Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. 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. REVATIO is used to treat a rare disease called pulmonary arterial hypertension (PAH). Sildenafil tablets should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]).Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.How should I take sildenafil tablets?Take sildenafil tablets exactly as your healthcare provider tells you to take it.Your healthcare provider will tell you how much sildenafil tablets to take and when to take it.Your healthcare provider may change your dose if needed.Take sildenafil tablets about 1 hour before sexual activity.
- Patients with liver or kidney issues should consult a physician before use.
- Sildenafil 200 mg is a potent dose, usually used when lower doses are ineffective.
- Alcohol increases the risk of side effects like dizziness and fainting.
- The medication may cause a sudden decrease in blood pressure.
- Use sildenafil cautiously if taking antihypertensive medications.
- Always adhere to doctor’s advice for optimal safety.
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. 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). It is uncertain whether PDE5 inhibitors directly cause the vision loss. Stop taking sildenafil tablets and call your healthcare provider right away if you have sudden vision loss in one or both eyes.sudden hearing decrease or hearing loss.
4. Contraindications
For more information, ask your healthcare provider or pharmacist.Call your doctor for medical advice about side effects. 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. Do not use sildenafil tablets for a condition for which it was not prescribed. Do not give sildenafil tablets to other people, even if they have the same symptoms that you have. It may harm them.This Patient Information leaflet summarizes the most important information about sildenafil tablets.
Starting Sildenafil: Recommended First-Time Dosage
If you would like more information, talk with your healthcare provider. 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 tablet sildenafil 50 mg 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.
Antihypertensive and α-Adrenergic Blocking Agents
The makers of these brands are not affiliated with and do not endorse Umedica Laboratories Pvt. Advise the patient to read the FDA-approved patient labeling (Patient Information) 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? 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 low blood pressure, or high blood pressure that is not controlled 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 kidney problems or are having kidney dialysis Tell your healthcare provider about all the medicines you take*,including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking sildenafil tablets and contact a doctor right away.The most common side effects of sildenafil tablets are:headacheflushingupset stomachabnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred visionstuffy or runny noseback painmuscle painnauseadizzinessrashIn 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.Tell your healthcare provider if you have any side effect that bothers you or does not go away.These are not all the possible side effects of sildenafil tablets. For more information, ask your healthcare provider or pharmacist.Call your doctor for medical advice about side effects. 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. Do not use sildenafil tablets for a condition for which it was not prescribed. Do not give sildenafil tablets to other people, even if they have the same symptoms that you have. It may harm them.This Patient Information leaflet summarizes the most important information about sildenafil tablets. If you would like more information, talk with your healthcare provider.
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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 tablet sildenafil 50 mg 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. The makers of these brands are not affiliated with and do not endorse Umedica Laboratories Pvt. Advise the patient to read the FDA-approved patient labeling (Patient Information) 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.
13. Nonclinical Toxicology
Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. 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. REVATIO is used to treat a rare disease called pulmonary arterial hypertension (PAH). Sildenafil tablets should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil]).Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.How should I take sildenafil tablets?Take sildenafil tablets exactly as your healthcare provider tells you to take it.Your healthcare provider will tell you how much sildenafil tablets to take and when to take it.Your healthcare provider may change your dose if needed.Take sildenafil tablets about 1 hour before sexual activity.
2.4 Dosage Adjustments Due to Drug Interactions
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. 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). It is uncertain whether PDE5 inhibitors directly cause the vision loss.
12.2 Pharmacodynamics
Stop taking sildenafil tablets and call your healthcare provider right away if you have sudden vision loss in one or both eyes.sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking sildenafil tablets and contact a doctor right away.The most common side effects of sildenafil tablets are:headacheflushingupset stomachabnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred visionstuffy or runny noseback painmuscle painnauseadizzinessrashIn 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.Tell your healthcare provider if you have any side effect that bothers you or does not go away.These are not all the possible side effects of sildenafil tablets. What should I tell my healthcare provider before taking sildenafil tablets? 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 low blood pressure, or high blood pressure that is not controlled 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 kidney problems or are having kidney dialysis Tell your healthcare provider about all the medicines you take*,including prescription and over-the-counter medicines, vitamins, and herbal supplements. 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).
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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). 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: abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking sildenafil tablets. 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 erythromycin other medicines that treat high blood pressure 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]). Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Take sildenafil tablets exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much sildenafil tablets to take and when to take it.
- Sildenafil 200 mg should not be used with recreational drugs like ecstasy.
- Always consult a doctor if you notice vision changes or hearing loss.
- The medication may cause flushing, indigestion, or nasal stuffiness.
- It is crucial to stay hydrated when using sildenafil.
- Women using sildenafil should seek medical advice before use.
- Proper lifestyle changes can enhance erectile function alongside medication.
Your healthcare provider may change 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.
| Parameter | Description | Typical Values | Notes |
|---|---|---|---|
| Absorption | Time to peak plasma concentration (Tmax) | 30-120 minutes | Taken on an empty stomach for faster absorption |
| Bioavailability | Percentage absorbed into bloodstream | 40% | Affected by food intake |
| Half-life | Duration for plasma concentration to reduce by half | 4 hours | Determines dosing frequency |
| Metabolism | Liver enzyme involved | CYP3A4 | Also metabolized by CYP2C9 |
Sildenafil tablets can be taken with or without food.
| Storage Condition | Temperature Range | Light Exposure | Special Handling Notes |
|---|---|---|---|
| Indoor, dry place | 20-25°C (68-77°F) | Store in original container | Keep out of reach of children |
| Avoid Humid Areas | Humidity below 60% | Keep away from direct sunlight | Do not freeze or expose to extreme heat |
| Shelf Life | Up to 2 years | - | Check expiry date before use |
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, call your doctor or go to the nearest hospital emergency room right away. 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.
Full Prescribing Information
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 erythromycin other medicines that treat high blood pressure 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]). Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.
Tadalafil (Generic Cialis)
Take sildenafil tablets exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much sildenafil tablets to take and when to take it. Your healthcare provider may change 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.
Professional resources
Sildenafil tablets can be taken with or without food. 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, call your doctor or go to the nearest hospital emergency room right away. 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). 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: abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking sildenafil tablets.
| Interacting Drug/Class | Effect on Sildenafil | Clinical Significance | Recommendations |
|---|---|---|---|
| Nitrates | Potentiates vasodilation | Risk of severe hypotension | Avoid concomitant use |
| CYP3A4 inhibitors (e.g., Ritonavir) | Increase sildenafil plasma levels | Risk of increased side effects | Reduce dose or avoid |
| Alpha-blockers | Additive blood pressure lowering | Hypotension | Use with caution, monitor BP |
| CYP3A4 inducers (e.g., Rifampin) | Decrease sildenafil effectiveness | May reduce efficacy | Adjust dose accordingly |
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