Safety data of Sildenafil for Oral Suspension in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 Sildenafil for Oral Suspension-treated patients with PAH, WHO Group I[see Clinical Studies (14)].
- Sildenafil syrup may be preferred for those with swallowing issues.
- It can be mixed with water or other liquids if approved by a doctor.
- The taste of the syrup might require flavoring agents.
- There's limited data on the stability of sildenafil syrup long-term.
- Use of sildenafil in women is not approved and not well-studied.
The overall frequency of discontinuation in Sildenafil for Oral Suspension-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 for Oral Suspension-treated patients (20 mg three times a day) and were more frequent in Sildenafil for Oral Suspension-treated patients than in placebo-treated patients are shown in Table 1. 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 for Oral Suspension 20 mg three times a day was 1.4% versus 0% placebo and for all Sildenafil for Oral Suspension 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 for Oral Suspension (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, the adverse reactions that were more frequent in the Sildenafil + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2 [see Clinical Studies (14)]. 7 DRUG INTERACTIONS NitratesConcomitant use of Sildenafil for Oral Suspension with nitrates in any form is contraindicated [see Contraindications (4)].Ritonavir and other Potent CYP3A InhibitorsConcomitant use of Sildenafil for Oral Suspension 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.
2 DOSAGE AND ADMINISTRATION
Concomitant use of Sildenafil sildenafil 130mg for Oral Suspension with nitrates in any form is contraindicated [see Contraindications (4)]. 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 for Oral Suspension [see Warnings and Precautions (5.2)]. Animal reproduction studies conducted with sildenafil showed no evidence of embryo-fetal toxicity or teratogenicity at doses up to 32- and 65-times the recommended human dose (RHD) of 20 mg three times a day in rats and rabbits, respectively [See Data].The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
Recreational use
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.DataAnimal DataNo 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 65-times, respectively, the recommended human dose (RHD) of 20 mg three times a day. Limited clinical data during lactation preclude a clear determination of the risk of sildenafil to an infant during lactation.8.4 Pediatric UseIn a sildenafil cenforce 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, 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 37%; surgical repair in 30%).
Regional issues
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 on exercise capacity as measured by cardiopulmonary exercise testing in pediatric patients developmentally able to perform the test (n = 115). Administration of Sildenafil 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 remained on his/her dose of Sildenafil or, if originally randomized to placebo, was randomized to low-, medium-, or high-dose Sildenafil. After all patients completed 16 weeks of follow-up in the controlled study, the blind was broken and doses were adjusted as clinically indicated. 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 for Oral Suspension [see Warnings and Precautions (5.2)].
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Concomitant use of Sildenafil sildenafil 130mg for Oral Suspension with nitrates in any form is contraindicated [see Contraindications (4)]. 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 for Oral Suspension [see Warnings and Precautions (5.2)]. Animal reproduction studies conducted with sildenafil showed no evidence of embryo-fetal toxicity or teratogenicity at doses up to 32- and 65-times the recommended human dose (RHD) of 20 mg three times a day in rats and rabbits, respectively [See Data].The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S.
How Does Sildenafil For Oral Suspension Work?
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.DataAnimal DataNo 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 65-times, respectively, the recommended human dose (RHD) of 20 mg three times a day.
- Sildenafil syrup can cause side effects like headaches, flushing, or dizziness.
- Combining sildenafil syrup with nitrates can be dangerous.
- The syrup's consistency may vary; formulation stability is key.
- Misuse or overdose can lead to serious cardiovascular issues.
- Always consult a doctor before using sildenafil syrup.
Limited clinical data during lactation preclude a clear determination of the risk of sildenafil to an infant during lactation.8.4 Pediatric UseIn a sildenafil cenforce 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, 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 37%; 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 on exercise capacity as measured by cardiopulmonary exercise testing in pediatric patients developmentally able to perform the test (n = 115). Administration of Sildenafil 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 remained on his/her dose of Sildenafil or, if originally randomized to placebo, was randomized to low-, medium-, or high-dose Sildenafil.
| Country | Approval Status | Regulatory Body | Remarks |
|---|---|---|---|
| United States | Approved for pulmonary hypertension, off-label for ED | FDA | Prescription medication |
| European Union | Approved with similar indications | EMA | Prescription required |
| India | Approved for ED and pulmonary hypertension | CDSCO | Over the counter in some regions |
| Canada | Approved, prescription-only | Health Canada | Strict prescribing guidelines |
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: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 for Oral Suspension 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.
12. Sildenafil Oral Suspension - Clinical Pharmacology
Causes of death were typical of patients with PAH.
- The shelf life of sildenafil syrup depends on formulation and storage.
- Expiry dates should always be checked before use.
- Improper storage can lead to degradation of active ingredients.
- The liquid form allows for precise dose adjustments.
- Careful titration is essential to avoid overdose risks.
Use of Sildenafil for Oral Suspension, particularly chronic use, is not recommended in children.8.5 Geriatric UseClinical studies of Sildenafil for Oral Suspension 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)]. Animal reproduction studies conducted with sildenafil showed no evidence of embryo-fetal toxicity or teratogenicity at doses up to 32- and 65-times the recommended human dose liquid sildenafil citrate (RHD) of 20 mg three times a day in rats and rabbits, respectively [See Data]. In the U.S.
| Condition | Details | Remarks |
|---|---|---|
| Temperature | Store between 15°C to 30°C | Protect from excessive heat |
| Light Exposure | Keep in a dark place or in opaque container | Protect from light |
| Humidity | Avoid high humidity environments | Prevent product degradation |
| Shelf Life | Typically 2 years from manufacturing date | Check expiry date before use |
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. 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, 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 on exercise capacity as measured by cardiopulmonary exercise testing in pediatric patients developmentally able to perform the test (n = 115).
6. Adverse Reactions/Side Effects
Mortality during the long-term study, by originally assigned dose, is shown in Figure 6: 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 for Oral Suspension doses. Use of Sildenafil for Oral Suspension, particularly chronic use, is not recommended in children. Clinical studies of Sildenafil for Oral Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Sildenafil is also marketed as VIAGRA® for erectile dysfunction.Sildenafil citrate 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 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 for Oral Suspension is supplied as white to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil) in an amber glass bottle intended for reconstitution.
12.2 Pharmacodynamics
No patients died during the 16-week controlled study. After completing the 16-week controlled study, a patient originally randomized to Sildenafil remained on his/her dose of Sildenafil or, if originally randomized to placebo, was randomized to low-, medium-, or high-dose Sildenafil. Mortality during the long-term study, by originally assigned dose, is shown in Figure 6: 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 for Oral Suspension doses. Use of Sildenafil for Oral Suspension, particularly chronic use, is not recommended in children.
Before taking this medicine
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: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 for Oral Suspension 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 for Oral Suspension, particularly chronic use, is not recommended in children.8.5 Geriatric UseClinical studies of Sildenafil for Oral Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Terms of Sale
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)]. Animal reproduction studies conducted with sildenafil showed no evidence of embryo-fetal toxicity or teratogenicity at doses up to 32- and 65-times the recommended human dose liquid sildenafil citrate (RHD) of 20 mg three times a day in rats and rabbits, respectively [See Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.
12.3 Pharmacokinetics
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, 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 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 remained on his/her dose of Sildenafil or, if originally randomized to placebo, was randomized to low-, medium-, or high-dose Sildenafil. Clinical studies of Sildenafil for Oral Suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
5.4 Visual Loss
Safety data of Sildenafil for Oral Suspension in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 Sildenafil for Oral Suspension-treated patients with PAH, WHO Group I[see Clinical Studies (14)]. The overall frequency of discontinuation in Sildenafil for Oral Suspension-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 for Oral Suspension-treated patients (20 mg three times a day) and were more frequent in Sildenafil for Oral Suspension-treated patients than in placebo-treated patients are shown in Table 1. 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.
How should I store sildenafil?
The incidence of retinal hemorrhage with Sildenafil for Oral Suspension 20 mg three times a day was 1.4% versus 0% placebo and for all Sildenafil for Oral Suspension 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 for Oral Suspension (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, the adverse reactions that were more frequent in the Sildenafil + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2 [see Clinical Studies (14)]. 7 DRUG INTERACTIONS NitratesConcomitant use of Sildenafil for Oral Suspension with nitrates in any form is contraindicated [see Contraindications (4)].Ritonavir and other Potent CYP3A InhibitorsConcomitant use of Sildenafil for Oral Suspension 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.
Marketing and sales
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 for Oral Suspension [see Warnings and Precautions (5.2)]. Sildenafil is also marketed as VIAGRA® for erectile dysfunction.Sildenafil citrate 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 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 for Oral Suspension is supplied as white to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil) in an amber glass bottle intended for reconstitution.
| Condition | Patient Age Group | Dosage Recommendations | Notes |
|---|---|---|---|
| Erectile Dysfunction | Adults (18-65) | 20 mg, 1 hour before | 用于改善勃起功能 |
| Pulmonary Hypertension | Adults | 10–20 mg, 3 times daily | 用于降低肺动脉压力 |
| Off-label Performance Enhancement | Adults | Under medical supervision | 未经批准，需医生指导 |
| Children with Pulmonary Hypertension (Rare) | 1–17 years | 10 mg as prescribed | 特殊病例，严格监控 |
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