Norethisterone 5 Mg Tablets Cas No: 8061-51-6 at Best Price in Hyderabad

Norethisterone 5 Mg Tablets By Sanzyme (P) Ltd.

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Product Specifications

Active Ingredient	Norethisterone
Dosage	5 mg
Features	Hormonal balance, Menstrual regulation, Symptom relief
Form	Tablets
Packaging	Blister packs
Route of Administration	Oral
Strength	5mg
Usage	Treats menstrual irregularities, premenstrual syndrome, and endometriosis

Product Overview

Key Features

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 menstruation
Dysfunctional bleeding
Premenstrual 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 pregnancy
Lactation
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

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.