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PCE Dispertab and Sildenafil Tablets

Determining the interaction of PCE Dispertab and Sildenafil Tablets and the possibility of their joint administration.

Check result:
PCE Dispertab <> Sildenafil Tablets
Relevance: 03.12.2022 Reviewer: Shkutko P.M., M.D., in

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Consumer:

Talk to your doctor before using sildenafil together with erythromycin. Combining these medications may significantly increase the blood levels and effects of sildenafil. Depending on your condition, you may not be able to use these medications together, or you may need a dose adjustment or more frequent monitoring by your doctor to safely use both medications. Contact your doctor if your condition changes or you experience nausea, shortness of breath, dizziness, lightheadedness, fainting, visual disturbances, ringing in the ears, vision or hearing loss, chest pain or tightness, irregular heartbeat, and/or priapism (prolonged and painful erection unrelated to sexual activity), as these may be signs and symptoms of excessive sildenafil levels. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Professional:

ADJUST DOSE: Coadministration with potent inhibitors of CYP450 3A4 may significantly increase the plasma concentrations of sildenafil, which is primarily metabolized by the isoenzyme. The possibility of prolonged and/or increased pharmacologic effects of sildenafil should be considered. In 14 healthy volunteers, the potent CYP450 3A4 inhibitor ritonavir (500 mg twice a day for 7 days) increased mean peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) of sildenafil (100 mg single dose) by 300% and 1000%, respectively, compared to sildenafil given alone. At 24 hours, sildenafil plasma levels were still approximately 200 ng/mL as opposed to about 5 ng/mL with sildenafil alone. In a parallel study, saquinavir (SGC 1200 mg three times a day for 7 days) increased single-dose sildenafil Cmax and AUC by 140% and 210%, respectively, in 14 healthy volunteers. No change in safety or tolerability of sildenafil was observed with either protease inhibitor. In six HIV-infected patients stabilized on triple antiretroviral therapy containing indinavir (800 mg three times a day), the AUC of a single 25 mg dose of sildenafil was 4.4 times higher than dose-normalized data from historical controls. The patients experienced headache, flushing, dyspepsia and rhinitis, and there was a mean maximal decrease in blood pressure of 14/10 mmHg. The interaction was also suspected in the death of a 47-year-old man who used sildenafil (25 mg) during treatment with ritonavir and saquinavir. Another CYP450 3A4 inhibitor, erythromycin (500 mg twice daily for 5 days), increased single-dose sildenafil AUC by 182%.

MANAGEMENT: Caution is advised if sildenafil is coadministered with potent CYP450 3A4 inhibitors. Dosage adjustments may be appropriate for sildenafil whenever a CYP450 3A4 inhibitor is added to or withdrawn from therapy based on efficacy and side effects. For the treatment of erectile dysfunction, an initial sildenafil dosage of 25 mg should be considered in patients treated concomitantly with potent CYP450 3A4 inhibitors. Patients should be advised to promptly notify their physician if they experience pain or tightness in the chest or jaw, irregular heartbeat, nausea, shortness of breath, visual disturbances, syncope, or prolonged erection (greater than 4 hours). For the treatment of pulmonary arterial hypertension, a dosage adjustment for sildenafil should be considered during coadministration with some CYP450 3A4 inhibitors such as erythromycin, saquinavir, clarithromycin, telithromycin, and nefazodone. However, use with very potent CYP450 3A4 inhibitors such as ritonavir, ketoconazole, or itraconazole is not recommended. Some authorities consider the use of very potent CYP450 3A4 inhibitors with sildenafil to be contraindicated in patients with pulmonary arterial hypertension.

References
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  • Cerner Multum, Inc. "Australian Product Information." O 0
  • Merry C, Barry MG, Ryan M, Tjia JF, Hennessy M, Eagling VA, Mulcahy F, Back DJ "Interaction of sildenafil and indinavir when co-administered to HIV-positive patients." AIDS 13 (1999): f101-7
  • "Product Information. Viagra (sildenafil)." Pfizer US Pharmaceuticals, New York, NY.
  • Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  • Hyland R, Roe GH, Jones BC, Smith DA "Identification of the cytochrome P450 enzymes involved in the N-demethylation of sildenafil." Br J Clin Pharmaacol 51 (2001): 239-48
  • Hall MCS, Ahmad S "Interaction between sildenafil and HIV-1 combination therapy." Lancet 353 (1999): 2071-2
  • "Product Information. Revatio (sildenafil)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  • Warrington JS, Shader RI, vonMoltke LL, Greenblatt DJ "In vitro biotransformation of sildenafil (Viagra): Identification of human cytochromes and potential drug interactions." Drug Metab Disposition 28 (2000): 392-7
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PCE Dispertab

Generic Name: erythromycin

Brand name: EES. Granules, EES-400 Filmtab, EryPed 200, EryPed 400, Ery-Tab, Erythrocin Lactobionate, Erythrocin Stearate Filmtab, PCE Dispertab, E. E. S, EryPed, Erythrocin, Erythromycin Filmtabs, Erythromycin Lactobionate - IV

Synonyms: PCE Dispertab (Oral), PCE, PCE (Oral)

Sildenafil Tablets

Generic Name: sildenafil

Brand name: Revatio, Viagra

Synonyms: Sildenafil

In the course of checking the drug compatibility and interactions, data from the following reference sources was used: Drugs.com, Rxlist.com, Webmd.com, Medscape.com.

Interaction with food and lifestyle
Disease interaction