Ethinylestradiol + drospirenone


Generic Medicine Info
Contraindications
Adrenal insufficiency, current, suspected or history of breast cancer or other oestrogen- or progestin-sensitive cancer; presence of severe or multiple risk factors for venous or arterial thromboembolism (VTE/ATE) [e.g. DVT, pulmonary embolism, major surgery with prolonged immobilisation, MI, angina pectoris, cerebrovascular disease such as stroke or TIA; headaches with focal neurological symptoms, migraine headaches with or without aura if >35 years, diabetes mellitus with vascular symptoms, severe or uncontrolled hypertension, severe dyslipoproteinaemia, coronary artery disease, inherited or acquired hypercoagulopathies, thrombogenic valvular or heart rhythm diseases such as subacute bacterial endocarditis with valvular disease or atrial fibrillation; women >35 years who smoke, obesity BMI >30 kg/m2]; known hereditary or acquired predisposition to VTE/ATE such as activated protein C APC-resistance, Factor V Leiden mutation, antithrombin-III-deficiency, protein C and S deficiency, hyperhomocysteinaemia, anti-phospholipid antibodies e.g. anticardiolipin antibodies, lupus anticoagulant; SLE with unknown or positive antiphospholipid antibodies]; presence or history of hepatic tumours (benign or malignant), undiagnosed abnormal uterine/vaginal bleeding, acute viral hepatitis. Renal and hepatic impairment. Pregnancy. Concomitant use with hepatitis C drug combinations containing ombitasvir, paritaprevir/ritonavir with or without dasabuvir.
Special Precautions
Women with risk factors for CV disease (e.g. low HDL, high LDL or triglycerides); depression, prediabetes or diabetes mellitus, hypertriglyceridaemia, history of chloasma gravidarum, SLE, chronic inflammatory bowel disease, hereditary angioedema, history of pregnancy-related cholestasis, undergoing thyroid replacement therapy; who undergone specific bariatric procedures (e.g. Roux-en-Y, biliopancreatic diversion). Smokers. Not indicated for use prior to menarche, or in postmenopausal women. Not recommended for women with complicated organ transplants (e.g. graft failure, rejection, cardiac allograft vasculopathy). Lactation. Patient Counselling Monitoring Parameters Evaluate pregnancy (prior to treatment) and smoking status. Perform adequate diagnostic measures to rule out malignancy in case of undiagnosed vaginal bleeding. Monitor blood pressure prior to therapy and yearly; weight/BMI at baseline; vision changes, signs and symptoms of thromboembolic disorders, depression, and bleeding irregularities.
Adverse Reactions
Significant: Increased risk of cervical and breast cancer, cholestasis, pancreatitis, gallbladder disease; worsening of depression, Crohn's disease, and ulcerative colitis; recurrent, persistent or severe headache/migraine; induced or exacerbated angioedema, chloasma, hyperkalaemia, jaundice, unscheduled bleeding (breakthrough or intracyclic), spotting, amenorrhoea, oligomenorrhoea, retinal vein thrombosis, impaired glucose tolerance, adverse lipid level changes (including serum triglycerides), increased thyroid-binding globulin levels, disturbance of LFT. Rarely, increased risk of hepatocellular carcinoma (prolonged use), increased blood pressure. Cardiac disorders: Rarely, tachycardia. Eye disorders: Rarely, dry eye, conjunctivitis. Gastrointestinal disorders: Nausea, abdominal pain, vomiting, diarrhoea, dyspepsia, flatulence, gastritis. General disorders and administration site conditions: Asthenia, oedema. Hepatobiliary disorders: Rarely, biliary pain, cholecystitis. Immune system disorders: Hypersensitivity. Investigations: Weight increased. Metabolism and nutrition disorders: Rarely, increased appetite, hyponatraemia. Musculoskeletal and connective tissue disorders: Back pain, muscle cramps. Nervous system disorders: Dizziness, paraesthesia. Psychiatric disorders: Emotional lability, nervousness, somnolence. Reproductive system and breast disorders: Breast tenderness/pain, metrorrhagia, pelvic pain, breast enlargement, dysmenorrhoea, vaginal discharge, vulvovaginal candidiasis, decreased libido. Skin and subcutaneous tissue disorders: Acne, rash, pruritus, increased sweating. Vascular disorders: Hot flushes.
Potentially Fatal: Increased risk of VTE, ATE (e.g. DVT, pulmonary embolism, MI). Rarely, hepatic adenomas or tumours (benign/malignant).
Drug Interactions
May increase risk of breakthrough bleeding and diminished efficacy with CYP3A4 inducers (e.g. rifampicin, barbiturates, bosentan, carbamazepine, phenytoin, primidone, efavirenz, felbamate, griseofulvin, oxcarbazepine, topiramate). May increase the plasma concentrations of ciclosporin. May significantly decrease the plasma levels of lamotrigine. Plasma concentrations may be increased by moderate or strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, verapamil, clarithromycin, erythromycin, diltiazem). Increased serum K concentration with ACE inhibitors, angiotensin-II receptor antagonists, K-sparing diuretics, K supplements, heparin, aldosterone antagonists, NSAIDS. Ethinylestradiol: May inhibit clearance and increase plasma concentrations of CYP1A2 substrates (e.g. theophylline, tizanidine). May elevate plasma levels with ascorbic acid.
CIMS Class
Oestrogens & Progesterones & Related Synthetic Drugs
ATC Classification
G03AC10 - drospirenone ; Belongs to the class of progestogens. Used as systemic contraceptives.
Disclaimer: This information is independently developed by CIMS based on ethinylestradiol + drospirenone 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 CIMSAsia.com
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