Sildenafil
Generic Name: sildenafil
Brand Names:
Sildenafil
11 DESCRIPTION Sildenafil tablets, USP an oral therapy for erectile dysfunction, is the salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Overview
11 DESCRIPTION Sildenafil tablets, USP an oral therapy for erectile dysfunction, is the salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Uses
1 INDICATIONS AND USAGE Sildenafil tablets are indicated for the treatment of erectile dysfunction. Sildenafil tablets is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED)
Dosage
2 DOSAGE AND ADMINISTRATION • 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 ) 2.1 Dosage Information 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. The maximum recommended dosing frequency is once per day.
Side Effects
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Cardiovascular [see Warnings and Precautions (5.1) ] • Prolonged Erection and Priapism [see Warnings and Precautions (5.2) ] • Effects on the Eye [see Warnings and Precautions (5.3) ] • Hearing Loss [see Warnings and Precautions (5.4) ] • Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions (5.5) ] • Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings and Precautions (5.6) ] • Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions (5.7) ] • Effects on Bleeding [see Warnings and Precautions (5.8 )] • Counseling Patients About Sexually Transmitted Diseases [see Warnings a...
Interactions
7 DRUG INTERACTIONS • Sildenafil tablets 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 tablets at 25 mg dose ( 2.3 ) • CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, erythromycin): Increase sildenafil tablets exposure ( 2.4 , 7.4 , 12.3 ) Ritonavir: Do not exceed a maximum single dose of 25 mg in a 48 hour period ( 2.4 , 5.6 ) Erythromycin or strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, saquinavir): Consider a starting dose of 25 mg ( 2.4 , 7.4 ) 7.1 Nitrates Administration of sildenafil tablets with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated.
Warnings
5 WARNINGS AND PRECAUTIONS • Patients should not use sildenafil tablets if sexual activity is inadvisable due to cardiovascular status ( 5.1 ) • Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil tablets 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). 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. 4 CONTRAINDICATIONS • Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil tablets were 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 rioc...
Pregnancy
8.1 Pregnancy Risk Summary Sildenafil tablets are not indicated for use in females. There are no data with the use of Sildenafil tablets in pregnant women to inform any drug-associated risks for adverse developmental outcomes. Animal reproduction studies conducted with sildenafil did not show adverse developmental outcomes when administered during organogenesis in rats and rabbits at oral doses up to 16 and 32 times, respectively, the maximum recommended human dose (MRHD) of 100 mg/day on a mg/m 2 basis (see DATA ).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil tablets, USP are supplied as white, film-coated, rounded-diamond-shaped tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil and debossed on the obverse and reverse sides as follows: 25 mg 50 mg 100 mg Obverse AC 338 AC 339 AC 340 Reverse Plain Plain Plain Bottle of 30 NDC 55801-338-01 NDC 55801-339-01 NDC...
Frequently Asked Questions
What is Sildenafil used for?▼
1 INDICATIONS AND USAGE Sildenafil tablets are indicated for the treatment of erectile dysfunction. Sildenafil tablets is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED)
What are the side effects of Sildenafil?▼
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Cardiovascular [see Warnings and Precautions (5.1) ] • Prolonged Erection and Priapism [see Warnings and Precautions (5.2) ] • Effects on the Eye [see Warnings and Precautions (5.3) ] • Hearing Loss [see Warnings and Precautions (5.4) ] • Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions (5.5) ] • Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings and Precautions (5.6) ] • Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions (5.7) ] • Effects on Bleeding [see Warnings and Precautions (5.8 )] • Counseling Patients About Sexually Transmitted Diseases [see Warnings a...
Can I take Sildenafil during pregnancy?▼
8.1 Pregnancy Risk Summary Sildenafil tablets are not indicated for use in females. There are no data with the use of Sildenafil tablets in pregnant women to inform any drug-associated risks for adverse developmental outcomes. Animal reproduction studies conducted with sildenafil did not show adverse developmental outcomes when administered during organogenesis in rats and rabbits at oral doses up to 16 and 32 times, respectively, the maximum recommended human dose (MRHD) of 100 mg/day on a mg/m 2 basis (see DATA ).
What are the important warnings for Sildenafil?▼
5 WARNINGS AND PRECAUTIONS • Patients should not use sildenafil tablets if sexual activity is inadvisable due to cardiovascular status ( 5.1 ) • Patients should seek emergency treatment if an erection lasts >4 hours. Use sildenafil tablets 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). 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. 4 CONTRAINDICATIONS • Administration of sildenafil tablets to patients using nitric oxide donors, such as organic nitrates or organic nitrites in any form. Sildenafil tablets were 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 rioc...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.