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Armodafinil and Gildess Fe 1/20

Determining the interaction of Armodafinil and Gildess Fe 1/20 and the possibility of their joint administration.

Check result:
Armodafinil <> Gildess Fe 1/20
Relevance: 23.08.2022 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:

Using ethinyl estradiol together with armodafinil may decrease the effectiveness of ethinyl estradiol. If you are using low-dose oral contraceptives you may have an increased risk of breakthrough bleeding and unintended pregnancy. You should discuss the use of alternative or additional methods of birth control with your healthcare provider. If you take hormone replacement for menopause, notify your doctor if you have decreased efficacy of your hormones such as increased hot flashes, vaginal dryness or menstrual problems. It is important that you tell your healthcare provider about all other medications that you are using including vitamins and herbs. Do not stop using your medications without first talking to your doctor first.

Professional:

ADDITIONAL CONTRACEPTION RECOMMENDED: Coadministration with modafinil (the racemate) or armodafinil (the R-enantiomer) may decrease the plasma concentrations of ethinyl estradiol and other contraceptive hormones. The mechanism involves induction of CYP450 3A4-mediated metabolism by modafinil and armodafinil. In female volunteers treated chronically with an oral contraceptive containing ethinyl estradiol (0.035 mg) and norgestimate (0.18 to 0.25 mg), an 18% reduction in mean ethinyl estradiol systemic exposure (AUC) from baseline was observed in 16 subjects receiving modafinil (200 mg once daily for 7 days, then 400 mg for 21 days) compared to a 4% reduction in 18 subjects receiving placebo. The mean peak plasma concentration (Cmax) of ethinyl estradiol was also reduced by 11% versus 5% from baseline, respectively. The clinical significance of these alterations is unknown. In the study, pharmacodynamic effects as measured by plasma levels of FSH and LH showed no statistically significant differences between treatment groups before or after treatment with modafinil versus placebo. However, pharmacokinetic effects and interactions involving ethinyl estradiol are often subject to a high degree of interpatient variability, and the clinical significance may be increased in certain susceptible patients.

MANAGEMENT: Women using hormonal contraceptives (including depot and implantable contraceptives) should be advised of the risk of breakthrough bleeding and unintended pregnancy during concomitant therapy with modafinil or armodafinil. Alternative or additional methods of birth control are recommended during and for one month after treatment with modafinil or armodafinil. Intrauterine systems are unlikely to be significantly affected because of their local action. Input from a gynecologist or similar expert on adequate contraception, including emergency contraception, should be sought as needed.

References
  • "Product Information. Provigil (modafinil)." Cephalon, Inc, West Chester, PA.
  • "Product Information. Nuvigil (armodafinil)." Cephalon Inc, West Chester, PA.
  • 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]):
  • Robertson P, Decory HH, Madan A, Parkinson A "In vitro inhibition and induction of human hepatic cytochrome P450 enzymes by modafinil." Drug Metab Dispos 28 (2000): 664-71
  • Robertson P Jr, Hellriegel ET, Arora S, Nelson M "Effect of modafinil on the pharmacokinetics of ethinyl estradiol and triazolam in healthy volunteers." Clin Pharmacol Ther 71 (2002): 46-56
  • Cerner Multum, Inc. "Australian Product Information." O 0
Armodafinil

Generic Name: armodafinil

Brand name: Nuvigil

Synonyms: n.a.

Gildess Fe 1/20

Generic Name: ethinyl estradiol / norethindrone

Brand name: Blisovi 24 Fe, Blisovi Fe 15/30, Blisovi Fe 1/20, Estrostep Fe, Gildess 24 Fe, Gildess Fe 15/30, Gildess Fe 1/20, Junel Fe 15/30, Junel Fe 1/20, Junel Fe 24, Larin 24 Fe, Larin Fe 15/30, Larin Fe 1/20, Lo Loestrin Fe, Loestrin 24 Fe, Loestrin Fe 15/30, Loestrin Fe 1/20, Lomedia 24 Fe, Microgestin 24 Fe, Microgestin Fe 15/30, Microgestin Fe 1/20, Tarina Fe 1/20, Taytulla, Tilia Fe, Tri-Legest Fe, Blisovi 24 Fe, Femcon Fe, Kaitlib FE, Lo Minastrin Fe, Microgestin 24 Fe, Norinyl 1+35, Ortho-Novum 7/7/7, Tri-Norinyl, Zenchent, femhrt 05 mg/25 mcg, Fyavolv, Jevantique Lo, Jinteli, Femcon Fe, Generess FE, Loestrin 1/20, Ovcon 35, Brevicon

Synonyms: n.a.

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.

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Disease interaction