Sildenafil 10 mg/ml Oral suspension
White to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g of sildenafil) in a bottle for reconstitution to 10 mg/mL. 4 CONTRAINDICATIONS Sildenafil is 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 (5.1)].Concomitant use of riociguat, a guanylate cyclase stimulator. Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.Known hypersensitivity to sildenafil or any component of the oral suspension. Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.1)]. Known hypersensitivity to sildenafil or any component of the oral suspension. 5 WARNINGS AND PRECAUTIONS 5.1 HypotensionSildenafil has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil.5.2 Worsening Pulmonary Vascular Occlusive DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Should signs of pulmonary edema occur when sildenafil is administered, consider the possibility of associated PVOD.5.3 EpistaxisThe incidence of epistaxis was 13% in patients taking sildenafil with PAH secondary to CTD. The incidence of epistaxis was also higher in sildenafil-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 is unknown in patients with bleeding disorders or active peptic ulceration.5.4 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 post marketing in temporal association with the use of PDE-5 inhibitors, including sildenafil.
What happens if I miss a dose?
Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”).Advise patients to seek immediate medical attention in the buy sildenafil citrate online canada event of a sudden loss of vision in one or both eyes while taking sildenafil.There are no controlled clinical data on the safety or efficacy of sildenafil in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases.
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Therefore, use of sildenafil in patients with retinitis pigmentosa is not recommended.5.5 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. It is not possible to determine whether these reported events are related directly to the use of sildenafil, 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.5.6 Combination with Other PDE-5 InhibitorsSildenafil is also marketed as VIAGRA®.
| Side Effect | Frequency | Severity | Management |
|---|---|---|---|
| Headache | Common | Mild | Analgesics, hydration |
| Flushing | Common | Mild | Cool environment, monitor |
| Nasal congestion | Common | Mild | Decongestants, hydration |
| Dizziness | Less common | Moderate | Avoid sudden movements |
| Vision disturbances | Rare | Moderate | Discontinue, consult physician |
| Priapism (prolonged erection) | Rare | Severe | Emergency medical attention |
Inform patients taking sildenafil not to take VIAGRA or other PDE-5 inhibitors.5.7 PriapismUse sildenafil 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.5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell DiseaseIn 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 than by those randomized to placebo. 6 ADVERSE REACTIONS The following serious adverse events are discussed elsewhere in the labeling:Hypotension [see Warnings and Precautions (5.1)]Vision Loss [see chew sildenafil Warnings and Precautions (5.4)]Hearing Loss [see Warnings and Precautions (5.5)]Priapism [see Warnings and Precautions (5.7)]Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease [see Warnings and Precautions (5.8)]6.1 Clinical Trials ExperienceBecause 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.In a 12-week, placebo-controlled clinical study and an open-label extension study (SUPER-1) in 277 sildenafil-treated adults with PAH (WHO Group I) [see Clinical Studies (14)] the adverse reactions that were reported by at least 10% of sildenafil-treated patients in any dosing group, and were more frequent in sildenafil-treated patients than in placebo-treated patients are shown in Table 1.
6. Adverse Reactions/Side Effects
The overall frequency of discontinuation for placebo was 3%.Table 1. Most Common Adverse Reactions in Patients Treated with Sildenafil 20 mg, 40 mg, 80 mg and Placebo sildenafil citrate drug three times per day in SUPER-1 (More Frequent in Sildenafil-Treated Patients than Placebo-Treated Patients)In a placebo-controlled fixed dose titration study (PACES-1) of sildenafil (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, no new safety issues were identified except for edema, which occurred in 25% of subjects in the combined sildenafil + epoprostenol group compared with 13% of subjects in the epoprostenol group [see Clinical Studies (14)].Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) for Oral Suspension. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.6.2 Post-marketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.Cardiovascular EventsIn postmarketing experience with sildenafil at doses indicated for erectile dysfunction, serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, pulmonary hemorrhage, and subarachnoid and intracerebral hemorrhages have been reported in temporal association with the use of the drug. 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 recurrenceOphthalmologicNAION [see Warnings and Precautions (5.4), Patient Counseling Information (17)].
12.3 Pharmacokinetics
7 DRUG INTERACTIONS NitratesConcomitant use of sildenafil with nitrates in any form is contraindicated [see Contraindications (4)].Strong CYP3A InhibitorsConcomitant use of sildenafil with strong CYP3A inhibitors is not recommended [see Clinical Pharmacology (12.3)].Moderate-to-Strong CYP3A InducersConcomitant use of sildenafil with moderate-to-strong CYP3A inducers (such as bosentan) decreases the sildenafil exposure. 8 USE IN SPECIFIC POPULATIONS 8.1 PregnancyRisk SummaryLimited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy. 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. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.Clinical ConsiderationsDisease-Associated Maternal and/or Embryo/Fetal RiskPregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death.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.
Marketing and sales
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 LactationRisk SummaryLimited published data from a case report describe the presence of sildenafil and its active metabolite in human milk. Limited clinical data during lactation preclude a clear determination of the risk of sildenafil to an infant during lactation8.4 Pediatric UseThe safety and effectiveness of sildenafil have not been established in pediatric patients younger than 1 year of age.Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) for Oral Suspension. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.8.5 Geriatric UseClinical studies of sildenafil did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. The overall frequency of discontinuation for placebo was 3%.Table 1. Most Common Adverse Reactions in Patients Treated with Sildenafil 20 mg, 40 mg, 80 mg and Placebo sildenafil citrate drug three times per day in SUPER-1 (More Frequent in Sildenafil-Treated Patients than Placebo-Treated Patients)In a placebo-controlled fixed dose titration study (PACES-1) of sildenafil (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, no new safety issues were identified except for edema, which occurred in 25% of subjects in the combined sildenafil + epoprostenol group compared with 13% of subjects in the epoprostenol group [see Clinical Studies (14)].Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) for Oral Suspension.
- Investigational drugs or supplements claim to mimic sildenafil effects.
- The safety of homemade sildenafil syrup is not guaranteed.
- Pharmacovigilance involves monitoring adverse effects.
- Patients should inform providers of all medications taken.
- Regulatory oversight ensures quality and efficacy of medications.
However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.6.2 Post-marketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.Cardiovascular EventsIn postmarketing experience with sildenafil at doses indicated for erectile dysfunction, serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, pulmonary hemorrhage, and subarachnoid and intracerebral hemorrhages have been reported in temporal association with the use of the drug. 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 recurrenceOphthalmologicNAION [see Warnings and Precautions (5.4), Patient Counseling Information (17)]. 7 DRUG INTERACTIONS NitratesConcomitant use of sildenafil with nitrates in any form is contraindicated [see Contraindications (4)].Strong CYP3A InhibitorsConcomitant use of sildenafil with strong CYP3A inhibitors is not recommended [see Clinical Pharmacology (12.3)].Moderate-to-Strong CYP3A InducersConcomitant use of sildenafil with moderate-to-strong CYP3A inducers (such as bosentan) decreases the sildenafil exposure. 8 USE IN SPECIFIC POPULATIONS 8.1 PregnancyRisk SummaryLimited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy. 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.
Overdose/Missed Dose
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Mechanism of Action
In the U.S.
How is this medicine (Sildenafil Oral Suspension) best taken?
Other Medical Problems
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.Clinical ConsiderationsDisease-Associated Maternal and/or Embryo/Fetal RiskPregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death.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.
Pregnancy & Lactation
White to off-white powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g of sildenafil) in a bottle for reconstitution to 10 mg/mL. 4 CONTRAINDICATIONS Sildenafil is 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 (5.1)].Concomitant use of riociguat, a guanylate cyclase stimulator. Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.Known hypersensitivity to sildenafil or any component of the oral suspension. Concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see Warnings and Precautions (5.1)]. Known hypersensitivity to sildenafil or any component of the oral suspension.
6.1 Clinical Trials Experience
5 WARNINGS AND PRECAUTIONS 5.1 HypotensionSildenafil has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil.5.2 Worsening Pulmonary Vascular Occlusive DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Should signs of pulmonary edema occur when sildenafil is administered, consider the possibility of associated PVOD.5.3 EpistaxisThe incidence of epistaxis was 13% in patients taking sildenafil with PAH secondary to CTD. The incidence of epistaxis was also higher in sildenafil-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 is unknown in patients with bleeding disorders or active peptic ulceration.5.4 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 post marketing in temporal association with the use of PDE-5 inhibitors, including sildenafil. Most patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio (“crowded disc”).Advise patients to seek immediate medical attention in the buy sildenafil citrate online canada event of a sudden loss of vision in one or both eyes while taking sildenafil.There are no controlled clinical data on the safety or efficacy of sildenafil in patients with retinitis pigmentosa, a minority of whom have genetic disorders of retinal phosphodiesterases.
Incidence not known
Therefore, use of sildenafil in patients with retinitis pigmentosa is not recommended.5.5 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. It is not possible to determine whether these reported events are related directly to the use of sildenafil, 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.5.6 Combination with Other PDE-5 InhibitorsSildenafil is also marketed as VIAGRA®. Inform patients taking sildenafil not to take VIAGRA or other PDE-5 inhibitors.5.7 PriapismUse sildenafil 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.5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell DiseaseIn 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 than by those randomized to placebo. 6 ADVERSE REACTIONS The following serious adverse events are discussed elsewhere in the labeling:Hypotension [see Warnings and Precautions (5.1)]Vision Loss [see chew sildenafil Warnings and Precautions (5.4)]Hearing Loss [see Warnings and Precautions (5.5)]Priapism [see Warnings and Precautions (5.7)]Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease [see Warnings and Precautions (5.8)]6.1 Clinical Trials ExperienceBecause 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.In a 12-week, placebo-controlled clinical study and an open-label extension study (SUPER-1) in 277 sildenafil-treated adults with PAH (WHO Group I) [see Clinical Studies (14)] the adverse reactions that were reported by at least 10% of sildenafil-treated patients in any dosing group, and were more frequent in sildenafil-treated patients than in placebo-treated patients are shown in Table 1. 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 LactationRisk SummaryLimited published data from a case report describe the presence of sildenafil and its active metabolite in human milk. Limited clinical data during lactation preclude a clear determination of the risk of sildenafil to an infant during lactation8.4 Pediatric UseThe safety and effectiveness of sildenafil have not been established in pediatric patients younger than 1 year of age.Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) for Oral Suspension.
| 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 |
However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.8.5 Geriatric UseClinical studies of sildenafil did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.
- 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.
