It is not possible to determine whether these

Medication effectiveness can be impacted by certain health conditions.
Men should not use sildenafil if they have a history of stroke.
Sildenafil 10mg can sometimes cause nasal congestion.
It’s important to report any unusual side effects to your doctor.
Do not use sildenafil if you are taking other ED medications.

reported events are related directly to the use of

The drug is generally safe when used as prescribed.
Patients should inform their doctor about all health conditions.
Sildenafil 10mg is sometimes used to treat high-altitude pulmonary hypertension.
Do not take sildenafil with heavy or fatty foods for better absorption.
Store the medication at room temperature away from moisture.

sildenafil, to the patient’s underlying risk factors for

What Are Side Effects Associated with Using Sildenafil?

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 sildenafil oral jelly 100mg hypertension (PH) secondary to sickle 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.

When and How to Take Sildenafil for Best Results

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. 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). hearing loss, a combination of these factors, or to

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other factors.Advise patients to

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seek prompt medical attention

The medication can be part of a treatment plan for ED.
Do not share sildenafil with others, even if they have similar symptoms.
Taking sildenafil on an empty stomach may increase effectiveness.
Be aware of possible allergic reactions, such as rash.
Follow-up with your healthcare provider regularly when using sildenafil.

in the event of sudden decrease or loss of hearing while taking PDE-5

Side Effect	Severity	Likelihood	Management Tips
Headache	Mild to moderate	Common	Mild analgesics, hydration
Flushing	Mild	Common	Cool environment, stay hydrated
Nasal congestion	Mild	Moderately common	Decongestants if necessary
Dizziness	Mild	Possible	Avoid sudden movements
Visual disturbances	Mild	Rare	Rest and monitor if occurs

inhibitors, including sildenafil.5.6 Combination

Before taking this medicine

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. 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.

Mechanism of Action

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. 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. Therefore, use of sildenafil in patients with retinitis pigmentosa is not recommended.5.5 Hearing LossCases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including sildenafil. In some of the cases, medical conditions and other factors were reported that may have played a role. In many cases, medical follow-up information was limited. with other PDE-5 InhibitorsSildenafil

5.3 Epistaxis

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. (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.

Pulmonary Arterial Hypertension

(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. is also marketed as VIAGRA®.

Sildenafil 10mg can cause dizziness or vision changes in some users.
Always check for drug interactions before taking sildenafil.
It is important to stay hydrated when using sildenafil.
The medication is not effective as an aphrodisiac without stimulation.
Seek emergency help if you experience chest pain after use.

The safety and efficacy

How are they different?

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Revatio Injection

® Registered Marks and SM Service Marks of the Blue Cross and Blue Shield Association. ®´ Registered Marks of Blue Cross Blue Shield of Massachusetts, Inc. ®´ Registered Marks, TM Trademarks, and SM Service Marks are property of their respective owners. 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. of combinations of sildenafil with

Liver Dose Adjustments

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). 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.

Key Takeaways

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. 5 WARNINGS AND PRECAUTIONS 5.1 HypotensionSildenafil has vasodilatory properties, resulting in mild and transient decreases in blood pressure. VIAGRA or other PDE-5 inhibitors have not been studied.

Condition	Risk Factors	Recommendations
Use with nitrates	Severe hypotension, risk of significant blood pressure drop	Avoid combining, consult healthcare provider
Severe cardiovascular disease	Risk of adverse cardiovascular events	Use only under medical supervision
Liver impairment	Altered metabolism, increased side effects	Dose adjustment or avoid use
Retinitis pigmentosa	Potential for increased visual side effects	Use with caution, consult ophthalmologist