DOSAGE FORMS AND STRENGTHS

Use with strong CYP3A inhibitors: Not recommended.

• PDE5 inhibitors like sildenafil improve blood flow in penile tissues.
• Use sildenafil only when planning sexual activity.
• Men taking antihypertensives should consult their doctor before use.
• Sildenafil can cause flushing and visual disturbances temporarily.
• Follow your healthcare provider’s instructions carefully for best results.

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

• Myths and misconceptions about sildenafil are common and should be addressed.
• It is not a "party drug" or aphrodisiac; it requires sexual stimulation to work.
• It does not cause spontaneous erections without sexual arousal.
• More is not always better; higher doses increase side effect risk, not pleasure.
• It is not addictive, but psychological dependence on its use can develop.
• It does not permanently cure erectile dysfunction; effects are temporary.
• It is not safe to use just because it is widely available or discussed.
• Herbal "natural Viagra" products are not regulated and can be dangerous.
• It does not protect against sexually transmitted infections or prevent pregnancy.
• It is not approved or proven to enhance sexual performance in men without ED.
• Accurate information from a healthcare provider is essential.

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.

Dose Adjustments

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. 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.

Sildenafil Tablets Dosage and Administration

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. 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). 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.

Pregnancy & Lactation

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. ( 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.

Alcohol interaction warning

( 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. ( 5.6)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. [see Clinical Studies (14)] .Pediatric use information is approved for Viatris Specialty LLC's, REVATIO ®(sildenafil) tablets.

10. Overdosage

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. 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.

5.2 Prolonged Erection and Priapism

Place the medication in a safe location – sildenafil citrate tablet 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. 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. 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.

11. Sildenafil Tablets Description

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. 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.

Oral Administration

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

5.3 Epistaxis

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. 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.

What Are the Available Sildenafil Dosages?

The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication. 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. Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil.

12.3 Pharmacokinetics

Adults: 150mg sildenafil for sale 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. 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.