FDA

Sildenafil Citrate

Approved 27 Nov 2019OralFor suspension

The FDA lists this product in 60 strengths and forms.

Indications

Adults Sildenafil 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. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.

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. ( 1 )

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.

Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. · Use with organic nitrates or riociguat. ( 4 ) · History of hypersensitivity reaction to sildenafil or any component of the tablet, injection, or oral suspension. ( 4 )

Warnings and precautions

Vasodilation 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. ( 5.4 , 5.5 ) Pulmonary hypertension (PH) secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises.

( 5.8 )

5.1Hypotension

Sildenafil 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).

At a glance

Brand name: Sildenafil Citrate
Route: Oral
Dosage form: For suspension
Applicant: Alkem Labs LTD
Status: Prescription
FDA approval: 27 Nov 2019
Application: ANDA212440-001

Indications

Contraindications

Warnings and precautions

( 5.8 )

5.1Hypotension

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 )] Adults: Headache, dyspepsia, flushing, pain in limb, myalgia, back pain and diarrhea.

( 6.1 , 6.2 ) Children: Priapism. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

Because 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.

Adverse reactions were generally transient and mild to moderate in nature. The overall frequency of discontinuation in sildenafil -treated patients was 3% (20 mg three times a day). The overall frequency of discontinuation for placebo was 3%. Table 1. 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) Sildenafil 20 mg (n = 69) Placebo (n = 70) Headache 46% 39% Flushing 10% 4% Pain in Limb 7% 6% Myalgia 7% 4% Back Pain 13% 11% Dyspepsia 13% 7% Diarrhea 9% 6% 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.

6.2Postmarketing Experience

The following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular Events In postmarketing experience with sildenafil at doses indicated for erectile dysfunction, serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, pulmonary hemorrhage, and subarachnoid and intracerebral hemorrhages have been reported in temporal association with the use of the drug.

Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil without sexual activity. Others were reported to have occurred hours to days after use concurrent with sexual activity. 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 System Seizure, seizure recurrence Ophthalmologic NAION [see Warnings and Precautions ( 5.4 ), Patient Counseling Information ( 17 )] .

Sildenafil Citrate

Indications

Contraindications

Warnings and precautions

5.1Hypotension

At a glance

Two medicines in one question?

Sildenafil Citrate

Indications

Contraindications

Warnings and precautions

5.1Hypotension

At a glance

Two medicines in one question?

5.2Worsening Pulmonary Vascular Occlusive Disease

5.3Epistaxis

5.4Visual Loss

5.5Hearing Loss Cases

5.6Combination with Other PDE-5 Inhibitors

5.7Priapism

Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information