Label: SILDENAFIL CITRATE- sildenafil tablet, film coated

Sildenafil > sildenafil citrate tables


Sildenafil citrate pills ( 100mg IP ) work by relaxing the blood vessels in the penis, thereby allowing the blood to flow into the penis when the person is sexually excited. No, sildenafil citrate tablets used with nitrates can be risky. Taking sildenafil citrate pills with medicines used to treat angina/chest pain, such as nitrates/nitroglycerin, may cause severe lowering of blood pressure.

Brand names

Sildenafil citrate was 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 citrate if sexual activity is inadvisable due to cardiovascular status ( 5.1) Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil citrate 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). 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 citrate is 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. Decrease in Sildenafil citrate 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).

Pulmonary hypertension

To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or Sildenafil citrate 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 citrate at 25 mg dose ( 2.3) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase Sildenafil citrate 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) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 Dosage Information2.2 Use with Food2.3 Dosage Adjustments in Specific Situations2.4 Dosage Adjustments Due to Drug Interactions2.5 Dosage Adjustments in Special Populations3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions4.3 Concomitant Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Prolonged Erection and Priapism5.3 Effects on the Eye5.4 Hearing Loss5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives5.6 Adverse Reactions with the Concomitant Use of Ritonavir5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies5.8 Effects on Bleeding5.9 Counseling Patients About Sexually Transmitted Diseases6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Nitrates7.2 Alpha-blockers7.3 Amlodipine7.4 Ritonavir and other CYP3A4 inhibitors7.5 Alcohol8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Renal Impairment8.7 Hepatic Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed.

Binding Characteristics

Consult your doctor if you have a history of heart attack/stroke.

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Can I take blood pressure-lowering medicines with Sildenafil Citrate Tablet 100mg IP? Caution is advised if Sildenafil Citrate Tablet 100mg IP is taken with alpha-blockers or blood-pressure-lowering medicines.

5.3 Epistaxis

You can take Sildenafil Citrate Tablet 100mg IP with or without food. Therefore, you are advised to take Sildenafil Citrate Tablet 100mg IP with light meals. Can I take 2 doses of Sildenafil Citrate Tablet 100mg IP for better results? Never take 2 doses at the same time. It could lead to severe adverse events.

What causes an erection?

Can I get Sildenafil Citrate Tablet 100mg IP without a prescription? Sildenafil Citrate Tablet 100mg IP is only available with a prescription. Can I take Sildenafil Citrate Tablet 100mg IP for premature ejaculation? Sildenafil Citrate Tablet 100mg IP has been demonstrated to be effective in treating premature ejaculation (PE). However, it should be taken only if prescribed by the doctor.

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The information provided on this website is for general informational purposes only and is not intended as a substitute for professional medical advice, diagnosis, or treatment. Always consult with a physician or qualified sildenafil pricing healthcare provider for any medical concerns. Never disregard professional advice or delay seeking it based on the information you read here. NDC Code(s): 71335-3049-0, 71335-3049-1, 71335-3049-2, 71335-3049-3, view more71335-3049-4, 71335-3049-5, 71335-3049-6, 71335-3049-7, 71335-3049-8, 71335-3049-9 If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. Sildenafil Citrate Tablet 100mg IP relaxes and widens the blood vessels; this causes a decrease in blood pressure. Therefore, if Sildenafil Citrate Tablet 100mg IP is taken along with blood-pressure-lowering medicines, it might cause further lowering in blood pressure. Consult your doctor if you are taking alpha-blockers or anti-hypertensives. Does sildenafil citrate tablets uses can cause vision disturbances? In some cases, Sildenafil Citrate Tablet 100mg IP may cause sudden vision loss in one or both eyes. Stop taking Sildenafil Citrate Tablet 100mg IP and consult your doctor immediately if you experience a sudden decrease or loss of vision.

Overdose/Missed Dose

Sildenafil citrate pills ( 100mg IP ) work by relaxing the blood vessels in the penis, thereby allowing the blood to flow into the penis when the person is sexually excited. No, sildenafil citrate tablets used with nitrates can be risky. Taking sildenafil citrate pills with medicines used to treat angina/chest pain, such as nitrates/nitroglycerin, may cause severe lowering of blood pressure. Consult your doctor if you have a history of heart attack/stroke. Can I take blood pressure-lowering medicines with Sildenafil Citrate Tablet 100mg IP?

Does Viagra prevent ejaculation?

Caution is advised if Sildenafil Citrate Tablet 100mg IP is taken with alpha-blockers or blood-pressure-lowering medicines. Sildenafil Citrate Tablet 100mg IP relaxes and widens the blood vessels; this causes a decrease in blood pressure. Therefore, if Sildenafil Citrate Tablet 100mg IP is taken along with blood-pressure-lowering medicines, it might cause further lowering in blood pressure. Consult your doctor if you are taking alpha-blockers or anti-hypertensives. Does sildenafil citrate tablets uses can cause vision disturbances?

Is Viagra Right for You?

In some cases, Sildenafil Citrate Tablet 100mg IP may cause sudden vision loss in one or both eyes. Stop taking Sildenafil Citrate Tablet 100mg IP and consult your doctor immediately if you experience a sudden decrease or loss of vision. Does Sildenafil Citrate Tablet 100mg IP cause low blood pressure? Sildenafil Citrate Tablet 100mg IP may cause low blood pressure, leading to dizziness on standing. If you experience this, do not try to stand up suddenly or start walking; instead, lie down and get up slowly only when you feel better. Does Sildenafil Citrate Tablet 100mg IP cause low blood pressure? Sildenafil Citrate Tablet 100mg IP may cause low blood pressure, leading to dizziness on standing. If you experience this, do not try to stand up suddenly or start walking; instead, lie down and get up slowly only when you feel better. You can take Sildenafil Citrate Tablet 100mg IP with or without food. Therefore, you are advised to take Sildenafil Citrate Tablet 100mg IP with light meals. Can I take 2 doses of Sildenafil Citrate Tablet 100mg IP for better results? Never take 2 doses at the same time. It could lead to severe adverse events.

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Can I get Sildenafil Citrate Tablet 100mg IP without a prescription? Sildenafil Citrate Tablet 100mg IP is only available with a prescription. Can I take Sildenafil Citrate Tablet 100mg IP for premature ejaculation?

7.1 Nitrates

Sildenafil Citrate Tablet 100mg IP has been demonstrated to be effective in treating premature ejaculation (PE). However, it should be taken only if prescribed by the doctor. The information provided on this website is for general informational purposes only and is not intended as a substitute for professional medical advice, diagnosis, or treatment.

Liver Dose Adjustments

See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S. Approval:1998RECENT MAJOR CHANGESWarnings and Precautions, Effects on the Eye ( 5.3) 08/2017INDICATIONS AND USAGESildenafil citrate is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED). (1)DOSAGE AND ADMINISTRATIONFor 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)DOSAGE FORMS AND STRENGTHSTablets: 25 mg, 50 mg and 100 mg ( 3)CONTRAINDICATIONSAdministration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil citrate was 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)WARNINGS AND PRECAUTIONSPatients should not use sildenafil citrate if sexual activity is inadvisable due to cardiovascular status ( 5.1)Patients should seek emergency treatment if an erection lasts >4 hours.

Common Adverse Effects

Use sildenafil citrate 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 citrate is 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.

Professional resources

In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased. Decrease in Sildenafil citrate dosage is recommended ( 2.4, 5.6)ADVERSE REACTIONSMost 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 Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or INTERACTIONSSildenafil citrate 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 citrate at 25 mg dose ( 2.3)CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase Sildenafil citrate 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)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 3/2026 Warnings and Precautions, Effects on the Eye ( 5.3) 08/2017 Sildenafil citrate is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED). 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 and 100 mg ( 3) Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Always consult with a physician or qualified sildenafil pricing healthcare provider for any medical concerns. Never disregard professional advice or delay seeking it based on the information you read here. NDC Code(s): 71335-3049-0, 71335-3049-1, 71335-3049-2, 71335-3049-3, view more71335-3049-4, 71335-3049-5, 71335-3049-6, 71335-3049-7, 71335-3049-8, 71335-3049-9 If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S. Approval:1998RECENT MAJOR CHANGESWarnings and Precautions, Effects on the Eye ( 5.3) 08/2017INDICATIONS AND USAGESildenafil citrate is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED).

  • The onset of action is usually within 30 minutes.
  • Peak effect occurs around 1 hour after ingestion.
  • The duration of action can last up to 4-6 hours.

(1)DOSAGE AND ADMINISTRATIONFor 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)DOSAGE FORMS AND STRENGTHSTablets: 25 mg, 50 mg and 100 mg ( 3)CONTRAINDICATIONSAdministration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil citrate was 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)WARNINGS AND PRECAUTIONSPatients should not use sildenafil citrate if sexual activity is inadvisable due to cardiovascular status ( 5.1)Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil citrate 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.

Medication Class Interaction Type Effect Clinical Significance
Nitrates Additive hypotensive effect Severe hypotension Contraindicated
Alpha-blockers Enhanced hypotension Blood pressure drop Use with caution
CYP3A4 inhibitors Increased sildenafil levels Prolonged or intensified side effects Dose adjustment may be needed
Protease inhibitors Elevated sildenafil levels Increased adverse effects Monitoring required

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 citrate is 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 citrate dosage is recommended ( 2.4, 5.6)ADVERSE REACTIONSMost 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 Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or INTERACTIONSSildenafil citrate 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 citrate at 25 mg dose ( 2.3)CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase Sildenafil citrate 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)USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 3/2026 Warnings and Precautions, Effects on the Eye ( 5.3) 08/2017 Sildenafil citrate is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED). 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 and 100 mg ( 3) Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil citrate was 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 citrate if sexual activity is inadvisable due to cardiovascular status ( 5.1) Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil citrate 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). 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 citrate is 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. Decrease in Sildenafil citrate 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).

  • Store sildenafil tablets in a cool, dry place away from moisture.
  • Keep out of reach of children and pets.
  • Expiry date can be checked on the packaging.

To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or Sildenafil citrate 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 citrate at 25 mg dose ( 2.3) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase Sildenafil citrate 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) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 Dosage Information2.2 Use with Food2.3 Dosage Adjustments in Specific Situations2.4 Dosage Adjustments Due to Drug Interactions2.5 Dosage Adjustments in Special Populations3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions4.3 Concomitant Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Prolonged Erection and Priapism5.3 Effects on the Eye5.4 Hearing Loss5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives5.6 Adverse Reactions with the Concomitant Use of Ritonavir5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies5.8 Effects on Bleeding5.9 Counseling Patients About Sexually Transmitted Diseases6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Nitrates7.2 Alpha-blockers7.3 Amlodipine7.4 Ritonavir and other CYP3A4 inhibitors7.5 Alcohol8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Renal Impairment8.7 Hepatic Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed.