Sildenafil 10 mg/ml Oral suspension

Write the expiration date of the reconstituted oral suspension on the bottle label (the expiration date of the reconstituted oral suspension is 60 days from the date of reconstitution).IncompatibilitiesDo not mix with any other medication or additional flavoring agent.

Note: Reconstitute the contents of the bottle with a total volume of 93 mL (60 mL followed by 33 mL).

How do I store and/or throw out Sildenafil Oral Suspension?

6 ADVERSE REACTIONS 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)]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. The overall frequency of discontinuation in sildenafil -treated patients was 3% (20 mg three times a day). Most Common Adverse Reactions in Patients Treated with Sildenafil 20 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)].In a study to assess the effects of multiple doses of sildenafil on mortality in adults with PAH (StudyA1481324), the lower dose 5 mg TID group showed a higher observed number of deaths (all related to underlying disease/disease under study), serious adverse events, and severe adverse events than the 20 mg TID groups [see Clinical Studies (14)].Additional 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.6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). 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)].

Alcohol interaction warning

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 sildenafil 100mg blue pill 20 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)]. In a study to assess the effects of multiple doses of sildenafil on mortality in adults with PAH (StudyA1481324), the lower dose 5 mg TID group showed a higher observed number of deaths (all related to underlying disease/disease under study), serious adverse events, and severe adverse events than the 20 mg TID groups [see Clinical Studies (14)]. 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. Limited clinical data during lactation preclude a clear determination of the risk of sildenafil to an infant during lactation.8.4 Pediatric UseAdditional information is approved for Viatris Specialty LLC's REVATIO® (sildenafil) product.

Patients & Visitors

Disease-Associated Maternal and/or Embryo/Fetal Risk Additional information is approved for Viatris Specialty LLC's REVATIO® (sildenafil) product. 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 or almost white, slightly hygroscopic crystalline powder with a solubility of 10 mg/ 100ml in water and a molecular weight of 666.7.Sildenafil for Oral Suspension: 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. Following reconstitution with 93 mL water, the total volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. 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 with a solubility of 10 mg/ 100ml in water and a molecular weight of 666.7. 3 DOSAGE FORMS AND STRENGTHS Sildenafil for Oral SuspensionWhite 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. Following reconstitution with 93 mL of water, the total volume of the oral suspension is 112 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.

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How is sildenafil supplied (dosage forms)?

Description of Services

Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.· Known hypersensitivity to sildenafil or any component of the tablet, injection, or oral suspension.

What do I need to tell my doctor BEFORE I take Sildenafil Oral Suspension?

Write the expiration date of the reconstituted oral suspension on the bottle label (the expiration date of the reconstituted oral suspension is 60 days from the date of reconstitution).IncompatibilitiesDo not mix with any other medication or additional flavoring agent. Note: Reconstitute the contents of the bottle with a total volume of 93 mL (60 mL followed by 33 mL). 3 DOSAGE FORMS AND STRENGTHS Sildenafil for Oral SuspensionWhite 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. Following reconstitution with 93 mL of water, the total volume of the oral suspension is 112 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.

How Sildenafil works

Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.· Known hypersensitivity to sildenafil or any component of the tablet, injection, or 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 tablet, injection, or oral suspension. 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 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.

Dosage Forms & Strengths

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 sildenafil citrate 150 mg red pill predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia). 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). 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. · 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 tablet, injection, or oral suspension.

• Sildenafil syrup is sometimes used in pediatric cases, off-label.
• Off-label use in children requires careful dosage adjustment.
• Lack of standardization makes typical dosing guidelines difficult.
• Pharmacokinetics in syrup form are less well-studied.
• Always seek professional medical advice before use.

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 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. 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 sildenafil citrate 150 mg red pill predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia). 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). 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. 6 ADVERSE REACTIONS 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)]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. The overall frequency of discontinuation in sildenafil -treated patients was 3% (20 mg three times a day). Most Common Adverse Reactions in Patients Treated with Sildenafil 20 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)].In a study to assess the effects of multiple doses of sildenafil on mortality in adults with PAH (StudyA1481324), the lower dose 5 mg TID group showed a higher observed number of deaths (all related to underlying disease/disease under study), serious adverse events, and severe adverse events than the 20 mg TID groups [see Clinical Studies (14)].Additional 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.6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). 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)].

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 sildenafil 100mg blue pill 20 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)]. In a study to assess the effects of multiple doses of sildenafil on mortality in adults with PAH (StudyA1481324), the lower dose 5 mg TID group showed a higher observed number of deaths (all related to underlying disease/disease under study), serious adverse events, and severe adverse events than the 20 mg TID groups [see Clinical Studies (14)]. 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.

• Sildenafil syrup is an off-label form of erectile dysfunction medication.
• It's designed for easier ingestion compared to tablets.
• Not approved by most regulatory agencies for syrup form.
• Dosing and safety information are less documented for syrup.
• Usually, sildenafil is available in tablet form, not syrup.

Limited clinical data during lactation preclude a clear determination of the risk of sildenafil to an infant during lactation.8.4 Pediatric UseAdditional information is approved for Viatris Specialty LLC's REVATIO® (sildenafil) product. Disease-Associated Maternal and/or Embryo/Fetal Risk Additional information is approved for Viatris Specialty LLC's REVATIO® (sildenafil) product.

13 NONCLINICAL TOXICOLOGY

Sildenafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

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 or almost white, slightly hygroscopic crystalline powder with a solubility of 10 mg/ 100ml in water and a molecular weight of 666.7.Sildenafil for Oral Suspension: 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. Following reconstitution with 93 mL water, the total volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. 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 with a solubility of 10 mg/ 100ml in water and a molecular weight of 666.7.

• 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.