norethisterone Tablets 5 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #18993

Manufacturer usually replies in 1 days

NORETHISTERONE

Norethisterone is a synthetic hormone, similar in action to the female hormone; progesterone.it is used to treat menstrual disorders and abnormal vaginal bleeding in women caused due to hormonal imbalances. It steadies the hormone levels artificially without the body shedding its lining and while preventing the period. It is sold in both low-dose and high-dose formulations, alone or in combination with an estrogen. It is recommended for women to use Norethisterone on an occasional basis. As a synthetic progestogen, it acts as an agonist of the progesterone receptor. Even at higher doses.

It has weak androgenic and estrogenic activity and no other important hormonal activity. Norethisterone is a hormonal contraceptive taken with estrogen, usually ethinylestradiol. It is usually present in combined oral contraceptive pills and alone in progestogen-only pills to alleviate pain related to endometriosis. Endometriosis pain and discomfort gets worse during ovulation, Norethisterone induces endometrial proliferation in the secretory phase that alleviates endometrial pain complaints. This action could be a result of inhibition of ovulation.

Norethisterone is sold under the brand names Primvar, Regestrone, Sysron amongst others. Syntex, SA Laboratories developed norethindrone in 1951 in Mexico City, receiving a patent 1956. However, it was originally sold as a remedy for irregular menstruation and endometriosis. It sale as an oral contraceptive did not start till 1962. It is a "first-generation" progestin. Norethisterone is one of the only two progestins that are widely available as a progestogen-only "mini-pill" for birth control.

Forms and Dosage:

Norethisterone is available as s tablet and injection and taken orally or, as an injection into a muscle. Women who are planning to get pregnant should not use this medicine, also breastfeeding are recommended not to use this medicine if they plan to breastfeed or during the breastfeeding period. The Usual Adult Dose for Abnormal Uterine Bleeding is between 2.5 to 10 mg, taken orally once a day, for 5 to 10 days.

In the treatment of Amenorrhea, the recommended Usual Adult Dose is 2.5 to 10 mg orally, taken once a day, for a period of 5 to 10 days. if being used in Contraception/ Prevention of pregnancy, the recommended usual adult dose is 0.35 mg, taken orally once a day. In the treatment of Endometriosis, the Usual Adult Dose starts at 5 mg orally once a day for 2 weeks.

The price of Norethisterone

In the USA, the consumers have to pay an average retail price of US$0.98 per pill, totalling about USD90 for a supply of 90 tablets. This medicine is, however, much cheaper in the developing world. In India, a supply of 100 tablets of 5mg strength cost USD0.75.

How does Norethisterone work?

Norethisterone acts like any other endogenous progesterone. However, it has a much higher potency. Its actions at the pelvic level alter cervical and endometrial function. This is in addition to inhibiting pituitary hormones that play a role in follicular maturation and ovulation.

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