Generic Medicine Info
Active or recent arterial thromboembolic disease (e.g. angina, MI); current or previous idiopathic venous thromboembolism (e.g. DVT, pulmonary embolism); known, previous, or suspected breast cancer or other estrogen dependent tumours (e.g. endometrial cancer); untreated endometrial hyperplasia, undiagnosed abnormal vaginal bleeding; acute or active liver disease or a history of liver disease wherein LFTs have failed to return to normal; porphyria. Pregnancy and lactation. Concomitant use with ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, and sofosbuvir/velpatasvir/voxilaprevir.
Special Precautions
Patients with asthma, diabetes mellitus with or without vascular involvement, cholelithiasis, uterine fibroids (e.g. leiomyoma), endometriosis, hypertension, hypertriglyceridaemia, otosclerosis, thyroid disorders; history of seizures or epilepsy, severe headache or migraine, breast nodules or fibrocystic disease; diseases which may be exacerbated by fluid retention (e.g. CV disease); hereditary or acquired angioedema; risk factors for venous thromboembolism (e.g. family or personal history, obesity [BMI >30 kg/m2], SLE, presence of antiphospholipid bodies, known thrombophilic states, prolonged immobilisation, major trauma or surgery). Predisposition to estrogen-dependent tumours (e.g. breast cancer in first-degree relative). Hepatic and renal impairment. Monitoring Parameters Perform routine physical examination that includes blood pressure, breast and pelvic exam, and mammogram. Asses for signs of endometrial cancer in female patients with uterus.
Adverse Reactions
Significant: Break-through bleeding, spotting; exacerbation of endometriosis; venous thromboembolism (e.g. DVT, pulmonary embolism), hypercalcaemia, increased thyroid binding globulin causing increased circulating total thyroid hormone. Rarely, increased triglycerides leading to pancreatitis; increased risk of endometrial breast or ovarian cancer, endometrial hyperplasia (prolonged use). Cardiac disorders: MI. Endocrine disorders: Reduced glucose tolerance. Eye disorders: Contact lens intolerance. Gastrointestinal disorders: Nausea, vomiting. Hepatobiliary disorders: Cholelithiasis, cholestatic jaundice. Metabolism and nutrition disorders: Na and water retention. Nervous system disorders: Headache, migraine, dementia. Psychiatric disorders: Mood changes. Reproductive system and breast disorders: Breast tenderness, pain, enlargement, and secretion. Gynaecomastia, feminisation, testicular atrophy, impotence (men). Skin and subcutaneous tissue disorders: Chloasma, erythema multiforme, erythema nodosum, rash. Vascular disorders: Hypertension.
Drug Interactions
May increase metabolism with CYP450 enzyme inducers including anticonvulsants (e.g. phenobarbital, phenytoin, carbamazepine), anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz), modafinil. May reduce the effects of insulin or hypoglycaemic drugs, anticoagulants (e.g. warfarin, phenindione, acenocoumarol). May inhibit the metabolism and reduce the clearance of theophylline. Decreased serum concentrations of lamotrigine. Increased risk of imipramine toxicity (doses >50 mcg daily).
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 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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