Norethisterone

Also known as: Northidrone

Drug #2151

This belongs to the group of medicines known as progestogens. Norethisterone and its acetate and enantate esters are progestogens derived from nortestosterone that have weak oestrogenic and androgenic properties. They are commonly used as hormonal contraceptives. Norethisterone (Acetate, Heptanoate) was the first highly active oral progestational agent to be synthesized and to achieved widespread use. It was patented in 1951. it is prepared by chemical synthesis from precursors obtained from the Mexican yam. it is available in combination preparations. Chemically it(17a)-17-hydroxy-19-norpregn-4-en-20-yn-3-one. Norethisterone acetate is administered orally and Norethisterone enanthate is administered intramuscularly. itused for contraception and for the treatment of uterine bleeding.

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Primary Characteristics

Norethisterone is also known as Northidrone.

It is of Synthetic origin and belongs to Steroid.

It belongs to Progesterone agonist pharmacological group on the basis of mechanism of action and also classified in Contraceptive Hormonal pharmacological group. It is also classified under Sex Hormones .

Molecular Weight: 298.4 · Solubility in Water: 1 in 10000 · Solubility in Alcohol: 1 in 50 · Non-proprietary name: Norethisterone.

Pharmacokinetics

Absorption: Norethisterone has an oral bioavailability is 100%, pre-systemic (first-pass) metabolism accounts for 40%.

Distribution: Norethisterone has a volume of distribution is 240 litre. plasma protein binding is 95 %.

Elimination: it is metabolised via Hepatic, plasma half-life is 5-12 hr, renal excretion is 65 %.

Indications

Norethisterone is primarily indicated in conditions like Contraception, Dysfunctional uterine bleeding, Dysmenorrhoea, Endometriosis, Menstruation disorders, Postponement of menstruation, Premenstrual tension.

Norethisterone is also indicated for secondary conditions like Premenstrual syndrome.

Contraindications

Norethisterone is contraindicated in conditions like Acute renal failure, Epilepsy, Breast cancer, Cardiovascular disease, Hepatitis, Liver carcinoma, Amenorrhoea, Herpes gestations, Skin diseases, Bronchial asthma, Hypersensitivity to the drug.

Dosage

Norethisterone's dosage details are as follows:

Dose	Single Dose	Frequency	Route	Instructions
Adult Dosage
200 mg	200 mg	—	IM	This dose provide contraception for 8 weeks. The dose is for Norethisterone Enanthate.
15 mg	15 mg	—	Oral	Premenstrual syndrome
60 mg	60 mg	—	Oral	In Breast cancer
700 mg	700 mg	—	Oral	Menopausal HRT
6.25 mg	6.25 mg	Every 24h	PO	As Required. This dose is for Norethisterone (Acetate, Heptanoate).
Paediatric Dosage (20kg)
No data.
Neonatal Dosage (3kg)
No data.

Drug Interactions

Unknown5 interactions

Always consult your physician for the change of dose regimen or an alternative drug of choice that may strictly be required.

Side Effects

Norethisterone in overdosage may give rise to further complications which include Cataract, Cholestatic jaundice , Hypertension , Hepatitis , Optic neuritis , Hyperglycemia , Mental disturbances , Uterine myomata , Retinal thrombosis , Decreased libido , Vaginitis , Galactorrhea, Thromboembolism, Breakthrough bleeding, Leukorrhea.

Norethisterone produces potentially life-threatening effects which include Reduced HDL levels. Careful monitoring is needed with proper medical management.

The signs and symptoms that are produced after acute overdosage of Norethisterone are Nausea, Thromboembolism, Jaundice .

Norethisterone is known to cause more or less tolerable side effects which are usually transient. These include Abdominal pain, Acne, Anorexia , Anxiety, Bloating , Breast discomfort, Cervicitis, Depression, Dizziness, Edema, Elevation of liver enzymes, Exacerbation of epilepsy, Exacerbation of migraine, Fatigue, Hirsutism , Intermenstrual bleeding or spotting, Menstrual irregularity, Nausea and vomiting, Rashes , Weight gain, Weight LossX.

Warnings / Precautions

Norethisterone should be used with caution in patients with medical history, including any allergies (especially drug allergies), abnormal vaginal bleeding, liver, kidney or heart disease, cancer of the breast or genitals, missed abortion, blood clots, seizures, migraine, asthma, depression or diabetes. Limit alcohol, as this may increase side effects of this drug. It is not recommended to take it in early pregnancy. Norethisterone Enanthate should be used with caution in patients with cardiovascular or renal impairment, diabetes mellitus, asthma, epilepsy, and migraine, or other conditions which may be aggravated by fluid retention. They should also be used with care in persons with a history of depression. High doses should be used with caution in patients susceptible to thromboembolism. It should not be given to the patients with undiagnosed vaginal bleeding, nor to those with a history or current high risk of arterial disease and should generally be avoided in hepatic impairment, especially if severe.

Interference in Pathology

Norethisterone may interfere in the diagnosis of Gonadotrophin Test , Pregnanediol Test , Oestrogen Test , Glucose Test , Progesterone Test , Testosterone Test , Cortisol Test , Metyrapane Test .

Available Brands

Click on a strength to view available brands.

Single Ingredient

Inj

200 mg/ml

Tabs

5 mg

Multi-Ingredient Combinations

Inj

50 mg/ml

Tabs

1 mg 10 mg

Storage Conditions

Norethisterone should be stored Tab.

Drug Classification

1.18.3.1 — Hormonal contraceptives

Manufacturers

Manufacturers of Norethisterone in Pakistan:

Bayer Geofman Global Hygeia LCPW Medicraft Novo Regent Sami Social Zafa Zephyr