Ethinylestradiol + gestodene

Generic Medicine Info
Current or history of venous thromboembolism (VTE) (e.g. pulmonary embolism, DVT), known hereditary or acquired predisposition for VTE (e.g. APC-resistance, antithrombin-III deficiency, protein C or S deficiency), presence of multiple risk factors for VTE, conditions requiring prolonged immobilisation (e.g. major surgery); current or history of arterial thromboembolism (ATE) (e.g. stroke, MI) or prodromal conditions (e.g. angina pectoris, TIA), known hereditary or acquired predisposition to ATE (e.g. hyperhomocysteinaemia, anti-phospholipid antibodies), history of headache/migraine with focal neurological symptoms (e.g. aura), presence of multiple risk factors for ATE (e.g. severe hypertension, diabetes mellitus with vascular symptoms); current or history of pancreatitis associated with severe hypertriglyceridaemia, undiagnosed abnormal genital bleeding, breast or other estrogen-dependent neoplasms, current or history of hepatic adenoma or carcinoma. Severe hepatic impairment. Pregnancy. Concomitant use with the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (with or without ribavirin).
Special Precautions
Patient with Crohn's disease or ulcerative colitis, gallbladder disease, SLE, epilepsy, history of depression, hereditary angioedema, risk factors for CV disease (e.g. hypertension, dyslipidaemia), asthma. Obese patients, smokers (women >35 years). Renal and mild to moderate hepatic impairment. Lactation. Monitoring Parameters Assess pregnancy status prior to therapy. Monitor weight, blood pressure during therapy; symptoms of VTE and ATE.
Adverse Reactions
Significant: Chloasma, breakthrough bleeding, spotting, cholestasis, lipid changes, glucose intolerance, gallbladder disease, fluid retention, headache (e.g. migraine), optic neuritis, retinal vascular thrombosis. Eye disorders: Intolerance to contact lenses. Gastrointestinal disorders: Abdominal pain, nausea, vomiting. Investigations: Increased or decreased weight. Nervous system disorders: Dizziness, nervousness. Psychiatric disorders: Altered or depressed mood. Reproductive system and breast disorders: Amenorrhoea, dysmenorrhoea, breast tenderness, pain or enlargement; changes in libido, menstrual flow and cervical secretion or ectropion.
Potentially Fatal: VTE (e.g. DVT, pulmonary embolism), ATE (e.g. MI) or CV accident (e.g. stroke, TIA), hypertension, increased risk of breast, cervical, endometrial or ovarian cancer. Rarely, hepatic adenoma or carcinoma.
Drug Interactions
Ethinylestradiol: Reduced plasma concentration with hepatic enzyme-inducing drugs including antiretroviral agents (e.g. nevirapine), anticonvulsants (e.g. barbiturates, phenytoin), certain antibiotics (e.g. ampicillin, rifampicin) or antifungals (e.g. griseofulvin). Increased plasma concentrations with strong and moderate CYP3A4 inhibitors including azole antifungals (e.g. itraconazole), macrolide antibiotics (e.g. erythromycin); ascorbic acid, paracetamol, atorvastatin, etoricoxib. May increase the plasma concentrations of ciclosporin, theophylline, tizanidine. May decrease the plasma levels of lamotrigine.
CIMS Class
ATC Classification
G03CA01 - ethinylestradiol ; Belongs to the class of natural and semisynthetic estrogens used in estrogenic hormone preparations.
L02AA03 - ethinylestradiol ; Belongs to the class of estrogens.
Disclaimer: This information is independently developed by CIMS based on ethinylestradiol + gestodene from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by
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