* Dysfunctional uterine bleeding (DUB) * Premenstrual syndrome (PMS), Mastopathy * Timing of menstruation * Endometriosis * Menorrhagia
Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones, Oral Contraceptive
Norethisterone tablet is a preparation of Norethisterone which has progestational actions similar to those of progesterone, but is a more potent inhibitor of ovulation and has weak estrogenic and androgenic properties. It is used to treat a number of disorders of the menstrual cycle. Norethisterone is absorbed from the gastrointestinal tract and its effects last for at least 24 hours. It is excreted in the urine.
Oral (Adult)- Breast cancer: 40 mg daily increasing to 60 mg daily if no regression is noted. Contraception: 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. Premenstrual syndrome: 5 mg tid on days 16-25 of cycle. Progestogen component of menopausal hormonal replacement therapy: 0.7 mg as a continuous daily dose. As acetate: 1 mg daily for 10-12 days of a 28-day cycle. Endometriosis: 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. Menorrhagia: 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. Postponement of menstruation: 5 mg tid starting 3 days before expected onset of menstruation.
Drug interactions which result in an increased clearance of sex hormones can lead to decreased therapeutic efficacy. This has been established with many hepatic enzyme-inducing drugs (including phenytoin, barbiturates, primidone, carbamazepine, and rifampicin); griseofulvin, oxcarbazepine and rifabutin are also suspected.
Norethisterone should not be used in the presence of the conditions listed below, which are derived also from information on other progestogen-only products. Should any of the conditions appear during the use of Norethisterone, the use of the preparation must be discontinued immediately. Known or suspected pregnancy Lactation Thromboembolic processes Diabetes mellitus with vascular involvement Presence or history of severe hepatic disease as long as liver function values have returned to normal Presence or history of liver tumors (benign or malignant) Known or suspected sex-hormone dependent malignancies Hypersensitivity to the active substances or to any of the excipients
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.
Pregnancy Category X. Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
There have been no reports from overdosage and treatment is generally unnecessary. There are no special antidotes and treatment should be symptomatic.
Store below 30°C in a cool & dry place. Keep out of reach of children.
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