11 DESCRIPTION

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What Other Drugs Interact with Sildenafil?

This copyrighted material has been downloaded from a licensed data provider. The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment. ATTENTION: If you speak a language other than English, language assistance services are available to you free of charge. Blue Cross Blue Shield of Massachusetts is an Independent Licensee of the Blue Cross and Blue Shield Association. ®´ Registered Marks of Blue Cross and Blue Shield of Massachusetts, Inc., or Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc.

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®´´ Registered Marks, TM Trademarks, and SM Service Marks are the property of their respective owners. © 2024 Blue Cross and Blue Shield of Massachusetts, Inc., or Blue Cross and Blue Shield of Massachusetts HMO sildenafil white Blue, Inc. ® Registered Marks and SM Service Marks of the Blue Cross and Blue Shield Association.

• The medication can be part of a treatment plan for ED.
• Do not share sildenafil with others, even if they have similar symptoms.
• Taking sildenafil on an empty stomach may increase effectiveness.
• Be aware of possible allergic reactions, such as rash.
• Follow-up with your healthcare provider regularly when using sildenafil.

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Drug Interactions

You may report side effects to FDA at 1-800-FDA-1088 or at In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Before taking sildenafil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Vybrique Oral Film

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as heart attack or life-threatening irregular heartbeat in the past 6 months, chest pain/angina, heart failure) penis conditions (such as angulation, fibrosis/scarring, Peyronie's disease) conditions that may increase the risk of priapism (such as sickle cell anemia, leukemia, multiple myeloma) eye problems (such as retinitis pigmentosa, sudden decreased vision, NAION) other lung conditions (such as pulmonary veno-occlusive disease) This drug may make you dizzy or cause vision problems. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). ®´ Registered Marks, TM Trademarks, and SM Service Marks are property of their respective owners. If you are a consumer or patient please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SILDENAFIL INJECTION safely and effectively.

Brand/Source	Price per Tablet	Package Size	Cost per Pack	Notes
Brand A	$3.00	30 tablets	$90.00	Trademarked, pharmacy purchase
Generic B	$0.50	60 tablets	$30.00	FDA-approved generic
Online Supplier C	$0.20	90 tablets	$18.00	Bulk purchase, check authenticity
Local Pharmacy D	$1.00	20 tablets	$20.00	Over-the-counter available

See full prescribing information for SILDENAFIL INJECTION.SILDENAFIL injection, for intravenous useInitial U.S. Approval: 1998INDICATIONS AND USAGEAdultsSildenafil injection 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.

5.5 Hearing Loss

During pregnancy, sildenafil should be used only when clearly needed. Since high blood pressure in the lungs is a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, discuss with your doctor right away the benefits and risks of using this medication during pregnancy. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions.

Common Adverse Effects

Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug are: Sildenafil can cause a serious drop in your blood pressure when used with nitrates. A serious drop in blood pressure can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use sildenafil with any of the following: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide) recreational drugs called "poppers" containing amyl or butyl nitrite If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. (1)DOSAGE AND ADMINISTRATIONInjection (Adults): 10 mg three times a day administered as an intravenous bolus injection (2.1)DOSAGE FORMS AND STRENGTHSInjection: 10 mg/12.5 mL in a single-dose vial (3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSVasodilation 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)ADVERSE REACTIONSDRUG INTERACTIONSUse with strong CYP3A inhibitors: Not recommended. (7, 12.3)Concomitant PDE-5 inhibitors: Avoid use with Viagra® or other PDE-5 inhibitors.

Condition	Risk Factors	Recommendations
Use with nitrates	Severe hypotension, risk of significant blood pressure drop	Avoid combining, consult healthcare provider
Severe cardiovascular disease	Risk of adverse cardiovascular events	Use only under medical supervision
Liver impairment	Altered metabolism, increased side effects	Dose adjustment or avoid use
Retinitis pigmentosa	Potential for increased visual side effects	Use with caution, consult ophthalmologist

(5.6)Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil).

• Erectile dysfunction can be caused by various medical conditions; discuss treatment options with a doctor.
• The medication is generally well-tolerated but requires medical supervision.
• Side effects can include indigestion, muscle aches, or flushing.
• Avoid using sildenafil if you are pregnant or breastfeeding.
• Proper dosage and timing maximize the benefits of sildenafil 10mg.

However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.See 17 for PATIENT COUNSELING INFORMATION.Revised: 12/2023 Injection (Adults): 10 mg three times a day administered as an intravenous bolus injection (2.1) Injection: 10 mg/12.5 mL in a single-dose vial (3) Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy.

Renal Dose Adjustments

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. Use in pulmonary veno-occlusive disease (PVOD) may cause pulmonary edema and is not recommended.

Which Makes You Harder?

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. Different brands of this medication have different storage needs.

Azole Antifungals

Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. 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.

• Sildenafil 10mg can cause dizziness or vision changes in some users.
• Always check for drug interactions before taking sildenafil.
• It is important to stay hydrated when using sildenafil.
• The medication is not effective as an aphrodisiac without stimulation.
• Seek emergency help if you experience chest pain after use.

Use with strong CYP3A inhibitors: Not recommended.

Dosage	Recommended Use	Onset of Action	Duration of Effect	Typical Frequency
10 mg	Mild to moderate ED cases	30-60 minutes	Up to 4-6 hours	Once per day, as needed
20 mg	Moderate to severe ED	30-60 minutes	Up to 4-6 hours	Once per day, as needed
5 mg	For elderly or sensitive users	30-60 minutes	Up to 4 hours	Once per day, as needed

Concomitant PDE-5 inhibitors: Avoid use with Viagra® or other PDE-5 inhibitors. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil). However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.

How do you choose?

Your doctor may adjust your medications to minimize your risk of low blood pressure. Other medications can affect the removal of sildenafil from your body, which may affect how sildenafil works. Do not take this medication with any other product that contains sildenafil or other similar medications for erectile dysfunction-ED or pulmonary hypertension (such as tadalafil, vardenafil). If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away.

Popularity of Tadalafil and Sildenafil

US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: dizziness, fainting, painful/prolonged erection. Do not share this medication with others. Lab and/or medical tests (such as eye exams, blood pressure) may be done while you are taking this medication. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 Recommended Dosage in Adults3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS5.1 Hypotension5.2 Worsening Pulmonary Vascular Occlusive Disease5.3 Epistaxis5.4 Visual Loss5.5 Hearing Loss5.6 Combination with other PDE-5 Inhibitors5.7 Priapism5.8 Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric Use8.6 Patients with Hepatic Impairment8.7 Patients with Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, sildenafil 12 5 mg Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are not listed.