SILDENAFIL CITRATE powder, for suspension

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use SILDENAFIL FOR ORAL SUSPENSION safely and effectively. See the full prescribing information for SILDENAFIL FOR ORAL SUSPENSION.
SILDENAFIL for oral suspension
Initial U.S. Approval: 1998

RECENT MAJOR CHANGES

Indications and Usage (1) 1/2023
Dosage and Administration (2.1, 2.3) 1/2023

INDICATIONS AND USAGE

Adults
Sildenafil 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. Additionally, it may be indicated for other conditions as determined by a healthcare provider, including erectile dysfunction in specific cases.

DOSAGE AND ADMINISTRATION

• Adults: The recommended initial dose is 20 mg three times a day. Dosing may be adjusted based on individual symptoms, efficacy, tolerability, and clinical response, as determined by the attending physician.

DOSAGE FORMS AND STRENGTHS

• For oral suspension: 10 mg/mL when reconstituted, ensuring the powder is mixed as per the guidelines provided by a healthcare professional.

CONTRAINDICATIONS

• Contraindicated for use with organic nitrates or riociguat, as this combination may lead to severe hypotension.
• Patients with a known history of hypersensitivity reactions to sildenafil or any inactive components in the formulation should avoid using this product.

WARNINGS AND PRECAUTIONS

• Patients with hypotension or those on antihypertensive therapy may experience increased vasodilatory effects.
• Not recommended for use in pulmonary veno-occlusive disease (PVOD) as it may lead to pulmonary edema.
• Seek immediate medical attention if there is a sudden decrease or loss of vision or hearing.
• In patients with pulmonary hypertension secondary to sickle cell disease, sildenafil may precipitate serious vaso-occlusive crises.

ADVERSE REACTIONS

Adults: Commonly reported adverse reactions include headache, dyspepsia, flushing, limb pain, myalgia, back pain, and diarrhea.
In pediatric patients, priapism has been reported.

To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

DRUG INTERACTIONS

• Co-administration with strong CYP3A inhibitors is not recommended due to the potential for increased sildenafil plasma levels.
• Avoid concomitant use with other PDE-5 inhibitors like Viagra® or any alternative PDE-5 inhibitors due to increased risk of adverse effects.

Additional information regarding drug interactions can be found in the prescribing information for related products, but this specific formulation may not include that information due to marketing exclusivity rights.

USE IN SPECIFIC POPULATIONS

Pregnancy
Risk Summary: Limited published data do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when used during pregnancy. Nevertheless, there are significant risks to both the mother and fetus from untreated pulmonary arterial hypertension.

Pediatric Use
Additional dosing and safety information may be obtained from approved labels of similar sildenafil products; however, this product is not labeled with that information due to exclusivity rights.

OVERDOSAGE

In clinical studies involving healthy volunteers, single doses of up to 800 mg were tolerated, with adverse events correlating with those seen at lower doses but at higher rates and severities. If overdose occurs, standard supportive measures should be initiated as necessary.

DESCRIPTION

Sildenafil, a selective phosphodiesterase-5 (PDE-5) inhibitor, is provided as the citrate salt. It is commercially recognized under the brand VIAGRA® for erectile dysfunction. For oral suspension, sildenafil is available in an amber glass bottle containing white to off-white powders suitable for reconstitution.

CLINICAL PHARMACOLOGY

Mechanism of Action

Sildenafil inhibits the enzyme phosphodiesterase type 5 (PDE-5), promoting relaxation of smooth muscle in the pulmonary vasculature, leading to increased blood flow and vasodilation.

Pharmacokinetics

Sildenafil exhibits rapid absorption following oral administration, achieving a mean absolute bioavailability of approximately 41%. The drug is primarily metabolized by the CYP3A hepatic microsomal isoenzymes.

HOW SUPPLIED/STORAGE AND HANDLING

Sildenafil for oral suspension is packaged in amber glass bottles, each containing the requisite white to off-white powders. Store below 30°C (86°F) in the original container, and discard any remaining oral suspension 60 days post-reconstitution.

PATIENT COUNSELING INFORMATION

Patients are advised to review the FDA-approved patient information. It is crucial to inform patients about the contraindication of concurrent use with organic nitrates and to seek immediate medical assistance for any sudden loss of vision or hearing while administered with sildenafil.