The possibility that concomitant administration of sildenafil citrate tables rifampin, a
- Sildenafil 200 mg may cause visual disturbances like blurred vision.
- Consult your doctor if side effects persist or worsen.
- Avoid grapefruit or grapefruit juice while taking sildenafil.
- This medication should only be used under medical supervision.
- Sildenafil is also used to treat pulmonary arterial hypertension.
- Do not share sildenafil 200 mg with others.
potent CYP3A4 inducer, could decrease plasma concentrations of sildenafil should be considered. Additive hypotensive effects can occur if riociguat is used concomitantly with PDE type 5 inhibitors.
| Interacting Drug/Class | Effect on Sildenafil | Clinical Significance | Recommendations |
|---|---|---|---|
| Nitrates | Potentiates vasodilation | Risk of severe hypotension | Avoid concomitant use |
| CYP3A4 inhibitors (e.g., Ritonavir) | Increase sildenafil plasma levels | Risk of increased side effects | Reduce dose or avoid |
| Alpha-blockers | Additive blood pressure lowering | Hypotension | Use with caution, monitor BP |
| CYP3A4 inducers (e.g., Rifampin) | Decrease sildenafil effectiveness | May reduce efficacy | Adjust dose accordingly |
[1][247] In a study in patients with pulmonary arterial hypertension (PAH) who were receiving stable dosages of sildenafil (20 mg 3 times daily), administration of single doses of riociguat resulted in additive hemodynamic effects.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
[1][212][241] In one study in healthy men, concomitant use of bosentan (125 mg twice daily) and sildenafil at a dose not approved for the treatment of erectile dysfunction (80 mg 3 times daily) resulted in a 63% decrease in AUC and a 55% decrease in peak plasma concentrations of sildenafil at steady state; AUC and peak plasma concentrations of bosentan were increased by 50 and 42%, respectively. [1][241] The clinical importance of this pharmacokinetic interaction is unclear. Concomitant administration of sildenafil and heparin in rabbits had an additive effect on bleeding time. [1] Although the possibility of a similar interaction in humans has not been studied specifically to date, there currently is no evidence that would preclude the use of heparin in sildenafil-treated patients if indicated. Pretreatment with erythromycin (500 mg twice daily for 5 days), a specific CYP3A4 inhibitor, increased the AUC of a single 100-mg dose of sildenafil by 182%.
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[1][69][239] It is recommended that a lower initial sildenafil dose (25 mg) be considered in patients with ED receiving potent CYP3A4 inhibitors such as erythromycin. No pharmacokinetic interaction has been observed to date between azithromycin (500 mg daily for 3 days) and sildenafil. [1][138][239] Therefore, no dosage adjustments are required in patients receiving these drugs concomitantly. In a clinical trial combining a single dose of sildenafil (50 mg) and aspirin (150 mg), sildenafil did not potentiate the aspirin-induced increase in bleeding time. In an in vitro human platelet study, sildenafil potentiated the antiaggregatory effect of sodium nitroprusside. [247] A high rate of drug discontinuance generally has been observed among patients receiving combination therapy with sildenafil and riociguat; at least one death, possibly related to the combined use of these drugs, has been reported.
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Because of the risk of hypotension, concomitant use of sildenafil and riociguat is contraindicated.
7.2 Alpha-blockers
[1] Although symptomatic hypotension occurred in a few patients who received sildenafil 50 or 100 mg, syncope was not reported during these drug interaction studies. [1] Caution is advised when PDE type 5 inhibitors are used concomitantly with an α-adrenergic blocking agent. [1] Patients should be hemodynamically stable on α-adrenergic blocking therapy prior to initiating therapy with a PDE type 5 inhibitor. [1] Patients who demonstrate hemodynamic instability on α-adrenergic blocking therapy are at increased risk of symptomatic hypotension with concomitant use of PDE type 5 inhibitors. [1] In patients who are hemodynamically stable on α-adrenergic blocking therapy, PDE type 50 mg sildenafil price 5 inhibitors should be initiated at the lowest recommended dose.
Organic Nitrates, Nitrites, and Nitric Oxide Donors
[1] Conversely, in patients taking an optimized dose of a PDE type 5 inhibitor, therapy with an α-adrenergic blocking agent should be initiated at the lowest recommended dosage. [1] Incremental increases in the dosage of the α-adrenergic blocking agent during such concomitant therapy may be associated with a further lowering of blood pressure. [1] Safety of combination therapy with an α-adrenergic blocking agent may be affected by other variables, including intravascular volume depletion and concomitant use of other antihypertensive agents. Following administration of a single 100-mg sildenafil dose in hypertensive patients whose blood pressure was controlled with amlodipine 5 or 10 mg daily, mean supine blood pressure was reduced (systolic by 8 mm Hg, diastolic by 7 mm Hg). [1][29][154] The greatest decreases in supine systolic and diastolic blood pressures following sildenafil administration were in patients with the highest baseline blood pressures, suggesting that the likelihood of a hypotensive episode during combined use with amlodipine is low. The safety and efficacy of sildenafil in combination with other treatments for ED have not been established, and therefore such combined therapy currently is not recommended by the manufacturer.
| Use Case | Patient Group | Effect Duration | Common Side Effects |
|---|---|---|---|
| Erectile Dysfunction | Men aged 40-70 | 4-6 hours | Headache, flushing, nasal congestion |
| Pulmonary Hypertension | Adults with PAH | 4-6 hours | Dizziness, visual disturbances |
| Off-label Sexual Enhancement | Men over 40 | Varies | Muscle aches, digestive upset |
| Sildenafil for High Altitude Sickness | Travelers | 4-6 hours | Low blood pressure, dizziness |
[67] No pharmacokinetic interaction has been observed between warfarin, a CYP2C9 substrate, and sildenafil.
5.8 Effects on Bleeding
While reported experience with use of sildenafil in HIV-infected patients receiving antiretroviral therapy is limited, clinically important pharmacokinetic interactions have been demonstrated when the drug was used concomitantly with ritonavir and saquinavir. [1][240] Pretreatment with saquinavir (1200-mg liquid-filled capsules [no longer commercially available in the US] 3 times daily) or ritonavir (500 mg twice daily) followed by a single dose of sildenafil (100 mg) increased sildenafil AUC by 210 or 1000%, respectively, and sildenafil peak plasma concentrations by 140 or 300%, respectively. [1][85][136][137][139] In these patients receiving ritonavir and sildenafil, plasma concentrations at 24 hours were approximately 200 ng/mL compared with 5 ng/mL when sildenafil was given alone. [1][139] Sildenafil is only a weak inhibitor of CYP3A4 and CYP2D6 isoenzymes and single doses of the drug had no effect on steady-state saquinavir or ritonavir pharmacokinetics in healthy adults. A decrease in sildenafil clearance and a substantial increase in sildenafil concentrations also is expected with protease inhibitors alone or in combination with ritonavir (e.g., amprenavir , atazanavir, fosamprenavir, indinavir, lopinavir, nelfinavir, tipranavir, darunavir).
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In patients receiving protease inhibitors alone or in combination with ritonavir or the HIV integrase strand transfer inhibitor (INSTI) elvitegravir in combination with cobicistat (CYP3A4 inhibitor), experts recommended that sildenafil dosage not exceed 25 mg every 48 hours for the treatment of ED. The nonnucleoside reverse transcriptase inhibitors efavirenz, nevirapine, and etravirine may decrease sildenafil exposure via CY3A4 (and 2C19 for etravirine) induction, and experts state that sildenafil dose titration based upon clinical effect may be required. [1][250] Population pharmacokinetic analysis of data from clinical trials indicates that sildenafil clearance is reduced when the drug is administered concomitantly with CYP3A4 inhibitors sildenafil spray such as ketoconazole. Because of the possibility of increased systemic exposure and adverse effects, it is recommended that a lower initial sildenafil dose (25 mg) be considered in patients with ED receiving potent CYP3A4 inhibitors such as ketoconazole or itraconazole. Bosentan, a moderate inducer of CYP3A4, CYP2C9, and possibly CYP2C19, can increase sildenafil clearance and decrease plasma sildenafil concentrations. Sildenafil is a selective inhibitor of phosphodiesterases (PDEs), with the greatest selectivity for PDE type 5, the principal isoenzyme
- Patients with liver or kidney issues should consult a physician before use.
- Sildenafil 200 mg is a potent dose, usually used when lower doses are ineffective.
- Alcohol increases the risk of side effects like dizziness and fainting.
- The medication may cause a sudden decrease in blood pressure.
- Use sildenafil cautiously if taking antihypertensive medications.
- Always adhere to doctor’s advice for optimal safety.
of PDE involved in the metabolism of cyclic guanosine monophosphate (cGMP) to GMP in the corpora cavernosa of the penis.
- Sildenafil 200 mg may cause dizziness; avoid driving until effects are known.
- It is not a hormone and does not increase testosterone levels.
- Some men may experience a rash or skin reactions.
- Do not take sildenafil more than once in 24 hours.
- Discontinue use and seek medical advice if adverse reactions occur.
- Combining sildenafil with other vasodilators can be dangerous.
[1][2][4][5][7][8][10][24][27][33][41][42][54][56][57][67][87][88][91][131] Sildenafil has no direct relaxant effect on isolated human corpora cavernosa of the penis,
Dosage And Administration
[67][159] In patients in whom clearance of sildenafil and/or its metabolites may be prolonged (e.g., those with hepatic [e.g., cirrhosis] or severe renal impairment [e.g., creatinine clearance less than 30 mL/minute], those receiving a potent inhibitor of CYP3A4, geriatric patients older than 65 years of age), a more extended period of time between use of sildenafil and administration of a nitrate or nitrite may be necessary. [1][67][154] In either case, a short-acting nitrate formulation that can be titrated readily (e.g., IV nitroglycerin) is preferred and such use should be accompanied by close hemodynamic monitoring. Sildenafil 50 mg did not potentiate the hypotensive effect of alcohol (0.5 g/kg) in healthy individuals (mean maximum blood alcohol concentrations of 0.08% achieved). Sildenafil has systemic vasodilatory effects and may augment the blood pressure-lowering effect of other antihypertensive agents. [1] Hypotensive responses secondary to sildenafil use in patients receiving antihypertensive therapy have been observed.
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The risk of an undesired hypotensive response is of particular concern in patients with congestive heart failure and a borderline low blood volume and low blood pressure status as well as in patients with left-ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis), those with severely impaired autonomic control of blood pressure, and in those who are receiving a complex, multidrug antihypertensive regimen. The AUC of the active metabolite, N-desmethyl sildenafil, was increased 62% by loop and potassium-sparing diuretics and 102% by nonspecific β-adrenergic blocking agents; however, the increased active metabolite concentrations are not expected to be clinically important. Additive hypotensive effects may be anticipated when PDE type 5 inhibitors are administered concurrently with α-adrenergic blocking agents (e.g., terazosin, doxazosin, tamsulosin). [1] Stepwise increases in the dosage of the α-adrenergic blocking agent may further lower blood pressure when a PDE type 5 inhibitor is administered concurrently. [1] In several placebo-controlled crossover studies in patients with benign prostatic hyperplasia receiving doxazosin (4 or 8 mg daily) under steady-state conditions, administration of a single dose of sildenafil (50 or 100 mg) resulted in symptomatic hypotension (e.g., dizziness, lightheadedness, nausea, headache, fatigue) in some patients, occurring within approximately 0.5-4 hours of sildenafil administration. but enhances the effect of nitric oxide by inhibiting PDE type 5-mediated hydrolysis of cGMP.
| Storage Condition | Temperature Range | Light Exposure | Special Handling Notes |
|---|---|---|---|
| Indoor, dry place | 20-25°C (68-77°F) | Store in original container | Keep out of reach of children |
| Avoid Humid Areas | Humidity below 60% | Keep away from direct sunlight | Do not freeze or expose to extreme heat |
| Shelf Life | Up to 2 years | - | Check expiry date before use |