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Administration
May be taken with or without food.
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Contraindications
Known, suspected, or history of breast cancer or endometrial cancer, active or recent arterial thromboembolic disease (e.g. stroke, MI), current or history of venous thromboembolism (e.g. DVT, pulmonary embolism), angina pectoris, undiagnosed vaginal bleeding, porphyria, benign or malignant hepatic tumour; severe diabetes with vascular changes, pathologically increased blood pressure (as norethisterone enantate). Hepatic impairment or disease (e.g. Dubin-Johnson syndrome, Rotor syndrome). Pregnancy.
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Special Precautions
Patient with risk factors for cardiovascular disease (e.g. hypercholesterolaemia, hypertension, obesity), and/or venous thromboembolism (e.g. personal or family history of venous thromboembolism, SLE, prolonged immobilisation); depression, diabetes mellitus, conditions that may be aggravated by fluid retention (e.g. asthma, migraine, epilepsy, cardiac dysfunction). Smokers. Renal impairment. Lactation. Monitoring Parameters Assess pregnancy status prior to therapy, diagnostic measures (e.g. endometrial sampling). Monitor weight, vision changes (e.g. loss of vision, diplopia), signs or symptoms of depression, glycaemic control (in diabetic patients), lipid profile (patients treated for hyperlipidaemia). Perform breast and pelvic examination (e.g. Papanicolaou smear), as necessary.
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Adverse Reactions
Significant: As contraceptive: Irregular menstrual bleeding, breast cancer, visual abnormalities (e.g. partial or complete loss of vision, proptosis, diplopia), migraine, depression, decreased glucose tolerance, venous thromboembolism (e.g. deep vein thrombosis). Rarely, benign or malignant liver tumour.
Gastrointestinal disorders: Nausea, vomiting, abdominal pain.
General disorders and administration site conditions: Fatigue.
Hepatobiliary disorders: Cholestatic jaundice.
Immune system disorders: Hypersensitivity.
Investigations: Weight gain, abnormal LFT.
Metabolism and nutrition disorders: Oedema.
Nervous system disorders: Headache, dizziness.
Psychiatric disorders: Insomnia.
Reproductive system and breast disorders: Breast tenderness, amenorrhoea, spotting, decreased libido, change in cervical secretions, cervical erosion, breast hypertrophy.
Skin and subcutaneous tissue disorders: Acne, chloasma, pruritus, urticaria.
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Drug Interactions
Decreased therapeutic effect with barbiturates, phenytoin, carbamazepine, griseofulvin, felbamate. Increased plasma concentrations with CYP3A4 inhibitors (e.g. ketoconazole, erythromycin, verapamil, diltiazem). May reduce the therapeutic effect of ulipristal.
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ATC Classification
G03DC02 - norethisterone ; Belongs to the class of estren derivative progestogens used in progestogenic hormone preparations.
G03AC01 - norethisterone ; Belongs to the class of progestogens. Used as systemic contraceptives. |
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