Gestodene + Ethinylestradiol


Concise Prescribing Info
Indications/Uses
OC.
Dosage/Direction for Use
Adult : PO As combination product containing gestodene and ethinylestradiol in varying concentrations and pack sizes depending on brand. Use as directed. Generally, for a 21-day pack: 1 tab/day for 21 days starting on day 1 of cycle followed by 7 pill-free days. Start 2nd pack immediately on the day after the pill-free period.
Dosage Details
Oral
Oral contraception
Adult: As a combination product containing gestodene and ethinylestradiol in varying concentrations and pack sizes depending on brand. Generally, for a 21-day pack: 1 tablet daily for 21 days starting on the 1st day of menstruation, followed by 7 pill-free days, during which withdrawal bleeding will usually occur. The 2nd pack should be started immediately on the day after the 7 pill-free days, regardless of whether the bleeding has stopped. For a 28-day pack, 1 tablet daily for 28 days, to be started on the 1st day of menstruation, withdrawal bleeding will usually occur during the period when the 7 non-hormonal tablets are taken. Start the next pack immediately on the day after the last pill of the previous pack.
Administration
May be taken with or without food.
Contraindications
Severe hepatic impairment, jaundice or persistent itching during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome, previous or existing liver tumours. Personal or family history of venous thromboembolism (VTE). Risk factors for VTE. Sickle-cell anaemia, severe DM with vascular changes, lipid metabolism disorders, undiagnosed abnormal vaginal bleeding, history of herpes gestationis, worsening of otosclerosis during pregnancy. Exisiting or history of mammary or endometrial carcinoma. Pregnancy.
Special Precautions
May increase risk of arterial and venous thrombotic and thromboembolic diseases e.g. MI, stroke, deep venous thrombosis and pulmonary embolism. Caution when used in patients who are obese (BMI >30 kg/m2, have hypertension or dyslipoproteinaemia, vavular heart disease or atrial fibrillation. Heavy smokers >35 yr of age. Recommended to discontinue use at least 6 wk before and for 2 wk after elective surgery that may involve prolonged immobilisation. May increase severity and frequency of migraines. May increase risk of cervical carcinoma. May affect glucose tolerance. Efficacy of oral contraceptive may be reduced in the event of severe diarrhoea or vomiting. Lactation.
Adverse Reactions
Headaches, body wt changes, depressed/altered moods, breast pain or tenderness, changes in libido. GI disturbance such as nausea and abdominal pain.
Drug Interactions
Concurrent use with hepatic enzyme inducers e.g. barbiturates, primidone, phenobarbitone, phenytoin, phenylbutazone, rifampicin, carbamazepine and griseofulvin may affect contraceptive efficacy. Short courses of broad-spectrum antibiotics may also reduce the efficacy of the oral contraceptive. Concurrent use with HIV protease and non-nucleoside reverse transcriptase inhibitors may affect hepatic metabolism of gestodene and/or ethinylestradiol. May increase plasma concentrations of ciclosporin and decrease the serum levels of lamotrigine. Concurrent use with felbamate may increase the clearance of gestodene. Gestodene may increase serum levels of buprenorphine. Co-trimoxazole, miconazole and etoricoxib may increase serum levels of ethinylestradiol. Aprepitant, modafinil and bosentan may reduce the serum levels of ethinylestradiol. Metabolism of omeprazole may be inhibited by ethinylestradiol. GI absorption of ethinylestradiol may be increased by concurrent admin of paracetamol.
Food Interaction
Concurrent treatment with St John's wort may reduce efficacy of the oral contraceptive.
Lab Interference
May affect results of certain laboratory tests e.g. biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of (carrier) proteins such as corticosteroid binding globulin and lipid/lipoprotein fractions. May also affect parameters of coagulation, fibrinolysis and carbohydrate metabolism.
Action
Description: Gestodene is a progestogen while ethinylestradiol is a synthetic oestrogen. Used together, they inhibit ovulation by suppressing the mid-cycle surge of luteinising hormone which causes changes in the cervical mucus, thus forming a barrier to sperm, and making the endometrium unreceptive to implantation.
Pharmacokinetics:
Absorption: Gestodene and ethinylestradiol: Completely and rapidly absorbed when given via oral admin.
Distribution: Gestodene: Bound to serum albumin and to sex hormone binding globulin; apparent volume of distribution: 0.7 L/kg. Ethinylestradiol: About 98% bound to serum albumin.
Metabolism: Gestodene: Completely metabolised. Ethinylestradiol: Hepatic metabolism.
Excretion: Gestodene: <1 % excreted unchanged in the urine. Ethinylestradiol: Excreted in urine and faeces.
Storage
Store below 25°C.
MIMS Class
Disclaimer: This information is independently developed by MIMS based on Gestodene + 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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