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Demulen 1/50 and Tracleer (Bosentan Tablets for Oral Suspension)

Determining the interaction of Demulen 1/50 and Tracleer (Bosentan Tablets for Oral Suspension) and the possibility of their joint administration.

Check result:
Demulen 1/50 <> Tracleer (Bosentan Tablets for Oral Suspension)
Relevance: 03.06.2023 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:

Bosentan may reduce the blood levels and effects of ethinyl estradiol, which may make it less reliable as a form of birth control. Alternative or additional methods of birth control should be used during treatment with bosentan to avoid unintended pregnancy. This is particularly important because bosentan may cause major birth defects in the unborn child. Talk to your gynecologist or other healthcare professional for help in selecting an effective method of birth control that is best for you. If you take hormone replacement for menopause, you should contact your doctor if you experience increased frequency or worsening of your symptoms such as hot flashes, vaginal dryness, or abnormal bleeding. 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:

ADDITIONAL CONTRACEPTION RECOMMENDED: Coadministration with bosentan may decrease the plasma concentrations and efficacy of contraceptive hormones. The mechanism is bosentan induction of CYP450 3A4, the isoenzyme primarily responsible for the metabolic clearance of sex hormones. In one study, coadministration of bosentan and an oral contraceptive containing ethinyl estradiol and norethindrone resulted in average decreases of 31% and 14%, respectively, in plasma levels of the hormones. However, decreases in exposure were as much as 66% for ethinyl estradiol and 56% for norethindrone in individual subjects.

MANAGEMENT: Hormonal contraceptives, including oral, injectable, transdermal, and implantable forms, may not be reliable during concomitant therapy with bosentan. Because use of bosentan is likely associated with major birth defects, it is particularly important that patients not become pregnant during treatment. Therefore, hormonal contraceptives should not be used as the sole method of birth control in women of childbearing potential treated with bosentan. Input from a gynecologist or similar expert on adequate contraception, including emergency contraception, should be sought as needed. Intrauterine systems are unlikely to be significantly affected because of their local action.

References
  • Faculty of Sexual & Reproductive Healthcare "FSRH Clinical Guidance: Drug Interactions with Hormonal Contraception. Available from: URL: file:///C:/Users/df033684/Downloads/ceuguidancedruginteractionshormonal.pdf." ([2012, Jan 1]):
  • "Product Information. Tracleer (bosentan)." Acetelion Pharmaceuticals US, Inc, South San Francisco, CA.
Demulen 1/50

Generic Name: ethinyl estradiol / ethynodiol

Brand name: Kelnor, Zovia 1/35, Zovia 1/50, Demulen 1/35, Demulen 1/50, Zovia 1/35e, Kelnor 1/50, Kelnor 1/35, Zovia 1/50e

Synonyms: Demulen 1/50 (Oral)

Tracleer (Bosentan Tablets for Oral Suspension)

Generic Name: bosentan

Brand name: Tracleer

Synonyms: Tracleer

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.