Sildenafil 10 mg/ml Oral suspension
(See Figure E)If your child’s dose of sildenafil oral suspension is 1 mL (10 mg), measure 0.5 mL two times for a total of 1 mL of sildenafil oral suspension.If your or your child’s dose of sildenafil oral suspension is more than 2 mL (20 mg), you will need to divide the dose. Put the tip of the oral dosing syringe into your or your child’s mouth and point it towards the inside of the cheek. (See Figure G)If you are giving sildenafil oral suspension to a child, make sure they are in an upright position before giving the medicine.Step 7. Store the oral dosing syringe with the sildenafil oral suspension bottle.How should I store sildenafil for oral suspension?Store mixed (reconstituted) sildenafil for oral suspension below 86°F (30°C) or in a refrigerator between 36°F to 46°F (2°C to 8°C).Do not freeze mixed sildenafil for oral suspension.Throw away (discard) any remaining sildenafil oral suspension 60 days after mixed by the pharmacist. See the “Discard after” date written on the bottle label.Keep sildenafil for oral suspension and all medicines out of the reach of children.Manufactured by:Alkem Laboratories Ltd.,INDIA.Distributed by:Ascend Laboratories, LLCParsippany, NJ 07054This Instruction for Use has been approved by the U.S. Food and Drug Administration.Revised: July, 2023 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.
- Contraindications include hypersensitivity to sildenafil.
- Patients with heart conditions should consult a cardiologist before use.
- Sildenafil’s safety profile is well-studied in adults.
- The syrup should not be used with children without medical advice.
- Proper disposal of unused syrup is important to avoid misuse.
Ask your healthcare provider or pharmacist to show you how to measure and take or give your child’s prescribed dose of sildenafil oral suspension. · Sildenafil for oral suspension should not be mixed with any other medicine or flavoring. Supplies you will need to take or give a dose of sildenafil for oral suspension (See Figure A): · 1 bottle of sildenafil for oral suspension with pre- inserted bottle adaptor · 1 oral dosing syringe (provided in the carton) Shake the bottle of sildenafil for oral suspension for 10 seconds before each use. If your child’s dose of sildenafil oral suspension is 1 mL (10 mg), measure 0.5 mL two times for a total of 1 mL of sildenafil oral suspension. If your or your child’s dose of sildenafil oral suspension is more than 2 mL (20 mg), you will need to divide the dose.
| Parameter | Value | Description | Remarks |
|---|---|---|---|
| Absorption | Rapid, within 30-60 min | Time to peak plasma concentration | 最佳服用时间为餐前或空腹 |
| Bioavailability | Approx. 40% | Percentage of dose reaching systemic circulation | 影响药效强度 |
| Half-life | 4 hours | Time taken to reduce plasma concentration by half | 影响药物持续时间 |
| Metabolism | Hepatic (mainly CYP3A4) | Liver enzymes metabolize sildenafil | 酒精或药物相互作用可能影响代谢 |
If you are giving sildenafil oral suspension to a child, make sure they are in an upright position before giving the medicine.
Side Effects
(1) (1)DOSAGE AND ADMINISTRATIONAdults: 20 mg three times a day Dose may be increased based on symptoms and tolerability. (2.1)DOSAGE FORMS AND STRENGTHSFor oral suspension: 10 mg/mL (when reconstituted) (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSVasodilation effects sildenafil softgel capsule may be more common in patients with hypotension or on antihypertensive therapy. (5.4, 5.5)Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil for oral suspension may cause serious vaso-occlusive crises. (5.6)Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) product. (7)See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 1/2024 Adults: 20 mg three times a day Dose may be increased based on symptoms and tolerability.
12.2 Pharmacodynamics
Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil for oral suspension may cause serious vaso-occlusive crises. 1 INDICATIONS AND USAGE AdultsSildenafil 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)].Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) product. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage in AdultsOral DosageThe recommended dosage of Sildenafil for Oral Suspension is 20 mg three times a day. [see Clinical Studies (14)].Pediatric 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.2.3 Reconstitution of the Powder for Oral SuspensionNote: Reconstitute the contents of the bottle with a total volume of 92 mL (60 mL followed by 32 mL).
Interactions that increase your risk for side effects
3 DOSAGE FORMS AND STRENGTHS Sildenafil for Oral SuspensionWhite to off-white powders containing 1.60 g of sildenafil citrate (equivalent to 1.14 g of sildenafil) in a bottle for reconstitution. 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 postmarketing in temporal association with the use of PDE-5 inhibitors, including sildenafil. Inform patients taking sildenafil not to take VIAGRA or other PDE-5 inhibitors.5.7 PriapismUse sildenafil for oral suspension 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). 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 for Oral Suspension-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) product. In the U.S. See full prescribing information for SILDENAFIL FOR ORAL SUSPENSION. SILDENAFIL for oral suspension Initial U.S. Approval: 1998RECENT MAJOR CHANGESIndications and Usage (1) 1/2023Dosage and Administration (2.1, 2.2, 2.3) 1/2023INDICATIONS AND USAGEAdultsSildenafil for oral suspension is a phosphodiesterase-5 (PDE-5) inhibitor 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. (1) (1)DOSAGE AND ADMINISTRATIONAdults: 20 mg three times a day Dose may be increased based on symptoms and tolerability. (2.1)DOSAGE FORMS AND STRENGTHSFor oral suspension: 10 mg/mL (when reconstituted) (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSVasodilation effects sildenafil softgel capsule may be more common in patients with hypotension or on antihypertensive therapy. (5.4, 5.5)Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil for oral suspension may cause serious vaso-occlusive crises. (5.6)Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) product. (7)See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 1/2024 Adults: 20 mg three times a day Dose may be increased based on symptoms and tolerability. Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil for oral suspension may cause serious vaso-occlusive crises. 1 INDICATIONS AND USAGE AdultsSildenafil 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)].Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) product.
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2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage in AdultsOral DosageThe recommended dosage of Sildenafil for Oral Suspension is 20 mg three times a day. [see Clinical Studies (14)].Pediatric 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.2.3 Reconstitution of the Powder for Oral SuspensionNote: Reconstitute the contents of the bottle with a total volume of 92 mL (60 mL followed by 32 mL). 3 DOSAGE FORMS AND STRENGTHS Sildenafil for Oral SuspensionWhite to off-white powders containing 1.60 g of sildenafil citrate (equivalent to 1.14 g of sildenafil) in a bottle for reconstitution.
Chemical synthesis
8.1 Pregnancy
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 postmarketing in temporal association with the use of PDE-5 inhibitors, including sildenafil. Inform patients taking sildenafil not to take VIAGRA or other PDE-5 inhibitors.5.7 PriapismUse sildenafil for oral suspension 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).
7 DRUG INTERACTIONS
(See Figure E)If your child’s dose of sildenafil oral suspension is 1 mL (10 mg), measure 0.5 mL two times for a total of 1 mL of sildenafil oral suspension.If your or your child’s dose of sildenafil oral suspension is more than 2 mL (20 mg), you will need to divide the dose. Put the tip of the oral dosing syringe into your or your child’s mouth and point it towards the inside of the cheek. (See Figure G)If you are giving sildenafil oral suspension to a child, make sure they are in an upright position before giving the medicine.Step 7. Store the oral dosing syringe with the sildenafil oral suspension bottle.How should I store sildenafil for oral suspension?Store mixed (reconstituted) sildenafil for oral suspension below 86°F (30°C) or in a refrigerator between 36°F to 46°F (2°C to 8°C).Do not freeze mixed sildenafil for oral suspension.Throw away (discard) any remaining sildenafil oral suspension 60 days after mixed by the pharmacist. See the “Discard after” date written on the bottle label.Keep sildenafil for oral suspension and all medicines out of the reach of children.Manufactured by:Alkem Laboratories Ltd.,INDIA.Distributed by:Ascend Laboratories, LLCParsippany, NJ 07054This Instruction for Use has been approved by the U.S.
Pulmonary Arterial Hypertension
Food and Drug Administration.Revised: July, 2023 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. Ask your healthcare provider or pharmacist to show you how to measure and take or give your child’s prescribed dose of sildenafil oral suspension. · Sildenafil for oral suspension should not be mixed with any other medicine or flavoring. Supplies you will need to take or give a dose of sildenafil for oral suspension (See Figure A): · 1 bottle of sildenafil for oral suspension with pre- inserted bottle adaptor · 1 oral dosing syringe (provided in the carton) Shake the bottle of sildenafil for oral suspension for 10 seconds before each use. If your child’s dose of sildenafil oral suspension is 1 mL (10 mg), measure 0.5 mL two times for a total of 1 mL of sildenafil oral suspension.
Terms of Sale
If your or your child’s dose of sildenafil oral suspension is more than 2 mL (20 mg), you will need to divide the dose. If you are giving sildenafil oral suspension to a child, make sure they are in an upright position before giving the medicine. See full prescribing information for SILDENAFIL FOR ORAL SUSPENSION. SILDENAFIL for oral suspension Initial U.S. Approval: 1998RECENT MAJOR CHANGESIndications and Usage (1) 1/2023Dosage and Administration (2.1, 2.2, 2.3) 1/2023INDICATIONS AND USAGEAdultsSildenafil for oral suspension is a phosphodiesterase-5 (PDE-5) inhibitor 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. 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 for Oral Suspension-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) product. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 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. Limited clinical data during lactation preclude a clear determination of the risk of sildenafil to an infant during lactation.8.4 Pediatric UseThe safety and efficacy 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) product. 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)].
- 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.
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 666.7Sildenafil for Oral Suspension is supplied as white to off-white powders containing 1.60 g of sildenafil citrate (equivalent to 1.14 g sildenafil) in an amber glass bottle intended for reconstitution. The inhibition of PDE-5 in these tissues by sildenafil may be the basis for the enhanced platelet anti-aggregatory activity of nitric oxide observed in vitro, and the mild peripheral arterial-venous dilatation in vivo.12.2 PharmacodynamicsEffects of Sildenafil for Oral Suspension on Hemodynamic MeasuresAdultsPatients 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)]. Changes from Baseline in Hemodynamic Parameters at Week 12 [mean (95% CI) for the Sildenafil 20 mg Three Times a Day and Placebo GroupmPAP = mean pulmonary arterial pressure; PVR= pulmonary vascular resistance; SVR = systemic vascular resistance; RAP = right atrial pressure; CO = cardiac output; HR = heart rate.
- Manufacturing of sildenafil syrup requires specialized equipment.
- The syrup form must undergo stability testing before release.
- Some formulations may include sweeteners to improve taste.
- Off-label compounding can carry legal and safety risks.
- Clinicians should carefully consider risks before prescribing syrup.
*The number of patients per treatment group varied slightly for each parameter due to missing assessments.Effects of Sildenafil for Oral Suspension on Blood PressureSingle 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). An evaluation of visual function at doses up to 200 mg revealed no effects of sildenafil for oral suspension on visual acuity, intraocular pressure, or pupillometry.Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) product.
12.3 Pharmacokinetics
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 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. Limited clinical data during lactation preclude a clear determination of the risk of sildenafil to an infant during lactation.8.4 Pediatric UseThe safety and efficacy 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) product. 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)]. 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 666.7Sildenafil for Oral Suspension is supplied as white to off-white powders containing 1.60 g of sildenafil citrate (equivalent to 1.14 g sildenafil) in an amber glass bottle intended for reconstitution. The inhibition of PDE-5 in these tissues by sildenafil may be the basis for the enhanced platelet anti-aggregatory activity of nitric oxide observed in vitro, and the mild peripheral arterial-venous dilatation in vivo.12.2 PharmacodynamicsEffects of Sildenafil for Oral Suspension on Hemodynamic MeasuresAdultsPatients 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)].
Pregnancy Categories
Changes from Baseline in Hemodynamic Parameters at Week 12 [mean (95% CI) for the Sildenafil 20 mg Three Times a Day and Placebo GroupmPAP = mean pulmonary arterial pressure; PVR= pulmonary vascular resistance; SVR = systemic vascular resistance; RAP = right atrial pressure; CO = cardiac output; HR = heart rate. *The number of patients per treatment group varied slightly for each parameter due to missing assessments.Effects of Sildenafil for Oral Suspension on Blood PressureSingle 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). An evaluation of visual function at doses up to 200 mg revealed no effects of sildenafil for oral suspension on visual acuity, intraocular pressure, or pupillometry.Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) product.