Norelgestromin + Ethinylestradiol


Concise Prescribing Info
Indications/Uses
Contraception.
Dosage/Direction for Use
Adult : Transdermal Per patch contains norelgestromin 6 mg and ethinylestradiol 0.75 mg: 1 patch/wk for 3 wk, followed by 1 patch-free wk. New users: 1st patch should be used only when patient begins her menstruation.
Dosage Details
Transdermal
Contraception
Adult: Each patch containing norelgestromin 6 mg and ethinylestradiol 0.75 mg: 1 new patch to be applied every wk for 3 wk, followed by 1 patch-free wk. Patch should be applied on the same day of each wk. Subsequent cycle should be started immediately on the day after the patch-free wk, regardless of whether the menstrual period has started or ended. For new users, 1st patch should be used only when patient begins her menstruation.
Contraindications
Thrombophlebitis, thromboembolic disorders, history of deep vein thromboembolic disorders, cerebrovascular or coronary artery disease, valvular heart disease with complications, severe hypertension, DM with vascular involvement, headaches with focal neurological symptoms, major surgery with prolonged immobilisation. Known or suspected carcinoma of the breast or history of breast cancer, carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use. Acute or chronic hepatocellular disease with abnormal liver function, hepatic adenomas or carcinomas. Known or suspected pregnancy.
Special Precautions
Increased risk of CV side effects when used in women >35 yr and/or smokers. Women with other underlying risk factors for coronary artery disease such as hypertension, hypercholesterolaemia, morbid obesity and DM.
Adverse Reactions
Breast symptoms, headache, application site reaction, nausea, upper respiratory infection, menstrual cramps and abdominal pain. Changes in wt, cervical erosion and secretion. Diminution in lactation when given immediately postpartum, cholestatic jaundice , migraine, rash (allergic), mental depression, reduced tolerance to carbohydrates, vaginal candidiasis, changes in corneal curvature, intolerance to contact lenses.
Overdosage
Overdosage may lead to nausea and vomiting, and withdrawal bleeding may occur in females. Treatment is symptomatic and involves removal of patch.
Drug Interactions
Contraceptive efficacy may be reduced when used with barbiturates, griseofulvin, rifampicin, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate and ampicillin. Efficacy may be affected when used with HIV protease inhibitors. May raise the serum levels of ciclosporin, prednisolone and theophylline. May increase clearance of temazepam, salicylic acid, morphine and clofibric acid.
Lab Interference
May affect serum levels of triglycerides, lipids and other lipoproteins. May decrease glucose tolerance and serum folate levels. May increase sex hormone binding globulins and thyroid binding globulins.
Action
Description: Norelgestromin is a progestogen. It is used as the progestogenic component of a combined contraceptive transdermal patch. Ethinylestradiol is a synthetic oestrogen. Combination contraceptives work by suppressing gonadotropins, thus leading to inhibition of ovulation. It may also cause changes in the cervical mucus and the endometrium.
Pharmacokinetics:
Distribution: Norelgestromin and ethinylestradiol are bound to albumin.
Metabolism: Both norelgestromin and ethinylestradiol are metabolised hepatically.
Excretion: Half lives of norelgestromin and ethinylestradiol are 28 and 17 hr respectively.
Storage
Store at 15-30°C.
Disclaimer: This information is independently developed by MIMS based on Norelgestromin + 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 MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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