1 INDICATIONS AND USAGE

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)].

Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

Sildenafil for Oral Suspension

White to light yellow colored granular powder containing 1.57 g of sildenafil citrate (equivalent to 1.12 g of sildenafil) in a bottle intended for reconstitution. Following reconstitution with 90 mL of water, the volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. A 2 mL oral syringe (with 0.5 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided.

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. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil.

5 WARNINGS AND PRECAUTIONS

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)]

7 DRUG INTERACTIONS

Nitrates

Concomitant use of sildenafil with nitrates in any form is contraindicated [see Contraindications (4)].

Strong CYP3A Inhibitors

Concomitant use of sildenafil with strong CYP3A inhibitors is not recommended [see Clinical Pharmacology (12.3)].

Moderate-to-Strong CYP3A Inducers

Concomitant use of sildenafil with moderate-to-strong CYP3A inducers (such as bosentan) decreases the sildenafil exposure. Dose up-titration of sildenafil may be needed when initiating treatment with moderate-to-strong CYP3A inducers. Reduce the dose of Sildenafil to 20 mg three times a day when discontinuing treatment with moderate-to-strong CYP3A inducers [see Clinical Pharmacology (12.3) and Clinical Studies (14)].

8 USE IN SPECIFIC POPULATIONS

10 OVERDOSAGE

In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses but rates and severities were increased.

In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine.

11 DESCRIPTION

Sildenafil, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction.

Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula:

Sildenafil citrate is a white or almost white, slightly hygroscopic, crystalline powder and a molecular weight of 666.7.

Sildenafil for Oral Suspension: Sildenafil for oral suspension is supplied as white to light yellow colored granular powder containing 1.57 g of sildenafil citrate (equivalent to1.12 g sildenafil) in an amber glass bottle intended for reconstitution. Following reconstitution with 90 mL water, the total volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. The inactive ingredients include citric acid anhydrous, colloidal silicon dioxide, grape flavor, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, titanium dioxide and xanthan gum. In addition to the bottle, a press-in bottle adapter and an oral dosing syringe (with 0.5 mL and 2 mL dose markings) are provided.

12 CLINICAL PHARMACOLOGY

12.3 Pharmacokinetics

Absorption and Distribution

Sildenafil is rapidly absorbed after oral administration, with a mean absolute bioavailability of 41% (25 to 63%). Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state. When sildenafil is taken with a high-fat meal, the rate of absorption is reduced, with a mean delay in Tmax of 60 minutes and a mean reduction in Cmax of 29%. The mean steady state volume of distribution (Vss) for sildenafil is 105 L, indicating distribution into the tissues. Sildenafil and its major circulating N-desmethyl metabolite are both approximately 96% bound to plasma proteins. Protein binding is independent of total drug concentrations.

Bioequivalence was established between the 20 mg tablet and the 10 mg/mL oral suspension when administered as a 20 mg single oral dose of sildenafil (as citrate).

Metabolism and Excretion

Sildenafil is cleared predominantly by the CYP3A (major route) and cytochrome P450 2C9 (CYP2C9, minor route) hepatic microsomal isoenzymes. The major circulating metabolite results from N-desmethylation of sildenafil, and is, itself, further metabolized. This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE-5 approximately 50% of the parent drug. In healthy volunteers, plasma concentrations of this metabolite are approximately 40% of those seen for sildenafil, so that the metabolite accounts for about 20% of sildenafil's pharmacologic effects. In patients with PAH, however, the ratio of the metabolite to sildenafil is higher. Both sildenafil and the active metabolite have terminal half-lives of about 4 hours.

After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the feces (approximately 80% of the administered oral dose) and to a lesser extent in the urine (approximately 13% of the administered oral dose).

Sildenafil Injection: The pharmacokinetic profile of sildenafil has been characterized following intravenous administration. A 10 mg dose of sildenafil injection is predicted to provide a pharmacological effect of sildenafil and its N-desmethyl metabolite equivalent to that of a 20 mg oral dose.

Population Pharmacokinetics

Age, gender, race, and renal and hepatic function were included as factors assessed in the population pharmacokinetic model to evaluate sildenafil pharmacokinetics in patients with PAH. The dataset available for the population pharmacokinetic evaluation contained a wide range of demographic data and laboratory parameters associated with hepatic and renal function. None of these factors had a significant impact on sildenafil pharmacokinetics in patients with PAH.

In patients with PAH, the average steady-state concentrations were 20 to 50% higher when compared to those of healthy volunteers. There was also a doubling of Cmin levels compared to healthy volunteers. Both findings suggest a lower clearance and/or a higher oral bioavailability of sildenafil in patients with PAH compared to healthy volunteers.

Pediatric Patients

Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.

Geriatric Patients

Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil, resulting in approximately 84% and 107% higher plasma concentrations of sildenafil and its active N-desmethyl metabolite, respectively, compared to those seen in healthy younger volunteers (18 to 45 years). Due to age-differences in plasma protein binding, the corresponding increase in the AUC of free (unbound) sildenafil and its active N-desmethyl metabolite were 45% and 57%, respectively.

Renal Impairment

In volunteers with mild (CLcr = 50 to 80 mL/min) and moderate (CLcr = 30 to 49 mL/min) renal impairment, the pharmacokinetics of a single oral dose of sildenafil (50 mg) was not altered. In volunteers with severe (CLcr less than 30 mL/min) renal impairment, sildenafil clearance was reduced, resulting in approximately doubling of AUC and Cmax compared to age-matched volunteers with no renal impairment. In addition, N-desmethyl metabolite AUC and Cmax values were significantly increased 200 % and 79 %, respectively, in patients with severe renal impairment compared to patients with normal renal function.

Hepatic Impairment

In volunteers with mild to moderate hepatic cirrhosis (Child-Pugh class A and B), sildenafil clearance was reduced, resulting in increases in AUC (84%) and Cmax (47%) compared to age-matched volunteers with no hepatic impairment. Patients with severe hepatic impairment (Child-Pugh class C) have not been studied.

Drug Interaction Studies

In vitro studies

Sildenafil metabolism is principally mediated by the CYP3A (major route) and CYP2C9 (minor route) cytochrome P450 isoforms. Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance.

Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A (IC50 greater than150 µM).

Sildenafil is not expected to affect the pharmacokinetics of compounds which are substrates of these CYP enzymes at clinically relevant concentrations.

In vivo studies

The effects of other drugs on sildenafil pharmacokinetics and the effects of sildenafil on the exposure to other drugs are shown in Figure 1 and Figure 2, respectively.

Figure 1. Effects of Other Drugs on Sildenafil Pharmacokinetics

Figure 2. Effects of Sildenafil on Other Drugs

CYP3A Inhibitors and Beta Blockers

Population pharmacokinetic analysis of data from patients in clinical trials indicated an approximately 30% reduction in sildenafil clearance when it was co-administered with mild/moderate CYP3A inhibitors and an approximately 34% reductions in sildenafil clearance when co-administered with beta-blockers. Sildenafil exposure at a dose of 80 mg three times a day without concomitant medication is shown to be 5-fold the exposure at a dose of 20 mg three times a day. This concentration range covers the same increased sildenafil exposure observed in specifically-designed drug interaction studies with CYP3A inhibitors (except for potent inhibitors such as ketoconazole, itraconazole, and ritonavir).

Sildenafil Injection: Predictions based on a pharmacokinetic model suggest that drug-drug interactions with CYP3A inhibitors will be less than those observed after oral sildenafil administration.

CYP3A4 Inducers Including Bosentan

Concomitant administration of strong CYP3A inducers is expected to cause substantial decreases in plasma levels of sildenafil.

Population pharmacokinetic analysis of data from patients in clinical trials indicated approximately 3-fold the sildenafil clearance when it was co-administered with mild CYP3A inducers.

Epoprostenol

The mean reduction of sildenafil (80 mg three times a day) bioavailability when co-administered with epoprostenol was 28%, resulting in about 22% lower mean average steady state concentrations. Therefore, the slight decrease of sildenafil exposure in the presence of epoprostenol is not considered clinically relevant. The effect of sildenafil on epoprostenol pharmacokinetics is not known.

No significant interactions were shown with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolized by CYP2C9.

Alcohol

Sildenafil (50 mg) did not potentiate the hypotensive effect of alcohol in healthy volunteers with mean maximum blood alcohol levels of 0.08%.

13 NONCLINICAL TOXICOLOGY

14 CLINICAL STUDIES

SUPER-1 (NCT00644605) - Sildenafil monotherapy [20 mg, 40 mg, and 80 mg three times a day]

A randomized, double-blind, placebo-controlled study of Sildenafil (SUPER-1)was conducted in 277 patients with PAH (defined as a mean pulmonary artery pressure ≥ 25 mmHg at rest with a pulmonary capillary wedge pressure <15 mmHg). Patients were predominantly WHO Functional Classes II-III. Allowed background therapy included a combination of anticoagulants, digoxin, calcium channel blockers, diuretics, and oxygen. The use of prostacyclin analogues, endothelin receptor antagonists, and arginine supplementation were not permitted. Patients who had failed to respond to bosentan were also excluded. Patients with left ventricular ejection fraction less than 45% or left ventricular shortening fraction less than 0.2 also were not studied.

Patients were randomized to receive placebo (n=70) or Sildenafil 20 mg (n = 69), 40 mg (n = 67) or 80 mg (n = 71) three times a day for a period of 12 weeks. They had either primary pulmonary hypertension (PPH) (63%), PAH associated with CTD (30%), or PAH following surgical repair of left-to-right congenital heart lesions (7%). The study population consisted of 25% men and 75% women with a mean age of 49 years (range: 18 to 81 years) and baseline 6-minute walk distance between 100 and 450 meters (mean 343).

The primary efficacy endpoint was the change from baseline at Week 12 (at least 4 hours after the last dose) in the 6-minute walk distance. Placebo-corrected mean increases in walk distance of 45 to 50 meters were observed with all doses of Sildenafil. These increases were significantly different from placebo, but the Sildenafil dose groups were not different from each other (see Figure 3), indicating no additional clinical benefit from doses higher than 20 mg three times a day. The improvement in walk distance was apparent after 4 Week of treatment and was maintained at week 8 and week 12.

Figure 3. Change from Baseline in 6-Minute Walk Distance (meters) at Weeks 4, 8, and 12 in SUPER-1: Mean (95% Confidence Interval)

Figure 4 displays subgroup efficacy analyses in SUPER-1 for the change from baseline in 6-Minute Walk Distance at Week 12 including baseline walk distance, disease etiology, functional class, gender, age, and hemodynamic parameters.

Figure 4. Placebo-Corrected Change From Baseline in 6-Minute Walk Distance (meters) at Week 12 by Study Subpopulation in SUPER-1: Mean (95% Confidence Interval)

Key: PAH = pulmonary arterial hypertension; CTD = connective tissue disease; PH = pulmonary hypertension;

PAP = pulmonary arterial pressure; PVRI = pulmonary vascular resistance index; TID = three times daily.

SUPER-2 (NCT00159887) Long-term Treatment of PAH

In a long-term follow-up of patients who were treated with sildenafil (n=277), K-M estimates of survival at 1, 2, and 3 years were 94%, 88% , and 79%, respectively. These uncontrolled observations do not allow comparison with a group not given sildenafil and cannot be used to determine the long term-effect of sildenafil on mortality.

PACES-1 (NCT00159861) - Sildenafil Co-administered with Epoprostenol

A randomized, double-blind, placebo controlled study (PACES-1) was conducted in 267 patients with PAH who were taking stable doses of intravenous epoprostenol. Patients had to have a mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg and a pulmonary capillary wedge pressure (PCWP) less than or equal to 15 mmHg at rest via right heart catheterization within 21 days before randomization, and a baseline 6-minute walk test distance greater than or equal to 100 meters and less than or equal to 450 meters (mean 349 meters). Patients were randomized to placebo or sildenafil (in a fixed titration starting from 20 mg to 40 mg and then 80 mg, three times a day) and all patients continued intravenous epoprostenol therapy.

At baseline patients had PPH (80%) or PAH secondary to CTD (20%);WHO Functional Class I (1%), II (26%), III (67%), or IV (6%); and the mean age was 48 years, 80% were female, and 79% were Caucasian.

There was a statistically significant greater increase from baseline in 6-minute walk distance at Week 16 (primary endpoint) for the sildenafil group compared with the placebo group. The mean change from baseline at Week 16 (last observation carried forward) was 30 meters for the sildenafil group compared with 4 meters for the placebo group giving an adjusted treatment difference of 26 meters (95% CI: 10.8, 41.2) (p = 0.0009).

Patients on sildenafil achieved a statistically significant reduction in mPAP compared to those on placebo. A mean placebo-corrected treatment effect of -3.9 mmHg was observed in favor of sildenafil (95% CI: -5.7, -2.1) (p = 0.00003).

Time to clinical worsening of PAH was defined as the time from randomization to the first occurrence of a clinical worsening event (death, lung transplantation, initiation of bosentan therapy, or clinical deterioration requiring a change in epoprostenol therapy). Table 4 displays the number of patients with clinical worsening events in (PACES-1). 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). Kaplan- Meier plot of time to clinical worsening is presented in Figure 5.

Figure 5. Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in PACES-1

Improvements in WHO Functional Class for PAH were also demonstrated in patients on sildenafil compared to placebo. More than twice as many sildenafil-treated patients (36%) as placebo-treated patients (14%) showed an improvement in at least one functional New York Heart Association (NYHA) class for PAH.

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. The PAH patients included those with primary PAH and PAH associated with CTD. Patients were randomized to placebo or sildenafil (20 mg three times a day) in combination with bosentan (62.5 to 125 mg twice a day).The primary efficacy endpoint was the change from baseline at Week 12 in 6-minute walk distance (6MWD). The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil 20 mg plus bosentan and bosentan alone.

Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.

16 HOW SUPPLIED/STORAGE AND HANDLING

Sildenafil powder for oral suspension is supplied in amber glass bottles. Each bottle contains white to light yellow colored granular powder containing 1.57 g of sildenafil citrate (equivalent to 1.12 g sildenafil). Following reconstitution, the volume of the oral suspension is 112 mL (10 mg sildenafil/mL). A 2 mL oral dosing syringe (with 0.5 mL and 2 mL dose markings) and a press-in bottle adaptor are also provided.

Recommended storage for Sildenafil for oral suspension: Store below 30°C (86°F) in the original package in order to protect from moisture.

Recommended storage for reconstituted oral suspension

Store below 30°C (86°F) or in refrigerator at 2° to 8°C (36° to 46°F). Do not freeze. The shelf-life of the reconstituted oral suspension is 60 days. Any remaining oral suspension should be discarded 60 days after reconstitution.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

•   Inform patients of contraindication of sildenafil for oral suspension with regular and/or intermittent use of organic nitrates.
•   Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients taking sildenafil for oral suspension not to take VIAGRA or other PDE-5 inhibitors.
•   Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil for oral suspension. Such an event may be a sign of NAION.
•   Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil for oral suspension. These events may be accompanied by tinnitus and dizziness.

The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Goa - 403 722

India

Revised: December 2023

PATIENT INFORMATION

Sildenafil (Sil-DEN-a-fil) for Oral Suspension

What is the most important information I should know about sildenafil for oral suspension?

Never take sildenafil for oral suspension with any nitrate or guanylate cyclase stimulator medicines.

• Your blood pressure could drop quickly to an unsafe level.

Nitrates include:

• Medicines that treat chest pain (angina)
• Nitroglycerin in any form including tablets, patches, sprays, and ointments
• Isosorbide mononitrate or dinitrate
• Street drugs called "poppers" (amyl nitrate, butyl nitrate or nitrite)

Guanylate cyclase stimulators include:

• Riociguat ,a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.

Ask your healthcare provider or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine.

See "What are the possible side effects of Sildenafil for oral suspension?" for more information about side effects.

What is Sildenafil for oral suspension?

Sildenafil for oral suspension is a prescription medicine used to treat pulmonary arterial hypertension (PAH). PAH is a type of high blood pressure in the arteries of your lungs. Sildenafil for oral suspension may be used in:

• adults to improve your ability to exercise and help slow down the worsening of your physical condition.
• It is not known if sildenafil for oral suspension is safe and effective in children younger than 1 year of age.

Do not take sildenafil for oral suspension if you:

• take medicines called nitrates.
• take riociguat, a guanylate cyclase stimulator medicine.
• are allergic to sildenafil or any of the ingredients in sildenafil for oral suspension. See the end of this leaflet for a complete list of ingredients in sildenafil for oral suspension.

Before taking sildenafil for oral suspension, tell your healthcare provider about all of your medical conditions, including if you:

• have low blood pressure
• have heart problems
• have pulmonary veno-occlusive disease (PVOD)
• have bleeding problems or a stomach (peptic) ulcer. It is not known if sildenafil for oral suspension is safe in people with bleeding
• problems or who have a stomach ulcer.
• have an eye problem called retinitis pigmentosa
• have ever had sudden loss of vision in one or both eyes, including an eye problem called non-arteritic anterior
• ischemic optic neuropathy (NAION)
• have ever had hearing problems such as ringing in the ears, dizziness, or loss of hearing
• have a deformed penis shape or Peyronie's disease
• have any blood cell problems such as sickle cell anemia
• are pregnant or plan to become pregnant. It is not known if sildenafil for oral suspension will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Sildenafil for oral suspension passes into your breast milk. It is not known if it can harm your baby. Talk with your healthcare provider about the best way to feed your baby during treatment with sildenafil for oral suspension.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Sildenafil for oral suspension and certain other medicines may affect each other and can cause side effects

Especially tell your healthcare provider if you take:

• nitrates or guanylate cyclase stimulators. See "What is the most important information I should know aboutsildenafil for oral suspension?"
• medicines to treat high blood pressure
• medicines for erectile dysfunction (impotence). Sildenafil for oral suspension contains sildenafil, which is the same medicine found in another medicine called VIAGRA®. VIAGRA is used for the treatment of erectile dysfunction. Do nottake VIAGRA or other PDE-5 inhibitors during treatment with sildenafil for oral suspension.

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you or your child take. Keep a list of your or your child's medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take sildenafil for oral suspension?

• Take or give sildenafil for oral suspension exactly as your healthcare provider tells you.
• Your healthcare provider may change your dose of sildenafil for oral suspension as needed. Do not change your dose or stop taking sildenafil for oral suspension without talking to your healthcare provider.
• Sildenafil may be prescribed to you as sildenafil oral suspension.
• Take your prescribed dose of sildenafil for oral suspension 3 times a day.
• See the detailed Instructions for Use that comes with sildenafil for oral suspension for information on how to take or give sildenafil oral suspension.Sildenafil oral suspension will be mixed for you by your pharmacist. Do not mix sildenafil oral suspension with other medicine or flavoring.
• If you take too much sildenafil for oral suspension, call your healthcare provider or go to the nearest hospital emergencyroom right away.

What are the possible side effects of sildenafil for oral suspension?

Sildenafil for oral suspension may cause serious side effects, including:

• See "What is the most important information I should know about sildenafil for oral suspension?"
• Decreased blood pressure.Sildenafil for oral suspension may cause low blood pressure that last for a short time. If you take medicines to treat high blood pressure, your healthcare provider should monitor your blood pressure during treatment with sildenafil for oral suspension.
• Decreased eyesight or permanent loss of vision in one or both eyescan be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Most people who develop NAION have certain risk factors. You can ask your healthcare provider if you have questions about risk factors for NAION. If you notice a sudden decrease or loss of vision in one or both eyes during treatment with sildenafil for oral suspension, contact your healthcare provider right away.
• Sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness. If you notice a sudden decrease or loss of hearing during treatment with sildenafil for oral suspension, contact your healthcare provider right away.
• In men, an erection that lasts for more than 4 hours (priapism). If you have an erection, with or without pain, that lasts more than 4 hours, contact your healthcare provider or get emergency medical help right away. A painful erection that lasts more than 6 hours must be treated right away or you can have lasting damage to your penis, including the inability to have erections.

The most common side effects of sildenafil for oral suspension in adults include:

• nosebleeds
• muscle aches and pain
• headache
• back pain
• upset stomach
• diarrhea
• getting red or hot in the face (flushing)
• arm or leg pain

These are not all the possible side effects of sildenafil for oral suspension.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 -800-FDA-1088.

How should I store sildenafil for oral suspension?

• Store mixed (reconstituted) sildenafil 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 oral suspension.
• Throw away (discard) any remaining sildenafil oral suspension 60 days after mixed by the pharmacist. See the "Discard after" date written on the bottle label.

Keep sildenafil for oral suspension and all medicines out of the reach of children.

General information about the safe and effective use of sildenafil for oral suspension

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use sildenafil for oral suspension for a condition for which it was not prescribed. Do not give sildenafil for oral suspension to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about sildenafil for oral suspension that is written for health professionals.

For more information, go to www.lupinpharmaceuticals.com or call 1-800-399-2561.

What are the ingredients in sildenafil for oral suspension?

Sildenafil for oral suspension

Active ingredients: sildenafil citrate

Inactive ingredients: citric acid anhydrous, colloidal silicon dioxide, grape flavor, sodium benzoate, sodium citrate dihydrate, sorbitol, sucralose, titanium dioxide and xanthan gum

Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.

This Patient Information has been approved by the U.S. Food and Drug Administration

The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Goa - 403 722

India

Revised: December 2023                                                                                                                                                                                                                                                                                                                                                                                           

Instructions for Use

Sildenafil (Sil-DEN-a-fil) for oral suspension

Read this Instructions for Use before you start taking sildenafil oral suspension and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Important information:

• Ask your healthcare provider or pharmacist to show you how to measure and take your prescribed dose of sildenafil oral suspension.
• Your pharmacist will mix (reconstitute) sildenafil for oral suspension before it is given to you. Do nottake or give sildenafil oral suspension and contact your pharmacist if the medicine in the bottle is still a powder.
• Always use the oral dosing syringe that comes with sildenafil oral suspension. If your carton does not come with an oral dosing syringe, contact your pharmacist.
• Do nottake or give sildenafil oral suspension if the bottle adaptor is not in the bottle. If the bottle adaptor is not in the bottle, contact your pharmacist.
• Sildenafil oral suspension should not be mixed with any other medicine or flavoring.

Supplies you will need to take or give a dose of sildenafil oral suspension (See Figure A):

• 1 bottle of sildenafil oral suspension with pre-inserted bottle adaptor
• 1 oral dosing syringe (provided in the carton)

Step 1.Shake the bottle of sildenafil oral suspension for 10 seconds before each use. (See Figure B)

Step 2. Remove the cap. Open the bottle by pushing down on the cap and twisting it in the direction of the arrow (counter-clockwise). (See Figure C)

Step 3. Fully push down (depress) the plunger of the oral dosing syringe. Then insert the tip of the oral dosing syringe into the bottle adaptor while holding the bottle upright, on a flat surface. (See Figure D)

Step 4. Turn the bottle upside down while holding the oral dosing syringe in place. Slowly pull back the plunger of the oral dosing syringe until the bottom of the plunger is even with the mL marking on the syringe for your prescribed dose. (See Figure E)

If your dose of sildenafil oral suspension is 1 mL (10 mg), measure 0.5 mL two times for a total of 1 mL of sildenafil oral suspension.

If your dose of sildenafil oral suspension is more than 2 mL (20 mg), you will need to divide the dose. Follow the instructions given to you by your healthcare provider or pharmacist about how to prepare the divided dose.

If you see air bubbles in the oral dosing syringe, slowly push the plunger all the way up so that sildenafil oral suspension flows back into the bottle and repeat Step 4.

Step 5. Turn the bottle back upright with the oral dosing syringe still in place. Place the bottle on a flat surface. Remove the oral dosing syringe from the bottle adaptor by pulling straight up on the barrel of the oral dosing syringe. (See Figure F) Do not press on the plunger of the oral dosing syringe at this time.

Step 6. Put the tip of the oral dosing syringe into your mouth and point it towards the inside of the cheek. Slowly push the plunger of the oral dosing syringe all the way down to give the entire dose. Do not squirt the medicine out quickly. (See Figure G)

If you are giving sildenafil oral suspension, make sure they are in an upright position before giving the medicine.

Step 7. Replace the cap on the bottle, leaving the bottle adaptor in place. Turn the cap in the direction of the arrow (clockwise) to close the bottle. (See Figure H)

Step 8. Wash the oral dosing syringe after each use. Pull the plunger out of the barrel and rinse both parts with water. (See Figure I)

Step 9. Dry all parts with a clean paper towel. Push the plunger back into the barrel. Store the oral dosing syringe with the sildenafil oral suspension bottle.

How should I store sildenafil for oral suspension?

• Store mixed (reconstituted) sildenafil 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 oral suspension
• Throw away (discard) any remaining sildenafil oral suspension 60 days after mixed by the pharmacist. See the "Discard after" date written on the bottle label.

Keep sildenafil for oral suspension and all medicines out of the reach of children.

Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.

This Instruction for Use has been approved by the U.S. Food and Drug Administration.

This product's label may have been updated. For current full prescribing information, please visit www.lupinpharmaceuticals.com.

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Goa - 403 722

India

Revised: December 2023                                                                                            ID#: 275283

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68180-283-01

Sildenafil for oral suspension

10 mg/mL

Rx only

Glass Bottle of 112 mL

NDC 68180-283-01

Sildenafil for oral suspension

10 mg/mL

Rx only

Carton of 112 mL Glass Bottle