Norgest 5Mg

COMPOSITION Each tablet contains Norethisterone BP 5mg  

CHEMISTRY: Norethisterone is chemically, 17-hydroxy-19nor- 17alpha - pregn4-en-20-yn-3-one. 

PHARMACOLOGICAL CATEGORY: Synthetic Progestogen PHARMACOLOGY: Norethisterone is synthetic progestogen used in the treatment of abnormal uterine bleeding and endometriosis. It converts the endometrium from the proliferative to the secretory phase. It may also have some osteogenic, anabolic and androgenic activity though this may not be significant. It delays onset of periods, and controls abnormal uterine bleeding. Negative feedback inhibition of pituitary gonadotropin secretion which prevents ovulation-contraceptive effect. Mechanism of Action: Inhibits secretion of pituitary gonadotropin (LH) which prevents follicular maturation and ovulation. Pharmacokinetics: Norethisterone is absorbed from the gastrointestinal tract with peak plasma concentrations occurring 1 to 2 hours after an oral dose. It exhibits biphasic pharmacokinetics with an initial distribution phase followed by a prolonged elimination phase with a half-life of about 10 hours or more. It is metabolized in the liver and 80% of a dose is excreted in the urine and feces. Protein binding - 80%. 

INDICATIONS AND USES: Norethisterone is indicated in dysfunctional bleeding, primary and secondary amenorrhea, premenstrual syndrome, mastopathy, timing of menstruation, endometriosis, progressive carcinoma of the breast. 

CONTRAINDICATIONS: Known hypersensitivity to norethindrone, thromboembolic disorders, severe hepatic disease, breast cancer. undiagnosed vaginal bleeding. 

SIDE EFFECTS/ADVERSE REACTION: Breakthrough bleeding, amenorrhea, exacerbation of epilepsy and migraine. 

WARNING/PRECAUTIONS: Use of any progestin during the first w months of pregnancy is not recommended, use with caution in patients with asthma, diabetes, seizure disorders, migraine, cardiac or renal dysfunction, progressing-induced withdrawal bleeding occurs within 3-7 days after discontinuation of drug. 

DRUG INTERACTIONS: Decreased effect: Amino glutethimide may decrease effects by increasing hepatic metabolism. 

USE IN PREGNANCY AND LACTATION: stop using as soon as you suspect you may have become pregnant, stop taking the drug and report to the doctor. 

OVERDOSAGE, SYMPTOMS AND ANTIDOTE: Toxicity is unlikely following single exposures of excessive doses, supportive treatment is adequate in most cases. 

Manufactured by: MICRO LABS LIMITED