Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1.
What doses does sildenafil come in?
Especially tell your healthcare provider if you take any of the following: • medicines called nitrates (see 'What is the most important information I should know about sildenafil tablets?') • medicines called guanylate cyclase stimulators, such as riociguat (Adempas) • medicines called alpha blockers such as Hytrin (terazosin HCl), Flomax (tamsulosin HCl), Cardura (doxazosin mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl), Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin). In some patients, the use of sildenafil tablets with alpha-blockers can lead to a drop in blood pressure or to fainting. • medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase) or atazanavir sulfate (Reyataz) • some types of oral antifungal medicines, such as ketoconazole (Nizoral), and itraconozale (Sporanox) • some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycin • other medicines that treat high blood pressure • other medicines or treatments for ED • sildenafil tablets contains sildenafil, which is the same medicine found in another drug called REVATIO. Sildenafil tablets should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]). • Take sildenafil tablets exactly as your healthcare provider tells you to take it.
Dosage for pulmonary arterial hypertension (PAH)
• Your healthcare provider will tell you how much sildenafil tablets to take and when to take it. • Your healthcare provider may change white sildenafil tablets your dose if needed. • Take sildenafil tablets about 1 hour before sexual activity. You may take sildenafil tablets between 30 minutes to 4 hours before sexual activity if needed. • Sildenafil tablets can be taken with or without food.
Drugs Affecting Gastric Acidity
If you take sildenafil tablets after a high fat meal (such as a cheeseburger and french fries), sildenafil tablets may take a little longer to start working • Do nottake sildenafil tablets more than 1 time a day. • If you accidentally take too much sildenafil tablets, call your doctor or go to the nearest hospital emergency room right away. Sildenafil tablets can cause serious side effects . Rarely reported side effects include: • an erection that will not go away (priapism). • sudden vision loss in one or sildenafil white both eyes. WARNINGS AND PRECAUTIONS5.1 Mortality
- Sildenafil 20 mg is a prescription medication used for erectile dysfunction.
- It helps increase blood flow to the penis during sexual activity.
- Typically prescribed for men with ED to improve sexual performance.
with Pediatric Use5.2 Hypotension5.3 Worsening
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Pulmonary Vascular Occlusive Disease5.4
Before Using
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 tablets are phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. ( 1)Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. ( 1, 14)DOSAGE AND ADMINISTRATIONTablets: 20 mg three times a day, 4 to 6 hours apart ( 2.1)DOSAGE FORMS AND STRENGTHSTablets: 20 mg ( 3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSIncreased mortality with increasing doses in pediatric patients.
Most Asked Questions
( 5.1)Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. ( 5.2)Use in pulmonary veno-occlusive disease may cause pulmonary edema and is not recommended. ( 5.3)Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. ( 5.5, 5.6)Pulmonary hypertension secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. ( 5.9)ADVERSE REACTIONSMost common adverse reactions greater than or equal to 3% and more frequent than placebo were epistaxis, headache, dyspepsia, flushing, insomnia, erythema, dyspnea, and rhinitis.
5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies
( 6.1, 6.2)To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 888-413-0949 or FDA at 1-800-FDA-1088 or INTERACTIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 9/2024 Sildenafil tablets are phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity. Tablets: 20 mg three times a day, 4 to 6 hours apart ( 2.1) Increased mortality with increasing doses in pediatric patients. Pulmonary hypertension secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 888-413-0949 or FDA at 1-800-FDA-1088 or See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Epistaxis5.5 Visual Loss5.6 Hearing Loss5.7
What happens if I miss a dose?
Sildenafil Tablets, USP (sil den' a fil) What is the most important information I should know about sildenafil tablets? Sildenafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take sildenafil tablets if you take any other medicines called ''nitrates.'' Nitrates are used to treat chest pain (angina). Do not take sildenafil tablets if you take medicines called guanylate cyclase stimulators which include: • Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronicthromboembolic pulmonary hypertension. Tell all your healthcare providers that you take sildenafil tablets.If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took sildenafil tablets.
How Sildenafil Works to Treat ED
Sildenafil tablets does not protect you or your partner from getting sexually transmitted diseases, including HIV—the virus that causes AIDS. Sildenafil tablet is a prescription medicine used to treat erectile dysfunction (ED). Sildenafil tablets helps a man with erectile dysfunction get and keep an erection only when he is sexually excited (stimulated). Sildenafil tablets are not for use in women or children. It is not known if sildenafil tablets are safe and effective in women or children under 18 years of age.
Revatio Injection
Do not take sildenafil tablets if you: • take medicines called ''nitrates'' (such as nitroglycerin) • use street drugs called ''poppers'' such as amyl nitrate or amyl nitrite, and butyl nitrate • take any medicines called guanylate cyclase stimulators such as riociguat (Adempas) • are allergic to sildenafil, as contained in sildenafil tablets and REVATIO, or any of the ingredients in sildenafil tablets. See the end of this leaflet for a complete list of ingredients in sildenafil tablets. What should I tell my healthcare provider before taking sildenafil tablets? Before you take sildenafil tablets, tell your healthcare provider if you: • have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure • have had heart surgery within the last 6 months • have pulmonary hypertension • have had a stroke • have low blood pressure, or high blood pressure that is not controlled • have a deformed penis shape • have had an erection that lasted for more than 4 hours • have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia • have retinitis pigmentosa, a rare genetic (runs in families) eye disease • have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION) • have bleeding problems • have or have had stomach ulcers • have liver problems • have kidney problems or are having kidney dialysis • have any other medical conditions Tell your healthcare provider about all the medicines you take*,including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sildenafil tablets may affect the way other medicines work, and other medicines may affect the way sildenafil tablet works causing side effects. Combination with other PDE-5
- The usual starting dose of sildenafil for ED is 50 mg, but 20 mg may be prescribed for some patients.
- Prescription requirements ensure safe usage and proper dosing based on health conditions.
- Always follow a doctor’s instructions when taking sildenafil 20 mg.
inhibitors5.8 Priapism5.9 Vaso-occlusive Crisis in
- Sildenafil 20 mg is not intended for use by women or children.
- Keep medication out of reach of children to prevent accidental ingestion.
- Store in a cool, dry place away from direct sunlight.
Patients with Pulmonary Hypertension Secondary to Sickle Cell Anemia6.
4. Contraindications
Stop taking sildenafil tablets and call your healthcare provider right away if you have sudden vision loss in one or both eyes. If you have these symptoms, stop taking sildenafil tablets and contact a doctor right away. The most common side effects of sildenafil tablets are: • headache • flushing • upset stomach • abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision • stuffy or runny nose • back pain • muscle pain • nausea • dizziness • rash In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking sildenafil tablets. Most, but not all, of these men had heart problems before taking sildenafil tablets. It is not known if sildenafil tablets caused these problems.
4.2 Hypersensitivity Reactions
• Store sildenafil tablets at room temperature between 20° to 25°C (68° to 77°F). Keep sildenafil tablets and all medicines out of the reach of children. General information about the safe and effective use of sildenafil tablets. Do not give sildenafil tablets to other people, even if they have the same symptoms that you have. This Patient Information leaflet summarizes the most important information about sildenafil tablets.
Sildenafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
You can ask your healthcare provider or pharmacist for information about sildenafil tablets that is written for health professionals. This Patient Information has been approved by the U.S. Food and Drug Administration. All brands listed are the registered trademarks of their respective owners and are not trademarks of Evaric Pharmaceuticals, Inc. Revised: 08/2019 sildenafil generic Cialis vs Viagra - What's the difference between them? ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7.
- Sildenafil 20 mg is contraindicated with nitrate medications due to risk of severe hypotension.
- Patients with heart problems should consult their doctor before use.
- It’s important to disclose all medications to your healthcare provider.