Norethisterone 5 Mg Tablets By Sanzyme (P) Ltd.

COMPOSITION:  Each uncoated tablet contains : Norethisterone 5 mg  ACTIONS:  Norethisterone is a strong progestogen with negligible androgenic effects. Complete transformation of the endometrium from a proliferative to a secretory state can be achieved in estrogen-primed women with orally administered doses of 100-150 mg norethisterone per cycle. The progestogenic effects of norethisterone on the endometrium is the basis of the treatment of dysfunctional bleeding, primary and secondary amenorrhea, and endometriosis with SIZEN. Gonadotropin secretion inhibition and anovulation can be achieved with daily intake of 0.5 mg of norethisterone. Positive effects of SIZEN on premenstrual symptoms can be traced back to suppression of ovarian function. Due to the stabilising effects of norethisterone on the endometrium, administration of SIZEN can be used to shift the timing of menstruation. Like progesterone, the thermogenic action of norethisterone alters the basal body temperature. PHARMACOKINETICS: Absorption: Orally administered norethisterone is rapidly and completely absorbed over a wide dose range. Peak serum concentrations of about 16 ng/ml are reached within about 1.5 hours of administration of one tablet SIZEN. Due to a marked first-pass effect, the bioavailability of norethisterone after an oral dose is about 64%. Distribution: Norethisterone is bound to serum albumin and to sex hormone binding globulin (SHBG). Only about 3-4%of the total serum drug concentrations are present as free steroid, about 35% and 61% are bound to SHBG and albumin, respectively. INDICATIONS: Timing of menstruationDysfunctional bleedingPremenstrual syndrome Mastopathy Endometriosis Menorrhagia. DOSAGE & ADMINISTRATION: DUB- 1 tab TID arrests bleeding within 1-3 days (for 10 days x 3 m.o)PMS & Mastopathy- 1 tab BID or TID (during the luteal phase of the cycle)Endometriosis- Start up: 1 tab BID (between 1st & 5th day of the cycle)Step up: 2 tabs BID for atleast 4-6 months Hypermenorrhoea: 1 tab TID (between 5th & 25th day of the cycle is effective in reducing blood loss)Timing of Menstruation: 1 tab at least 3 days prior to the due date and continue but not more than 14 days CONTRAINDICATIONS: Known or suspected pregnancyLactationThromboembolic processesDiabetes mellitus with vascular involvementPresence or history of severe hepatic disease as long as liver function values have returned to normalPresence or history of liver tumors (benign or malignant)Known or suspected sex-hormone dependent malignanciesHypersensitivity to the active substances or to any of the excipients WARNINGS & PRECAUTIONS: If any of the conditions / risk factors mentioned below is present or deteriorates, an individual risk-benefit analysis should be done before SIZEN is started or continued. Circulatory disorders Tumors Pregnancy & Lactation: The use of SIZEN during Pregnancy & Lactation is contraindicated  ADVERSE EFFECTS: Visual disturbances, nausea, head aches, edema, migraine, dyspnea, hypersensitivity reactions (e.g. rash, urticaria). INTERACTIONS: 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, primidone, carbamazepine, and rifampicin); griseofulvin, oxcarbazepine, and rifabutin are also suspected. PRESENTATION: Strip of 10 Tablets. Box of 10 Strips. FOR ORAL USE ONLY.