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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.
5.1 Cardiovascular
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%). 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).
Sildenafil Tablets or Oral Suspension for PAH
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, sildenafil syrup 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.
What should I know about sildenafil before taking it?
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. 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)]. 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)].
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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 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. 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%). Sixty-two percent of patients were female.
5.6 Combination with other PDE-5 inhibitors
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, sildenafil syrup 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.
- The effectiveness of sildenafil LP 100 mg can be affected by other health conditions.
- Consult your doctor regularly to assess ongoing suitability of the medication.
- Use as part of a broader treatment plan for sexual health.
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).
- 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.
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.
| Ingredient | Quantity per Tablet | Function | Additional Notes |
|---|---|---|---|
| Sildenafil Citrate | 100 mg | Active ingredient | Main component for efficacy |
| Mannitol | 50 mg | Fillers, solubility enhancer | Helps tablet disintegration |
| Microcrystalline Cellulose | 20 mg | Binder | Provides structural support |
| Magnesium Stearate | 2 mg | Lubricant | Prevents tablet from sticking |
| Titanium Dioxide | 1 mg | Coloring agent | Opacity and white color |
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)]. There are no adequate and well-controlled studies of sildenafil in pregnant women. In a rat pre- and sildenafil otc 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). The safety and efficacy of sildenafil citrate during labor and delivery have not been studied. It 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.
- 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.
In 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.
| Storage Parameter | Recommended Condition | Notes |
|---|---|---|
| Temperature | Keep below 25°C (77°F) | Avoid excessive heat or cold |
| Humidity | Store in a dry place | Protect from moisture |
| Light | Keep in original packaging | Prevent exposure to light |
| Shelf Life | 2-3 years from manufacturing date | Check expiration date before use |
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).
Before taking this medicine
There are no adequate and well-controlled studies of sildenafil in pregnant women. In a rat pre- and sildenafil otc 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). The safety and efficacy of sildenafil citrate during labor and delivery have not been studied. It 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.
More common
In 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. 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). 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.
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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 Dose During 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. Use of sildenafil citrate, particularly chronic use, is not recommended in children. Clinical 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)]. Severe impairment has not been studied [see Clinical Pharmacology (12.3)]. 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. 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 Dose During 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. Use of sildenafil citrate, particularly chronic use, is not recommended in children. Clinical 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)].
2.1 Dosage Information
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.
Corresponding author
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)]. 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 not syncope.
Serious Side Effects
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. 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. Severe impairment has not been studied [see Clinical Pharmacology (12.3)]. No dose adjustment is required (including severe impairment CLcr < 30 mL/min) [see Clinical Pharmacology (12.3)]. Sildenafil is also marketed as VIAGRA® for erectile dysfunction.Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula:Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7.Sildenafil Tablets: Sildenafil tablets are formulated as white to off-white, round shaped film-coated tablets for oral administration. Each tablet contains sildenafil citrate, USP equivalent to 20 mg of sildenafil.
2. Revatio
Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil Tablets: Sildenafil tablets are formulated as white to off-white, round shaped film-coated tablets for oral administration.
5.6 Hearing Loss
No dose adjustment is required (including severe impairment CLcr < 30 mL/min) [see Clinical Pharmacology (12.3)]. Sildenafil is also marketed as VIAGRA® for erectile dysfunction.Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula:Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7.Sildenafil Tablets: Sildenafil tablets are formulated as white to off-white, round shaped film-coated tablets for oral administration. Each tablet contains sildenafil citrate, USP equivalent to 20 mg of sildenafil. Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula: Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil Tablets: Sildenafil tablets are formulated as white to off-white, round shaped film-coated tablets for oral administration.
Are you currently using Sildenafil (Viagra, Revatio)?
In patients with PAH, this can lead to vasodilation of the pulmonary vascular bed and, to a lesser degree, vasodilatation in the systemic circulation.Studies in vitro have shown that sildenafil is selective for PDE-5. The approximately 4,000-fold selectivity for PDE-5 versus PDE3 is important because PDE3 is involved in control of cardiac contractility. In patients with PAH, this can lead to vasodilation of the pulmonary vascular bed and, to a lesser degree, vasodilatation in the systemic circulation.Studies in vitro have shown that sildenafil is selective for PDE-5. The approximately 4,000-fold selectivity for PDE-5 versus PDE3 is important because PDE3 is involved in control of cardiac contractility.
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