Noteron- Norethisterone is indicated in:
- Dysfunctional uterine bleeding (DUB)
- Premenstrual syndrome (PMS), Mastopathy
- Timing of menstruation
Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones, Oral Contraceptive preparations
Noteron- 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.
Dosage & Administration
>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 month. 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 month.
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.
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.
Noteron – 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 Noteron ( Norethisterone), the use of the preparation must be discontinued immediately.
- Known or suspected pregnancy
- 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 & Lactation
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.
Hypertension; CVS disease; hepatic impairment; epilepsy; lactation; new onset of migraine-type headache; asthma; renal impairment; history of clinical depression.
Acute toxicity studies performed with norethisterone acetate did not indicate a risk of acute adverse effects in case of inadvertent intake of a multiple of the daily therapeutic dose.
Store in a cool and dry place, protected from light and moisture. Keep out of reach of children
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