Label: SILDENAFIL tablet, film coated

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 Carcinogenesis, Mutagenesis, Impairment of Fertility14.

5.1 Hypotension

Neither the rare postmarketing reports, nor the association of PDE-5 inhibitor use and NAION in the observational studies, substantiate a causal relationship between PDE-5 inhibitor use and NAION [see Adverse Reactions (6.2)].

Sildenafil vs. tadalafil

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)]. 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.

6.1 Clinical Trials Experience

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 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.

8.4 Pediatric Use

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)]. 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.

Drug Interactions

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. 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)]. 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. 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. 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)]. 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.

Drug Label Information

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. The effectiveness and safety of sildenafil tablets in the treatment of PAH secondary to sickle cell anemia has not been established. In a sildenafil citrate tablets for female long-term trial in pediatric patients with PAH, an increase in mortality with increasing sildenafil tablets dose was observed. [see Use in Specific Populations (8.4)].

If you were to talk to a doctor about sildenafil, what would you ask first?

Sildenafil tablets has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil tablets. Should signs of pulmonary edema occur when sildenafil tablets are administered, consider the possibility of associated PVOD. The incidence of epistaxis was 13% in patients taking sildenafil tablets with PAH secondary to CTD. 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).

Warnings and Precautions

The safety of sildenafil tablets is unknown in patients with bleeding disorders or active peptic ulceration. When 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. 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. Deaths were first observed after about 1 year and causes of death were typical of patients with PAH. Use buy pills sildenafil 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). 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).

5.6 Hearing Loss

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.

• Sildenafil 20 mg is contraindicated with nitrate medications due to risk of severe hypotension.
• Patients with heart problems should consult their doctor before use.
• It’s important to disclose all medications to your healthcare provider.

Should signs of pulmonary edema occur when sildenafil tablets are administered, consider sildenafil 50 mg tab the possibility of associated PVOD.5.4 EpistaxisThe incidence of epistaxis was 13% in patients taking sildenafil tablets with PAH secondary to CTD. 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 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. 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 ®;.

Advice To Patients

Deaths were first observed after about 1 year and causes of death were typical of patients with PAH. Use buy pills sildenafil 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). 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).

7.3 Amlodipine

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 sildenafil 50 mg tab the possibility of associated PVOD.5.4 EpistaxisThe incidence of epistaxis was 13% in patients taking sildenafil tablets with PAH secondary to CTD. 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.

12.1 Sildenafil Tablets Mechanism of Action

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 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. 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 ®;. 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. The effectiveness and safety of sildenafil tablets in the treatment of PAH secondary to sickle cell anemia has not been established. In a sildenafil citrate tablets for female long-term trial in pediatric patients with PAH, an increase in mortality with increasing sildenafil tablets dose was observed. [see Use in Specific Populations (8.4)]. Sildenafil tablets has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil tablets.

Sildenafil Pricing in India

Should signs of pulmonary edema occur when sildenafil tablets are administered, consider the possibility of associated PVOD. The incidence of epistaxis was 13% in patients taking sildenafil tablets with PAH secondary to CTD. 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.

• Sildenafil 20 mg is not intended for use by women or children.
• Keep medication out of reach of children to prevent accidental ingestion.
• Store in a cool, dry place away from direct sunlight.

When 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. 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 relationship between PDE-5 inhibitor use and NAION [see Adverse Reactions (6.2)].