2 DOSAGE AND ADMINISTRATION

Hearing or sildenafil 50 mg tab 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. Use with strong CYP3A inhibitors: Not recommended.

• The societal impact of sildenafil has been profound since its introduction.
• It helped destigmatize the discussion and treatment of erectile dysfunction.
• It spawned a multi-billion dollar market for sexual health pharmaceuticals.
• The "Viagra" brand name became one of the most recognized in the world.
• It led to increased research and development in urology and sexual medicine.
• It also raised important questions about medicalization and lifestyle drugs.
• Direct-to-consumer advertising for ED treatments became widespread.
• It prompted debates about insurance coverage for quality-of-life medications.
• The success of sildenafil accelerated research into other PDE5 inhibitors.
• It highlighted the importance of serendipity in drug discovery.
• Its impact extends beyond medicine into cultural and social spheres.

Concomitant PDE-5 inhibitors: Avoid use with Viagra ®or other PDE-5 inhibitors.

12. Sildenafil Tablets - Clinical Pharmacology

Dispose of any unused suspension 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 sildenafil 50mg tablet unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet.

Does sildenafil interact with other medicines (drug interactions)?

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. Do not let anyone else take your medication.

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

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. If you are a consumer or patient please visit this version. 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. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. 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, 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. Sections or subsections omitted from the full prescribing information are not listed. 1 INDICATIONS AND USAGE AdultsSildenafil tablets are 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 .

Sildenafil tablets are 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)] . 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage in AdultsOral DosageThe recommended dosage of sildenafil tablets is 20 mg three times a day. [see Clinical Studies (14)] .Pediatric use information is approved for Viatris Specialty LLC's, REVATIO ®(sildenafil) tablets. The recommended dosage of sildenafil tablets is 20 mg three times a day. 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.

What should I know about storage and disposal of this medication?

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. Talk to your doctor about the risks of taking sildenafil.

8.7 Hepatic Impairment

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. If you are taking sildenafil (Liqrev, Revatio) for PAH, do not stop taking your medication until you talk to your doctor.

Common Side Effects

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). Store the suspension at room temperature or in a refrigerator, but do not freeze it. Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.Known hypersensitivity to sildenafil or any component of the tablet. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil.

• Regulatory status of sildenafil varies by country but generally requires a prescription.
• In the UK, it is a Prescription Only Medicine (POM) but can be prescribed by pharmacists.
• In some countries, it may be available in limited quantities without a prescription.
• The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Revatio.
• The REMS is designed to inform healthcare providers about the serious risks.
• This includes the risk of use with nitrates and the potential for hearing loss.
• The medication is subject to controlled substance regulations in some regions.
• Traveling with prescription medication requires carrying it in original packaging.
• It is advisable to have a copy of the prescription or a doctor's note when traveling.
• Laws regarding the importation of prescription drugs are strict and vary.
• Always check the legal status of the medication in your destination country.

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)] .

• Sildenafil works by relaxing blood vessels to increase blood flow.
• 20mg dosage is suitable for men with mild to moderate ED.
• It is available by prescription or over-the-counter in some regions.
• Avoid alcohol while taking sildenafil to prevent side effects.
• Do not exceed the prescribed dose to reduce health risks.

Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. Known hypersensitivity to sildenafil or any component of the tablet.

4. Contraindications

HIGHLIGHTS OF PRESCRIBING INFORMATION Sildenafil TabletsThese highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS.Sildenafil tablets, for oral useInitial U.S. Approval: 1998INDICATIONS AND USAGEAdultsSildenafil 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. ( 1)DOSAGE AND ADMINISTRATIONAdults: 20 mg three times a day. ( 2.1)DOSAGE FORMS AND STRENGTHSTablets: 20 mg ( 3)CONTRAINDICATIONSWARNINGS AND PRECAUTIONSVasodilation effects may be more common in patients with hypotension or on antihypertensive therapy.

How does sildenafil work (mechanism of action)?

( 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. 5 WARNINGS AND PRECAUTIONS 5.1 HypotensionSildenafil has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing sildenafil, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [blood pressure less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction).

• Sildenafil was originally developed to treat hypertension and angina.
• Its effect lasts approximately 4-6 hours depending on individual factors.
• Side effects may include muscle aches and skin rash in some cases.
• Discuss all medications with your doctor to avoid harmful interactions.
• Do not take sildenafil with fatty foods to ensure quicker action.

Monitor blood pressure when co-administering blood pressure lowering drugs with sildenafil.5.2 Worsening Pulmonary Vascular Occlusive DiseasePulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).

12.3 Pharmacokinetics

( 5.6)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.See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 3/2024 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. Adults: 20 mg three times a day. 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. Since there are no clinical data on administration of sildenafil to patients with veno-occlusive disease, administration of sildenafil to such patients is not recommended.