13 NONCLINICAL TOXICOLOGY

Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4) Caution is advised when sildenafil is co-administered with alpha-blockers or anti-hypertensives.

• Sildenafil is available in various dosages, including 25mg, 50mg, and 100mg.
• Do not take more than one tablet within 24 hours.
• It may interact with nitrates, causing dangerous drops in blood pressure.
• Consult your doctor before starting sildenafil if you have heart issues.

Concomitant use may lead to hypotension ( 5.5) Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures.

• Sildenafil is sometimes misused for recreational purposes.
• Misuse can lead to serious health risks, including cardiovascular events.
• Never take medication not prescribed specifically for you.
• Use only under the guidance of a qualified healthcare professional.

Decrease in sildenafil dosage is recommended ( 2.4, 5.6) Most common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash ( 6.1) Sildenafil can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1, 5.5, 7.1, 7.2, 7.3, 12.2) With concomitant use of alpha blockers, initiate sildenafil at 25 mg dose ( 2.3) CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil exposure ( 2.4, 7.4, 12.3) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Written By

Archived from the original on 30 November 2012. 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".

Why this range helps:

Archived from the original on 20 May 2013. ^ "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. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE2 DOSAGE AND ADMINISTRATION2.1 Dosage Information2.2 Use with Food2.3 Dosage Adjustments in Specific Situations2.4 Dosage Adjustments Due to Drug Interactions2.5 Dosage Adjustments in Special Populations3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2

Hypersensitivity Reactions4.3 Concomitant Guanylate Cyclase (GC) Stimulators5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Prolonged Erection and Priapism5.3 Effects on the Eye5.4 Hearing Loss5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives5.6 Adverse Reactions with the Concomitant Use of Ritonavir5.7 Combination with other PDE5 Inhibitors

8.7 Hepatic Impairment

{{cite web}}: CS1 maint: deprecated archival service (link) ^ Teva Canada Ltd. 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.

What dose should be taken?

"Canadian Supreme court rules Viagra patent invalid". 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 September 2013. ^ "Pfizer Canada drops Viagra price after generic versions get Supreme Court green light". or Other Erectile Dysfunction Therapies5.8 Effects on Bleeding5.9 Counseling Patients About Sexually Transmitted Diseases6 ADVERSE REACTIONS6.1 Clinical Trials Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Nitrates7.2 Alpha-blockers7.3 Amlodipine7.4 Ritonavir and other CYP3A4 inhibitors7.5 Alcohol8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.2 Lactation8.4 Pediatric Use8.5 Geriatric

Dosages of Sildenafil

^ "Is Viagra about to lose its pulling power in the UK?". 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".

Drugs you should not use with sildenafil

Archived from the original on 17 May 2021. ^ "Generic Viagra developers queue up, but may have to wait". Archived from sildenafil online ireland the original on 28 December 2021. ^ "Approved Viagra copies flood drugstores in Korea". ^ "Viagra prescriptions almost triple in a decade". Use8.6 Renal Impairment8.7 Hepatic 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.

• Sildenafil should be taken about 1 hour before sexual activity.
• It does not cause an erection on its own; arousal is needed.
• Food, especially high-fat meals, can delay the onset of action.
• Avoid grapefruit juice as it may increase sildenafil blood levels.

Sections or subsections omitted from the full prescribing information are not listed.

Mechanism of action

Archived from the original on 1 July 2024. ^ "MHRA reclassifies Viagra Connect tablets to a Pharmacy medicine". ^ "Viagra to be available without prescription in UK". NDC Code(s): 75834-240-00, 75834-240-01, 75834-240-05, 75834-240-30, view more75834-241-00, 75834-241-01, 75834-241-05, 75834-241-30, 75834-272-00, 75834-272-30, 75834-272-90 If you are a healthcare professional or from the pharmaceutical industry please visit this version. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively.

How are Sildenafil Citrate Tablets used?

See full prescribing information for SILDENAFIL TABLETS.SILDENAFIL TABLETS, for oral useInitial U.S. Approval: 1998RECENT MAJOR CHANGESWarnings and Precautions, Effects on the Eye (5.3) 08/2017INDICATIONS AND USAGESildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1)DOSAGE AND ADMINISTRATIONFor most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity ( 2.1)Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg ( 2.1)Maximum recommended dosing frequency is once per day ( 2.1)DOSAGE FORMS AND STRENGTHSTablets: 25 mg, 50 mg and 100 mg (3)CONTRAINDICATIONSAdministration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil tablets was shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2)Known hypersensitivity to sildenafil or any component of tablet ( 4.2)Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3)WARNINGS AND PRECAUTIONSPatients should not use sildenafil if sexual activity is inadvisable due to cardiovascular status ( 5.1)Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil with caution in patients predisposed to priapism ( 5.2)Patients should stop sildenafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION). 2 DOSAGE AND ADMINISTRATION 2.1 Dosage InformationFor most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.

• The safety and efficacy of sildenafil depend on proper dosing.
• Overdose symptoms might include severe hypotension or priapism.
• The medication is contraindicated in patients with severe liver impairment.
• Keep a list of all medications to prevent harmful interactions.

However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity. The maximum recommended dosing frequency is once per day.Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg.2.3 Dosage Adjustments in Specific SituationsSildenafil tablets was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors such as organic nitrates or organic nitrites in any form is therefore contraindicated [ see Contraindications (4.1), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].When sildenafil tablets are co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating sildenafil tablets

treatment and sildenafil tablets should be initiated at 25 mg [ see Warnings and Precautions (5.5), Drug Interactions (7.2), and Clinical Pharmacology (12.2)].2.4 Dosage Adjustments Due to Drug InteractionsRitonavirThe recommended dose for ritonavir-treated patients is 25 mg prior to sexual activity and the recommended maximum dose is 25 mg within a 48 hour period because concomitant administration increased the blood levels of sildenafil by 11-fold [ see Warnings and Precautions (5.6), Drug Interactions (7.4), and Clinical Pharmacology (12.3)].CYP3A4 InhibitorsConsider a starting dose of 25 mg in patients treated with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or saquinavir) or erythromycin.

5.4 Hearing Loss

Sildenafil tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be at an increased risk of NAION. ( 5.3)Patients should stop sildenafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.4)Caution is advised when sildenafil is co-administered with alpha-blockers or anti-hypertensives. Concomitant use may lead to hypotension ( 5.5)Decreased blood pressure, syncope, and prolonged erection may occur at higher sildenafil exposures. In patients taking strong CYP inhibitors, such as ritonavir, sildenafil exposure is increased.

What should I know about sildenafil before taking it?

Decrease in sildenafil dosage is recommended ( 2.4, 5.6)ADVERSE REACTIONSMost common adverse reactions (≥ 2%) include headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness and rash ( 6.1)To report SUSPECTED ADVERSE REACTIONS, contact Nivagen Pharmaceuticals, Inc. at 1-877-977-0687 or FDA at 1-800-FDA-1088 or INTERACTIONSSildenafil can potentiate the hypotensive effects of nitrates, alpha blockers, and anti-hypertensives ( 4.1, 5.5, 7.1, 7.2, 7.3, 12.2)With concomitant use of alpha blockers, initiate sildenafil at 25 mg dose ( 2.3)CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil exposure ( 2.4, 7.4, 12.3) USE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 6/2023 Warnings and Precautions, Effects on the Eye (5.3) 08/2017 Sildenafil is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED) (1) For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, sildenafil tablets may be taken anywhere from 30 minutes to 4 hours before sexual activity ( 2.1) Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg ( 2.1) Maximum recommended dosing frequency is once per day ( 2.1) Tablets: 25 mg, 50 mg and 100 mg (3) Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil tablets was shown to potentiate the hypotensive effect of nitrates ( 4.1, 7.1, 12.2) Known hypersensitivity to sildenafil or any component of tablet ( 4.2) Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3) Patients should not use sildenafil if sexual activity is inadvisable due to cardiovascular status ( 5.1) Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil with caution in patients predisposed to priapism ( 5.2) Patients should stop sildenafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non arteritic anterior ischemic optic neuropathy (NAION).