sildenafil citrate 100 mg

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In clinical studies, sildenafil was assessed for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity.

See also:

Effect of sildenafil and Placebo on Maintenance of Erection by Baseline Score.

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16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets USP are supplied as pale blue to blue, caplet shaped film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:For 100 mg - Pale blue to blue, caplet shaped film-coated tablets, debossed with ‘1A1’ on one side and plain on other side.For 50 mg - Pale blue to blue, caplet shaped film-coated tablets, debossed with ‘1A2’ on one side and plain on other side.For 25 mg - Pale blue to blue, round film-coated tablets, debossed with “25” on one side and “SL” on other side.Recommended Storage:Store at 25°C (77°F); excursions permitted within 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Sildenafil tablets USP are supplied as pale blue to blue, caplet shaped film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: Recommended Storage:Store at 25°C (77°F); excursions permitted within 15-30°C (59-86°F) [see USP Controlled Room Temperature].

4.2 Hypersensitivity Reactions

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 itraconazole (Sporanox)some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycinother medicines that treat high blood pressureother medicines or treatments for EDSildenafil tablets contains sildenafil, which is the same medicine found in another drug called REVATIO.

Recent Major Changes Section

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information)NitratesPhysicians should discuss with patients the contraindication of sildenafil with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [ see Contraindications (4.1)].Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of sildenafil with use of guanylate cyclase stimulators such as riociguat [ see Contraindications (4.3)].Concomitant Use with Drugs Which Lower Blood PressurePhysicians should advise patients of the potential for sildenafil to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications. Concomitant administration of sildenafil and an alpha - blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment and sildenafil should be initiated at the lowest dose [ see Warnings and premature ejaculation treatment Precautions (5.5)].Cardiovascular ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [ seeWarnings and Precautions (5.1)].Sudden Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil, and seek medical attention in the event of a sudden loss of vision in one or both eyes.

Side effects of Vigored Tablet

In clinical studies, sildenafil was assessed for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity. Effect of sildenafil and Placebo on Maintenance of Erection by Baseline Score. 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets USP are supplied as pale blue to blue, caplet shaped film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:For 100 mg - Pale blue to blue, caplet shaped film-coated tablets, debossed with ‘1A1’ on one side and plain on other side.For 50 mg - Pale blue to blue, caplet shaped film-coated tablets, debossed with ‘1A2’ on one side and plain on other side.For 25 mg - Pale blue to blue, round film-coated tablets, debossed with “25” on one side and “SL” on other side.Recommended Storage:Store at 25°C (77°F); excursions permitted within 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Sildenafil tablets USP are supplied as pale blue to blue, caplet shaped film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows: Recommended Storage:Store at 25°C (77°F); excursions permitted within 15-30°C (59-86°F) [see USP Controlled Room Temperature]. 17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information)NitratesPhysicians should discuss with patients the contraindication of sildenafil with regular and/or intermittent use of nitric oxide donors, such as organic nitrates or organic nitrites in any form [ see Contraindications (4.1)].Guanylate Cyclase (GC) StimulatorsPhysicians should discuss with patients the contraindication of sildenafil with use of guanylate cyclase stimulators such as riociguat [ see Contraindications (4.3)].Concomitant Use with Drugs Which Lower Blood PressurePhysicians should advise patients of the potential for sildenafil to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications.

12 Clinical Pharmacology

Concomitant administration of sildenafil and an alpha - blocker may lead to symptomatic hypotension in some patients. Therefore, when sildenafil is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment and sildenafil should be initiated at the lowest dose [ see Warnings and premature ejaculation treatment Precautions (5.5)].Cardiovascular ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician [ seeWarnings and Precautions (5.1)].Sudden Loss of VisionPhysicians should advise patients to stop use of all PDE5 inhibitors, including sildenafil, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil, for this uncommon condition [ see Warnings and Precautions (5.3)and Adverse Reactions (6.2)].Sudden Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including sildenafil, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including sildenafil. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including sildenafil, for this uncommon condition [ see Warnings and Precautions (5.3)and Adverse Reactions (6.2)].Sudden Hearing LossPhysicians should advise patients to stop taking PDE5 inhibitors, including sildenafil, and seek prompt medical attention in the event of sudden decrease or loss of hearing.

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Can I use it daily?

These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including sildenafil. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [ see Warnings and Precautions (5.4)and Adverse Reactions (6.2)].PriapismPhysicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil.

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If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [ see Warnings and Precautions (5.2)].Avoid Use with other PDE5 InhibitorsPhysicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil.

  • The "blue 100 pill" label is used by various manufacturers, making identification challenging without markings.
  • Many pills with similar appearances may contain different active ingredients, emphasizing caution.
  • The color blue is popular in pill design due to its calming association and easy recognition.
  • Always purchase medications from licensed pharmacies and avoid unverified sources.

The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [ see Warnings and Precautions (5.7)].Sexually Transmitted DiseaseThe use of sildenafil offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [ see Warnings and Precautions (5.9)].Manufactured by:Umedica Laboratories Pvt. 221 and 221/1, GIDC, II ndPhase,Vapi, Gujarat 396195, India (IND)Manufactured for:Nivagen Pharmaceuticals, Inc.Sacramento, CA 95827, USAToll free number: 1-877-977-0687Revised: June 2023, V-03Patient InformationSildenafil (sil den' a fil ) Tablets USPWhat is the most important information I should know about sildenafil ?Sildenafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.

Country Major Manufacturers Quality Certification Export Volume (annually)
China Shanghai Pharma GMP Certified 50 million pills
India Sun Pharma ISO Certified 30 million pills
Germany Bayer AG EU GMP Certified 10 million pills
USA Pfizer FDA Approved 5 million pills

A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.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 chronic-thromboembolic 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.Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex.Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.

  • The market for "blue 100" pills is highly varied, with genuine and fake products mixed.
  • Verification through official channels reduces the risk of adverse health effects.
  • Many countries have strict regulations regarding the sale and distribution of certain pills.
  • Always check the source and authenticity before using any pill labeled "blue 100."

Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.Sildenafil tablets does not ed gel protect you or your partner from getting sexually transmitted diseases, including HIV-the virus that causes AIDS.What are sildenafil tablets?Sildenafil tablets are a prescription medicine used to treat erectile dysfunction (ED).

  • Most common side effects: nausea, headache, dry mouth, and drowsiness.
  • Less common: QT prolongation, hyponatremia, and serotonin syndrome.
  • Long-term use may cause bone density loss in elderly patients.
  • Withdrawal symptoms if abruptly stopped: dizziness, anxiety, flu-like.

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.Who should not take sildenafil tablets?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 nitratetake 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 failurehave had heart surgery within the last 6 monthshave pulmonary hypertensionhave had a strokehave low blood pressure, or high blood pressure that is not controlledhave a deformed penis shapehave had an erection that lasted for more than 4 hourshave problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemiahave retinitis pigmentosa, a rare genetic (runs in families) eye diseasehave ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION)have bleeding problemshave or have had stomach ulcershave liver problemshave kidney problems or are having kidney dialysishave any other medical conditionsTell 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 tablets works causing side effects.

  • Some street drugs are designed to look like "blue 100" pills but contain dangerous substances.
  • The color and dosage markings do not guarantee the safety or authenticity of the pill.
  • Harm reduction organizations promote testing and cautious use among recreational users.
  • Education about pill identification helps reduce accidental poisonings and overdoses.

Especially tell your healthcare provider if you take any of the following:medicines called nitrates (see “What is the most importantinformation 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).

2.5 Dosage Adjustments in Special Populations

It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [ see Warnings and Precautions (5.4)and Adverse Reactions (6.2)].PriapismPhysicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result [ see Warnings and Precautions (5.2)].Avoid Use with other PDE5 InhibitorsPhysicians should inform patients not to take sildenafil tablets with other PDE5 inhibitors including REVATIO or other pulmonary arterial hypertension (PAH) treatments containing sildenafil. The safety and efficacy of sildenafil tablets with other PDE5 inhibitors, including REVATIO, have not been studied [ see Warnings and Precautions (5.7)].Sexually Transmitted DiseaseThe use of sildenafil offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered [ see Warnings and Precautions (5.9)].Manufactured by:Umedica Laboratories Pvt. 221 and 221/1, GIDC, II ndPhase,Vapi, Gujarat 396195, India (IND)Manufactured for:Nivagen Pharmaceuticals, Inc.Sacramento, CA 95827, USAToll free number: 1-877-977-0687Revised: June 2023, V-03Patient InformationSildenafil (sil den' a fil ) Tablets USPWhat is the most important information I should know about sildenafil ?Sildenafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.

5 Warnings And Precautions

A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.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 chronic-thromboembolic 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.Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex.Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.Sildenafil tablets does not ed gel protect you or your partner from getting sexually transmitted diseases, including HIV-the virus that causes AIDS.What are sildenafil tablets?Sildenafil tablets are 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.Who should not take sildenafil tablets?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 nitratetake 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 failurehave had heart surgery within the last 6 monthshave pulmonary hypertensionhave had a strokehave low blood pressure, or high blood pressure that is not controlledhave a deformed penis shapehave had an erection that lasted for more than 4 hourshave problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemiahave retinitis pigmentosa, a rare genetic (runs in families) eye diseasehave ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION)have bleeding problemshave or have had stomach ulcershave liver problemshave kidney problems or are having kidney dialysishave any other medical conditionsTell 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 tablets works causing side effects. Especially tell your healthcare provider if you take any of the following:medicines called nitrates (see “What is the most importantinformation 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 itraconazole (Sporanox)some types of antibiotics, such as clarithromycin (Biaxin), telithromycin (Ketek), or erythromycinother medicines that treat high blood pressureother medicines or treatments for EDSildenafil tablets contains sildenafil, which is the same medicine found in another drug called REVATIO.

5.9 Counseling Patients About Sexually Transmitted Diseases

Does Vigored Blue 100mg Tablet increase blood pressure?