Primolut - N

 

Dr. R. Nalini*

 

ABSTRACT:

Primolut-N contains norethisterone, which belongs to group of medicines called progestogens, which are female hormones. Primolut-N tablet is used to treat various menstrual problems including painful, heavy, or irregular periods, premenstrual syndrome (PMS) and a condition called endometriosis. It is a man-made version of the natural female sex hormone progesterone. The main ingredient in PrimolutN (Progesterone) is partly converted into estrogen so we should also consider the general warnings.

 

 

 

INTRODUCTION:

 

Figure 1:

Brand Names:

Amenova, Corolut-N, Cycloreg-G, Norgest, Primolut-N, Sysron-N, Regestrone, Relicalfin DS, Styptin.¹

 

Mechanism of Action:

The active pharmaceutical ingredient present in Primolut N tablets is Norethisterone.

 

Primolut N tablet contain the active ingredient Norethisterone which is a progestogen with negligible androgenic effects.

 

Primolut N is used for timing of menstruation and to treat disturbances of the monthly bleeding (dysfunctional bleeding), lack of the monthly bleeding (primary and secondary amenorrhoea), premenstrual complaints (premenstrual syndrome), in combination with oestrogen hormone replacement therapy and endometriosis.²

 

Primolut N Tablets – Dosage and Administration:

Primolut N tablets are to be swallowed whole with a sufficient quantity of water or other suitable liquid. The dosage varies as per indication being treated.

1 Tablet = 5mg Norethisterone³

 

Indication and Dosage:

·       Dysfunctional bleeding:

The recommended dosage of Primolut N is 1 tablet of Primolut N - 3 times daily for 10 days. In most cases bleeding will stop within 1 to 3 days, but Primolut N must be taken for the full 10 days. About 2 to 4 days after you stop taking the tablets, withdrawal bleeding will occur.

 

·       Primary and secondary amenorrhoea (lack of a period):

Hormone treatment of secondary amenorrhoea can be carried out only after pregnancy has been excluded. The doctor will prescribe the patient an oestrogen (usually for 14 days) before beginning treatment with Primolut N. After which the patient will have to take 1 tablet of Primolut N for 1 to 2 times daily continuously for 10 days. Normally withdrawal bleeding occurs a few days after taking the last tablet.

 

·       Premenstrual syndrome:

The recommended dosage is one tablet of Primolut N - one to three times daily during the 2^nd half (luteal phase) of the cycle may relieve or improve premenstrual symptoms such as headaches, depressive moods, water retention, and a feeling of tension in the breasts.

 

·       Delaying menstruation:

Monthly menstrual bleeding can be delayed by taking Primolut N. However, this method of delaying monthly period can be used when there is no risk of pregnancy during the treatment cycle. The recommended dosage is 1 tablet of Primolut N - two to three times daily to be taken from 3 days before expected menstruation. Usually bleeding will occur 2 to 3 days after taking the tablets. Continue for 10 to 14 days.

 

·       Endometriosis:

Treatment with Primolut N should begin between the first and 5^th day of the cycle with 1 tablet twice daily. In the event of spotting, the dose can be increased to 2 tablets twice daily. If bleeding stops, dose reduction to the initial dose should be considered. Treatment is to be continued for at least 4 to 6 months³.

 

Missed Dose:

The efficacy of Primolut N could be reduced if the patient forgets to take a tablet as directed. The missed dose of Primolut N has to be taken as soon as the patient remembers. Only the last missed dose should be taken and then the patient has to continue to take the tablet at the usual time on the next day. Double dose should not be taken⁴.

Storage Instructions for Primolut N Tablets:

Primolut N tablets should be kept at room temperature, 15-30°C (59-86°F) in a light-resistant, tight container and away from children⁵.

 

Contraindications:

Primolut N is contraindicated in patients with any of the conditions listed below. In case any of the conditions appear during treatment with Primolut N, the use of this medication has to immediately discontinued³.

·       Hypersensitivity

·       Known or suspected pregnancy

·       Lactation

·       Thromboembolic disorders and thrombophlebitis

·       Arterial and cardiovascular disease present in the patient or history of the same (e.g. myocardial infarction, cerebrovascular accident, ischemic heart disease)

·       Diabetes mellitus with vascular involvement

·       Presence or history of severe hepatic disease as long as liver function values have not returned to normal

·       Presence of history of liver tumors (benign or malignant)

·       Known or suspected sex hormone-dependent malignancies

·       Missed abortion

·       Undiagnosed vaginal or urinary bleeding

·       Undiagnosed breast pathology

 

Side Effects of Primolut N Tablets (Norethisterone):

The side effects reported by users of Primolut N are

·       Abnormal vision

·       Nausea

·       Headache

·       Fluid retention

·       Migraine

·       Shortness of breath

·       Hypersensitivity reactions (e.g rash, hives).

 

Normally the side effects are more common during the first months after beginning treatmet with PrimolutN but subside with the duration of treatment^4,6.

 

Nursing Consideration:

·       Assess menstrual history before administer the drug.

·       Drug should not be administered to pregnant and lactating women.

·       Inform the patient about presence of withdrawal bleeding after taking last tablet.

·       Advice the patient to take missed dose of tablet as soon as she remembers. Only one dose can be taken.

·       Instruct the patient to keep tablet out of reach for children².

 

REFERENCES:

1.      Tripathi, K.D. Essentials of Medical Pharmacology, Jaypee Brothers Medical Publishers: New Delhi. 2009, 6^th edition.

2.      Lippincott Williams and Wilkins. Nursing Drug Hand Book. Philadelphia, 2013;33rd edition.

3.      https://www.medicines.org.uk/emc/medicine/1838#gref

4.      www.mydr.com.au/medicines/cmis/primolut-n-tablets

5.      https://www.medicines.org.uk/emc/product/1135/pil#gref

6.      https://www.nps.org.au/assets/medicines/9024c6e7-a061-4676-8d2d-a53300fefeb3-reduced.pdf

 

 

Received on 20.03.2021         Modified on 08.04.2021

Accepted on 18.04.2021       ©A&V Publications All right reserved