A Bioequivalence study of Sildenafil 50 mg and Dapoxetine 30 mg Tablet in normal healthy, adult male subjects under fasting condition

Sildenafil > tablet sildenafil 50 mg


Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom).

Further information

Do not start these medications while taking sildenafil without discussing it with your healthcare provider. tell your doctor if you smoke, if you have had heart surgery within the last 6 months, if you have ever had an erection that lasted for more than 4 hours, and if you have recently lost a large amount of body fluids (dehydration). This can happen if you are sick with fever, diarrhea, or vomiting; sweat a lot; or do not drink enough liquids. Also tell your doctor if you have or have ever had pulmonary veno-occlusive disease (PVOD; blockage of veins in the lungs); a stomach ulcer; heart, kidney, or liver disease; a heart attack; heart failure; angina (chest pain); an irregular heartbeat; a stroke; chest pain; high or low blood pressure; high cholesterol; a bleeding disorder; blood circulation problems; blood cell problems such as sickle cell anemia (a disease of the red blood cells), multiple myeloma (cancer of the plasma cells), or leukemia (cancer of the white blood cells); conditions affecting the shape of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie's disease); or diabetes. Also tell your doctor if you or any of your family members have or have ever had an eye disease such as retinitis pigmentosa (an inherited eye condition that causes loss of vision) or if you have ever had sudden severe vision loss, especially if you were told that the vision loss was caused by a blockage of blood flow to the nerves that help you see.

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if you are a woman and you are taking sildenafil to treat PAH, tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking sildenafil, call your doctor. if you are having surgery, including dental surgery, tell your doctor or dentist that you are taking sildenafil. if you are taking sildenafil to treat erectile dysfunction, tell your doctor if you have ever been advised by a healthcare professional to avoid sexual activity for medical reasons or if you have ever experienced chest pain during sexual activity. Sexual activity may be a strain on your heart, especially if you have heart disease. Store the suspension at room temperature or in a refrigerator, but do not freeze it.

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Dispose of any unused suspension after 60 days.

Key features of Sildenafil 50mg Tablets

If you experience chest pain, dizziness, or nausea during sexual activity, call your doctor immediately and avoid sexual activity until your doctor tells you otherwise. tell all your healthcare providers that you are taking sildenafil. If you ever need emergency medical treatment for a heart problem, the sildenafil 20 mg prescription healthcare providers who treat you will need to know when you last took sildenafil. Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine. If you are taking sildenafil for erectile dysfunction, you are unlikely to miss a dose since this medication is taken as needed, not on a regular dosing schedule.

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If you are taking sildenafil for PAH, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. numbness, burning, or tingling in the arms, hands, feet, or legs pain in muscles, back, arms, or legs changes in color vision (seeing a blue tinge on objects or having difficulty telling the difference between blue and green) sudden severe loss of vision (see below for more information) erection that is painful or lasts longer than 4 hours rash; itching; hives; difficulty breathing or swallowing; swelling of the eyes, face, throat, tongue, or lips Some patients experienced a sudden loss of some or all of their vision after they took sildenafil or other medications that are similar to sildenafil. The vision loss was permanent in some cases. Keep all medication out of sight and reach of children as many containers are not child-resistant.

  • Sildenafil 50 mg may cause dizziness; avoid driving if affected.
  • Combining sildenafil with certain drugs can be dangerous; discuss with your doctor.
  • Do not use if you have severe liver or kidney disease.

Place the medication in a safe location – one that is up and away and out of their sight and reach. Dispose of unneeded medications in a way so that pets, children, and other people cannot take them.

Who Should Avoid Sildenafil

Tell your doctor if sildenafil is not working well or if you are experiencing side effects. If you are taking sildenafil for PAH, you should know that sildenafil controls PAH but does not cure it. Continue to take sildenafil even if you feel well. Do not stop taking sildenafil without talking to your doctor. Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Side Effects

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information. tell your doctor and pharmacist if you are allergic to sildenafil, any other medications, or any of the ingredients in sildenafil tablet or suspension. Ask your pharmacist for a list of the ingredients. Some medications should not be taken with sildenafil. Make sure you have discussed any other medications you are currently taking or plan to take before starting sildenafil with your doctor and pharmacist. Do not flush this medication down the toilet.

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However, if you take sildenafil with a high-fat meal, it will take longer for the medication to start to work. If you are taking sildenafil to treat PAH, you will probably take sildenafil three times a day with or without food. Take sildenafil at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Do not take more or less of it or take it more often than prescribed by your doctor.

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

Shake the liquid well for 10 seconds before each use to mix the medication evenly. Use the oral syringe provided with your medication to measure and take your dose. Follow the manufacturer's directions to use and clean the oral syringe. Do not mix the liquid with other medications or add anything to flavor the medication. If you are taking sildenafil for erectile dysfunction, your doctor will probably start you on an average dose of sildenafil and increase or decrease your dose depending on your response to the medication. Talk to your pharmacist about take-back programs in your community.

5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives

Before starting, stopping, or changing any medications while taking sildenafil, please get the advice of your doctor or pharmacist. tell your doctor if you are taking street drugs containing nitrates ('poppers') such as amyl nitrate, amyl nitrite, or butyl nitrate while taking sildenafil. Your doctor will tell you not to take sildenafil if you are taking street drugs containing nitrates. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

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you should know that sildenafil is available under the brand names Liqrev, Revatio, and Viagra. You should only be treated with one of these products at a time. The following nonprescription or herbal products may interact with sildenafil: cimetidine (Tagamet HB), St. John's wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking sildenafil. Visit the FDA's Safe Disposal of Medicines website for more information. In case of overdose, call the poison control helpline at 1-800-222-1222.

Condition Caution or Contraindication Rationale
Use of Nitrates Contraindicated Risk of dangerous blood pressure drop
Severe Liver Impairment Use with caution Altered metabolism
Cardiovascular disease Consult doctor before use Potential strain on heart
Retinal Disorders Caution; consult healthcare provider Risk of vision-related side effects

Information is also available online at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

6.2 Postmarketing Experience

If you are taking sildenafil (Viagra) for erectile dysfunction, do not take any more doses of sildenafil (Viagra) or similar medications such as tadalafil (Cialis) or vardenafil (Levitra) until you talk to your doctor. If you are taking sildenafil (Liqrev, Revatio) for PAH, do not stop taking your medication until you talk to your doctor. Call your doctor if you have any unusual problems while you are taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( or by phone (1-800-332-1088). Keep this medication in the container it came in, tightly closed, and out of reach of children. Do not let anyone else take your medication.

  • Common side effects include headaches, flushing, and nasal congestion.
  • Serious side effects are rare but may include vision changes or prolonged erections.
  • Seek medical help if adverse reactions occur.

Ask your pharmacist any questions you have about refilling your prescription. Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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It is not known if the vision loss was caused by the medication. If you experience a sudden loss of vision while you are taking sildenafil, call your doctor immediately. Do not take any more doses of sildenafil or similar medications such as tadalafil (Cialis) or vardenafil (Levitra) until you talk to your doctor. There have been reports of heart attack, stroke, irregular heartbeat, bleeding in the brain or lungs, high blood pressure, and sudden death in men who took sildenafil for erectile dysfunction. Most, but not all, of these people had heart problems before taking sildenafil.

How to Use Sildenafil Tablet

It is not known whether these events were caused by sildenafil, sexual activity, heart disease, or a combination of these and other causes. Talk to your doctor about the risks of taking sildenafil. Some patients experienced a sudden decrease or loss of hearing after they took sildenafil or other medications that are similar to sildenafil. It is not known if the hearing loss was caused by the medication. If you experience a sudden loss of hearing, sometimes with ringing in the ears or dizziness, while you are taking sildenafil, call your doctor immediately. Ontologies Search Annotator Recommender Mappings Login Support Submit feedback Documentation Help Release notes How to cite Link to this page RxNORM Last uploaded: March 22, 2026 Summary Classes Properties Notes Mappings Widgets Details Visualization Notes ( 0 ) Mappings ( ) Id Preferred Name sildenafil 50 MG Oral Tablet Synonyms sildenafil citrate 50 MG Oral Tablet sildenafil 50 MG (as sildenafil citrate) Oral Tablet Type All Properties altLabel sildenafil citrate 50 MG Oral Tablet sildenafil 50 MG (as sildenafil citrate) Oral Tablet prefLabel sildenafil 50 MG Oral Tablet RXN Boss From {316664} AM RXAUI 6362427 3805164 1456254 Has dose form type RXN AVAILABLE STRENGTH 50 MG RXN AM {316664} 136411 tui T200 RXCUI 312950 RXN HUMAN DRUG US isa RXTERM FORM Tab notation 312950 Semantic type UMLS property Has tradename cui C0980159 RXN AI {316664} 221161 Consists of NDC 00093534256 71610025612 31722071001 68071363103 71205079560 50090464600 82647021130 33342004211 71205026720 70954040810 76519121801 82647021114 60219175207 35561025214 72241007022 71335102804 27241006805 72865010230 55801033901 65862069099 68071374303 71205072104 72789040515 65862069005 71205079530 63629783306 71335102806 42291074702 13668018705 13668018710 72865010201 71335102801 55801033903 13668018718 42291074730 70518164100 72789010315 71610025604 75834024000 42291074706 71610067906 31722071030 13668018730 71610067902 76282064430 42291074701 50090718100 31722071005 72888001601 60219175203 59762003502 68071364601 71205079590 63629783305 69097095202 71205026760 63629783307 71335102805 75834024030 68071374506 76519121803 52817034130 50090680400 75834024001 71610025602 43063094115 63629783304 75834024005 71209010701 71610025606 33342004207 71205079510 68071467403 72888001600 70518184400 76420056460 76420056401 63629783301 72241007011 70518184401 69097095207 71205079520 65862069001 71205054230 72888001630 13668018701 27241006810 61919075530 71209010705 71335102803 76420056430 59762003501 71209010711 71205026730 70748013206 70748013201 76420056490 55801033902 52817034110 71205026790 27241006803 00378165993 33342004244 61919075510 71335102802 63629783302 72789040530 65862069030 76282064401 60219175201 71205054260 63629783303 71610067904 33342004298 50090541500 72241007005 71205054290 35561025210 00093534201 See more See less Add comment Add proposal Subscribe to notes emails Delete Subject Author Type Created No notes to display