3 DOSAGE FORMS & STRENGTHS

Keep out of the

12 CLINICAL PHARMACOLOGY

For current full prescribing information, please visit SILDENAFIL - sildenafil citrate for suspension ANI Pharmaceuticals, Inc. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information The recommended dosage of sildenafil for oral suspension is 20 mg three times a day. Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services.

How is sildenafil supplied (dosage forms)?

SILDENAFIL (sil DEN a fil) treats pulmonary arterial hypertension (PAH), a condition that causes high blood pressure in the lungs. It works by relaxing your blood vessels and lowering the blood pressure in your lungs, which makes it easier for your heart to pump blood to the rest of your body. It can also help you breathe easier and be more active. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions. They need to know if you have any of these conditions: History of blood diseases, such as sickle cell anemia or leukemia Stomach ulcers, other stomach or intestine problems An unusual or allergic reaction to sildenafil, other medications, foods, dyes, or preservatives Take it as directed on the prescription label at the same time every day.

Other Interactions

Use a specially marked oral syringe, spoon, or dropper to measure each dose. Do not mix this medication with other medications or flavoring. You can take it with or without food. If it 50 mg sildenafil price upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop. reach of children and pets.

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After this medication is

10 OVERDOSAGE

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Talk to your pharmacist or care team if you have questions. Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 1 year for selected conditions, precautions do apply.

Alcohol interaction warning

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others. If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose.

8.4 Pediatric Use

Do not take double or extra doses. Do not take this medication with any of the following: Nitrates, such as amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin This medication may also interact with the following: Other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended. This list may not describe all possible interactions. mixed by your pharmacist,

• 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.

store it below 30 degrees C (86 degrees

Region	Estimated Market Size (2023)	Growth Rate	Key Players	Typical Uses Scope
North America	$150 million	5% annually	Pfizer, Cipla, Teva	ED, pulmonary hypertension
Europe	$100 million	4.5% annually	Bayer, Sun Pharma	Pulmonary hypertension, off-label uses
Asia-Pacific	$200 million	7% annually	Cipla, Aurobindo, Zydus	Broader use, pediatric cases
Rest of World	$50 million	3.5% annually	Various local manufacturers	Growing awareness and approval

F) or in a refrigerator between 2 and

5.3 Epistaxis

Decreased eyesight or permanent loss of vision in one or both eyescan be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). The most common side effects of sildenafil for oral suspension in adults include: getting red or hot in the face (flushing) These are not all the possible side effects of sildenafil for oral suspension. You may report side effects to FDA at 1 -800-FDA-1088. See the "Discard after" date written on the bottle label. 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.

2.3 Reconstitution of the Powder for Oral Suspension

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

Before taking sildenafil,

Do nottake or give sildenafil oral suspension and contact your pharmacist if the medicine in the bottle is still a powder. Do nottake or give sildenafil oral suspension if the bottle adaptor is not in the bottle. 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. Do not freeze mixed sildenafil oral suspension Throw away (discard) any remaining sildenafil oral suspension 60 days after mixed by the pharmacist. This product's label may have been updated. 8 degrees C (36 and 46 degrees F).

Mechanism of action

Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine. Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. Throw away any unused

• 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.

medication after 60 days.

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

It may not cover all possible information.

Parameter	Value	Description	Remarks
Absorption	Rapid, within 30-60 min	Time to peak plasma concentration	最佳服用时间为餐前或空腹
Bioavailability	Approx. 40%	Percentage of dose reaching systemic circulation	影响药效强度
Half-life	4 hours	Time taken to reduce plasma concentration by half	影响药物持续时间
Metabolism	Hepatic (mainly CYP3A4)	Liver enzymes metabolize sildenafil	酒精或药物相互作用可能影响代谢

If you have questions

What is Liqrev?

Sildenafil (Sil-DEN-a-fil) for Oral Suspension What is the most important information I should know about sildenafil for oral suspension? Nitroglycerin in any form including tablets, patches, sprays, and ointments Street drugs called "poppers" (amyl nitrate, butyl nitrate or nitrite) 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?" Before taking sildenafil for oral suspension, tell your healthcare provider about all of your medical conditions, including if you: have bleeding problems or a stomach (peptic) 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 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.

California Pet Pharmacy (CPP Pet Care) Terms and Conditions

Sildenafil for oral suspension passes into your breast milk. 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: See "What is the most important information I should know aboutsildenafil for oral suspension?" Do nottake VIAGRA or other PDE-5 inhibitors during treatment with sildenafil for oral suspension. 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. Your healthcare provider may change your dose of sildenafil for oral suspension as needed.

Dosage Forms and Strengths

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. If you take too much sildenafil for oral suspension, call your healthcare provider or go to the nearest hospital emergencyroom right away. 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. about this medicine, talk

• Sildenafil syrup is an off-label form of erectile dysfunction medication.
• It's designed for easier ingestion compared to tablets.
• Not approved by most regulatory agencies for syrup form.
• Dosing and safety information are less documented for syrup.
• Usually, sildenafil is available in tablet form, not syrup.

to your doctor, pharmacist,

• 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.

or health care provider.

5.6 Hearing Loss

Tell your care team right away if you have any change in your eyesight or hearing. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.