Label: SILDENAFIL CITRATE- sildenafil tablet, film coated
Monitor the therapeutic effect of sildenafil pfizer sildenafil 100 during coadministration with fenofibric acid.
| Form | Dose Range per Tablet | Typical Strengths | Administration Route | Manufacturer Examples |
|---|---|---|---|---|
| Oral Tablets | 25 mg - 100 mg | 25 mg, 50 mg, 100 mg | Oral (once or as needed) | Pfizer, Teva, Cipla |
| Chewable Tablets | 50 mg | 50 mg | Oral (chewed) | Generic brands |
| Sublingual Tablets | 50 mg | 50 mg | Sublingual | Experimental formulations |
Fluconazole: (Moderate) Monitor for an increase in sildenafil-related adverse reactions if coadministration with fluconazole is necessary; consider a starting dose of 25 mg of sildenafil when prescribed for erectile dysfunction.
What should I do if I forget a dose?
When sildenafil is used for erectile dysfunction, the dose of sildenafil should not exceed 25 mg in 48 hours. Dexamethasone: (Moderate) Monitor for decreased efficacy of sildenafil if coadministration with dexamethasone is necessary as concurrent use may decrease sildenafil exposure. Dextromethorphan; Diphenhydramine; Phenylephrine: (Minor) The therapeutic effect of phenylephrine injection may be decreased in patients receiving phosphodiesterase inhibitors. Dextromethorphan; Guaifenesin; Phenylephrine: (Minor) The therapeutic effect of phenylephrine injection may be decreased in patients receiving phosphodiesterase inhibitors. Dextromethorphan; Quinidine: (Moderate) Sildenafil is metabolized principally by the hepatic isoenzymes CYP3A4 and CYP2C9.
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Inhibitors of these isoenzymes, such as quinidine, sildenafil citrate 150 mg red pill may reduce sildenafil clearance. Increased systemic exposure to sildenafil may result in an increase in sildenafil-induced adverse effects. Diltiazem: (Moderate) Monitor for an increase in sildenafil-related adverse reactions if coadministration with diltiazem is necessary; consider a starting dose of 25 mg of sildenafil when prescribed for erectile dysfunction. Diphenhydramine; Phenylephrine: (Minor) The therapeutic effect of phenylephrine injection may be decreased in patients receiving phosphodiesterase inhibitors. Doxazosin: (Moderate) Due to the potential for symptomatic hypotension, patients should be stable on alpha-blocker therapy before initiating therapy with the lowest dose of sildenafil.
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Dronedarone: (Moderate) Monitor for an increase in sildenafil-related adverse reactions if coadministration with dronedarone is necessary; a dose reduction of sildenafil may be necessary when prescribed for erectile dysfunction. Duloxetine: (Moderate) Orthostatic hypotension and syncope have been reported during duloxetine administration. The concurrent administration of antihypertensive agents and duloxetine may increase the risk of hypotension. It is advisable to monitor blood pressure if the combination is necessary. Dutasteride; Tamsulosin: (Moderate) Due to the potential for symptomatic hypotension, patients should be stable on tamsulosin therapy before initiating therapy with the lowest dose of sildenafil. Fluvoxamine: (Moderate) Monitor for an increase in sildenafil-related adverse reactions if coadministration with fluvoxamine is necessary; a dose reduction of sildenafil may be necessary when prescribed for erectile dysfunction.
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In a drug interaction study, coadministration of fluvoxamine increased the sildenafil AUC by 40%.
What to avoid
The clinical relevance of the in vivo effect of encorafenib on CYP3A4 is not established. Enzalutamide: (Moderate) Monitor for decreased efficacy of sildenafil if coadministration with enzalutamide is necessary. Erythromycin: (Moderate) Monitor for an increase in sildenafil-related adverse reactions if coadministration with erythromycin is necessary; consider a starting dose of 25 mg of sildenafil when prescribed for erectile dysfunction. In a drug interaction study, coadministration with erythromycin increased the Cmax and AUC of sildenafil by 160% and 182%, respectively. Etravirine: (Moderate) Etravirine is an inducer of CYP3A4; coadministration may result in decreased sildenafil concentrations. Fosamprenavir: (Moderate) Monitor for an increase in sildenafil-related adverse reactions if coadministration with fosamprenavir is
4.3 Concomitant Guanylate Cyclase (GC) Stimulators
Cobicistat: (Major) Sildenafil is contraindicated for use with cobicistat when used for pulmonary arterial hypertension (PAH). Codeine; Phenylephrine; Promethazine: (Minor) The therapeutic effect of phenylephrine injection may be decreased in patients receiving phosphodiesterase inhibitors. Conivaptan: (Moderate) Monitor for an increase in sildenafil-related adverse reactions if coadministration with conivaptan is necessary; consider a starting dose of 25 mg of sildenafil when prescribed for erectile dysfunction. In a drug interaction study, coadministration with a moderate CYP3A inhibitor increased the peak and overall exposure of sildenafil by 160% and 182%, respectively. Predictions based on a pharmacokinetic model suggest that drug-drug interactions with CYP3A inhibitors will be less for sildenafil injection than those observed after oral sildenafil administration.
Other Interactions
Crizotinib: (Moderate) Monitor for an increase in sildenafil-related adverse reactions if coadministration with crizotinib is necessary; consider a starting dose of 25 mg of sildenafil when prescribed for erectile dysfunction. Dabrafenib: (Major) The concomitant use of dabrafenib and sildenafil may lead to decreased sildenafil concentrations and loss of efficacy. Use of an alternative agent is recommended. If concomitant use of these agents together is unavoidable, monitor patients for loss of sildenafil efficacy. Concomitant use of dabrafenib with a single dose of another sensitive CYP3A4 substrate decreased the AUC value of the sensitive CYP3A4 substrate by 65%.
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Danazol: (Moderate) Monitor for an increase in sildenafil-related adverse reactions if coadministration with danazol is necessary; a dose reduction of sildenafil may be necessary when prescribed for erectile dysfunction. Darunavir: (Major) Sildenafil is contraindicated for use with darunavir when used for pulmonary arterial hypertension (PAH). Darunavir; Cobicistat: (Major) Sildenafil is contraindicated for use with cobicistat when used for pulmonary arterial hypertension (PAH). (Major) Sildenafil is contraindicated for use with darunavir when used for pulmonary arterial hypertension (PAH). Delavirdine: (Major) Coadministration of delavirdine is not recommended in patients receiving sildenafil for pulmonary arterial hypertension (PAH). necessary; consider a starting dose of 25 mg of sildenafil when prescribed for erectile dysfunction.
- Using sildenafil with certain medicines can cause serious interactions.
- Blood pressure medications and alpha-blockers are common concerns.
- Always inform your doctor of all medications you're taking.
When used for pulmonary arterial hypertension, this combination is listed as a contraindication in the fosamprenavir FDA-approved labeling.
- Common side effects include headache and flushing.
- Some may experience nasal congestion or dizziness.
- Serious side effects require immediate medical attention.
In a drug interaction study, coadministration with a moderate CYP3A inhibitor increased the Cmax and AUC of sildenafil by 160% and 182%, respectively.
| Condition | Risk | Recommendations |
|---|---|---|
| Concomitant Nitrate Use | Severe hypotension | Avoid combination |
| Cardiac Conditions | Risk of myocardial infarction or arrhythmia | Consult cardiologist |
| Severe Liver Impairment | Altered drug metabolism | Dose adjustment needed |
| Hypotension (low BP) | Further blood pressure reduction | Use with caution |
Glycerol Phenylbutyrate: (Moderate) Monitor for decreased efficacy of sildenafil if coadministration with glycerol phenylbutyrate is necessary as concurrent use may decrease sildenafil exposure.
| Medication Class | Interaction Type | Effect | Clinical Significance |
|---|---|---|---|
| Nitrates | Additive hypotensive effect | Severe hypotension | Contraindicated |
| Alpha-blockers | Enhanced hypotension | Blood pressure drop | Use with caution |
| CYP3A4 inhibitors | Increased sildenafil levels | Prolonged or intensified side effects | Dose adjustment may be needed |
| Protease inhibitors | Elevated sildenafil levels | Increased adverse effects | Monitoring required |
Grapefruit juice: (Moderate) Sildenafil is metabolized via the cytochrome CYP 3A4 isozyme.
7.3 Amlodipine
Dosage adjustments may be needed based on clinical efficacy. Fedratinib: (Moderate) Monitor for an increase in sildenafil-related adverse reactions if coadministration with fedratinib is necessary; consider a starting dose of 25 mg of sildenafil when prescribed for erectile dysfunction. Fenofibric Acid: (Minor) At therapeutic concentrations, fenofibric acid is a mild-to-moderate inhibitor of CYP2C9. Concomitant use of fenofibric acid with CYP2C9 substrates, such as sildenafil , has not been formally studied. Fenofibric acid may theoretically increase plasma concentrations of CYP2C9 substrates and could lead to toxicity for drugs that have a narrow therapeutic range. Grapefruit juice contains a compound that inhibits CYP3A4 in enterocytes in the GI tract.
5.5 Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives
Conversely, patients already receiving an optimized dose of sildenafil should be started on the lowest dose of tamsulosin; increases in the alpha-blocker dose should be done in a stepwise fashion. Other variables, such as intravascular volume depletion, concurrent antihypertensive therapy, or evidence of hemodynamic instability with alpha-blocker monotherapy, may affect the safety of concomitant use of sildenafil and tamsulosin. Duvelisib: (Moderate) Monitor for an increase in sildenafil-related adverse reactions if coadministration with duvelisib is necessary; a dose reduction of sildenafil may be necessary when prescribed for erectile dysfunction. Efavirenz: (Moderate) Efavirenz induces CYP3A4 and may decrease serum concentrations of drugs metabolized by this enzyme, such as sildenafil. Elagolix: (Moderate) Monitor for reduced therapeutic effect of chew sildenafil sildenafil if coadministered with elagolix.
What are the most common side effects of sildenafil?
Concurrent use may decrease sildenafil plasma concentrations. Population pharmacokinetic analysis of data from patients in clinical trials indicated approximately 3-fold the sildenafil clearance when it was coadministered with weak CYP3A inducers. Elagolix; Estradiol; Norethindrone acetate: (Moderate) Monitor for reduced therapeutic effect of sildenafil if coadministered with elagolix. Elbasvir; Grazoprevir: (Moderate) Administering sildenafil with elbasvir; grazoprevir may result in elevated sildenafil plasma concentrations. If these drugs are used together, closely monitor for signs of adverse events.
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Elexacaftor; tezacaftor; ivacaftor: (Moderate) Increased monitoring is recommended if ivacaftor is administered concurrently with CYP2C9 substrates, such as sildenafil. Ivacaftor is an inhibitor of CYP3A and a weak inhibitor of CYP2C9; sildenafil is metabolized by CYP3A and CYP2C9. Co-administration of ivacaftor with CYP3A and CYP2C9 substrates, such as sildenafil, can theoretically increase sildenafil exposure leading to increased or prolonged therapeutic effects and adverse events; however, the clinical impact of this has not yet been determined. Encorafenib: (Moderate) Coadministration of encorafenib with sildenafil may result in increased toxicity or decreased efficacy of sildenafil. In vitro studies with encorafenib showed time-dependent inhibition of CYP3A4 and induction of CYP3A4. Sildenafil levels may increase; it is possible that sildenafil-induced side effects could also be increased in some individuals.
- Overdose symptoms may include dizziness, nausea, or prolonged erections.
- Seek emergency help if an erection lasts over 4 hours.
- Avoid excessive dosing to prevent adverse events.
One study has confirmed a potential interaction; sildenafil's AUC increased 23 percent with coadministration of grapefruit juice.
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