12 CLINICAL PHARMACOLOGY

Approval: 1998INDICATIONS AND USAGEAdultsSildenafil tablets are 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.

What Is Sex Time?

Archived from the original on 30 October 2013. Archived from the original on 22 August 2009. Archived from the original on 25 June 2007. "Viagra from the pharmacist: insight from reclassification in New Zealand". Archived from the original on 17 May 2021. (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.

5.4 Visual Loss

^ a b "Viagra now available over the counter without prescription in the UK". Archived from the original on 26 March 2021. Archived from the original on 8 December 2013. "The coming generics threat to Pfizer's Viagra brand just got scarier". Archived from the original on 9 September 2017.

Organic Nitrates, Nitrites, and Nitric Oxide Donors

^ "Viagra to go generic in 2017 according to Pfizer agreement". Archived from the original on 1 December 2017. "Sex, Drugs and That Little Blue Pill". Archived from the original on 6 December 2017. "Why Pfizer Is About to Slash Viagra's Price in Half".

Sildenafil Oral Film for ED

Archived from the original on 7 December 2017. "Pfizer to lose patent of drug Viagra, Indian companies gear up with copycat versions: Pfizer's patent for the formulation of Viagra, used to treat impotence in men, ends in the US in 2020". Archived from the original on 17 April 2021. ^ "Set to conquer US, Indian 'Viagras' may give Pfizer a hard Time". Archived from the original on 22 December 2020. (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 citrate 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.

• Potential side effects of sildenafil tablets include headache, flushing, and nasal congestion.
• Serious side effects are rare but can include vision changes or prolonged erections.
• Seek medical attention if you experience chest pain or an erection lasting over 4 hours.

(5.6)Pediatric use information is sildenafil 20 mg tablets approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets.

• Patients should avoid grapefruit or grapefruit juice while taking sildenafil tablets.
• Consult your doctor if you experience persistent pain or vision changes.
• Sildenafil tablets can be part of a broader treatment plan including lifestyle changes.

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: 3/2026 Sildenafil tablets are 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.

• Sildenafil tablets typically start working within 30 to 60 minutes after ingestion.
• The effects of sildenafil tablets can last up to 4-6 hours.
• Taking sildenafil with high-fat meals may delay its effectiveness.

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 citrate may cause serious vaso-occlusive crises. Use with strong CYP3A inhibitors: Not recommended.

Non-medical use

^ "Generic Viagra developers queue up, but may have to wait". Archived from the original on 28 December 2021. ^ "Approved Viagra copies flood drugstores in Korea". ^ "Viagra prescriptions almost triple in a decade". Archived from the original on 1 July 2024. 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) 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 Post-marketing 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 STUDIES17 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.

What happens if I miss a dose?

Archived from the original on 11 November 2012. ^ "Viagra patent tossed out by Supreme Court: Decision allows generic versions of drug to be produced". Archived from the original on 18 sildenafil 100 mg tab September 2013. ^ "Pfizer Canada drops Viagra price after generic versions get Supreme Court green light". Archived from the original on 30 November 2012.

Related treatment guides

Archived from the original on 27 December 2013. "In rare move, Pfizer asks Supreme Court to reconsider ruling that killed Viagra patent". Archived from the original on 5 February 2013. "The Supreme Court of Canada holds Pfizer's Viagra patent invalid". Archived from the original on 20 May 2013.

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

^ "Actavis Launches Generic Viagra in Europe as Patents Expire". Archived from the original on 29 October 2013. "What Will Happen When Viagra Goes Generic?". Archived from the original on 23 April 2011. ^ "Is Viagra about to lose its pulling power in the UK?". 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. 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)] .

Dosage And Administration

^ "MHRA reclassifies Viagra Connect tablets to a Pharmacy medicine". ^ "Viagra to be available without prescription in UK". 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 TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL tablets, for oral useInitial U.S. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage in AdultsOral DosageThe recommended dosage of sildenafil tablet is 20 mg three times a day [see Clinical Studies (14)] .Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets.

Some of the most commonly reported side-effects of sildenafil are:

^ a b "Pfizer Settles Viagra® Patent Litigation With Teva". "Lockout Supplements Issues Voluntary Nationwide Recall of Boner Bears Chocolate Syrup Due to Undeclared Sildenafil". Archived from the original on 19 November 2016. "Counterfeit Viagra, Cialis, Levitra: The Ultimate Guide". Archived from the original on 10 January 2017.

Pulmonary hypertension

"Online pharmacies suspected of counterfeit drug sales". ^ "Erectile Dysfunction Medication the Most Seized Drug During Global Crackdown, Interpol Says". ^ "Global illicit medicines targeted by INTERPOL operation". Archived from the original sildenafil 50mg tablet on 10 December 2023. ^ "Israeli-made AI exposes international fake Viagra network".

Prior authorization

^ "Counterfeit Viagra Pills, Footwear, Belts, Car Emblems and Headphones Worth over $32 Million Seized at the LA/Long Beach Seaport U.S. Customs and Border Protection". Archived from the original on 12 October 2013. "Yes, There Is a Way to Get Generic Viagra". Archived from the original on 2 May 2016. The recommended dosage of sildenafil tablet is 20 mg three times a day [see Clinical Studies (14)] . 4 CONTRAINDICATIONS Sildenafil tablets are 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. Phosphodiesterase-5 (PDE-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat.Known hypersensitivity to sildenafil or any component of the tablet.

Detection in biological fluids

"Pfizer Wins Viagra Patent Infringement Case Against Teva Pharmaceuticals". Archived from the original on 11 January 2015. ^ "Pfizer Completes Transaction to Combine Its Upjohn Business with Mylan". Retrieved 17 June 2024 – via Business Wire. Archived from the original on 17 June 2024.

Study of Flexible Dose Escalation, Efficacy, and Safety with a Long-Term, Open-Label Extension

"Viagra patent expires in June, says Brazilian court". Archived from the original on 17 April 2012. ^ "Revatio patent ruled invalid for lack of sound prediction and obviousness". Archived from the original on 3 March 2016. {{cite web}}: CS1 maint: deprecated archival service (link) ^ Teva Canada Ltd.

Dosage for erectile dysfunction (ED)

v. Pfizer Canada Inc., 2012 SCC 60 at par. "Supreme Court ruling could lead to cheaper versions of Viagra". Archived from the original on 10 March 2013. "Canadian Supreme court rules Viagra patent invalid". Hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. Sildenafil tablets are 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)] .