FULL PRESCRIBING INFORMATION: CONTENTS*

Sildenafil is metabolized principally by cytochrome P450 (CYP) 3A4 (major route) and 2C9 (minor route) enzymes.

6.2 Post-marketing Experience

Particular caution should be used when prescribing phosphodiesterase type 5 (PDE5) inhibitors to patients receiving tipranavir. [28] When sildenafil is coadministered with tipranavir and used for erectile dysfunction, use sildenafil at reduced doses of 25 mg every 48 hours with increased monitoring for adverse reactions. [27][28] Coadministration is expected to substantially increase the PDE5 inhibitor plasma concentrations and may result in increased associated adverse events including hypotension, syncope, visual changes, and prolonged erection. Particular caution should be used when prescribing phosphodiesterase type 5 (PDE5) inhibitors to patients receiving delavirdine. Coadministration of delavirdine with these drugs is expected to substantially increase their plasma concentrations and may result in increased associated adverse events including hypotension, syncope, visual changes, and prolonged erection.

12.3 Pharmacokinetics

Use sildenafil at reduced doses of 25 mg every 48 hours with increased monitoring for adverse reactions. Efavirenz induces CYP3A4 and may decrease serum concentrations of drugs metabolized by this enzyme, such as sildenafil. [19][41] In healthy subjects who received fluvoxamine for 10 days, the AUC of sildenafil was increased by 40% after a single 50 mg dose of sildenafil was given. [42] One case of fluvoxamine-induced erectile dysfunction has been reported to have been treated with sildenafil. [43] A starting dose of sildenafil 25 mg is suggested for patients on fluvoxamine therapy; doses should be increased only if 25 mg is not sufficient.

What’s the difference between sildenafil and Viagra?

Fluvoxamine is likely to have an interaction with similar agents such as tadalafil and vardenafil since they are also metabolized by CYP3A4. Other selective serotonin reuptake inhibitors such as citalopram, escitalopram, paroxetine, sertraline, and venlafaxine have no significant effects on CYP3A4 and are not likely to affect sildenafil pharmacokinetics. Altered sildenafil serum concentrations may pfizer sildenafil 50 occur, leading to either an increased risk of sildenafil-related adverse reactions or a risk of decreased sildenafil efficacy. Sildenafil is metabolized principally by the hepatic cytochrome P450 (CYP) 3A4 (major route) and 2C9 (minor route) isoenzymes. Inhibitors of these isoenzymes may reduce sildenafil clearance. [20] In healthy subjects, coadministration of multiple doses of 125 mg twice daily bosentan with 80 mg three times

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daily sildenafil has resulted in a reduction of sildenafil plasma concentrations by 63% and increased bosentan plasma concentrations by 50%.

Warnings for Viagra

Sildenafil is contraindicated for use with atazanavir; cobicistat when used for pulmonary arterial hypertension (PAH). Sildenafil is contraindicated for use with darunavir; cobicistat when used for pulmonary arterial hypertension (PAH). Particular caution should be used when prescribing phosphodiesterase type 5 (PDE5) inhibitors to patients receiving indinavir. Additionally, sildenafil is contraindicated for use with the anti-retroviral protease inhibitors when used for pulmonary arterial hypertension (PAH).28731 When sildenafil is coadminstered with indinavir and used for erectile dysfunction, use sildenafil at reduced doses of 25 mg every 48 hours with increased monitoring for adverse reactions. [27] Substantially increased PDE5 inhibitor plasma concentrations are seen and may result in increased associated adverse events including hypotension, syncope, visual changes, and prolonged erection.

Patient resources

In a small pharmacokinetic study, the coadministration of a single dose of sildenafil (25 mg) to patients receiving indinavir (800 mg every 8 hours) resulted in markedly increased sildenafil AUC values (340% increase), as compared to historical controls. The Cmax for indinavir was increased by 48% and the 8-hour AUC was increased 11% following concurrent administration. In two of the six subjects, prolonged clinical effects of sildenafil were noted for 72 hours after a single dose of sildenafil. Particular caution should be used when prescribing phosphodiesterase type 5 (PDE5) inhibitors to patients receiving lopinavir; ritonavir (Kaletra). Coadministration of lopinavir; ritonavir (Kaletra) with these drugs is expected to substantially increase their plasma concentrations and may result in increased associated adverse events including hypotension, syncope, visual changes, and prolonged erection.

What are the most common side effects of sildenafil?

Lopinavir; ritonavir is contraindicated for use with sildenafil when sildenafil is used for the treatment of pulmonary arterial hypertension (PAH). [37] If coadministered when sildenafil is used for erectile dysfunction, use 20mg sildenafil sildenafil at reduced doses of 25 mg every 48 hours with increased monitoring for adverse reactions. Particular caution should be used when prescribing phosphodiesterase type 5 (PDE5) inhibitors to patients receiving nelfinavir. [38] When sildenafil is coadministered with nelfinavir and used for erectile dysfunction, use sildenafil at reduced doses of 25 mg every 48 hours with increased monitoring for adverse reactions. [27][38] Coadministration of nelfinavir with PDE5 inhibitors is expected to substantially increase their plasma concentrations and may result in increased associated adverse events including hypotension, syncope, visual changes, and prolonged erection. [60] Dosage adjustment for this interaction is not needed for bosentan or

• Sildenafil tablets 125 mg are available by prescription only.
• They work by inhibiting the PDE5 enzyme.
• Do not mix sildenafil with alcohol to avoid adverse effects.
• Use with caution if you have heart or liver conditions.
• Sildenafil may interact with certain antibiotics.
• Be aware of potential side effects like flushing.
• Take sildenafil about 30-60 minutes before activity.
• Avoid using grapefruit juice while on sildenafil.

sildenafil (including when used to treat pulmonary arterial hypertension or erectile dysfunction).

• Sildenafil tablets 125 mg are manufactured by various brands.
• Always verify the authenticity of medication sources.
• Use only FDA-approved or certified pharmacies.
• Cost can vary based on brand and location.
• Generic versions are typically more affordable.
• Beware of counterfeit sildenafil products.
• Read customer reviews before purchasing online.
• Consult your doctor about the best brand for you.

[20] It can be expected that concomitant administration of sildenafil with CYP3A4 enzyme inducers, such as barbiturates,

17. Patient Counseling Information

The manufacturer recommends dosage reduction in patients receiving potent cytochrome CYP3A4 inhibitors such as erythromycin (see Dosage). [20] When a single 100 mg dose of sildenafil is administered with erythromycin (500 mg bid for 5 days), a specific CYP3A4 inhibitor, at steady state, there is a 182% increase in sildenafil systemic exposure (AUC). [20] In vivo studies of healthy male volunteers show no clinically significant effect of azithromycin (500 mg PO daily for 3 days) on the systemic exposure of sildenafil or its major circulating metabolite. The manufacturer recommends dosage reduction in patients receiving potent cytochrome CYP3A4 inhibitors such as ketoconazole (see Dosage). [20] Population data from patients in clinical trials did indicate a reduction in sildenafil clearance when it was coadministered with CYP3A4 inhibitors.

Indications and Usage for Sildenafil Oral Suspension

The manufacturer recommends dosage reduction in patients receiving potent cytochrome CYP3A4 inhibitors such as itraconazole (see Dosage). The manufacturer recommends dosage reduction in patients receiving potent cytochrome CYP3A4 inhibitors such as mibefradil (see Dosage). The use of clarithromycin and sildenafil is not recommended due to the potential increased sildenafil concentrations due to the CYP3A4 inhibition of clarithromycin. The manufacturer recommends dosage reduction in patients receiving potent cytochrome CYP3A4 inhibitors (see Dosage). [41][47][48][49][50][51][52][53][54][55][56][57][58][59] This list is not inclusive of all medications that may inhibit CYP3A4. carbamazepine, dexamethasone, phenytoin, fosphenytoin, nevirapine, rifabutin, rifampin, troglitazone,

Dosage for Viagra

[29] If sildenafil is coadministered with amprenavir and used for erectile dysfunction, use sildenafil at reduced doses of 25 mg every 48 hours with increased monitoring for adverse reactions. [27][30] Substantially increased sildenafil plasma concentrations may result in increased associated adverse events including hypotension, syncope, visual changes, and prolonged erection. Particular caution should be used when prescribing phosphodiesterase type 5 (PDE5) inhibitors to patients receiving fosamprenavir. [29] If sildenafil is coadministered with fosamprenavir and used for erectile dysfunction, use sildenafil at reduced doses of 25 mg every 48 hours with increased monitoring for adverse reactions. [27][29] Coadministration with sildenafil results in a 210% increase in sildenafil AUC.

Regional issues

Substantially increased sildenafil plasma concentrations may result in increased associated adverse events including hypotension, syncope, visual changes, and prolonged erection. Particular caution should be used when prescribing phosphodiesterase type 5 (PDE5) inhibitors to patients receiving atazanavir. [31] If sildenafil is coadministered with atazanavir and used for erectile dysfunction, use sildenafil at reduced doses of 25 mg every 48 hours with increased monitoring for adverse reactions. [27][31] Coadministration of atazanavir with PDE5 inhibitors is expected to substantially increase their plasma concentrations and may result in increased associated adverse events including hypotension, syncope, visual changes, and prolonged erection. Particular caution should be used when prescribing phosphodiesterase type 5 (PDE5) inhibitors to patients receiving darunavir.

What happens if I take too much sildenafil?

[32] When sildenafil is coadministered with darunavir and used for erectile dysfunction, use sildenafil at reduced doses of 25 mg every 48 hours with increased monitoring for adverse reactions. [27][32] Coadministration of darunavir with PDE5 inhibitors is expected to substantially increase their plasma concentrations and may result in increased associated adverse events including hypotension, syncope, visual changes, and prolonged erection. Sildenafil is contraindicated for use with cobicistat when sildenafil citrate chewable tablets used for pulmonary arterial hypertension (PAH). If used for erectile dysfunction, the dose of sildenafil should not exceed 25 mg every 48 hours with increased monitoring for adverse reactions during times of coadministration. Concurrent use is expected to substantially increase the sildenafil plasma concentrations and may result in increased associated adverse events including hypotension, syncope, visual changes, and prolonged erection. cisapride, mifepristone (RU-486) in vitro, tacrolimus, tolbutamide, or warfarin.

Side Effect	Frequency	Severity	Description
Headache	Common	Mild	Throbbing headache
Flushing	Common	Mild	Skin redness, warmth
Nasal Congestion	Common	Mild	Stuffy nose
Visual Disturbances	Less common	Mild	Blurred vision, blue tint
Dizziness	Less common	Mild	Feeling lightheaded

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