8 USE IN SPECIFIC POPULATIONS
silodosinsildenafil increases effects of silodosin by pharmacodynamic synergism.
Highlights of Prescribing Information
Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels. mitotane decreases levels of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. nafcillinnafcillin will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels nafcillin will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Patients receiving indinavir with ritonavir should receive not more than 25 mg of sildenafil for treatment of erectile dysfunction in a 48-hour period, and patients receiving other protease inhibitors should use a lower initial sildenafil dose of 25 mg.
IV Administration
Patient taking sildenafil for PAH with ritonavir is not recommended. pentobarbitalpentobarbital will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels pentobarbital will decrease the level or effect of sildenafil by affecting pfizer sildenafil 100 hepatic/intestinal enzyme CYP3A4 metabolism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels phenobarbitalphenobarbital will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels phenobarbital will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
Missed Dose
Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels phenoxybenzaminesildenafil increases effects of phenoxybenzamine by pharmacodynamic synergism. sildenafil increases effects of phenoxybenzamine by pharmacodynamic synergism. phentolaminesildenafil increases effects of phentolamine by pharmacodynamic synergism. sildenafil increases effects of phentolamine by pharmacodynamic synergism. phenytoinphenytoin will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. sildenafil increases effects of silodosin by pharmacodynamic synergism. St John's WortSt John's Wort will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
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Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels St John's Wort will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
Warnings & Precautions
After discontinuation of a strong CYP3A inhibitor, resume crizotinib dose used prior to initiating the strong CYP3A4 inhibitor. crizotinib increases levels of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. dabrafenibdabrafenib will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels dabrafenib will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels doxazosinsildenafil increases effects of doxazosin by pharmacodynamic synergism.
What are the serious side effects of sildenafil?
sildenafil increases effects of doxazosin by pharmacodynamic synergism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels eslicarbazepine acetate will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels fexinidazolefexinidazole will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Coadministration may increase risk for adverse effects of CYP3A4 substrates. fexinidazole will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
8.7 Hepatic Impairment
ivosidenibivosidenib will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternative therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs. ivosidenib will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ketoconazoleketoconazole will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels terazosinsildenafil increases effects of terazosin by pharmacodynamic synergism. sildenafil increases effects of terazosin by pharmacodynamic synergism. tovorafenibtovorafenib will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
8. Use In Specific Populations
Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels phenytoin will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels prazosinsildenafil increases effects of prazosin by pharmacodynamic synergism. sildenafil increases effects of prazosin by pharmacodynamic synergism. primidoneprimidone will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels primidone will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid coadministration of tovorafenib (a weak CYP3A4 inducer) with CYP3A substrates where minimal concentration changes may lead to serious therapeutic failures. If unavoidable, monitor patients for loss of efficacy unless otherwise recommended in the CYP3A4 substrate prescribing information. tovorafenib will decrease the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. tucatinibtucatinib will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
Before taking this medicine
Potent CYP3A4 inducers are expected to cause substantial decreases in sildenafil plasma levels relacorilantrelacorilant increases levels of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid coadministration of sildenafil with strong CYP3A4 inhibitors. relacorilant increases levels of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ritonavirritonavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. ritonavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling. tucatinib will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
12.2 Pharmacodynamics
Coadministration with strong CYP3A4 inhibitors and sildenafil (for pulmonary arterial hypertension) is not recommended. When used for erectile dysfunction, consider reducing initial sildenafil dose of 25 mg in patients also taking a strong CYP3A4 inhibitor and monitor for sildenafil toxicities (eg, dyspepsia, headache, hypotension). ketoconazole will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. lenacapavirlenacapavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Refer to the prescribing information of PDE5 inhibitors for dose recommendations.
7.5 Alcohol
lenacapavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. levoketoconazole will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. lonafarniblonafarnib will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling. lonafarnib will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
Related treatment guides
lopinavirlopinavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. lopinavir will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. mifepristonemifepristone will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. mifepristone will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. mitotanemitotane decreases levels of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. acebutololacebutolol increases effects of sildenafil by additive vasodilation.
- Regulatory status of sildenafil varies by country but generally requires a prescription.
- In the UK, it is a Prescription Only Medicine (POM) but can be prescribed by pharmacists.
- In some countries, it may be available in limited quantities without a prescription.
- The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for Revatio.
- The REMS is designed to inform healthcare providers about the serious risks.
- This includes the risk of use with nitrates and the potential for hearing loss.
- The medication is subject to controlled substance regulations in some regions.
- Traveling with prescription medication requires carrying it in original packaging.
- It is advisable to have a copy of the prescription or a doctor's note when traveling.
- Laws regarding the importation of prescription drugs are strict and vary.
- Always check the legal status of the medication in your destination country.
Sildenafil has systemic vasodilatory properties and may further lower blood pressure in patients taking antihypertensive medications. Monitor blood pressure response to sildenafil in patients receiving concurrent blood pressure lowering therapy.
| Drug Class | Interaction Effect | Recommendation |
|---|---|---|
| Nitrates | Severe hypotension | Avoid combination |
| Alpha-blockers | Additive blood pressure lowering effect | Use with caution |
| CYP3A4 inhibitors (e.g., ketoconazole) | Increased sildenafil levels | Dose adjustment may be necessary |
| Antihypertensives | Enhanced blood pressure reduction | Monitor blood pressure |
| Grapefruit juice | Increased plasma concentration | Avoid during treatment |
acebutolol increases effects of sildenafil by additive vasodilation. amifostineamifostine increases effects of sildenafil by additive vasodilation. amifostine increases effects of sildenafil by additive vasodilation.
- A large body of post-marketing surveillance data exists for sildenafil.
- Spontaneous reporting systems have helped identify rare adverse events.
- These include NAION, sudden hearing loss, and serious cardiovascular events.
- The overall benefit-risk profile remains positive for its approved indications.
- Studies continue to monitor long-term safety in chronic users.
- Data is collected on use in special populations, like the elderly.
- Real-world evidence often confirms the findings from controlled trials.
- Pharmacovigilance is ongoing to detect any new or changing safety signals.
- This data is used to update product labeling and inform healthcare providers.
- Patients are encouraged to report any suspected side effects to their doctor or FDA/MedWatch.
- This surveillance is a critical component of ensuring drug safety.
aprepitantaprepitant will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism. aprepitant will increase the level or effect of sildenafil by affecting hepatic/intestinal enzyme CYP3A4 metabolism.