4 CONTRAINDICATIONS
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 Precautions (5.5)].Cardiovascular ConsiderationsPhysicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors.
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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.
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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.
2.1 Dosage Information
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 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.
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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. 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. 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.
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Ask your doctor if your heart is healthy enough to handle the extra strain of having sex.Sildenafil tablets does not 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 fildena online 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.
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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.
- Widely available at chain pharmacies like CVS, Walgreens, and Rite Aid.
- Also procurable through online pharmacies with a valid prescription.
- Not available over-the-counter; requires doctor's prescription.
- May be obtained in hospital pharmacies for inpatient use.
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.
| 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 |
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 workingDo nottake sildenafil tablets more than 1 time a day.If you accidentally take too much sildenafil, call your doctor or go to the nearest hospital emergency room right away.What are the possible side effects of sildenafil tablets?Sildenafil tablets can cause serious side effects. Rarely reported side effects include:an erection that will not go away (priapism).If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis.sudden vision loss in one or both eyes.Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). You may report side effects to FDA at 1-800-FDA-1088.How should I store sildenafil tablets?Store sildenafil tablets at room temperature between 68°F to 77°F (20°C to 25°C).Keep sildenafil tablets and all medicines out of the reach of children.General information about the safe and effective use of sildenafil tablets.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
- "Blue 100 pills" can sometimes be illicit substances mistaken for pharmaceuticals, posing health risks.
- Testing kits are available to verify the composition of blue pills before consumption.
- In some cases, "blue 100" pills may contain illicit chemicals like MDMA or other recreational drugs.
- Consuming unknown pills without proper identification can lead to overdose or adverse effects.
You can ask your healthcare provider or pharmacist for information about sildenafil tablets that is written for health professionals.For more information, call Nivagen Pharmaceuticals, Inc. at 1-877-977-0687.What are the ingredients in sildenafil tablets?Active ingredient:sildenafil citrate, USPInactive ingredients:colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, FD&C Blue # 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.This Patient Information has been approved by the U.S. Food and Drug Administration.Manufactured by:Umedica Laboratories Pvt.
12.3 Pharmacokinetics
You can ask your healthcare provider or pharmacist for information about sildenafil tablets that is written for health professionals.For more information, call Nivagen Pharmaceuticals, Inc. at 1-877-977-0687.What are the ingredients in sildenafil tablets?Active ingredient:sildenafil citrate, USPInactive ingredients:colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate anhydrous, FD&C Blue # 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin.This Patient Information has been approved by the U.S. Food and Drug Administration.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-03*The other brands listed are trademarks of their respective owners and are not trademarks of Umedica Laboratories Pvt.
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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-03*The other brands listed are trademarks of their respective owners and are not trademarks of Umedica Laboratories Pvt.
5.1 Cardiovascular
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 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 fildena online 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).
Patient Information
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. 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 workingDo nottake sildenafil tablets more than 1 time a day.If you accidentally take too much sildenafil, call your doctor or go to the nearest hospital emergency room right away.What are the possible side effects of sildenafil tablets?Sildenafil tablets can cause serious side effects. Rarely reported side effects include:an erection that will not go away (priapism).If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis.sudden vision loss in one or both eyes.Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). You may report side effects to FDA at 1-800-FDA-1088.How should I store sildenafil tablets?Store sildenafil tablets at room temperature between 68°F to 77°F (20°C to 25°C).Keep sildenafil tablets and all medicines out of the reach of children.General information about the safe and effective use of sildenafil tablets.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.