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At low dose: Dysfunctional uterine bleeding, endometriosis, polymenorrhoea, menorrhagia, metropathia, haemorrhagia, postponement of menstruation and premenstrual syndrome.
At high dose: Disseminated carcinoma of the breast.
Low dose:
Dysfunctional uterine bleeding, polymenorrhoea, menorrhagia, dysmenorrhoea and metropathia haemorrhagia: 1 tablet three times daily for 10 days; bleeding usually stops within 48 hours. Withdrawal bleeding resembling true menstruation occurs a few days after the end of treatment. One tablet twice daily, from days 19 to 26 of the two subsequent cycles, should be given to prevent recurrence of the condition.
Endometriosis: 1 tablet three times daily for a minimum treatment period of six months. The dosage should be increased to 4 or 5 tablets a day if spotting occurs. The initial dosage should be resumed when bleeding or spotting stops.
Postponement of menstruation: 1 tablet three times daily, starting three days before the expected onset of menstruation. Menstruation usually follows within three days of finishing the treatment.
Pre-menstrual syndrome: 1 tablet daily from days 16 to 25 of the menstrual cycle.
High dose:
For disseminated breast carcinoma the starting dose is 8 tablets (40mg) per day increasing to 12 tablets (60mg) if no regression is noted.
Direction for use: For oral use.
Progestogens given alone at low doses have been associated with the following undesirable effects:
Genitourinary: breakthrough bleeding, spotting, amenorrhoea, abnormal uterine bleeding, (irregular, increase, decrease), alterations of cervical secretions, cervical erosions, prolonged anovulation
Reproductive system and breast disorders: galactorrhoea, mastodynia, tenderness
Central Nervous System: depression, headache, dizziness, fatigue, insomnia, nervousness, somnolence, confusion, euphoria, loss of concentration, vision disorders
Gastrointestinal/Hepatobiliary: nausea, vomiting, cholestatic icterus/jaundice, constipation, diarrhoea, dry mouth, disturbed liver function
Neoplasms benign, malignant and unspecified (incl cysts and polyps): hepatic adenoma
Metabolic & Nutritional: altered serum lipid and lipoprotein profiles, increased fasting glucose levels, increased fasting insulin levels, decreased glucose tolerance, adrenergic-like effects (e.g., fine hand tremors, sweating, cramps in calves at night), corticoid-like effects (e.g., Cushingoid syndrome), diabetic cataract, exacerbation of diabetes mellitus, glycosuria
Cardiovascular: thrombo-embolic disorders, cerebral and myocardial infarction, congestive heart failure, increased blood pressure, palpitations, pulmonary embolism, retinal thrombosis, tachycardia, thrombophlebitis
Skin & Mucous Membranes: acne, hirsutism, alopecia, pruritis, rash, urticaria
Allergy: hypersensitivity reactions (e.g., anaphylaxis & anaphylactoid reactions, angioedema)
Miscellaneous: oedema/fluid retention, bloating, weight gain, pyrexia, change in appetite, change in libido, hypercalcaemia, malaise
If menstrual bleeding should fail to follow a course of Deymor-N, the possibility of pregnancy must be excluded before a further course is given.
Therapy should be discontinued if the following occur:
– Jaundice or deterioration in liver function
– Significant increase in blood pressure
– New onset of migraine-type headache
Progestogens may cause fluid retention. Special care should be taken when prescribing norethisterone in patients with conditions which might be aggravated by this factor:
– Epilepsy
– Migraine
– Asthma
– Cardiac dysfunction
– Renal dysfunction
Risk of venous thromboembolism (VTE)
Long term use of low dose progestogens as part of combined oral contraception or combined hormone replacement therapy has been associated with an increased risk of venous thromboembolism, although the role of progestogens in this aetiology is uncertain. A patient who develops symptoms suggestive of thromboembolic complications should have her status and need for treatment carefully assessed before continuing therapy.
Store in a dry place below 30°C and protect from light.
Keep out of reach of children.
3 x 10 Alu-PVC blister packs.
Norethisterone Tablets BP 5 mg are available in an Alu-PVC blister of 10 tablets. Such 03 blisters in a unit carton with package insert.
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