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DANAZOL is a brand name for Danazol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Danazol capsules are recommended for the treatment of: 1. Endometriosis. To control pain, pelvic tenderness and other associated symptoms and to resolve or reduce the extent of endometriotic foci. Danazol capsules may be used as sole therapy, in preparation for or following surgery or in patients not responding to…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults The usual range of dosage is 200 mg to 800 mg daily in up to four divided doses. Danazol should be given as a continuous course, dosage being adjusted according to the severity of the condition and the patient’s response.
A reduction in dosage once a satisfactory response has been achieved may prove possible. In fertile females, Danazol should be started during menstruation, preferably on the first day, to avoid exposing a pregnancy to its possible effects.
Where doubt exists, appropriate checks should be made to exclude pregnancy before starting medication. Females of child-bearing age should employ non-hormonal contraception throughout the course of treatment. In endometriosis, the recommended dosage is 200-800 mg daily in a course of treatment lasting normally three to six months, although up to nine months may be necessary in some cases.
Dosage should be increased if normal cyclical bleeding still persists after two months therapy, a higher dosage (not exceeding 800 mg per day) may also be needed for severe disease. For dysfunctional uterine bleeding presenting as menorrhagia, the dosage should be 200 mg daily, normally for 3 months.
In severe cyclical mastalgia, treatment should commence at a dose of 200-300 mg daily, according to the severity of the symptoms, a course of treatment normally lasting 3-6 months. In benign breast fibrocystic disease, treatment should commence at a dose of 300 mg daily, a course of treatment normally lasting 3 to 6 months.
In gynaecomastia a six-month course of therapy is recommended at a dose of 200 mg daily in adolescents which may be increased to 400 mg daily if no response is obtained after two months. Adults may be given 400 mg daily. For pre-operative thinning of the endometrium, the usual dose is 400-800 mg daily given as a continuous course normally lasting 3-6 weeks.
Elderly Danazol Capsules are not recommended. Paediatric population Danazol Capsules are not recommended. Method of administration For oral administration only.
The possible causal relationship between danazol and many of the following events reportedly associated with its use remains to be defined. Blood and lymphatic system disorders Increase in red cell and platelet count. Reversible erythrocytosis or polycythaemia may be provoked.
Eosinophilia, leucopenia, splenic peliosis and thrombocytopenia have also been noted.
Endocrine disorders Androgenic effects:
Acne, weight gain, increased appetite, seborrhoea, hirsutism, hair loss, voice change, which may take the form of hoarseness, sore throat or of instability or deepening of pitch. Hypertrophy of the clitoris, fluid retention.
Other endocrine effects:
Menstrual disturbances in the form of spotting, alteration of the timing of the cycle and amenorrhoea. Flushing, vaginal dryness, vaginal irritation and reduction in breast size. Vaginal dryness and irritation and reduction in breast size may reflect a lowering of oestrogen.
Although cyclical bleeding and ovulation usually return within 60-90 days after danazol, persistent amenorrhoea has occasionally been reported. Modest reduction in spermatogenesis. Metabolism and nutrition disorders Insulin resistance may be increased in diabetes mellitus but symptomatic hypoglycaemia in non-diabetic patients has also been reported as an increase in plasma glucagon level, mild impairment of glucose tolerance.
A temporary alteration of lipoproteins in the form of an increase in LDL cholesterol, a decrease in HDL cholesterol, affecting all subfractions, and a decrease in apolipoproteins A1 and AII. The clinical significance of these changes is not established.
Induction of aminolevulinic acid (ALA) synthetase, and reduction in thyroid binding globulin, T4, with increased uptake of T3 but without disturbance of thyroid stimulating hormone or free thyroxin index, is also likely during therapy.
In view of its pharmacology, known interactions and side effects, particular care should be observed when using danazol in patients with hepatic or renal disease, hypertension or other cardiovascular disease and in any state which may be exacerbated by fluid retention as well as in diabetes mellitus, polycythaemia, epilepsy, lipoprotein disorder, in those with a history of thrombosis, and in those who have shown marked or persistent androgenic reaction to previous gonadal steroid therapy.
Adjustment in concomitant therapy may be called for particularly in patients with hypertension, diabetes mellitus or epilepsy when introducing or discontinuing danazol as well as during Danazol treatment. Caution is advised in patients with migraine.
Until more is known, caution is advised in the use of danazol in the presence of known or suspected malignant disease (see also contraindications). Before treatment initiation, the presence of hormone-dependent carcinoma should be excluded at least by careful clinical examination, as well as if breast nodules persist or enlarge during danazol treatment.
In the event of virilisation, Danazol should be withdrawn. Whilst androgenic reactions will generally prove reversible, continued use of danazol in the face of evident virilisation is likely to cause irreversible androgenic effects.
Danazol should be stopped if any clinically significant adverse event arises, and particularly if there is evidence of papilloedema, headache, visual disturbances or other signs or symptoms of raised intracranial pressure, jaundice or other indication of significant hepatic disturbance, thrombosis or thromboembolism.
In addition to clinical monitoring in all patients, appropriate laboratory monitoring should be considered which may include periodic measurement of hepatic function and haematological state. For long-term treatment (> 6 months) or repeated courses of treatment, biannual hepatic ultrasonography is recommended.
1. Pregnancy 2. Breastfeeding: danazol may be excreted in breast milk 3. Markedly impaired hepatic, renal or cardiac function 4. Porphyria: danazol can induce ALA synthetase activity and hence porphyrin metabolism 5. Active thrombosis or thromboembolic disease and a history of such events 6.
Androgen dependent tumour 7. Abnormal genital bleeding that has not been fully investigated. 8. 1. 9. 5)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Psychiatric disorders Emotional lability, anxiety, depressed mood, nervousness and changes in libido. Nervous system disorders Dizziness, headache, vertigo, benign intracranial hypertension. Danazol may aggravate epilepsy and expose the condition in those so predisposed.
Fluid retention may explain the occasional reports of carpal tunnel syndrome. Danazol may also provoke migraine. Eye disorders Visual disturbances which may take the form of blurring or difficulty in focusing and in wearing contact lenses or need for temporary alteration in refractive correction have been noted.
Cardiac disorders Hypertension, palpitation and tachycardia. Thrombotic events including sagittal sinus, cerebrovascular thrombosis as well as arterial thrombosis. Myocardial infarction. Vascular disorders Flushing, exacerbation of hypertension Respiratory, thoracic and mediastinal disorders Pleuritic pain, interstitial pneumonitis Gastrointestinal disorders Nausea, epigastric pain Hepatobiliary disorders Modest increase in serum transaminase levels and rarely cholestatic jaundice, benign hepatic adenomata and pancreatitis.
Peliosis hepatis as well as malignant hepatic tumour have been observed with long term use. Hepatocellular injury, hepatic failure, jaundice hepatocellular, hepatocellular focal nodular hyperplasia. Skin and subcutaneous tissue disorders Rashes, which may be maculopapular, petechial, or purpuric or may take an urticarial form and may be accompanied by facial oedema.
Associated fever has also been reported. Rarely, sun-sensitive rash has been noted. Inflammatory erythematous nodules, changes in skin pigmentation, exfoliative dermatitis and erythema multiforme have also been reported. Musculoskeletal and connective tissue disorders Backache and muscle cramps which can be severe.
Creatine phosphokinase levels may also rise. Muscle tremors, fasciculation, limb pain, joint pain and joint swelling have also been reported. Renal and urinary disorders Haematuria has rarely been reported with prolonged use in patients with hereditary angioedema.
General disorders and administration site conditions Fatigue Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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Danazol should be initiated during menstruation. 6). The lowest effective dose of danazol should always be sought. Experience of long term therapy with danazol is limited. Whilst a course of therapy may need to be repeated, care should be observed as no safety data are available in relation to repeated courses of treatment over time.
The long-term risk of 17-alkylated steroids (including benign hepatic adenomata, hepatocellular focal nodular hyperplasia, peliosis hepatis and hepatic carcinoma), should be considered when danazol, which is chemically related to these compounds, is used for periods longer than those normally recommended.
Data, from two case-control epidemiological studies, were pooled to examine the relationship between endometriosis, endometriosis treatments and ovarian cancer. These preliminary results suggest that the use of danazol might increase the baseline risk of ovarian cancer in - patients treated for endometriosis.
Danazol capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.