primolut n tablet uses

primolut n گولی کا استعمال

Written by Dr. Hiba Yousuf Mughal [PharmD, DOW University Of Health Sciences (DUHS)], Karachi, Pakistan.

Brand name:

PRIMOLUT N ® 5 mg tablets

Generic name:

Norethisterone.

Available dosage forms and their doses:

Tablets

Price:

Rs. 380 per box

Therapeutic class:

synthetic hormone (chemical messenger) that mimics progesterone

Pharmacological class:

Progesterone Receptor agonist

Manufacturer:

OBS Pharmaceutical

Storage:

Store in the original packaging to protect from light.

Prescription drug:

Prescription Only Medicine

Clinical pharmacology (mechanism of action):

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 oestrogen-primed women with orally administered doses of 100 - 150 mg norethisterone per cycle. The progestogenic effects of norethisterone on the endometrium are the basis of the treatment of dysfunctional bleeding, and endometriosis with PRIMOLUT N.

Gonadotropin secretion inhibition and anovulation can be achieved with a daily intake of 0.5 mg of norethisterone. Positive effects of PRIMOLUT Nnon premenstrual symptoms can be traced back to suppression of ovarian function. Due to the stabilising effects of norethisterone on the endometrium, administration of PRIMOLUT N can be used to shift the timing of menstruation. Like progesterone, the thermogenic action of norethisterone alters the basal body temperature.

Indications and dosages:

• Dysfunctional bleeding

• premenstrual syndrome

• cyclical mastopathy

• timing of menstruation

• endometriosis

• menorrhagia.

Dose:

The dose is 1 tablet of Primolut N three times daily, starting 3 days before the expected onset of menstruation and continuing for not longer than 10 to 14 days.

Side effects:

• Immune system disorders: Hypersensitivity reactions

• Nervous system disorders: Headache Migraine

• Eye disorders: Visual disturbances

• Respiratory, thoracic and mediastinal disorders: Dyspnoea

• Gastrointestinal disorders: Nausea

• Skin and subcutaneous tissue disorders: Urticaria, Rash

• Reproductive system and breast disorders: Uterine/Vaginal bleeding including Spotting, Hypomenorrhoea, Amenorrhoea

• General disorders at administration site conditions: Oedema.

Interactions:

Interactions have been reported for combined oral contraceptives.

Pregnancy:

The use of PRIMOLUT N during pregnancy is contraindicated. Pregnancy (Category

D): “Medicines which have caused, are suspected to have caused, or may be expected to

cause, an increased incidence of human foetal malformations or irreversible damage. These

medicines may also have adverse pharmacological effects.”

Lactation:

PRIMOLUT N should not be used during lactation

Precautions:

If any of the conditions/risk factors mentioned below is present or deteriorates,

an individual risk-benefit analysis should be done before PRIMOLUT N is started or continued.

This includes:

• venous thromboembolism (VTE)

• malignant liver tumours, diabetes

• Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum.

Counselling points:

A normal period should occur 2-3 days after the patient has stopped taking tablets.