Sildenafil 10 mg/ml Oral suspension

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%). When sildenafil is taken with a high-fat meal, the rate of absorption is reduced, with a mean delay in T maxof 60 minutes and a mean reduction in C maxof 29%. Metabolism and Excretion Sildenafil is cleared predominantly by the CYP3A (major route) and cytochrome P450 2C9 (CYP2C9, minor route) hepatic microsomal isoenzymes. This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitropotency for PDE-5 approximately 50% of the parent drug.

5.3 Worsening Pulmonary Vascular Occlusive Disease

In vivo studies The effects of other drugs on sildenafil pharmacokinetics and the effects of sildenafil on the exposure to other drugs are shown in Figure 1 and Figure 2, respectively. Effects of Other Drugs on Sildenafil Pharmacokinetics CYP3A Inhibitors and Beta Blockers Population pharmacokinetic analysis of data from patients in clinical trials indicated an approximately 30% reduction in sildenafil clearance when it was co-administered with mild/moderate CYP3A inhibitors and an approximately 34% reductions in sildenafil clearance when co-administered with beta-blockers. CYP3A4 Inducers Including Bosentan Concomitant administration of strong CYP3A inducers is expected to cause substantial decreases in plasma levels of sildenafil. Epoprostenol The mean reduction of sildenafil (80 mg three times a day) bioavailability when co-administered with epoprostenol was 28%, resulting in about 22% lower mean average steady state concentrations. Alcohol Sildenafil (50 mg) did not potentiate the hypotensive effect of alcohol in healthy volunteers with mean maximum blood alcohol levels of 0.08%.

How it works

Sildenafil was not carcinogenic when administered to male and female mice for up to 21 and 18 months, respectively, at doses up to a maximally tolerated level of 10 mg/kg/day, a dose equivalent to the RHD on a mg/m 2basis. SUPER-1 (NCT00644605) -Sildenafil monotherapy [20 mg, 40 mg, and 80 mg three times a day] A randomized, double-blind, placebo-controlled study of sildenafil (SUPER-1) was conducted in 277 patients with PAH (defined as a mean pulmonary artery pressure ≥25 mmHg at rest with a pulmonary capillary wedge pressure <15 mmHg). Patients were randomized to receive placebo (n= 70) or sildenafil 20 mg (n = 69), 40 mg (n = 67) or 80 mg (n = 71) three times a day for a period of 12 weeks. Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in SUPER-1: Mean (95% Confidence Interval) Figure 4 displays subgroup efficacy analyses in SUPER-1 for the change from baseline in 6-Minute Walk Distance at Week 12 including baseline walk distance, disease etiology, functional class, gender, age, and hemodynamic parameters. SUPER-2 (NCT00159887) Long-term Treatment of PAH In a long-term follow-up of patients who were treated with sildenafil (n=277), K-M estimates of survival at 1, 2, and 3 years were 94%, 88% , and 79%, respectively.

12.3 Pharmacokinetics

Each bottle contains white to off-white crystalline powders containing 1.57 g of sildenafil citrate USP (equivalent to 1.12 g sildenafil). Recommended storage for sildenafil for oral suspension: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in the original package in order to protect from moisture. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 This Patient Information has been approved by the U.S. Food and Drug Administration. There was also a doubling of C minlevels compared to healthy volunteers. Pediatric Patients Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) for oral suspension. Geriatric Patients Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 84% and 107% higher plasma concentrations of sildenafil and its active N-desmethyl metabolite, respectively, compared to those seen in healthy younger volunteers (18 to 45 years). Renal Impairment In volunteers with mild (CLcr = 50 to 80 mL/min) and moderate (CLcr = 30 to 49 mL/min) renal impairment, the pharmacokinetics of a single oral dose of sildenafil (50 mg) was not altered. In volunteers with severe (CLcr less than 30 mL/min) renal impairment, sildenafil clearance was reduced, resulting in approximately doubling of AUC and C maxcompared to age-matched volunteers with no renal impairment. In addition, N-desmethyl metabolite AUC and C maxvalues were significantly increased 200% and 79%, respectively, in patients with severe renal impairment compared to patients with normal renal function.

Aspect	Sildenafil Syrup	Sildenafil Tablets
Ease of administration	Easy for children or those swallowing difficulties	Convenient for most adults
Dosage flexibility	Precise dosage adjustments possible	Fixed doses, less flexible
Onset of action	Usually quicker due to liquid form	Similar, around 30–60 min
Bioavailability	Slightly higher (due to faster absorption)	Slightly lower
Storage requirements	Same storage conditions	Same storage conditions

Hepatic Impairment In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh class A and B), sildenafil clearance was reduced, resulting in increases in AUC (84%) and C max(47%) compared to age-matched volunteers with no hepatic impairment. Drug Interaction Studies In vitro studies Sildenafil metabolism is principally mediated by the CYP3A (major route) and CYP2C9 (minor route) cytochrome P450 isoforms. Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A (IC50 greater than 150 µM). In vivo studies The effects of other drugs on sildenafil pharmacokinetics and the effects of sildenafil on the exposure to other drugs are shown in Figure 1 and Figure 2, respectively. Effects of Other Drugs on Sildenafil Pharmacokinetics CYP3A Inhibitors and Beta Blockers Population pharmacokinetic analysis of data from patients in clinical trials indicated an approximately 30% reduction in sildenafil clearance when it was co-administered with mild/moderate CYP3A inhibitors and an approximately 34% reductions in sildenafil clearance when co-administered with beta-blockers.

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CYP3A4 Inducers Including Bosentan Concomitant administration of strong CYP3A inducers is expected to cause substantial decreases in plasma levels of sildenafil. Epoprostenol The mean reduction of sildenafil (80 mg three times a day) bioavailability when co-administered with epoprostenol was 28%, resulting in about 22% lower mean average steady state concentrations. Alcohol Sildenafil (50 mg) did not potentiate the hypotensive effect of alcohol in healthy volunteers with mean maximum blood alcohol levels of 0.08%. Sildenafil was not carcinogenic when administered to male and female mice for up to 21 and 18 months, respectively, at doses up to a maximally tolerated level of 10 mg/kg/day, a dose equivalent to the RHD on a mg/m 2basis.

• Sildenafil's patent expired, leading to generic versions in pill form.
• The syrup form may be compounded at pharmacies if needed.
• It is crucial to verify the source and quality of compounded syrup.
• Sildenafil's effects typically begin within 30-60 minutes.
• The duration of action is approximately 4-6 hours.

SUPER-1 (NCT00644605) -Sildenafil monotherapy [20 mg, 40 mg, and 80 mg three times a day] A randomized, double-blind, placebo-controlled study of sildenafil (SUPER-1) was conducted in 277 patients with PAH (defined as a mean pulmonary artery pressure ≥25 mmHg at rest with a pulmonary capillary wedge pressure <15 mmHg). Patients were randomized to receive placebo (n= 70) or sildenafil 20 mg (n = 69), 40 mg (n = 67) or 80 mg (n = 71) three times a day for a period of 12 weeks. Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in SUPER-1: Mean (95% Confidence Interval) Figure 4 displays subgroup efficacy analyses in SUPER-1 for the change from baseline in 6-Minute Walk Distance at Week 12 including baseline walk distance, disease etiology, functional class, gender, age, and hemodynamic parameters. SUPER-2 (NCT00159887) Long-term Treatment of PAH In a long-term follow-up of patients who were treated with sildenafil (n=277), K-M estimates of survival at 1, 2, and 3 years were 94%, 88% , and 79%, respectively. Each bottle contains white to off-white crystalline powders containing 1.57 g of sildenafil citrate USP (equivalent to 1.12 g sildenafil).

Mechanism of action

After chronic dosing of 80 mg three times a day to patients with PAH, no clinically relevant effects on electrocardiogram (ECG). SUPER-1 (NCT00644605) - Sildenafil monotherapy [20 mg, 40 mg, and 80 mg three times a day] A randomized, double-blind, placebo-controlled study of Sildenafil (SUPER-1)was conducted in 277 patients with PAH (defined as a mean pulmonary artery pressure ≥ 25 mmHg at rest with a pulmonary capillary wedge pressure <15 mmHg). Patients were randomized to receive placebo (n=70) or Sildenafil 20 mg (n = 69), 40 mg (n = 67) or 80 mg (n = 71) three times a day for a period of 12 weeks. The improvement in walk distance was apparent after 4 Week of treatment and was maintained at week 8 and week 12. PACES-1 (NCT00159861) - Sildenafil Co-administered with Epoprostenol A randomized, double-blind, placebo controlled study (PACES-1) was conducted in 267 patients with PAH who were taking stable doses of intravenous epoprostenol. Recommended storage for sildenafil for oral suspension: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in the original package in order to protect from moisture.

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

Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 This Patient Information has been approved by the U.S. Food and Drug Administration. Sildenafil for Oral Suspension (sil den' a fil) Read this Instructions for Use before you start taking sildenafil for oral suspension and each time you get a refill. Supplies you will need to take or give a dose of sildenafil 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. (See Figure E) If your dose of sildenafil for oral suspension is 1 mL (10 mg), measure 0.5 mL two times for a total of 1 mL of sildenafil for oral suspension. (See Figure G) If you are giving sildenafil for oral suspension, make sure they are in an upright position before giving the medicine. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 SILDENAFIL- sildenafil powder, for suspension Lupin Pharmaceuticals, Inc. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets.

What special precautions should I follow?

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%). When sildenafil is taken with a high-fat meal, the rate of absorption is reduced, with a mean delay in T maxof 60 minutes and a mean reduction in C maxof 29%. Metabolism and Excretion Sildenafil is cleared predominantly by the CYP3A (major route) and cytochrome P450 2C9 (CYP2C9, minor route) hepatic microsomal isoenzymes.

Warnings for other groups

This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitropotency for PDE-5 approximately 50% of the parent drug. There was also a doubling of C minlevels compared to healthy volunteers. Pediatric Patients Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) for oral suspension. Geriatric Patients Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 84% and 107% higher plasma concentrations of sildenafil and its active N-desmethyl metabolite, respectively, compared to those seen in healthy younger volunteers (18 to 45 years). Renal Impairment In volunteers with mild (CLcr = 50 to 80 mL/min) and moderate (CLcr = 30 to 49 mL/min) renal impairment, the pharmacokinetics of a single oral dose of sildenafil (50 mg) was not altered.

Prior authorization

In volunteers with severe (CLcr less than 30 mL/min) renal impairment, sildenafil clearance was reduced, resulting in approximately doubling of AUC and C maxcompared to age-matched volunteers with no renal impairment. In addition, N-desmethyl metabolite AUC and C maxvalues were significantly increased 200% and 79%, respectively, in patients with severe renal impairment compared to patients with normal renal function. Hepatic Impairment In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh class A and B), sildenafil clearance was reduced, resulting in increases in AUC (84%) and C max(47%) compared to age-matched volunteers with no hepatic impairment. Drug Interaction Studies In vitro studies Sildenafil metabolism is principally mediated by the CYP3A (major route) and CYP2C9 (minor route) cytochrome P450 isoforms. Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A (IC50 greater than 150 µM). Do not mix with any other medication or additional flavoring agent White to light yellow colored granular powder containing 1.57 g of sildenafil citrate (equivalent to 1.12 g of sildenafil) in a bottle intended for reconstitution. Most, patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio ("crowded disc"). 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. Inform patients taking sildenafil for oral suspension not to take VIAGRA or other PDE5 inhibitors.

Uses of Sildenafil For Oral Suspension

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). The safety and efficacy of Sildenafil have been established in pediatric patients younger than 1 year of age. Clinical studies of sildenafil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients. 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 or almost white, slightly hygroscopic, crystalline powder and a molecular weight of 666.7. Sildenafil for Oral Suspension: Sildenafil for oral suspension is supplied as white to light yellow colored granular powder containing 1.57 g of sildenafil citrate (equivalent to1.12 g sildenafil) in an amber glass bottle intended for reconstitution. 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 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 sildenafil uk price + epoprostenol group compared with 13% of subjects in the epoprostenol group [see Clinical Studies (14)]. 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). The safety and efficacy of Sildenafil have been established in pediatric patients younger than 1 year of age. Clinical studies of sildenafil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients. 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 or almost white, slightly hygroscopic, crystalline powder and a molecular weight of 666.7. Sildenafil for Oral Suspension: Sildenafil for oral suspension is supplied as white to light yellow colored granular powder containing 1.57 g of sildenafil citrate (equivalent to1.12 g sildenafil) in an amber glass bottle intended for reconstitution. After chronic dosing of 80 mg three times a day to patients with PAH, no clinically relevant effects on electrocardiogram (ECG). SUPER-1 (NCT00644605) - Sildenafil monotherapy [20 mg, 40 mg, and 80 mg three times a day] A randomized, double-blind, placebo-controlled study of Sildenafil (SUPER-1)was conducted in 277 patients with PAH (defined as a mean pulmonary artery pressure ≥ 25 mmHg at rest with a pulmonary capillary wedge pressure <15 mmHg).

Ingredient	Quantity per 100ml	Function	备注
Sildenafil citrate	20 mg	Active pharmaceutical ingredient	主要成分，用于治疗勃起功能障碍
Xanthan gum	0.5 g	Thickening agent	用于增加粘稠度
Flavored syrup base	50 ml	Flavor enhancement	改善口感
Preservatives	As required	Prevent microbial growth	确保产品稳定性
Purified water	49.45 ml	Solvent	溶剂基础

Patients were randomized to receive placebo (n=70) or Sildenafil 20 mg (n = 69), 40 mg (n = 67) or 80 mg (n = 71) three times a day for a period of 12 weeks. The improvement in walk distance was apparent after 4 Week of treatment and was maintained at week 8 and week 12.

ADVERSE REACTIONS

Sildenafil for Oral Suspension (sil den' a fil) Read this Instructions for Use before you start taking sildenafil for oral suspension and each time you get a refill. Supplies you will need to take or give a dose of sildenafil 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. (See Figure E) If your dose of sildenafil for oral suspension is 1 mL (10 mg), measure 0.5 mL two times for a total of 1 mL of sildenafil for oral suspension. (See Figure G) If you are giving sildenafil for oral suspension, make sure they are in an upright position before giving the medicine. This Instructions for Use has been approved by the U.S.

Pulmonary hypertension

Food and Drug Administration. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 SILDENAFIL- sildenafil powder, for suspension Lupin Pharmaceuticals, Inc. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. Do not mix with any other medication or additional flavoring agent White to light yellow colored granular powder containing 1.57 g of sildenafil citrate (equivalent to 1.12 g of sildenafil) in a bottle intended for reconstitution.

Sildenafil side effects

Most, patients had underlying anatomic or vascular risk factors for developing NAION, including low cup to disc ratio ("crowded disc"). 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. Inform patients taking sildenafil for oral suspension not to take VIAGRA or other PDE5 inhibitors. 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 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 sildenafil uk price + epoprostenol group compared with 13% of subjects in the epoprostenol group [see Clinical Studies (14)]. PACES-1 (NCT00159861) - Sildenafil Co-administered with Epoprostenol A randomized, double-blind, placebo controlled study (PACES-1) was conducted in 267 patients with PAH who were taking stable doses of intravenous epoprostenol.

• Sildenafil has been investigated for alternative uses like altitude sickness.
• The syrup form is rarely available in commercial pharmacies.
• Reactions to sildenafil can vary based on individual health.
• Do not share sildenafil syrup with others to avoid adverse effects.
• Always adhere to prescribed dosages to prevent health risks.