Norethisterone 5 Mg Tablets By Sanzyme (P) Ltd.

COMPOSITION:

Each uncoated tablet contains :
Norethisterone 5 mg

ACTIONS:

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:

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.

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.