Sildenafil Oral Suspension (PAH)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Side Effect	Frequency	Severity	Management
Headache	Common	Mild	Analgesics, hydration
Flushing	Common	Mild	Cool environment, monitor
Nasal congestion	Common	Mild	Decongestants, hydration
Dizziness	Less common	Moderate	Avoid sudden movements
Vision disturbances	Rare	Moderate	Discontinue, consult physician
Priapism (prolonged erection)	Rare	Severe	Emergency medical attention

Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization

DOSAGE FORMS AND STRENGTHS

However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. numbness, burning, or tingling in the arms, hands, feet, or legs pain in muscles, back, arms, or legs changes in color vision (seeing a blue tinge on objects or having difficulty telling the difference between blue and green) sudden severe loss of vision (see below for more information) erection that is painful or lasts longer than 4 hours rash; itching; hives; difficulty breathing or swallowing; swelling of the eyes, face, throat, tongue, or lips Some patients experienced a sudden loss of some or all of their vision after they took sildenafil or other medications that are similar to sildenafil. The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication.

Who should not take sildenafil?

If you experience a sudden loss of vision while you are taking sildenafil, call your doctor immediately. Do not take any more doses of sildenafil or similar medications such as tadalafil (Cialis) or vardenafil (Levitra) until you talk to your doctor. There have been reports of heart attack, stroke, irregular heartbeat, bleeding in the brain or lungs, high blood pressure, and sudden death in men who took sildenafil for erectile dysfunction. Most, but not all, of these people had heart problems before taking sildenafil. It is not known whether these events were caused by sildenafil, sexual activity, heart disease, or a combination of these and other causes.

Incidence not known

Talk to your doctor about the risks of taking sildenafil. Some patients experienced a sudden decrease or loss of hearing after they took sildenafil or other medications that are similar to sildenafil. It is not known if the hearing loss was caused by the medication. If you experience a sudden loss of hearing, sometimes with ringing in the ears or dizziness, while you are taking sildenafil, call your doctor immediately. If you are taking sildenafil (Viagra) for erectile dysfunction, do not take any more doses of sildenafil (Viagra) or similar medications such as tadalafil (Cialis) or vardenafil (Levitra) until you talk to your doctor. [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)].

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Pediatric Patients (1 to 17 Years Old) Sildenafil for oral suspension is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH)

• Sildenafil's patent expired, leading to generic versions in pill form.
• The syrup form may be compounded at pharmacies if needed.
• It is crucial to verify the source and quality of compounded syrup.
• Sildenafil's effects typically begin within 30-60 minutes.
• The duration of action is approximately 4-6 hours.

(WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise [see Clinical Studies (14)]. The recommended dosage of sildenafil for oral suspension is 20 mg three times a day.

• Sildenafil interacts with alpha-blockers, leading to hypotension.
• The syrup should be measured with a proper dosing device.
• The syrup form is less common and might have inconsistent absorption.
• Researchers are exploring alternative delivery methods like liquids.
• Pharmaceutical companies rarely produce sildenafil syrup commercially.

Dose may be titrated to a maximum of 80 mg three times a day, if required, based on symptoms and tolerability [see Clinical Studies (14)].

Introduction to Sildenafil For Oral Suspension

tell your doctor if you smoke, if you have had heart surgery within the last 6 months, if you have ever had an erection that lasted for more than 4 hours, and if you have recently lost a large amount of body fluids (dehydration). This can happen if you are sick with fever, diarrhea, or vomiting; sweat a lot; or do not drink enough liquids. Also tell your doctor if you have or have ever had pulmonary veno-occlusive disease (PVOD; blockage of veins in the lungs); a stomach ulcer; heart, kidney, or liver disease; a heart attack; heart failure; angina (chest pain); an irregular heartbeat; a stroke; chest pain; high or low blood pressure; high cholesterol; a bleeding disorder; blood circulation problems; blood cell problems such as sickle cell anemia (a disease of the red blood cells), multiple myeloma (cancer of the plasma cells), or leukemia (cancer of the white blood cells); conditions affecting the shape of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie's disease); or diabetes. Also tell your doctor if you or any of your family members have or have ever had an eye disease such as retinitis pigmentosa (an inherited eye condition that causes loss of vision) or if you have ever had sudden severe vision loss, especially if you were told that the vision loss was caused by a blockage of blood flow to the nerves that help you see. if you are a woman and you are taking sildenafil to treat PAH, tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.

Patients & Visitors

If you become pregnant while taking sildenafil, call your doctor. if you are having surgery, including dental surgery, tell your doctor or dentist that you are taking sildenafil. if you are taking sildenafil to treat erectile dysfunction, tell your doctor if you have ever been advised by a healthcare professional to avoid sexual activity for medical reasons or if you have ever experienced chest pain during sexual activity. Sexual activity may be a strain on your heart, especially if you have heart disease. If you experience chest pain, dizziness, or nausea during sexual activity, call your doctor immediately and avoid sexual activity until your doctor tells you otherwise.

How sildenafil is used

tell all your healthcare providers that you are taking sildenafil. If you ever need emergency medical treatment for a heart problem, the healthcare providers who treat you will need to know when you last took sildenafil. Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine. If you are taking sildenafil for erectile dysfunction, you are unlikely to miss a dose since this medication is taken as needed, not on a regular dosing schedule. If you are taking sildenafil for PAH, take the missed dose as soon as you remember it. Although dose-response improvement in exercise ability was not observed in short-term studies in adults with PAH, the delay in clinical worsening with long-term

• 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.

use of sildenafil in Study A1481324 supports dosing up to a maximum of 80 mg three times a day [see Clinical Studies (14)].

5.8 Priapism

Injection (Adults): 10 mg three times a day administered as an intravenous bolus injection. For oral suspension: 10 mg/mL (when reconstituted) (3) Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. 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 hypertension (PH) secondary to sickle cell disease: Sildenafil may cause serious vaso-occlusive crises. The recommended dose is 10 mg administered as an intravenous bolus injection three times a day.

8.2 Lactation

If you are taking sildenafil (Liqrev, Revatio) for PAH, do not stop taking your medication until you talk to your doctor. Call your doctor if you have any unusual problems while you are taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( or by phone (1-800-332-1088). Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom).

Warnings for other groups

Store the suspension at room temperature or in a refrigerator, but do not freeze it. Dispose of any unused suspension sildenafil pick up after 60 days. Keep all medication out of sight and reach of children as many containers are not child-resistant. Place the medication in a safe location – one that is up and away and out of their sight and reach. Dispose of unneeded medications in a way so that pets, children, and other people cannot take them.

5.7 Priapism

Do not flush this medication down the toilet. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website for more information. In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. The dose of sildenafil injection does not need to be adjusted for body weight.

• Sildenafil syrup is sometimes used in pediatric cases, off-label.
• Off-label use in children requires careful dosage adjustment.
• Lack of standardization makes typical dosing guidelines difficult.
• Pharmacokinetics in syrup form are less well-studied.
• Always seek professional medical advice before use.

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.

Overdose/Missed Dose

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription. Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

8.2 Lactation

Package insert / product label Generic name: sildenafil citrate Dosage form: powder, for oral suspension Drug classes: Agents for pulmonary hypertension, Impotence medications Adults Sildenafil 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. Pediatric Patients (1 to 17 years old) Sildenafil for oral suspension is indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standard exercise testing, pulmonary hemodynamics thought to underlie improvements in exercise (1, 14) Adults: 20 mg orally three times a day. Dose may be increased based on symptoms and tolerability. Pediatric patients (2.2) ≤ 20 kg: 10 mg three times a day20 kg to 45 kg: 20 mg three times a day> 45 kg: 20 mg three times a day. ≤ 20 kg: 10 mg three times a day 20 kg to 45 kg: 20 mg three times a day > 45 kg: 20 mg three times a day.