Norethisterone oral high strength
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Tablets containing norethisterone 5 mg
Drugs List
Therapeutic Indications
Uses
Disseminated carcinoma of breast
Dysfunctional uterine bleeding
Dysmenorrhoea (adjunctive treatment)
Endometriosis
Menstruation - postponement of
Metropathia haemorrhagica
Premenstrual syndrome
Unlicensed Uses
Sexual maturation in females: induction and maintenance of
Dosage
Adults
Dysfunctional uterine bleeding (menorrhagia and polymenorrhoea)
5mg three times daily for ten days.
5mg twice daily from 19th to the 26th day of each subsequent cycle to prevent recurrence.
Metropathia haemorrhagica
5mg three times daily for ten days. Bleeding usually stops within one to three days. A withdrawal bleed resembling normal menstruation occurs within two to four days after discontinuing treatment.
Premenstrual syndrome (including premenstrual mastalgia)
5mg daily from days 16 to 25 of the cycle to relieve symptoms such as headache, migraine, breast discomfort, water retention, tachycardia and psychological disturbances. Treatment should be repeated for several cycles.
When treatment is stopped, the patient may remain asymptomatic for a number of months.
Postponement of menstruation
In special circumstances (e.g. surgical treatment, travel, sports) or in cases of too frequent menstrual bleeding, 5mg three times daily starting three days before the expected onset of menstruation will postpone onset. A normal period should occur two to three days after the patient has stopped taking the tablets.
Endometriosis (pseudo-pregnancy treatment)
Treatment should begin between the 1st and 5th day of the cycle with 5mg three times daily. In the event of 'spotting' bleeding, the dose is increased to 10mg twice daily. If bleeding ceases, dose reduction to the initial dose should be considered. Continue treatment for four to six months continuously or longer, if necessary. With uninterrupted daily intake, ovulation and menstruation do not usually occur.
High dose treatment of disseminated carcinoma of the breast
40mg per day increasing to 60mg if no regression is noted.
Children
Induction and maintenance of sexual maturation in females (unlicensed)
5mg once daily for the last seven days of a 28-day cycle. Give with an oestrogen, after receiving twelve to eighteen months of oestrogen therapy.
Postponement of menstruation (unlicensed)
Three days before expected onset of menstruation, give 5mg three times daily.
Contraindications
Breast neoplasms - unless for treatment
Breastfeeding
Deep vein thrombosis
Diabetes mellitus with vascular involvement
Endometrial hyperplasia
Familial conjugated hyperbilirubinaemias
Female genital neoplasms - unless for treatment
Focal migraine
Galactosaemia
Hepatic neoplasm
History of cholestatic jaundice during pregnancy
History of hepatic neoplasm
History of herpes gestationis
History of pruritus during pregnancy
History of severe arterial disorder
History of venous thromboembolism
Porphyria
Pregnancy
Pulmonary embolism
Severe arterial disorder
Severe hepatic impairment
Thromboembolic disorder
Undiagnosed gynaecological haemorrhage
Precautions and Warnings
Body mass index above 30kg per square metre
Family history of venous thromboembolism
History of recurrent spontaneous abortion
Major surgery
Prolonged immobilisation
Severe trauma
Asthma
Cardiac impairment
Diabetes mellitus
Epileptic disorder
Glucose-galactose malabsorption syndrome
History of chloasma
History of depression
History of thromboembolic disorder without anticoagulant therapy
Hypertension
Lactose intolerance
Migraine
Renal impairment
Sickle cell disease
Not all available brands are licensed for all indications
If intra-abdominal haemorrhage consider liver tumour
If upper abdominal complaints/liver enlargement consider liver tumour
Monitor blood glucose closely in patients with diabetes mellitus
Increased risk of VTE during travel involving >5hr immobilisation
May induce or enhance hepatic tumour development
Discontinue 4 - 6 weeks before major surgery
Advise patient to seek advice at first indications of pregnancy
Discontinue at first signs of jaundice, hepatitis or whole body itching
Discontinue at first signs of thrombophlebitis or thromboembolism
Discontinue if epilepsy is exacerbated
Discontinue if pain or tightness in chest
Discontinue if significant rise in blood pressure occurs
Discontinue if sudden occurrence of visual/hearing/perceptual disorders
Discontinue-first occurrence/worsening migraine/severe or frequent headache
Advise patient not to take St John's wort concurrently
Changes in menstrual bleeding patterns should be expected
Norethisterone is partly metabolised to ethinylestradiol after oral administration or norethisterone or norethisterone acetate in humans. This conversion results in an equivalent dose of about of about 4 to 6 micrograms ethinylestradiol per 1 mg orally administered norethisterone or norethisterone acetate.
Pregnancy and Lactation
Pregnancy
Use during pregnancy is contraindicated.
Virilisation in females and hypospadias in males has been reported in the offspring of mothers who have received norethisterone during pregnancy.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Use during lactation should be avoided as norethisterone is present in breast milk.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Side Effects
"Spotting" bleeding
Abdominal pain
Acne
Allergic skin reactions
Alopecia
Altered serum lipid profile
Amenorrhoea
Anaphylactoid-like reaction
Angioedema
Benign hepatic adenomata
Bloating
Breakthrough bleeding
Breast discomfort
Breast enlargement
Breast tenderness
Cerebral dysfunction
Cervical erosion
Changes in cervical secretion
Changes in libido
Chloasma
Cholestatic liver changes
Concentration difficulties
Confusion
Congestive cardiac failure
Constipation
Cramp
Cushing's syndrome
Decreased glucose tolerance
Depression
Diabetic cataract
Diarrhoea
Diplopia
Disturbances of appetite
Dizziness
Drowsiness
Dry mouth
Dyspnoea
Euphoria
Exacerbation of diabetes
Exacerbation of epilepsy
Fatigue
Fine tremor (usually hands)
Fluid retention
Galactorrhoea
Glycosuria
Headache
Hirsutism
Hypercalcaemia
Hyperglycaemia
Hypersensitivity reactions
Hypertension
Increased fasting blood glucose
Insomnia
Intolerance to contact lenses
Jaundice
Liver function disturbances
Malaise
Melasma
Menorrhagia
Menstrual disturbances
Migraine
Myocardial infarction
Nausea
Nervousness
Oedema
Ovarian cysts
Palpitations
Premenstrual symptoms
Prolonged anovulation
Pruritus
Pulmonary embolism
Pyrexia
Rash
Retinal vascular thrombosis
Somnolence
Sweating
Tachycardia
Thrombophlebitis
Urticaria
Visual disturbances
Vomiting
Weight gain
Further Information
Last Full Review Date: June 2013
Reference Sources
Summary of product characteristics: Norethisterone tablets. Wockhardt UK Ltd. Revised February 2017.
Summary of Product Characteristics: Primolut N. Bayer plc. Revised May 2017.
Summary of Product Characteristics: Utovlan Tablets. Pharmacia Limited. Revised February 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 13 September 2017
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.