Kaplan-Meier estimates and a stratified log-rank test demonstrated that placebo-treated patients were 3 times more likely to experience a clinical worsening event than sildenafil -treated patients and that sildenafil -treated patients experienced a significant delay in time to clinical worsening versus placebo-treated patients (p = 0.0074).

5.6 Hearing Loss

Kaplan-Meier estimates and a stratified log-rank test demonstrated that placebo-treated patients were 3 times more likely to experience a clinical worsening event than sildenafil -treated patients and that sildenafil -treated patients experienced a significant delay in time to clinical worsening versus placebo-treated patients (p = 0.0074). Study A1481243 (NCT00323297) -Sildenafil Added to Bosentan Therapy – Lack of Effect on Exercise Capacity A randomized, double-blind, placebo-controlled study was conducted in 103 patients with PAH who were on bosentan therapy for a minimum of 3 months. Sildenafil for Oral Suspension 10 mg/mL is supplied in amber glass bottles. Each bottle contains white to off-white powders containing 1.60 g of sildenafil citrate (equivalent to 1.14 g sildenafil). Sildenafil for Oral Suspension 10 mg/mL Recommended storage for Sildenafil for oral suspension 10 mg/mL: Store below 30°C (86°F) in the original package in order to protect from moisture.Reconstituted Oral Suspension Store below 30°C (86°F) or in refrigerator at 2°C to 8°C (36°F to 46°F).

Are you currently using Sildenafil (Viagra, Revatio)?

This Patient Information has been approved by the U.S. Food and Drug Administration. 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. Ask your healthcare provider or pharmacist to show you how to measure and take your prescribed dose of Sildenafil for oral suspension. 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). Study A1481243 (NCT00323297) -Sildenafil Added to Bosentan Therapy – Lack of Effect on Exercise Capacity A randomized, double-blind, placebo-controlled study was conducted in 103 patients with PAH who were on bosentan therapy for a minimum of 3 months. Sildenafil for Oral Suspension 10 mg/mL is supplied in amber glass bottles. Each bottle contains white to off-white powders containing 1.60 g of sildenafil citrate (equivalent to 1.14 g sildenafil). Sildenafil for Oral Suspension 10 mg/mL Recommended storage for Sildenafil for oral suspension 10 mg/mL: Store below 30°C (86°F) in the original package in order to protect from moisture.Reconstituted Oral Suspension Store below 30°C (86°F) or in refrigerator at 2°C to 8°C (36°F to 46°F). This Patient Information has been approved by the U.S. Food and Drug Administration.

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. Ask your healthcare provider or pharmacist to show you how to measure and take your prescribed dose of Sildenafil for oral suspension. 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. Slowly pull back the plunger of the oral dosing syringe until the bottom of the plunger is even with the mL markings on the syringe for your prescribed dose. 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.

8.4 Pediatric Use

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.

2.2 Recommended Dosage in Pediatric Patients

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 150mg sildenafil for sale 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. If your dose of Sildenafil for oral suspension is more than 2 mL (20 mg), you will need to divide the dose. If you are giving Sildenafil for oral suspension, make sure they are in an upright position before giving the medicine.

• 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.

Store the oral dosing syringe with Sildenafil for oral suspension bottle.

1 INDICATIONS AND USAGE

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. Store sildenafil citrate tablets 50mg 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 for oral suspension 60 days after mixed by the pharmacist. See full prescribing information for SILDENAFIL FOR ORAL SUSPENSION.SILDENAFIL for oral suspensionInitial U.S. Approval: 1998INDICATIONS 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.

• Sildenafil can cause visual disturbances like blurred vision.
• Alcohol consumption may increase side effects when using sildenafil.
• The syrup should be stored at room temperature away from light.
• Patients should avoid heavy meals before taking sildenafil.
• Regular monitoring is recommended for long-term use.

(1)DOSAGE AND ADMINISTRATIONDOSAGE FORMS AND STRENGTHS· For oral suspension: 10 mg/mL (when reconstituted) (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSVasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. (5.6)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.See 17 for PATIENT COUNSELING INFORMATION.Revised: 9/2023 · For oral suspension: 10 mg/mL (when reconstituted) (3) Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. Additional information is approved for Viatris Specialty LLC's REVATIO® (sildenafil) product. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 Recommended Dosage in Adults2.3 Reconstitution of the Powder for Oral Suspension3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS5.1 Hypotension5.2 Worsening Pulmonary Vascular Occlusive Disease5.3 Epistaxis5.4 Visual Loss5.5 Hearing Loss5.6 Combination with Other PDE-5 Inhibitors5.7 Priapism5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Patients with Hepatic Impairment8.7 Patients with Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. 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)].Additional information is approved for Viatris Specialty LLC's REVATIO® (sildenafil) product.

• The shelf life of sildenafil syrup depends on formulation and storage.
• Expiry dates should always be checked before use.
• Improper storage can lead to degradation of active ingredients.
• The liquid form allows for precise dose adjustments.
• Careful titration is essential to avoid overdose risks.

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.Additional information is sildenafil citrate tablets 150 mg 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 93 mL (60 mL followed by 33 mL). Add another 33 mL of water to the bottle.5.

2.1 Recommended Dosage in Adults

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). 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. 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.

What special dietary instructions should I follow?

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 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.

FULL PRESCRIBING INFORMATION: CONTENTS*

Shake the bottle of Sildenafil for oral suspension for 10 seconds before each use. Slowly pull back the plunger of the oral dosing syringe until the bottom of the plunger is even with the mL markings on the syringe for your prescribed dose. 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. If your dose of Sildenafil for oral suspension is more than 2 mL (20 mg), you will need to divide the dose. If you are giving Sildenafil for oral suspension, make sure they are in an upright position before giving the medicine.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Store the oral dosing syringe with Sildenafil for oral suspension bottle. Store sildenafil citrate tablets 50mg 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 for oral suspension 60 days after mixed by the pharmacist. See full prescribing information for SILDENAFIL FOR ORAL SUSPENSION.SILDENAFIL for oral suspensionInitial U.S. 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 150mg sildenafil for sale 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 predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia).

What are some side effects that I need to call my doctor about right away?

Approval: 1998INDICATIONS 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)DOSAGE AND ADMINISTRATIONDOSAGE FORMS AND STRENGTHS· For oral suspension: 10 mg/mL (when reconstituted) (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSVasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. (5.6)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.See 17 for PATIENT COUNSELING INFORMATION.Revised: 9/2023 · For oral suspension: 10 mg/mL (when reconstituted) (3) Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. Additional information is approved for Viatris Specialty LLC's REVATIO® (sildenafil) product.

Sildenafil Oral Suspension Dosage and Administration

Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 Recommended Dosage in Adults2.3 Reconstitution of the Powder for Oral Suspension3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS5.1 Hypotension5.2 Worsening Pulmonary Vascular Occlusive Disease5.3 Epistaxis5.4 Visual Loss5.5 Hearing Loss5.6 Combination with Other PDE-5 Inhibitors5.7 Priapism5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Patients with Hepatic Impairment8.7 Patients with Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed. 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)].Additional 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.Additional information is sildenafil citrate tablets 150 mg 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 93 mL (60 mL followed by 33 mL). Add another 33 mL of water to the bottle.5. 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).

• 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.

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.