-91-251-6619500 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 at 25 mg dose ( 2.3)CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil exposure ( 2.4, 7.4, 12.3)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 6/2018 Warnings and Precautions, Effects on the Eye ( 5.3) Sildenafil tablets are 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.
How to Take Sildenafil Correctly for Erectile Dysfunction
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. NDC Code(s): 52817-340-30, 52817-341-10, 52817-341-30, 52817-342-10, view more52817-342-30 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. 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) 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.
| Side Effect | Incidence | Severity | Management Suggestions |
|---|---|---|---|
| Headache | Common | Mild to moderate | Take pain relievers |
| Flushing | Common | Mild | Cool compress, hydration |
| Dizziness | Common | Mild | Sit or lie down immediately |
| Nasal Congestion | Less common | Mild | Use decongestants if needed |
| Visual Disturbances | Rare | Mild | Discontinue and consult doctor |
- Label: SILDENAFIL- sildenafil citrate injection, solution
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