Label: SILDENAFIL CITRATE- sildenafil tablet, film coated

Pulmonary hypertension secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises.

Reviews of Viagra

Pediatric use information is approved for Viatris Speciality LLC's, REVATIO (sildenafil) tablets. CONTRAINDICATIONS Sildenafil tablets are contraindicated in patients with:Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.2)].Concomitant use of riociguat, a guanylate cyclase stimulator. PDE-5 inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.Known hypersensitivity to sildenafil or any component of the tablet. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. Sildenafil tablets are contraindicated in patients with: Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.2)].

Adjusting Your Sildenafil Dosage Over Time

PDE-5 inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. Known hypersensitivity to sildenafil or any component sildenafil citrate tablets 150 mg of the tablet. WARNINGS AND PRECAUTIONS 5.1 Mortality with Pediatric UseIn a long-term trial in pediatric patients with PAH, an increase in mortality with increasing sildenafil tablets dose was observed. Deaths were first observed after about 1 year and causes of death were typical of patients with PAH. Use of sildenafil tablets, particularly chronic use, is not recommended in children. Most common adverse reactions greater than or equal to 3% and more frequent than placebo were epistaxis, headache, dyspepsia, flushing, insomnia, erythema, dyspnea, and rhinitis. To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 888-413-0949 or FDA at 1-800-FDA-1088 or See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1. WARNINGS AND PRECAUTIONS5.1 Mortality with Pediatric Use5.2 Hypotension5.3 Worsening Pulmonary Vascular Occlusive Disease5.4 Epistaxis5.5 Visual Loss5.6 Hearing Loss5.7 Combination with other PDE-5 inhibitors5.8 Priapism5.9 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Anemia6. ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7. USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Patients with Hepatic Impairment8.7 Patients with Renal Impairment10. CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13. NONCLINICAL TOXICOLOGY13.1 sildenafil citrate chewable tablets Carcinogenesis, Mutagenesis, Impairment of Fertility14. PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. INDICATIONS AND USAGE Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when Sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)].Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)]. Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when Sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)].

Medical uses

INDICATIONS AND USAGE Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when Sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)].Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)]. Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when Sildenafil tablets were added to background epoprostenol therapy [see Clinical Studies (14)]. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).

Does sildenafil interact with foods or drinks?

Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)]. DOSAGE AND ADMINISTRATION 2.1 Sildenafil TabletsThe recommended dose of sildenafil tablets is 20 mg three times a day. [See Clinical Studies (14)]Pediatric use information is approved for Viatris Speciality LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Speciality LLC's marketing exclusivity rights, this drug product is not labeled with that information. The recommended dose of sildenafil tablets is 20 mg three times a day. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class II-III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%). Limitation of Use: Adding sildenafil to bosentan therapy does not result in any beneficial effect on exercise capacity [see Clinical Studies (14)]. DOSAGE AND ADMINISTRATION 2.1 Sildenafil TabletsThe recommended dose of sildenafil tablets is 20 mg three times a day. [See Clinical Studies (14)]Pediatric use information is approved for Viatris Speciality LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Speciality LLC's marketing exclusivity rights, this drug product is not labeled with that information.

The recommended dose of sildenafil tablets is 20 mg three times a day. Pediatric use information is approved for Viatris Speciality LLC's, REVATIO (sildenafil) tablets. CONTRAINDICATIONS Sildenafil tablets are contraindicated in patients with:Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.2)].Concomitant use of riociguat, a guanylate cyclase stimulator.

8.6 Patients with Hepatic Impairment

Usual Pediatric Dose for:

PDE-5 inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.Known hypersensitivity to sildenafil or any component of the tablet. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil.

7.2 Alpha-blockers

Physicians should also discuss the increased risk of NAION with patients who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators, such as PDE-5 inhibitors.There are no controlled clinical data on the safety or efficacy of sildenafil tablets in patients with retinitis pigmentosa, a minority whom have genetic disorders of retinal phosphodiesterases. Prescribe sildenafil tablets with caution in these patients.5.6 Hearing LossCases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including sildenafil tablets. In some of the cases, medical conditions and other factors were reported that may have played a role. It is not possible to determine whether these reported events are related directly to the use of Sildenafil tablets, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors.Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including sildenafil tablets.5.7 Combination with other PDE-5 inhibitorsSildenafil is also marketed as VIAGRA ®;. The safety and efficacy of combinations of sildenafil tablets with VIAGRA or other PDE-5 inhibitors have not been studied.

1. Regulatory Documentation Provided

Inform patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors.5.8 PriapismUse sildenafil tablets with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie's disease) or in patients who have conditions, which may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia). If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.5.9 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell AnemiaIn a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil tablets than by those randomized to placebo. Sildenafil tablets are contraindicated in patients with: Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.2)]. PDE-5 inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.

6.1 Clinical Trials Experience

Pulmonary hypertension secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. Most common adverse reactions greater than or equal to 3% and more frequent than placebo were epistaxis, headache, dyspepsia, flushing, insomnia, erythema, dyspnea, and rhinitis. To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 888-413-0949 or FDA at 1-800-FDA-1088 or See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1. WARNINGS AND PRECAUTIONS5.1 Mortality with Pediatric Use5.2 Hypotension5.3 Worsening Pulmonary Vascular Occlusive Disease5.4 Epistaxis5.5 Visual Loss5.6 Hearing Loss5.7 Combination with other PDE-5 inhibitors5.8 Priapism5.9 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Anemia6.

Dosage Forms & Strengths

ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7. USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Patients with Hepatic Impairment8.7 Patients with Renal Impairment10. CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13. NONCLINICAL TOXICOLOGY13.1 sildenafil citrate chewable tablets Carcinogenesis, Mutagenesis, Impairment of Fertility14. PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. Known hypersensitivity to sildenafil or any component sildenafil citrate tablets 150 mg of the tablet. WARNINGS AND PRECAUTIONS 5.1 Mortality with Pediatric UseIn a long-term trial in pediatric patients with PAH, an increase in mortality with increasing sildenafil tablets dose was observed. Deaths were first observed after about 1 year and causes of death were typical of patients with PAH. Use of sildenafil tablets, particularly chronic use, is not recommended in children. [see Use in Specific Populations (8.4)].5.2 HypotensionSildenafil tablets has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing sildenafil tablets, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [BP less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction).

• Patients with liver or kidney issues need dose adjustments and careful monitoring.
• The recommended maximum dose for sildenafil is generally 100 mg per day.
• Excessive use increases the likelihood of adverse cardiovascular events.
• Use of sildenafil does not provide protection against sexually transmitted infections.
• Some users report a persistent blue-tinged vision after high doses.
• It’s essential to obtain sildenafil from reputable sources to avoid counterfeit products.

Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil tablets.5.3 Worsening Pulmonary Vascular Occlusive DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of sildenafil tablets to patients with veno-occlusive disease, administration of sildenafil tablets to such patients is not recommended.

5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives

[see Use in Specific Populations (8.4)].5.2 HypotensionSildenafil tablets has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing sildenafil tablets, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [BP less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction). Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil tablets.5.3 Worsening Pulmonary Vascular Occlusive DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of sildenafil tablets to patients with veno-occlusive disease, administration of sildenafil tablets to such patients is not recommended. Should signs of pulmonary edema occur when sildenafil tablets are administered, consider the possibility of associated PVOD.5.4 EpistaxisThe incidence of epistaxis was 13% in patients taking sildenafil tablets with PAH secondary to CTD.

Factors That Influence the Right Dosage for You

This effect was not seen in idiopathic PAH (sildenafil tablets 3%, placebo 2%) patients. The incidence of epistaxis was also higher in sildenafil tablets-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist).The safety of sildenafil tablets is unknown in patients with bleeding disorders or active peptic ulceration.5.5 Visual LossWhen used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE-5) inhibitors, including sildenafil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking. Based on published literature, the annual incidence of NAION is 2.5–11.8 cases per 100,000 males aged ≥ 50 per year in the general population.An observational case-crossover study evaluated the risk of NAION when PDE-5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE-5 inhibitor use in a prior time period. Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies.Neither the rare postmarketing reports, nor the association of PDE-5 inhibitor use and NAION in the observational studies, substantiate a causal canada sildenafil relationship between PDE-5 inhibitor use and NAION [see Adverse Reactions (6.2)].Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking PDE-5 inhibitors, including sildenafil tablets. Should signs of pulmonary edema occur when sildenafil tablets are administered, consider the possibility of associated PVOD.5.4 EpistaxisThe incidence of epistaxis was 13% in patients taking sildenafil tablets with PAH secondary to CTD.

• Sildenafil citrate is primarily used to treat erectile dysfunction.
• 120 mg is a high dosing level and should only be used under medical supervision.
• The typical starting dose for sildenafil is 50 mg; 120 mg exceeds standard recommendations.
• High doses can increase the risk of side effects such as headaches and low blood pressure.
• Sildenafil works by relaxing blood vessels in the penis to facilitate an erection.
• Overdose of sildenafil citrate can cause severe hypotension and vision disturbances.

This effect was not seen in idiopathic PAH (sildenafil tablets 3%, placebo 2%) patients. The incidence of epistaxis was also higher in sildenafil tablets-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist).The safety of sildenafil tablets is unknown in patients with bleeding disorders or active peptic ulceration.5.5 Visual LossWhen used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE-5) inhibitors, including sildenafil.

• Sildenafil 120 mg is not approved by all regulatory agencies for general use.
• The maximum recommended dose for most individuals is 100 mg.
• Using high doses can lead to increased cardiovascular strain.
• Always inform your doctor of all medications to prevent interactions.
• Sildenafil may cause a sudden drop in blood pressure, especially with certain drugs.
• The medication can be used as part of a treatment plan for erectile dysfunction.

Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking. Based on published literature, the annual incidence of NAION is 2.5–11.8 cases per 100,000 males aged ≥ 50 per year in the general population.An observational case-crossover study evaluated the risk of NAION when PDE-5 inhibitor use, as a class, occurred immediately before NAION onset (within 5 half-lives), compared to PDE-5 inhibitor use in a prior time period. Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies.Neither the rare postmarketing reports, nor the association of PDE-5 inhibitor use and NAION in the observational studies, substantiate a causal canada sildenafil relationship between PDE-5 inhibitor use and NAION [see Adverse Reactions (6.2)].Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking PDE-5 inhibitors, including sildenafil tablets. Physicians should also discuss the increased risk of NAION with patients who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators, such as PDE-5 inhibitors.There are no controlled clinical data on the safety or efficacy of sildenafil tablets in patients with retinitis pigmentosa, a minority whom have genetic disorders of retinal phosphodiesterases. Prescribe sildenafil tablets with caution in these patients.5.6 Hearing LossCases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including sildenafil tablets.

5.9 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Anemia

Drugs Affecting Gastric Acidity

In some of the cases, medical conditions and other factors were reported that may have played a role. It is not possible to determine whether these reported events are related directly to the use of Sildenafil tablets, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors.Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including sildenafil tablets.5.7 Combination with other PDE-5 inhibitorsSildenafil is also marketed as VIAGRA ®;. The safety and efficacy of combinations of sildenafil tablets with VIAGRA or other PDE-5 inhibitors have not been studied. Inform patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors.5.8 PriapismUse sildenafil tablets with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie's disease) or in patients who have conditions, which may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia). If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.5.9 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell AnemiaIn a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received sildenafil tablets than by those randomized to placebo.