Sildenafil 10 mg/ml Oral suspension

Study 2 (Sildenafil for Oral Suspension co-administered with epoprostenol) A randomized, double-blind, placebo controlled study (Study 2) was conducted in 267 patients with PAH who were taking stable doses of intravenous epoprostenol. Patients were randomized to placebo or Sildenafil for Oral Suspension (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 for Oral Suspension group compared with the placebo group. The mean change from baseline at Week 16 (last observation carried forward) was 30 meters for the Sildenafil for Oral Suspension 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 for Oral Suspension 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 for Oral Suspension (95% CI: -5.7, -2.1) (p = 0.00003).

• Sildenafil has been investigated for alternative uses like altitude sickness.
• The syrup form is rarely available in commercial pharmacies.
• Reactions to sildenafil can vary based on individual health.
• Do not share sildenafil syrup with others to avoid adverse effects.
• Always adhere to prescribed dosages to prevent health risks.

Kaplan-Meier plot of time to clinical worsening is presented in Figure 11.

DOSAGE AND ADMINISTRATION

Study 2 (Sildenafil for Oral Suspension co-administered with epoprostenol) A randomized, double-blind, placebo controlled study (Study 2) was conducted in 267 patients with PAH who were taking stable doses of intravenous epoprostenol. Patients were randomized to placebo or Sildenafil for Oral Suspension (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 for Oral Suspension group compared with the placebo group. The mean change from baseline at Week 16 (last observation carried forward) was 30 meters for the Sildenafil for Oral Suspension 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).

Does sildenafil interact with other medicines (drug interactions)?

Patients on Sildenafil for Oral Suspension 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 for Oral Suspension (95% CI: -5.7, -2.1) (p = 0.00003). Kaplan-Meier plot of time to clinical worsening is presented in Figure 11. Improvements in WHO functional class for PAH were also demonstrated in subjects on Sildenafil for Oral Suspension compared to placebo. More than twice as many Sildenafil for Oral Suspension-treated patients (36%) as placebo-treated patients (14%) showed an improvement in at least one functional New York Heart Association (NYHA) class for PAH.

12.3 Pharmacokinetics

Study 3 (Sildenafil for Oral Suspension monotherapy (1 mg, 5 mg, and 20 mg three times a day)) A randomized, double-blind, parallel dose study (Study 3) was planned in 219 patients with PAH. Patients were randomized to 1 of 3 doses of Sildenafil for Oral Suspension: 1 mg, 5 mg, and 20 mg, three times a day. At baseline patients had PPH (74%) or secondary PAH (26%); WHO functional class II (57%), III (41%), or IV (2%); the mean age was 44 years; and 67% were female. The majority of subjects were Asian (67%), and 28% were Caucasian. These sildenafil 200 mg increases were significantly better than those observed in the 1 mg dose group (Figure 12). Improvements in WHO functional class for PAH were also demonstrated in subjects on Sildenafil for Oral Suspension compared to placebo.

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More than twice as many Sildenafil for Oral Suspension-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 3 (Sildenafil for Oral Suspension monotherapy (1 mg, 5 mg, and 20 mg three times a day)) A randomized, double-blind, parallel dose study (Study 3) was planned in 219 patients with PAH. Patients were randomized to 1 of 3 doses of Sildenafil for Oral Suspension: 1 mg, 5 mg, and 20 mg, three times a day. At baseline patients had PPH (74%) or secondary PAH (26%); WHO functional class II (57%), III (41%), or IV (2%); the mean age was 44 years; and 67% were female.

5 WARNINGS AND PRECAUTIONS

Talk to your doctor first.If you take too much Sildenafil for Oral Suspension, call your doctor or go to the nearest hospital emergency room.What are the possible side effects of Sildenafil for Oral Suspension?low blood pressure. Low blood pressure may cause you to feel faint or dizzy. Lie down if you feel faint or dizzy.more shortness of breath than usual. Tell your doctor if you get more short of breath after you start Sildenafil for Oral Suspension. More shortness of breath than usual may be due to your underlying medical condition.decreased eyesight or loss of sight in one or both eyes (NAION).

5.5 Hearing Loss

If you notice a sudden decrease or loss of eyesight, talk to your doctor right away.sudden decrease or loss of hearing. If you notice a sudden decrease or loss of hearing, talk to your doctor right away. It is not possible to determine whether these events are related directly to this class of oral medicines, including Sildenafil for Oral Suspension, or to other diseases or medicines, to other factors, or to a combination of factors.heart attack, stroke, irregular heartbeats, and death.

Patients & Visitors

The majority of subjects were Asian (67%), and 28% were Caucasian.

Aspect	Sildenafil Syrup	Sildenafil Tablets
Ease of administration	Easy for children or those swallowing difficulties	Convenient for most adults
Dosage flexibility	Precise dosage adjustments possible	Fixed doses, less flexible
Onset of action	Usually quicker due to liquid form	Similar, around 30–60 min
Bioavailability	Slightly higher (due to faster absorption)	Slightly lower
Storage requirements	Same storage conditions	Same storage conditions

These sildenafil 200 mg increases were significantly better than those observed in the 1 mg dose group (Figure 12). Study 4 (Sildenafil for Oral Suspension 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 three months. 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil for Oral Suspension is supplied in amber glass bottles. Each bottle contains white to off-white powders containing 1.57 g ofsildenafil citrate (equivalent to 1.12 g sildenafil). Following constitution, the volume of the oral suspension is 112 mL (10 mgsildenafil/mL). Sildenafil for Oral Suspension is supplied in amber glass bottles. Each bottle contains white to off-white powders containing 1.57 g of STORAGE AND HANDLING Recommended storage for Sildenafil for Oral Suspension: Store below 30°C (86°F) in the original package in order to protect frommoisture.Reconstituted Oral SuspensionStore below 30°C (86°F) or in refrigerator at 2°C to 8°C (36°F - 46°F). The shelf-life of the reconstituted oral suspensionis 60 days. Recommended storage for Sildenafil for Oral Suspension: Store below 30°C (86°F) in the original package in order to protect from 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information).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. See FDA-approved patient labeling (Patient Information). PATIENT INFORMATION SILDENAFIL (sil den’ a fil) FOR ORAL SUSPENSIONRead this Patient Information before you start taking Sildenafil for Oral Suspension and each time you get a refill. This information does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about Sildenafil for Oral Suspension, ask your doctor or pharmacist.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.Nitrate medicines include:Medicines that treat chest pain (angina)Nitroglycerin in any form including tablets, patches, sprays, and ointmentsIsosorbide mononitrate or dinitrateStreet drugs called "poppers" (amyl nitrate or nitrite)Guanylate cyclase stimulators include:Riociguat (Adempas)Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine.What is Sildenafil for Oral Suspension?Sildenafil for Oral Suspension is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH). With 200mg sildenafil citrate PAH, the blood pressure in your lungs is too high.

• Sildenafil works by relaxing blood vessels to improve blood flow.
• Used primarily to treat erectile dysfunction and pulmonary hypertension.
• Syrup formulations may be used in children or those with swallowing difficulties.
• Proper storage of sildenafil syrup is essential to maintain efficacy.
• It is important to follow a healthcare provider’s instructions when using.

Your heart has to work hard to pump blood into your lungs.Sildenafil for Oral Suspension improves the ability to exercise and can slow down worsening changes in your physical condition.Sildenafil for Oral Suspension is not for use in childrenAdding Sildenafil for Oral Suspension to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise.Sildenafil for Oral Suspension contains the same medicine as VIAGRA® (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take Sildenafil for Oral Suspension with VIAGRA or other PDE-5 inhibitors.Who should not take Sildenafil for Oral Suspension?Do not take Sildenafil for Oral Suspension if you:take nitrate medicines. See "What is the most important information I should know about Sildenafil for Oral Suspension? "are allergic to sildenafil or any other ingredient inSildenafil for Oral Suspension. See "What are the ingredients in Sildenafil for Oral Suspension?" at the end of this leaflet.What should I tell my doctor before taking Sildenafil for Oral Suspension?Tell your doctor about all of your medical conditions, including if youhave heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attackhave a disease called pulmonary veno-occlusive disease (PVOD)have high or low blood pressure or blood circulation problemshave an eye problem called retinitis pigmentosahave or had loss of sight in one or both eyeshave any problem with the shape of your penis or Peyronie's diseasehave any blood cell problems such sickle cell anemiahave a stomach ulcer or any bleeding problemsare pregnant or planning to become pregnant. It is not known if Sildenafil for Oral Suspension could harm your unborn baby.are breastfeeding. Sildenafil for Oral Suspension passes into your breast milk, it is not known if it could harm your baby.Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. Sildenafil for Oral Suspension and certain other medicines can cause side effects if you take them together. The doses of some of your medicines may need to be adjusted while you take Sildenafil for Oral Suspension.Especially tell your doctor if you takeNitrate medicines. "Ritonavir (Norvir®) or other medicines used to treat HIV infectionKetoconazole (Nizoral®)Itraconazole (Sporanox)High blood pressure medicineKnow the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.How should I take Sildenafil for Oral Suspension?Take Sildenafil for Oral Suspension exactly as your doctor tells you.Take Sildenafil for Oral Suspension 3 times a day about 4 to 6 hours apartTake Sildenafil for Oral Suspension at the same times every day.Sildenafil for Oral Suspension will be mixed for you by your pharmacist. Do not mix Sildenafil for Oral Suspension with other medicine or flavoring. Shake well for at least 10 seconds before each dose.If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose, and take your next dose at the regular time.Do not take more than one dose of Sildenafil for Oral Suspension at a time.Do not change your dose or stop taking Sildenafil for Oral Suspension on your own. Talk to your doctor first.If you take too much Sildenafil for Oral Suspension, call your doctor or go to the nearest hospital emergency room.What are the possible side effects of Sildenafil for Oral Suspension?low blood pressure. Low blood pressure may cause you to feel faint or dizzy. Lie down if you feel faint or dizzy.more shortness of breath than usual.

5.8 Priapism

Study 4 (Sildenafil for Oral Suspension 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 three months. 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil for Oral Suspension is supplied in amber glass bottles. Each bottle contains white to off-white powders containing 1.57 g ofsildenafil citrate (equivalent to 1.12 g sildenafil). Following constitution, the volume of the oral suspension is 112 mL (10 mgsildenafil/mL). Sildenafil for Oral Suspension is supplied in amber glass bottles.

How sildenafil is used

Each bottle contains white to off-white powders containing 1.57 g of STORAGE AND HANDLING Recommended storage for Sildenafil for Oral Suspension: Store below 30°C (86°F) in the original package in order to protect frommoisture.Reconstituted Oral SuspensionStore below 30°C (86°F) or in refrigerator at 2°C to 8°C (36°F - 46°F). The shelf-life of the reconstituted oral suspensionis 60 days. Recommended storage for Sildenafil for Oral Suspension: Store below 30°C (86°F) in the original package in order to protect from 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information).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.

5.6 Combination with Other PDE-5 Inhibitors

See FDA-approved patient labeling (Patient Information). PATIENT INFORMATION SILDENAFIL (sil den’ a fil) FOR ORAL SUSPENSIONRead this Patient Information before you start taking Sildenafil for Oral Suspension and each time you get a refill. This information does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about Sildenafil for Oral Suspension, ask your doctor or pharmacist.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.Nitrate medicines include:Medicines that treat chest pain (angina)Nitroglycerin in any form including tablets, patches, sprays, and ointmentsIsosorbide mononitrate or dinitrateStreet drugs called "poppers" (amyl nitrate or nitrite)Guanylate cyclase stimulators include:Riociguat (Adempas)Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine.What is Sildenafil for Oral Suspension?Sildenafil for Oral Suspension is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH). Tell your doctor if you get more short of breath after you start Sildenafil for Oral Suspension. More shortness of breath than usual may be due to your underlying medical condition.decreased eyesight or loss of sight in one or both eyes (NAION).

If OVERDOSE is suspected:

With 200mg sildenafil citrate PAH, the blood pressure in your lungs is too high. Your heart has to work hard to pump blood into your lungs.Sildenafil for Oral Suspension improves the ability to exercise and can slow down worsening changes in your physical condition.Sildenafil for Oral Suspension is not for use in childrenAdding Sildenafil for Oral Suspension to another medication used to treat PAH, bosentan (Tracleer®), does not result in improvement in your ability to exercise.Sildenafil for Oral Suspension contains the same medicine as VIAGRA® (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take Sildenafil for Oral Suspension with VIAGRA or other PDE-5 inhibitors.Who should not take Sildenafil for Oral Suspension?Do not take Sildenafil for Oral Suspension if you:take nitrate medicines. See "What is the most important information I should know about Sildenafil for Oral Suspension? "are allergic to sildenafil or any other ingredient inSildenafil for Oral Suspension.

Related treatment guides

See "What are the ingredients in Sildenafil for Oral Suspension?" at the end of this leaflet.What should I tell my doctor before taking Sildenafil for Oral Suspension?Tell your doctor about all of your medical conditions, including if youhave heart problems such as angina (chest pain), heart failure, irregular heartbeats, or have had a heart attackhave a disease called pulmonary veno-occlusive disease (PVOD)have high or low blood pressure or blood circulation problemshave an eye problem called retinitis pigmentosahave or had loss of sight in one or both eyeshave any problem with the shape of your penis or Peyronie's diseasehave any blood cell problems such sickle cell anemiahave a stomach ulcer or any bleeding problemsare pregnant or planning to become pregnant. It is not known if Sildenafil for Oral Suspension could harm your unborn baby.are breastfeeding. Sildenafil for Oral Suspension passes into your breast milk, it is not known if it could harm your baby.Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. Sildenafil for Oral Suspension and certain other medicines can cause side effects if you take them together. The doses of some of your medicines may need to be adjusted while you take Sildenafil for Oral Suspension.Especially tell your doctor if you takeNitrate medicines.

Missed Dose

"Ritonavir (Norvir®) or other medicines used to treat HIV infectionKetoconazole (Nizoral®)Itraconazole (Sporanox)High blood pressure medicineKnow the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.How should I take Sildenafil for Oral Suspension?Take Sildenafil for Oral Suspension exactly as your doctor tells you.Take Sildenafil for Oral Suspension 3 times a day about 4 to 6 hours apartTake Sildenafil for Oral Suspension at the same times every day.Sildenafil for Oral Suspension will be mixed for you by your pharmacist. Do not mix Sildenafil for Oral Suspension with other medicine or flavoring. Shake well for at least 10 seconds before each dose.If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose, and take your next dose at the regular time.Do not take more than one dose of Sildenafil for Oral Suspension at a time.Do not change your dose or stop taking Sildenafil for Oral Suspension on your own. If you notice a sudden decrease or loss of eyesight, talk to your doctor right away.sudden decrease or loss of hearing. If you notice a sudden decrease or loss of hearing, talk to your doctor right away. It is not possible to determine whether these events are related directly to this class of oral medicines, including Sildenafil for Oral Suspension, or to other diseases or medicines, to other factors, or to a combination of factors.heart attack, stroke, irregular heartbeats, and death.