Sildenafil Citrate Tablet NDC Package 71205-657-02

The patients experiencing these reactions had risk factors for hemorrhage including concurrent anticoagulant therapy.In a placebo-controlled fixed dose titration study (Study 2) of sildenafil citrate (starting with recommended dose of 20 mg three times a day and increased to 40 mg three times a day and then 80 mg three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, the adverse reactions that were more frequent in the sildenafil citrate + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2 [see Clinical Studies (14)].^includes peripheral edema6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient’s underlying cardiovascular disease, or to a combination of these or other factors.Nervous systemSeizure, seizure recurrence The following serious adverse events are discussed elsewhere in the labeling: Mortality with pediatric use [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)] Hypotension [see Warnings and Precautions (5.2)] Vision loss [see Warnings and Precautions (5.5)] Hearing loss [see Warnings and Precautions (5.6)] Priapism [see Warnings and Precautions (5.8)] Vaso-occlusive crisis [see Warnings and Precautions (5.9)] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Safety data of sildenafil citrate in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 sildenafil citrate-treated patients with PAH, WHO Group I [see Clinical Studies (14)]. The overall frequency of discontinuation in sildenafil citrate-treated patients on 20 mg three times a day was 3% and was the same for the placebo group. In Study 1, the adverse reactions that were reported by at least 3% of sildenafil citrate-treated patients (20 mg three times a day) and were more frequent in sildenafil citrate-treated patients than in placebo-treated patients are shown in Table 1. In Study 1, the adverse reactions that were reported by at least 3% of sildenafil citrate-treated patients (20 mg TID) and were more frequent in sildenafil citrate-treated patients than in placebo-treated patients are shown in Table 1. Most Common Adverse Reactions in Patients with PAH in Study 1 (More Frequent in Sildenafil Citrate-Treated Patients than Placebo-Treated Patients and Incidence ≥3% in Sildenafil Citrate-Treated Patients) At doses higher than the recommended 20 mg three times a day, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances. Visual disturbances were identified as mild and transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision. The incidence of retinal hemorrhage with sildenafil citrate 20 mg three times a day was 1.4% versus 0% placebo and for all sildenafil citrate doses studied was 1.9% versus 0% placebo. The patients experiencing these reactions had risk factors for hemorrhage including concurrent anticoagulant therapy. In a placebo-controlled fixed dose titration study (Study 2) of sildenafil citrate (starting with recommended dose of 20 mg three times a day and increased to 40 mg three times a day and then 80 mg three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, the adverse reactions that were more frequent in the sildenafil citrate + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2 [see Clinical Studies (14)]. It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient’s underlying cardiovascular disease, or to a combination of these or other factors.

What is sildenafil?

In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology (12.3)].8.6 Patients with Hepatic ImpairmentNo dose adjustment for mild to moderate impairment is required. Severe impairment has not been studied [see Clinical Pharmacology (12.3)].8.7 Patients with Renal ImpairmentNo dose adjustment is required (including severe impairment CLcr < 30 mL/min) [see Clinical Pharmacology (12.3)].

Revatio for Oral Suspension

7 DRUG INTERACTIONS NitratesConcomitant use of sildenafil citrate with nitrates in any form is contraindicated [see Contraindications (4)].Ritonavir and other Potent CYP3A InhibitorsConcomitant use of sildenafil citrate with ritonavir and other potent CYP3A inhibitors is not recommended [see Clinical Pharmacology (12.3)].Other drugs that reduce blood pressureAlpha blockers. In drug-drug interaction studies, sildenafil (25 mg, 50 mg, or 100 mg) and the alpha-blocker doxazosin (4 mg or 8 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy. In these study populations, mean additional reductions of supine systolic and diastolic blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, respectively, were observed. Mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively, were also observed. There were infrequent reports of patients who experienced symptomatic postural hypotension. These reports included dizziness and light-headedness, but not syncope.Amlodipine. When sildenafil 100 mg oral was co-administered with amlodipine, 5 mg or 10 mg oral, to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic.Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil citrate [see Warnings and Precautions (5.2)].

• Sildenafil tablets LP 100 mg should be used with caution in renal impairment.
• Adjust dosage as recommended by your healthcare provider.
• Do not share your medication with others; it is for personal use only.

Concomitant use of sildenafil citrate with nitrates in any form is contraindicated [see Contraindications (4)]. Concomitant use of sildenafil citrate with ritonavir and other potent CYP3A inhibitors is not recommended [see Clinical Pharmacology (12.3)].

These reports included dizziness and light-headedness, but sildenafil 25 mg tablets not syncope. When sildenafil 100 mg oral was co-administered with amlodipine, 5 mg or 10 mg oral, to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic. Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil citrate [see Warnings and Precautions (5.2)]. 8 USE IN SPECIFIC POPULATIONS 8.1 PregnancyPregnancy Category BThere are no adequate and well-controlled studies of sildenafil in pregnant women. No evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m2 basis, 32- and 68-times, respectively, the recommended human dose (RHD) of 20 mg three times a day.

• Sildenafil tablets LP 100 mg can cause visual disturbances in some users.
• Headaches are among the most common side effects reported.
• Avoid driving if you experience dizziness after taking the medication.

In a rat pre- and postnatal development study, the no-observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the RHD on a mg/m2 basis).8.2 Labor and DeliveryThe safety and efficacy of sildenafil citrate during labor and delivery have not been studied.8.3 Nursing MothersIt is not known if sildenafil or its metabolites are excreted in human breast milk.

4.2 Hypersensitivity Reactions

Sixty-two percent of patients were female. Drug or placebo was administered three times a day.The primary objective of the study was to assess the effect of sildenafil citrate on exercise capacity as measured by cardiopulmonary exercise testing in pediatric patients developmentally able to perform the test (n = 115). Administration of sildenafil citrate did not result in a statistically significant improvement in exercise capacity in those patients. No patients died during the 16-week controlled study.After completing the 16-week controlled study, a patient originally randomized to sildenafil citrate remained on his/her dose of sildenafil citrate or, if originally randomized to placebo, was randomized to low-, medium-, or high-dose sildenafil citrate. After all patients completed 16 weeks of follow-up in the controlled study, the blind was broken and doses were adjusted as clinically indicated.

What does VIAGRA (Brand for SILDENAFIL CITRATE) look like?

Patients treated with sildenafil were followed for a median of 4.6 years (range 2 days to 8.6 years). Mortality during the long-term study, by originally assigned dose, is shown in Figure 6:Figure 6: Kaplan-Meier Plot of Mortality by Sildenafil Citrate DoseDuring the study, there were 42 reported deaths, with 37 of these deaths reported prior to a decision to titrate subjects to a lower dosage because of a finding of increased mortality with increasing sildenafil citrate doses. For the survival analysis which included 37 deaths, the hazard ratio for high dose compared to low dose was 3.9, p=0.007. Causes of death were typical of patients with PAH. Use of sildenafil citrate, particularly chronic use, is not recommended in children.8.5 Geriatric UseClinical studies of sildenafil citrate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Because many drugs are excreted in human milk, caution should be exercised when sildenafil citrate is administered to a nursing woman.8.4 Pediatric UseIn a randomized, double-blind, multi-center, placebo-controlled, parallel-group, dose-ranging study, 234 patients with PAH, aged 1 to 17 years, body weight greater than or equal to 8 kg, were randomized, on the basis of body weight, to three dose levels of sildenafil citrate, or placebo, for 16 weeks of treatment.

• Sildenafil tablets LP 100 mg helps maintain an erection during sexual activity.
• Its effectiveness varies among individuals; some may need different doses.
• Regular exhaustion or health issues could affect medication results.

Most patients had mild to moderate symptoms at baseline: WHO Functional Class I (32%), II (51%), III (15%), or IV (0.4%).

2.1 Sildenafil Tablets

Concomitant use of sildenafil citrate with ritonavir and other potent CYP3A inhibitors is not recommended [see Clinical Pharmacology (12.3)]. These reports included dizziness and light-headedness, but sildenafil 25 mg tablets not syncope. When sildenafil 100 mg oral was co-administered with amlodipine, 5 mg or 10 mg oral, to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic. Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil citrate [see Warnings and Precautions (5.2)]. 8 USE IN SPECIFIC POPULATIONS 8.1 PregnancyPregnancy Category BThere are no adequate and well-controlled studies of sildenafil in pregnant women.

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No evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m2 basis, 32- and 68-times, respectively, the recommended human dose (RHD) of 20 mg three times a day. In a rat pre- and postnatal development study, the no-observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the RHD on a mg/m2 basis).8.2 Labor and DeliveryThe safety and efficacy of sildenafil citrate during labor and delivery have not been studied.8.3 Nursing MothersIt is not known if sildenafil or its metabolites are excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when sildenafil citrate is administered to a nursing woman.8.4 Pediatric UseIn a randomized, double-blind, multi-center, placebo-controlled, parallel-group, dose-ranging study, 234 patients with PAH, aged 1 to 17 years, body weight greater than or equal to 8 kg, were randomized, on the basis of body weight, to three dose levels of sildenafil citrate, or placebo, for 16 weeks of treatment. Most patients had mild to moderate symptoms at baseline: WHO Functional Class I (32%), II (51%), III (15%), or IV (0.4%). One-third of patients had primary PAH; two-thirds had secondary PAH (systemic-to-pulmonary shunt in 36%; surgical repair in 30%). One-third of patients had primary PAH; two-thirds had secondary PAH (systemic-to-pulmonary shunt in 36%; surgical repair in 30%).

• Sildenafil LP 100 mg is a prescription medication; do not buy online without a script.
• Follow your doctor’s instructions for safe and effective use.
• Report any unusual symptoms or concerns during treatment promptly.

Sixty-two percent of patients were female.

Drug or placebo was administered three times a day.The primary objective of the study was to assess the effect of sildenafil citrate on exercise capacity as measured by cardiopulmonary exercise testing in pediatric patients developmentally able to perform the test (n = 115).

5.9 Counseling Patients About Sexually Transmitted Diseases

In a placebo-controlled fixed dose titration study (Study 2) of sildenafil citrate (starting with recommended dose of 20 mg three times a day and increased to 40 mg three times a day and then 80 mg three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, the adverse reactions that were more frequent in the sildenafil citrate + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2 [see Clinical Studies (14)]. It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient’s underlying cardiovascular disease, or to a combination of these or other factors. 7 DRUG INTERACTIONS NitratesConcomitant use of sildenafil citrate with nitrates in any form is contraindicated [see Contraindications (4)].Ritonavir and other Potent CYP3A InhibitorsConcomitant use of sildenafil citrate with ritonavir and other potent CYP3A inhibitors is not recommended [see Clinical Pharmacology (12.3)].Other drugs that reduce blood pressureAlpha blockers. In drug-drug interaction studies, sildenafil (25 mg, 50 mg, or 100 mg) and the alpha-blocker doxazosin (4 mg or 8 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy. In these study populations, mean additional reductions of supine systolic and diastolic blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, respectively, were observed.

Less common

Mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively, were also observed. There were infrequent reports of patients who experienced symptomatic postural hypotension. These reports included dizziness and light-headedness, but not syncope.Amlodipine. When sildenafil 100 mg oral was co-administered with amlodipine, 5 mg or 10 mg oral, to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic.Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil citrate [see Warnings and Precautions (5.2)]. Concomitant use of sildenafil citrate with nitrates in any form is contraindicated [see Contraindications (4)]. Administration of sildenafil citrate did not result in a statistically significant improvement in exercise capacity in those patients. No patients died during the 16-week controlled study.After completing the 16-week controlled study, a patient originally randomized to sildenafil citrate remained on his/her dose of sildenafil citrate or, if originally randomized to placebo, was randomized to low-, medium-, or high-dose sildenafil citrate. After all patients completed 16 weeks of follow-up in the controlled study, the blind was broken and doses were adjusted as clinically indicated. Patients treated with sildenafil were followed for a median of 4.6 years (range 2 days to 8.6 years). Mortality during the long-term study, by originally assigned dose, is shown in Figure 6:Figure 6: Kaplan-Meier Plot of Mortality by Sildenafil Citrate DoseDuring the study, there were 42 reported deaths, with 37 of these deaths reported prior to a decision to titrate subjects to a lower dosage because of a finding of increased mortality with increasing sildenafil citrate doses. For the survival analysis which included 37 deaths, the hazard ratio for high dose compared to low dose was 3.9, p=0.007.

8.3 Nursing Mothers

The patients experiencing these reactions had risk factors for hemorrhage including concurrent anticoagulant therapy.In a placebo-controlled fixed dose titration study (Study 2) of sildenafil citrate (starting with recommended dose of 20 mg three times a day and increased to 40 mg three times a day and then 80 mg three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, the adverse reactions that were more frequent in the sildenafil citrate + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2 [see Clinical Studies (14)].^includes peripheral edema6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient’s underlying cardiovascular disease, or to a combination of these or other factors.Nervous systemSeizure, seizure recurrence The following serious adverse events are discussed elsewhere in the labeling: Mortality with pediatric use [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)] Hypotension [see Warnings and Precautions (5.2)] Vision loss [see Warnings and Precautions (5.5)] Hearing loss [see Warnings and Precautions (5.6)] Priapism [see Warnings and Precautions (5.8)] Vaso-occlusive crisis [see Warnings and Precautions (5.9)] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Safety data of sildenafil citrate in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 sildenafil citrate-treated patients with PAH, WHO Group I [see Clinical Studies (14)]. The overall frequency of discontinuation in sildenafil citrate-treated patients on 20 mg three times a day was 3% and was the same for the placebo group. In Study 1, the adverse reactions that were reported by at least 3% of sildenafil citrate-treated patients (20 mg three times a day) and were more frequent in sildenafil citrate-treated patients than in placebo-treated patients are shown in Table 1.

How should I store sildenafil?

In Study 1, the adverse reactions that were reported by at least 3% of sildenafil citrate-treated patients (20 mg TID) and were more frequent in sildenafil citrate-treated patients than in placebo-treated patients are shown in Table 1. Most Common Adverse Reactions in Patients with PAH in Study 1 (More Frequent in Sildenafil Citrate-Treated Patients than Placebo-Treated Patients and Incidence ≥3% in Sildenafil Citrate-Treated Patients) At doses higher than the recommended 20 mg three times a day, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances. Visual disturbances were identified as mild and transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision. The incidence of retinal hemorrhage with sildenafil citrate 20 mg three times a day was 1.4% versus 0% placebo and for all sildenafil citrate doses studied was 1.9% versus 0% placebo. The patients experiencing these reactions had risk factors for hemorrhage including concurrent anticoagulant therapy. Causes of death were typical of patients with PAH. Use of sildenafil citrate, particularly chronic use, is not recommended in children.8.5 Geriatric UseClinical studies of sildenafil citrate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Clinical Pharmacology (12.3)].8.6 Patients with Hepatic ImpairmentNo dose adjustment for mild to moderate impairment is required. Severe impairment has not been studied [see Clinical Pharmacology (12.3)].8.7 Patients with Renal ImpairmentNo dose adjustment is required (including severe impairment CLcr < 30 mL/min) [see Clinical Pharmacology (12.3)].