Formulary
Ethinylestradiol with norethisterone: Indications, Dosing, Side Effects and Interactions
Ethinylestradiol with norethisterone clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 8 min read
Ethinylestradiol with norethisterone: Indications, Dosing, Side Effects and Interactions
Ethinylestradiol with norethisterone clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Menstrual symptoms with 21-day combined preparations for ethinylestradiol with norethisterone**
- **Females of childbearing potential** (By mouth): 1 tablet once daily for 21 days; subsequent courses repeated after 7-day interval, withdrawal bleeding occurs during the 7-day interval, if reasonably certain woman is not pregnant, first course can be started on any day of cycle-if starting on day 6 of cycle or later, additional precautions (barrier methods) necessary during first 7 days, tablets should be taken at approximately the same time each day.
**Contraception with 21-day combined preparations for ethinylestradiol with norethisterone**
- **Females of childbearing potential** (By mouth): 1 tablet once daily for 21 days; subsequent courses repeated after hormone-free interval, withdrawal bleeding occurs during the hormone-free interval, if reasonably certain woman is not pregnant, first course can be started on any day of cycle-if starting on day 6 of cycle or later, additional precautions (barrier methods) necessary during first 7 days, tablets should be taken at approximately the same time each day, see Contraceptives, hormonal for recommendations from the CoSRH on 'traditional' and 'tailored' regimens in which there is a shortened, less frequent, or no hormone-free interval.
Cautions
For all combined hormonal contraceptives General cautions: Carrier of breast cancer gene mutations e.g. BRCA1, BRCA2-seek specialist advice before use; cervical intraepithelial neoplasia or cancer; cholestasis during pregnancy; cholestasis with previous use of combined hormonal contraception-seek specialist advice before use; focal nodular hyperplasia; gallbladder disease-if medically treated or current, seek specialist advice before use; history of breast cancer-seek specialist advice before use; history of negative mood changes induced by hormonal contraceptive (a product containing an alternative progestogen may be tried); inflammatory bowel disease; organ transplantation-when complicated, seek specialist advice before use; personal or family history of hypertriglyceridaemia (increased risk of pancreatitis); prolactinoma-seek specialist advice before use; risk factors for cardiovascular disease; risk factors for venous thromboembolism; sickle-cell disease; undiagnosed mass or breast symptoms during combined hormonal contraception treatment-if symptoms exist prior to initiation, seek specialist advice before use; undiagnosed vaginal bleeding; viral hepatitis during combined hormonal contraception treatment-if condition exists prior to initiation, seek specialist advice before use Specific cautions: With oral use Bariatric surgery with body mass index 30 kg/m 2 to 34 kg/m 2 (possible reduction in contraceptive efficacy)-if body mass index 35 kg/m 2 , seek specialist advice before use; severe diarrhoea (possible reduction in contraceptive efficacy); vomiting (possible reduction in contraceptive efficacy) Cautions, further information Risk of venous thromboembolism There is an increased risk of venous thromboembolic disease in users of combined hormonal contraceptives particularly during the first year and possibly after restarting combined hormonal contraceptives following a break of four weeks or more. This risk is smaller than that associated with pregnancy and the postpartum period. In all cases the risk of venous thromboembolism increases with age and in the presence of other risk factors, such as obesity. The risk also varies depending on the type of progestogen and oestrogen dose. Risk factors for venous thromboembolism Use with caution if any of following factors present. If multiple risk factors are present, clinical judgement must be applied to decide whether the risk of using the combined hormonal contraceptive outweighs the benefit; referral to a specialist contraceptive provider may be required (for risk factors where treatment with combined hormonal contraceptives should be avoided, see Contraindications ). Age 40 years and older-if 50 years and older, seek specialist advice before use; 6 weeks to 6 months postpartum in breastfeeding women ; 3 to 6 weeks postpartum in non-breastfeeding women in the absence of additional risk factors for venous thromboembolism-if 3 to 6 weeks postpartum with risk factors, or if less than 3 weeks postpartum without risk factors, seek specialist advice before use; Smoking if age under 35 years, or if 35 years and older and have stopped smoking at least 1 year ago-if 35 years and older smoking less than 15 cigarettes a day or stopped smoking less than 1 year ago, seek specialist advice before use; Obesity with body mass index 30 kg/m 2 to 34 kg/m 2 -if body mass index 35 kg/m 2 , seek specialist advice before use; History of hypertension during pregnancy in currently normotensive women; Family history of venous thromboembolism in a first-degree relative aged 45 years and older-if first-degree relative is under 45 years, seek specialist advice before use; Major surgery without prolonged immobilisation; Long-term immobility (e.g. wheelchair use, debilitating illness)-seek specialist advice before use; Superficial venous thrombosis ; Uncomplicated valvular heart disease ; Uncomplicated congenital heart disease ; Cardiomyopathy with normal cardiac function; Long QT syndrome ; Systemic lupus erythematosus with no antiphospholipid antibodies; High altitudes : women travelling above 4500 m or 14500 feet for more than 1 week should consider alternative contraceptive methods (risk of thrombosis). Combined Hormonal Contraception and Risk of Venous Thromboembolism Progestogen in Combined Hormonal Contraceptive Estimated incidence per 10 000 women per year of use Non-pregnant, not using combined hormonal contraception 2 Levonorgestrel 1 5-7 Norgestimate 1 5-7 Norethisterone 1 5-7 Etonogestrel 1 6-12 Norelgestromin 1 6-12 Gestodene 1 9-12 Desogestrel 1 9-12 Drospirenone 1 9-12 Dienogest 2 Not known-insufficient data Nomegestrol 2 Not known-insufficient data 1 Combined with ethinylestradiol 2 Combined with estradiol Risk of cardiovascular disease Combined hormonal contraceptives also slightly increase the risk of cardiovascular disease such as myocardial infarction and ischaemic stroke; risk appears to be greater with higher oestrogen doses. Risk factors for cardiovascular disease Use with caution if any one of following factors present. If multiple risk factors are present, clinical judgement must be applied to decide whether the risk of using the combined hormonal contraceptive outweighs the benefit; referral to a specialist contraceptive provider may be required (for risk factors where treatment with combined hormonal contraceptives should be avoided, see Contraindications ). Age 40 years and older-if 50 years and older, seek specialist advice before use; Smoking if age under 35 years, or if 35 years and older and have stopped smoking at least 1 year ago-if 35 years and older smoking less than 15 cigarettes a day, or stopped smoking less than 1 year ago, seek specialist advice before use; Hypertension if adequately controlled or if blood pressure systolic 140-159 mmHg or diastolic 90-99 mmHg , seek specialist advice before use; History of hypertension during pregnancy in currently normotensive women; Dyslipidaemias ; Non-migrainous headache (mild or severe) during combined hormonal contraceptive use; Migraine without aura prior to initiation of combined hormonal contraceptives-if migraine without aura occurs during combined hormonal contraceptive use or when history of migraine with aura is 5 or more years ago, seek specialist advice; Idiopathic intracranial hypertension ; Uncomplicated valvular heart disease ; Uncomplicated congenital heart disease ; Cardiomyopathy with normal cardiac function; Long QT syndrome ; Diabetes mellitus -if vascular disease present, seek specialist advice before use; Rheumatoid arthritis ; Systemic lupus erythematosus without antiphospholipid antibodies.
Contraindications
For all combined hormonal contraceptives Acute porphyrias ; atrial fibrillation; benign hepatocellular adenoma; Budd-Chiari syndrome; cardiomyopathy with impaired cardiac function; complicated congenital heart disease; complicated valvular heart disease; current breast cancer; hepatocellular carcinoma; hypertension (blood pressure systolic 160 mmHg or diastolic 100 mmHg or higher); hypertensive retinopathy; ischaemic heart disease; known thrombogenic mutations (e.g. factor V Leiden, prothrombin mutation, protein S, protein C and antithrombin deficiencies); less than 3 weeks postpartum in non-breastfeeding women with other risk factors for venous thromboembolism; less than 6 weeks postpartum in breastfeeding women; major surgery with prolonged immobilisation; migraine with aura; peripheral vascular disease with intermittent claudication; positive antiphospholipid antibodies; previous or current venous thrombosis; smoking in patients aged 35 years and over (15 or more cigarettes daily); stroke; systemic lupus erythematosus with antiphospholipid antibodies; transient ischaemic attack
Side effects
For all combined hormonal contraceptives Common or very common Abdominal pain; breast abnormalities; diarrhoea; fluid retention; headaches; metrorrhagia; mood altered; nausea; sexual dysfunction; skin reactions; vaginal discharge; vomiting; weight increased Uncommon Alopecia Rare or very rare Embolism and thrombosis Side-effects, further information Breast cancer There is a small increase in the risk of having breast cancer diagnosed in women taking the combined oral contraceptive pill; this relative risk may be due to an earlier diagnosis. In users of combined oral contraceptive pills the cancers are more likely to be localised to the breast. The most important factor for diagnosing breast cancer appears to be the age at which the contraceptive is stopped rather than the duration of use; any increase in the rate of diagnosis diminishes gradually during the 10 years after stopping and disappears by 10 years. Cervical cancer Use of combined oral contraceptives for 5 years or longer is associated with a small increased risk of cervical cancer; the risk diminishes after stopping and disappears by about 10 years. The possible small increase in the risk of breast cancer and cervical cancer should be weighed against the protective effect against cancers of the ovary and endometrium. Side-effects For ethinylestradiol with norethisterone Frequency not known Angioedema aggravated
Pregnancy
For all combined hormonal contraceptives Not known to be harmful.
Breast feeding
For all combined hormonal contraceptives CoSRH advises usually suitable for use from 6 weeks postpartum (benefits generally outweigh risks); safe for use 6 months or more postpartum.
Hepatic impairment
For all combined hormonal contraceptives In general, manufacturer advises caution; avoid in acute disease, severe chronic disease, or liver tumour.
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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