Norethisterone

Indications
Oral
Menorrhagia
Adult: 10-15 mg daily in a cyclical regimen. Usual dose: 5 mg tid for 10 days as primary treatment, subsequently 5 mg bid on days 19-26 of cycle to prevent recurrence. As acetate: 2.5-10 mg daily in a cyclical regimen, beginning during the assumed latter half of the cycle.
Oral
Endometriosis
Adult: 10-25 mg daily continuously for 4-9 mth. As acetate: 5-15 mg daily, start at 5 mg daily and increase by 2.5 mg at 14 day intervals. Take continuously for 4-9 mth.
Oral
Contraception
Adult: 0.35 mg daily, or 0.5-1 mg daily when combined with oestrogen. As acetate: 0.6 mg daily, or 1-1.5 mg daily when combined with oestrogen.
Oral
Progestogen component of menopausal hormonal replacement therapy
Adult: 0.7 mg as a continuous daily dose. As acetate: 1 mg daily for 10-12 days of a 28-day cycle.
Oral
Premenstrual syndrome
Adult: 5 mg tid on days 16-25 of cycle.
Oral
Breast cancer
Adult: 40 mg daily increasing to 60 mg daily if no regression is noted.
Oral
Postponement of menstruation
Adult: 5 mg tid starting 3 days before expected onset of menstruation.
Transdermal
Progestogen component of menopausal hormonal replacement therapy
Adult: As acetate: 140, 170 or 250 mcg/day (as patch), applied twice wkly for 2 wk of a 4 wk cycle. Lower strength may also be applied twice wkly on a continuous basis.
Intramuscular
Contraception
Adult: As enantate: 200 mg every 8 wk.
Contraindications
Severe hepatic dysfunction; undiagnosed vaginal bleeding; porphyria; pregnancy; previous idiopathic or current thromboembolism; thromboembolic disease; DVT.
Warnings / Precautions
Hypertension; CVS disease; hepatic impairment; epilepsy; lactation; new onset of migraine-type headache; asthma; renal impairment; history of clinical depression.
Adverse Reactions
Mental depression, cholestatic jaundice, porphyria, epilepsy, migraine, headache, breast discomfort, dizziness, nausea and vomiting, changes in libido, appetite and weight, breakthrough bleeding, changes in menstrual flow, amenorrhoea, oedema, rash, melasma or cholasma, acne, urticaria, abnormal LFTs, moodswings, insomnia, thrombotic and thromoembolic events, optic neuritis, altered lipid profile.
Overdose Reactions
Symptoms include nausea, vomiting, breast enlargement, vaginal bleeding. Treatment should be symptomatic.
Drug Interactions
Concentration may be reduced by CYP450 inducers (e.g. phenobarbital, phenytoin, carbamazepine, rifampicin, rifabutin, nevirapine, efavirenz, tetracyclines, ampicillin, oxacillin, co-trimoxazole) and ritonavir, nelfinavir (usually inhibitors of CYP450 but have inducing properties when used with steroid hormones). May cause additive fluid retention with NSAIDs, vasodilators. Adjustment in antidiabetic, thyroid hormone and anticoagulant therapy may be required.
Potentially Fatal: May increase ciclosporin concentration.
See Below for More norethisterone Drug Interactions
Lab Interactions
Abnormal thyroid function tests, metyropone test and LFTs reported.
Food Interactions
St John's wort may induce norethisterone metabolism, leading to decreased concentrations.
Mechanism of Actions
Norethisterone has typical effects of a progestogen and converts the endometrium from the proliferative to the secretory phase. It may also have some oestrogenic, anabolic and androgenic activities, but these may not be significant. Norethisterone delays onset of periods and controls abnormal uterine bleeding. It also has contraceptive effects due to negative feedback inhibition of pituitary gonadotropin thus preventing ovulation.
Absorption: Absorbed from the GI tract (oral).
Distribution: Highly protein bound
Metabolism: Hepatic; extensive first-pass effect.
Excretion: Via urine (50-80%); via faeces (40%).
Administration
May be taken with or without food.
Storage Conditions
Oral: Store below 25°C. Transdermal: Store below 25°C.
ATC Classification
G03AC01 - norethisterone ; Belongs to the class of progestogens. Used as systemic contraceptives.
G03DC02 - norethisterone ; Belongs to the class of estren derivative progestogens used in progestogenic hormone preparations.
Storage
Oral: Store below 25°C. Transdermal: Store below 25°C.
Available As
  • Norethisterone 1 mg
  • Norethisterone 10 mg
  • Norethisterone 2.5 mg
  • Norethisterone 200 mg
  • Norethisterone 400 mg
  • Norethisterone 5 mg
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    One Response to Norethisterone

    1. rose otieno January 23, 2014 at 9:42 am #

      This is very good information. what is the cost of the drug?

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