Sildenafil 10 mg/ml Oral suspension
When sildenafil is taken with a high-fat
- Sildenafil interacts with alpha-blockers, leading to hypotension.
- The syrup should be measured with a proper dosing device.
- The syrup form is less common and might have inconsistent absorption.
- Researchers are exploring alternative delivery methods like liquids.
- Pharmaceutical companies rarely produce sildenafil syrup commercially.
meal, the rate of absorption is reduced, with a mean delay in T maxof 60 minutes and a mean reduction in C maxof 29%.
8.5 Geriatric Use
See the “Discard after” date written on the bottle label.Keep Sildenafil for oral suspension and all medicines out of the reach of children.This Instruction for Use has been approved by the U.S. Food and Drug Administration.Distributed By:Virtus Pharmaceuticals, LLCLanghorne, PA 190471-888-848-3593Revised: 01/2024Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) product. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.This Instruction for Use has been approved by the U.S. Food and Drug Administration.200391 Sildenafil (Sil den’ a fil) for oral suspension Read this Instructions for Use before you start taking Sildenafil for oral suspension and each time you get a refill. SILDENAFIL CITRATE - sildenafil citrate powder, for suspension Ascend Laboratories, LLC Adults Sildenafil for Oral Suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)].
What should I know about sildenafil before taking it?
Incompatibilities Do not mix with any other medication or additional flavoring agent. Risk Summary Limited 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). Data Animal Data 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 65-times, respectively, the recommended human dose (RHD) of 20 mg three times a day. Risk Summary Limited published data from a case report describe the presence of sildenafil and its active metabolite in human milk.
Warnings for other groups
More than twice as many sildenafil -treated patients (36%) as placebo-treated patients (14%) showed an improvement in at least one functional New York Heart Association (NYHA) class for PAH. Sildenafil (sil den′ a fil) oral suspension What is the most important information I should know about sildenafil for oral suspension? Especially tell your healthcare provider if you or your child take: See “What is the most important information I should know about sildenafil for oral suspension?” Sildenafil for oral suspension contains sildenafil, which is the same medicine found in another medicine called VIAGRA®. Sildenafil (sil den′ a fil) oral suspension Read this Instructions for Use before you start taking sildenafil oral suspension or giving sildenafil oral suspension to your child and each time you get a refill. SILDENAFIL - sildenafil powder, for suspension Camber Pharmaceuticals, Inc. Metabolism and Excretion Sildenafil is cleared predominantly by the CYP3A (major
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route) and cytochrome P450 2C9
8 USE IN SPECIFIC POPULATIONS
Adults Sildenafilfororal suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [ see Clinical Studies (14)] . Oral Dosage The recommendeddosage of sildenafil for oral suspension is 20 mg three times a day. Note:Reconstitute the contents of the bottle with a total volume of 90 mL (60 mL followed by 30 mL).Refer to the detailed instructions below.1. Replace the cap and shake the bottle vigorouslyfor a minimum of 30 seconds.4. Add another 30 mL of water to the bottle.5.
What is sildenafil used for?
Sildenafil for Oral Suspension White to off-white crystalline powders containing 1.57 g of sildenafil citrate (equivalent to 1.12 g of sildenafil) in a bottle for reconstitution to 10 mg/mL. Sildenafil for oral suspension is sildenafil gel 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)]. The following serious adverse events are discussed elsewhere in the labeling: Hypotension [ see Warnings and Precautions (5.1)] Vision Loss [ see 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)] 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. 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. Most Common Adverse Reactions in Patients Treated with Sildenafil 20 mg, 40 mg, 80 mg and Placebo 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)].
5.6 Combination with Other PDE-5 Inhibitors
Cardiovascular Events In 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. Nervous System Seizure, seizure recurrence Ophthalmologic NAION [ see Warnings and Precautions (5.4), Patient Counseling Information (17)]. Nitrates Concomitant use of sildenafil with nitrates in any form is contraindicated [ see Contraindications (4)] . Strong CYP3A Inhibitors Concomitant use of sildenafil with strong CYP3A inhibitors is not recommended [ see Clinical Pharmacology (12.3)]. Moderate-to-Strong CYP3A Inducers Concomitant use of sildenafil with moderate-to-strong CYP3A inducers (such as bosentan) decreases the sildenafil exposure. (CYP2C9, minor route) hepatic microsomal isoenzymes.
16 HOW SUPPLIED/STORAGE AND HANDLING
Reduce the dose of sildenafil to 20 mg three times a day when discontinuing treatment with moderate-to-strong CYP3A inducers [ see Clinical Pharmacology (12.3) and Clinical Studies (14)] . Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death. Data Animal Data 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/m 2basis, 32- and 65-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/m 2basis). 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)].
Raynaud's phenomenon
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 for oral suspension is supplied as white to off-white crystalline powders containing 1.57 g of sildenafil citrate USP (equivalent to 1.12 g sildenafil) in an amber glass bottle intended for reconstitution. Studies in vitrohave shown that sildenafil is selective for PDE5. This lower selectivity is thought to be the basis for abnormalities related to color vision observed with higher doses or plasma levels [ see Clinical Pharmacology (12.2)]. This metabolite has a phosphodiesterase
| Precaution/Contraindication | Details | Advice |
|---|---|---|
| Nitrate use | Contraindicated with sildenafil | Risk of severe hypotension |
| Cardiovascular disease risk | Use with caution | Consult cardiologist before use |
| Liver or kidney impairment | Dose adjustment needed | Monitor liver/kidney function tests |
| Allergies to sildenafil or excipients | Check ingredients before administration | Discontinue if allergic reactions occur |
selectivity profile similar to sildenafil and
Dosing & Uses
Effects of Sildenafil on Hemodynamic Measures Adults Patients on all sildenafil doses achieved a statistically significant reduction in mean pulmonary arterial pressure (mPAP) compared to those on placebo in a study with no background vasodilators [ see SUPER-1 in Clinical Studies (14)] . Effects of Sildenafil on Blood Pressure Single oral doses of sildenafil 100 mg administered to healthy volunteers produced decreases in supine blood pressure (mean maximum decrease in systolic/diastolic blood pressure of 8/5 mmHg). Larger effects were recorded among patients receiving concomitant nitrates [ see Contraindications (4)]. Effects of Sildenafil on Vision At single oral doses of 100 mg and 200 mg, transient dose-related impairment of color discrimination (blue/green) was detected using the Farnsworth-Munsell 100-hue test, with peak effects near the time of peak plasma levels. Absorption and Distribution Sildenafil is rapidly absorbed after oral administration, with a mean absolute bioavailability of 41% (25 to 63%). an in vitropotency for PDE-5 approximately 50% of the parent drug.
- 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.