Desogestrel + ethinylestradiol


Concise Prescribing Info
Indications/Uses
Contraception.
Dosage/Direction for Use
Adult: PO Each tab contains desogestrel (mg)/ethinylestradiol (mg): 0.15/0.02, 0.15/0.03: 1 tab once daily, exactly as directed from the blister pack. Refer to individual product guideline on how to manage missed doses and for detailed dosing instructions.
Contraindications
Current, suspected, or history of breast cancer, or other oestrogen- or progestin-dependent malignancies; presence or history of hepatic tumours (benign or malignant), endometrial hyperplasia, undiagnosed vaginal bleeding, venous or arterial thromboembolism (VTE/ATE) (e.g. DVT, pulmonary embolism, MI, angina pectoris, stroke, TIA), multiple risk factors for VTE/ATE (e.g. diabetes mellitus with vascular changes, severe or uncontrolled hypertension, severe dyslipoproteinaemia, coronary artery disease, major surgery with prolonged immobilisation, obesity [BMI >30 kg/m2]), known hereditary or acquired predisposition to VTE/ATE (e.g. activated protein C [APC] resistance, Factor V Leiden mutation, antithrombin-III-deficiency, protein C and S deficiency, hyperhomocysteinaemia, antiphospholipid antibodies), presence or history of CVA, history of migraine with aura (focal symptoms); pancreatitis, previous cholestatic jaundice of pregnancy or jaundice prior oral contraceptive use; SLE with unknown or positive antiphospholipid antibodies; acute porphyria. Women >35 years who smoke. Hepatic impairment. Pregnancy and lactation. Concomitant use with hepatitis C combination therapy containing ombitasvir/paritaprevir/ritonavir with or without dasabuvir.
Special Precautions
Women with CV disease-related risk factors (e.g. hypertension, prediabetes or diabetes, low HDL, high LDL or triglycerides), gallbladder disease, diseases exacerbated by fluid retention (e.g. asthma, epilepsy), SLE, hereditary angioedema, depression, history of migraine, chloasma gravidarum, haemolytic uraemic syndrome, sickle cell disease, chronic inflammatory bowel disease, severe gastrointestinal disturbances; who wear contact lens or undergone bariatric surgery. Smokers. Not recommended in women with complicated organ transplant and acute viral hepatitis. Not indicated for use prior to menarche, or in postmenopausal women. Renal impairment. Monitoring Parameters Screen for pregnancy before initiating treatment. Perform adequate diagnostic measures to rule out malignancy in all cases of undiagnosed abnormal vaginal bleeding; physical exams concerning the breasts, pelvis, and cervical screening when necessary. Monitor blood pressure prior to therapy and yearly; glucose (in diabetics), lipid profiles (in hyperlipidaemic patients), LFT, BMI at baseline. Assess for vision changes; signs and symptoms of thromboembolic disorders, breakthrough bleeding, and depression.
Adverse Reactions
Significant: Breakthrough or intracyclic bleeding, spotting; breast cancer, cervical cancer, impaired lipid levels (including serum triglycerides), impaired glucose tolerance, increased blood pressure, retinal vein thrombosis, depression or depressed mood, persistent or severe headache/migraine, gallbladder disease, induced or exacerbated angioedema, chloasma, cholestasis; Crohn's disease, ulcerative colitis, jaundice, porphyria, SLE. Rarely, hepatocellular carcinoma (prolonged use). Eye disorders: Contact lens intolerance. Gastrointestinal disorders: Nausea, vomiting, abdominal pain, diarrhoea. Investigations: Weight gain. Metabolism and nutrition disorders: Fluid retention. Reproductive system and breast disorders: Breast pain, breast tenderness, amenorrhoea, decreased libido. Skin and subcutaneous tissue disorders: Acne, rash, urticaria.
Potentially Fatal: Increased risk of VTE/ATE (e.g. DVT, pulmonary embolism, MI). Rarely, hepatic adenomas or tumours (benign or malignant).
Drug Interactions
Diminished efficacy and an increased risk of breakthrough bleeding with enzyme inducers (e.g. phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, ritonavir, efavirenz). May increase the plasma concentrations with CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, diltiazem). May increase the plasma concentrations of ciclosporin. May significantly decrease the plasma concentrations of lamotrigine. May increase or decrease the plasma levels with HIV protease inhibitors (e.g. nelfinavir), non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine) and agents for hepatitis C virus (e.g. boceprevir, telaprevir). Ethinylestradiol: Plasma concentrations and exposure may be increased by ascorbic acid and atorvastatin or rosuvastatin, respectively. May inhibit the metabolism and increase the plasma levels of theophylline and tizanidine.
CIMS Class
ATC Classification
G03AC09 - desogestrel ; Belongs to the class of progestogens. Used as systemic contraceptives.
Disclaimer: This information is independently developed by CIMS based on desogestrel + 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 CIMSAsia.com
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