DRUG INTERACTIONS

This can happen if you are sick with fever, diarrhea, or vomiting; sweat a lot; or do not drink enough liquids.

5.4 Epistaxis

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. Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom). Store the suspension at room temperature or in a refrigerator, but do not freeze it.

Make sure you’re turned on

Dispose of any unused suspension after 60 days. Keep all medication out of sight and reach of children as many containers are sildenafil premature ejaculation not child-resistant. 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. Do not flush this medication down the toilet. 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. 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. 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 healthcare providers who treat you will need to know when you last took sildenafil.

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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. If you are taking sildenafil for PAH, take the missed dose as soon as you remember it.

• Common side effects of sildenafil include headaches, flushing, and nasal congestion.
• Serious side effects are rare but require immediate medical attention.
• Patients should report any adverse reactions to their healthcare provider.

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. It is not known if the vision loss was caused by the medication.

12.2 Pharmacodynamics

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. 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.

8.5 Geriatric Use

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. 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 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.

Conclusion: Is Sildenafil Right for You?

However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity (2.1) •Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg (2.1) •Maximum recommended dosing frequency is once per day (2.1) Tablets: 25 mg, 50 mg, 100 mg (3) •Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil tablets were shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2) •Known hypersensitivity to sildenafil or any component of tablet (4.2) •Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3) •Patients should not use sildenafil tablets if sexual activity is inadvisable due to cardiovascular status (5.1) •Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil tablets with caution in patients predisposed to priapism (5.2) •Patients should stop sildenafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Sildenafil tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a”crowded” optic disc may also be at an increased risk of NAION.

8.7 Hepatic Impairment

(5.3) •Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.4) •Caution is advised when sildenafil tablets are co-administered with alpha-blockers or anti-hypertensives. Concomitant use may lead to hypotension (5.5) •Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in sildenafil tablets dosage is recommended (2.4,5.6) Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Evaric Pharmaceuticals, Inc. at 1-866-495-1995 or FDA at 1-800-FDA-1088 or •Sildenafil tablets can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1, 5.5, 7.1, 7.2, 7.3, 12.2) •With concomitant use of alpha blockers, initiate sildenafil tablets at 25 mg dose (2.3) •CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil tablets exposure (2.4, 7.4,12.3) •Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period ( 2.4, 5.6) •Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg (2.4,7.4) Sildenafil tablets are indicated for the treatment of erectile dysfunction. Most, but not all, of these people had heart problems before taking sildenafil. 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 canada sildenafil 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. 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.

• Alcohol can interact with sildenafil, reducing its effectiveness and increasing side effects.
• Avoid alcohol consumption when planning to use sildenafil.
• Always inform your doctor about alcohol use prior to prescription.

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).

8.5 Geriatric Use

For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.

Drugs Affecting Gastric Acidity

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom). Store the suspension at room temperature or in a refrigerator, but do not freeze it.

What to avoid

If you ever need emergency medical treatment for a heart problem, the 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. 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.

Special Populations

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. 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. Dispose of any unused suspension after 60 days. Keep all medication out of sight and reach of children as many containers are sildenafil premature ejaculation not child-resistant.

5.1 Hypotension

Talk to your pharmacist about take-back programs in your community. 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. 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. Do not let anyone else take your medication.

5.2 Prolonged Erection and Priapism

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. Package insert / product label Generic name: sildenafil citrate Dosage form: tablet, film coated Drug classes: Agents for pulmonary hypertension, Impotence medications Warnings and Precautions, Effects on the Eye (5.3) 08/2017 Sildenafil tablet is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1) •For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. 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. Do not flush this medication down the toilet. Talk to your pharmacist about take-back programs in your community. 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. 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. Do not let anyone else take your medication. 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.

• Sildenafil 20 mg tablets should be taken about 30 to 60 minutes before sexual activity.
• It’s important not to take more than one dose in 24 hours.
• Do not crush or chew the medication; swallow it whole with water.

You should carry the list with you in case of emergencies. Package insert / product label Generic name: sildenafil citrate Dosage form: tablet, film coated Drug classes: Agents for pulmonary hypertension, Impotence medications Warnings and Precautions, Effects on the Eye (5.3) 08/2017 Sildenafil tablet is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1) •For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity (2.1) •Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg (2.1) •Maximum recommended dosing frequency is once per day (2.1) Tablets: 25 mg, 50 mg, 100 mg (3) •Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil tablets were shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2) •Known hypersensitivity to sildenafil or any component of tablet (4.2) •Administration with guanylate cyclase (GC) stimulators, such as riociguat (4.3) •Patients should not use sildenafil tablets if sexual activity is inadvisable due to cardiovascular status (5.1) •Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil tablets with caution in patients predisposed to priapism (5.2) •Patients should stop sildenafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). Sildenafil tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a”crowded” optic disc may also be at an increased risk of NAION. (5.3) •Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.4) •Caution is advised when sildenafil tablets are co-administered with alpha-blockers or anti-hypertensives. Concomitant use may lead to hypotension (5.5) •Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.

6. Adverse Reactions/Side Effects

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. 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.

5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies

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 canada sildenafil 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. 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. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in sildenafil tablets dosage is recommended (2.4,5.6) Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Evaric Pharmaceuticals, Inc. at 1-866-495-1995 or FDA at 1-800-FDA-1088 or •Sildenafil tablets can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1, 5.5, 7.1, 7.2, 7.3, 12.2) •With concomitant use of alpha blockers, initiate sildenafil tablets at 25 mg dose (2.3) •CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil tablets exposure (2.4, 7.4,12.3) •Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period ( 2.4, 5.6) •Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg (2.4,7.4) Sildenafil tablets are indicated for the treatment of erectile dysfunction. For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.

I M P R E S S U M