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Contents
Norethisterone
Indications
Dysfunctional bleeding, primary & secondary amenorrhea, premenstrual syndrome, cyclical mastopathy, timing of menstruation, endometriosis.
Dosage
1 tab 3 times daily over 10 days. To ensure treatment success, Primolut N must be taken for full 10 days. 1 tab 1-2 times daily from days 16-25 of cycle. Primary & secondary amenorrhea 1 tab 1-2 times daily for 10 days. To stop estrogen treatment & to induce cyclical bleeding: 1 tab twice daily from days 16-25 of cycle. Premenstrual syndrome, cyclical mastopathy 1 tab 1-3 times daily. Timing of menstruation 1 tab 2-3 times daily for not >10-14 days, beginning about 3 days before expected menstruation. Endometriosis Treatment should begin between days 1-5 of cycle w/ 1 tab twice daily. Treatment is to be continued for at least 4-6 mth.
Administration
May be taken with or without food
Contraindications
Known or suspected pregnancy; lactation; thromboembolic processes; history or existing arterial & vascular diseases; DM w/ vascular involvement; presence or history of severe hepatic disease as long as liver function values have not returned to normal; presence or history of liver tumours (benign or malignant); known or suspected sex hormone-dependent malignancies.
Special Precautions
History of thromboembolic diseases; arterial or VTE; increased risk of thromboembolism in puerperium; rarely malignant liver tumors which may lead to life-threatening intra-abdominal hemorrhages; enlargement or signs of intra-abdominal hemorrhage occur in women taking Primolut N; chloasma may occasionally occur in women w/ a history of chloasma gravidarum.
Adverse Drug Reactions
Uterine/vag bleeding including spotting, hypomenorrhea; headache, nausea, amenorrhea, edema.
Click to view ADR Monitoring Form
Drug Interactions
Drug interactions which result in an increased clearance of sex hormones can lead to decreased therapeutic efficacy eg hepatic enzyme inducers (including phenytoin, barbiturates, primidone, carbamazepine & rifampicin); griseofulvin, oxcarbazepine & rifabutin are also suspected; cyclosporine, St. John's wort, rifabutin.
Click here for more Interaction Checks
Pregnancy Category (US FDA)






Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.
MIMS Class
Oestrogens & Progesterones & Related Synthetic Drugs
ATC Classification
G03DC02 - Norethisterone ; Belongs to the class of estren derivative progestogens used in progestogenic hormone preparations.
Poison Schedule
G
Packing/Presentation
FormPacking/PricePhoto
Primolut N tablet
Primolut N 5 mg x 30's (Rp150600)Primolut N

Manufacturer:Bayer Schering Pharma



source : MIMS