Sildenafil Citrate Oral Suspension for Managing Erectile Dysfunction: A Systematic Review and a Consensus Report from the Italian Society of Andrology (SIA)

Proper Use
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8.2 Lactation
What to avoid
8.5 Geriatric Use
12.2 Pharmacodynamics
How should I take sildenafil?

Browse singlecare.com to find drug discounts, helpful information about your prescription, and resources to help you make informed health decisions. Prescription savings vary by prescription and by pharmacy, and may reach up to 80% off cash price. This program offers you the opportunity to locate providers of various types of medical services who will offer their services to you at discounted rates. The range of discounts for medical or ancillary services provided under the plan will vary depending on the type of provider and service received. You are fully responsible for paying for all health care services but will be entitled to receive a discount from those health care providers in accordance with the specific pre-negotiated discounted fee schedule. This program does not guarantee the quality of the services or procedures offered by the providers. Except for prescription drugs which you will pay directly to the pharmacy at the time of purchase, all other services received through a program provider will be charged to the credit card on file in your member account. The charge will include an administrative fee for use of the program. Towers Administrators LLC is the licensed discount medical plan organization with its administrative office located at 4510 Cox Road, Suite 111, Glen Allen, VA 23060. SingleCare Services, LLC is the marketer of the discount medical plan organization including its website, singlecare.com, with its corporate office located at 99 High Street, Suite 2800, Boston, MA 02110. For additional information, including an up-to-date list of providers, or assistance with any issue related to program membership, please contact member support any time at or by calling toll-free 844-234-3057, 24 hours, 7 days a week (except major holidays). Pharmacy names, logos, brands, and other trademarks are the property of their respective owners. They are intended for general informational purposes and are not meant to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. If you think you may have a medical emergency, immediately call your physician or dial 911.

Common Side Effects	Severity	Management Tips
Headache	Mild	Hydration, pain relief as needed
Flushing	Mild	Cool environment, focus on gradual temperature changes
Nasal Congestion	Mild	Use of decongestants if necessary
Dyspepsia	Mild	Taking medication with food or avoiding fatty foods

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Proper Use

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 injection. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. 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)]. Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.

Alcohol interaction warning

Known hypersensitivity to sildenafil or any component of the injection. 5 WARNINGS AND PRECAUTIONS 5.1 HypotensionSildenafil has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing sildenafil, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [blood pressure less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction). Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil.5.2 Worsening Pulmonary Vascular Occlusive DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of sildenafil to patients with veno-occlusive disease, administration of sildenafil to such patients is not recommended. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SILDENAFIL INJECTION safely and effectively. See full prescribing information for SILDENAFIL INJECTION.SILDENAFIL injection, for intravenous useInitial U.S. Approval: 1998INDICATIONS AND USAGEAdultsSildenafil injection 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.

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(1)DOSAGE AND ADMINISTRATIONInjection (Adults): 10 mg three times a day administered as an intravenous bolus injection (2.1)DOSAGE FORMS AND STRENGTHSInjection: 10 mg/12.5 mL in a single-dose vial (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSVasodilation effects may be more common in patients with hypotension or on antihypertensive therapy.

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Use with strong CYP3A inhibitors: Not recommended. Concomitant PDE-5 inhibitors: Avoid use with Viagra® or other PDE-5 inhibitors. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil). However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 Recommended Dosage in Adults3 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.

Pulmonary Arterial Hypertension

Sections or subsections omitted from the full prescribing information are not listed. 1 INDICATIONS AND USAGE AdultsSildenafil injection 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). Sildenafil injection 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)]. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage in AdultsIntravenous DosageThe recommended dose is 10 mg administered as an intravenous bolus injection three times a day. The dose of sildenafil injection does not need to be adjusted for body weight.A 10 mg dose of sildenafil injection is predicted to provide pharmacological effect of sildenafil and its N-desmethyl metabolite equivalent to that of a 20 mg oral dose.Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil). (5.1)Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary edema and is not recommended.

8.2 Lactation

(5.1)Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary edema and is not recommended. (5.2)Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. (5.4, 5.5)Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. (5.8)ADVERSE REACTIONSDRUG INTERACTIONSUse with strong CYP3A inhibitors: Not recommended. (7, 12.3)Concomitant PDE-5 inhibitors: Avoid use with Viagra® or other PDE-5 inhibitors.

Professional resources

(5.6)Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil). 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: 12/2023 Injection (Adults): 10 mg three times a day administered as an intravenous bolus injection (2.1) Injection: 10 mg/12.5 mL in a single-dose vial (3) Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary edema and is not recommended. Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. Pulmonary hypertension (PH) secondary to sickle sildenafil cenforce cell disease: Sildenafil may cause serious vaso-occlusive crises. (5.2)Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. (5.4, 5.5)Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. (5.8)ADVERSE REACTIONSDRUG INTERACTIONSUse with strong CYP3A inhibitors: Not recommended. (7, 12.3)Concomitant PDE-5 inhibitors: Avoid use with Viagra® or other PDE-5 inhibitors. (5.6)Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil). 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: 12/2023 Injection (Adults): 10 mg three times a day administered as an intravenous bolus injection (2.1) Injection: 10 mg/12.5 mL in a single-dose vial (3) Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy.

What to avoid

For additional information, including an up-to-date list of providers, or assistance with any issue related to program membership, please contact member support any time at or by calling toll-free 844-234-3057, 24 hours, 7 days a week (except major holidays). Pharmacy names, logos, brands, and other trademarks are the property of their respective owners. They are intended for general informational purposes and are not meant to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. If you think you may have a medical emergency, immediately call your physician or dial 911.

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If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SILDENAFIL INJECTION safely and effectively. See full prescribing information for SILDENAFIL INJECTION.SILDENAFIL injection, for intravenous useInitial U.S. Approval: 1998INDICATIONS AND USAGEAdultsSildenafil injection 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 ADMINISTRATIONInjection (Adults): 10 mg three times a day administered as an intravenous bolus injection (2.1)DOSAGE FORMS AND STRENGTHSInjection: 10 mg/12.5 mL in a single-dose vial (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSVasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary edema and is not recommended. Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs.

Sildenafil 12.5 mg should be taken 30-60 minutes before sexual activity.
It is usually effective for up to 4-6 hours.
Does not cause an automatic erection; stimulation is needed.

Pulmonary hypertension (PH) secondary to sickle sildenafil cenforce cell disease: Sildenafil may cause serious vaso-occlusive crises. Use with strong CYP3A inhibitors: Not recommended. Concomitant PDE-5 inhibitors: Avoid use with Viagra® or other PDE-5 inhibitors. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil). However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.

Aspect	Rating (out of 5)	Comments
Efficacy	4.2	Generally effective for most users
Side effect profile	4.0	Mild side effects, well tolerated
Ease of use	4.5	Simple dosing regimen
Overall satisfaction	4.3	Positive feedback from majority of users

Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 Recommended Dosage in Adults3 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.

8.5 Geriatric Use

More common

This program does not guarantee the quality of the services or procedures offered by the providers. Except for prescription drugs which you will pay directly to the pharmacy at the time of purchase, all other services received through a program provider will be charged to the credit card on file in your member account. The charge will include an administrative fee for use of the program. Towers Administrators LLC is the licensed discount medical plan organization with its administrative office located at 4510 Cox Road, Suite 111, Glen Allen, VA 23060. SingleCare Services, LLC is the marketer of the discount medical plan organization including its website, singlecare.com, with its corporate office located at 99 High Street, Suite 2800, Boston, MA 02110. Sections or subsections omitted from the full prescribing information are not listed. 1 INDICATIONS AND USAGE AdultsSildenafil injection 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). Sildenafil injection 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)]. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage in AdultsIntravenous DosageThe recommended dose is 10 mg administered as an intravenous bolus injection three times a day. The dose of sildenafil injection does not need to be adjusted for body weight.A 10 mg dose of sildenafil injection is predicted to provide pharmacological effect of sildenafil and its N-desmethyl metabolite equivalent to that of a 20 mg oral dose.Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil).

Sildenafil 12.5 mg can improve confidence and quality of life.
Patients should discuss potential drug interactions with their doctor.
Be aware of potential side effects and report unusual symptoms promptly.

This dose is often used as a starting point before increasing if needed.
Combining with high-fat meals may slow absorption.
Avoid grapefruit juice, as it can affect sildenafil metabolism.

Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. 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)]. Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. Known hypersensitivity to sildenafil or any component of the injection.

12.2 Pharmacodynamics

Should signs of pulmonary edema occur when sildenafil is administered, consider the possibility of associated PVOD.5.3 EpistaxisThe incidence of epistaxis was 13% in patients taking sildenafil with PAH secondary to CTD. This effect was not seen in idiopathic PAH (sildenafil 3%, placebo 2%) patients. 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.

Chronic Obstructive Pulmonary Disease (COPD) (Off-Label Use)

5 WARNINGS AND PRECAUTIONS 5.1 HypotensionSildenafil has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing sildenafil, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [blood pressure less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction). Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil.5.2 Worsening Pulmonary Vascular Occlusive DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of sildenafil to patients with veno-occlusive disease, administration of sildenafil to such patients is not recommended.