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- Martindale: The Complete Drug Reference
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Information is provided on brand name, manufacturer, country of origin, active constituents, and licensed uses. Cross-references link each ingredient to an appropriate drug monograph when possible. In addition, more than disease treatment reviews offer overviews of the diseases and drugs used in their treatment, along with key references. Cross-references are provided between disease reviews and relevant drug monographs. Ann Intern Med ; PubMed id 3. Fermand JP, et al.
Danazol-induced hepatocellular adenoma. Am J Med ; PubMed id 4. Bray GP. Resolution of danazol-induced cholestasis with S- adenosylmethionine. Postgrad Med J ; PubMed id 5. Makdisi WJ, et al. Fatal peliosis of the liver and spleen in a patient with agnogenic myeloid metaplasia treated with danazol. Am J Gastroenterol ; PubMed id 6. Bork K, et al. Hepatocellular adenomas in patients taking danazol for hereditary angio-oedema.
Lancet ; PubMed id -- Effects on the pancreas. There have been reports of pancreatitis in patients receiving danazol. Chevalier X, et al. Danazol induced pancreatitis and hepatitis. Balasch J, et al. Acute pancreatitis associated with danazol treatment for endometriosis.
Hum Reprod ; 9: PubMed id -- Effects on the skin. Erythema multiforme developed in two patients receiving danazol for profuse bleeding. Danazol and erythema multiforme. PubMed id Precautions Breast feeding. Danazol should be used with caution in conditions which may be adversely affected by fluid retention, such as in cardiovascular, hepatic, and renal disorders, migraine, and epilepsy; it should be avoided in marked cardiac, hepatic, or renal dysfunction.
It should also be used with care in patients with diabetes mellitus or polycythaemia. Danazol should not be given to patients with undiagnosed genital bleeding or androgen-dependent tumours. It should not be used in patients with a thromboembolic disorder or a history of thrombosis.
Danazol should not be given during pregnancy because of a possible androgenic effect on the female fetus see Danazol , and non-hormonal contraception is recommended during treatment. Caution is required in children and adolescents since precocious sexual development may occur in boys and virilisation in girls, and premature epiphyseal closure may occur in both sexes. In the event of androgenic effects, danazol should be withdrawn, as they may prove irreversible on continued use.source url
Martindale: The Complete Drug Reference
The UK licensed product information warns that danazol should be avoided in breast-feeding women because of the theoretical potential for androgenic effects in the infant. Danazol has been associated with acute attacks of porphyria and is considered unsafe in porphyric patients. Reports of masculinisation of female infants born to mothers who had received danazol during pregnancy. Female pseudohermaphroditism associated with danazol exposure in utero: case report.
Br J Obstet Gynaecol ; Kingsbury AC. Danazol and fetal masculinization: a warning. Med J Aust ; Brunskill PJ. The effects of fetal exposure to danazol. Introduction of danazol appeared to reduce the maintenance requirement for alfacalcidol see Paricalcitol. For reference to rhabdomyolysis attributed to use of danazol with lovastatin, see Simvastatin.
Pharmacokinetics Danazol is absorbed from the gastrointestinal tract and metabolised in the liver; absorption is markedly increased if it is taken with food. A plasma elimination half-life of 3 to 6 hours has been reported after a single dose, but is increased to about 26 hours with repeated dosing.
Ethisterone, 2-hydroxymethylethisterone, and hydroxymethylethisterone are the major metabolites, though none have pituitary inhibiting activity.
Martindale: The Complete Drug Reference | MedicinesComplete
Danazol and its metabolites may undergo enterohepatic circulation. Metabolites are excreted in the urine and faeces. Uses and Administration Blood disorders. Hereditary angioedema. Premenstrual syndrome. Skin disorders. Danazol suppresses the pituitary-ovarian axis by inhibiting pituitary output of gonadotrophins. It has weak androgenic activity. Danazol has been given by mouth in the treatment of a variety of conditions including endometriosis, some benign breast disorders such as mastalgia and fibrocystic breast disease, gynaecomastia, menorrhagia associated with dysfunctional uterine bleeding, and prevention of hereditary angioedema.
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It may also be used for the pre-operative thinning of the endometrium prior to hysteroscopic endometrial ablation, and has been tried in a variety of other conditions including pubertal or pre-pubertal breast hypertrophy and various blood disorders. When given to women, treatment with danazol should be started on day 1 of the menstrual cycle or after pregnancy has been otherwise excluded.
In endometriosis the usual dose is to mg daily in 2 to 4 divided doses, adjusted according to the response. Therapy is given for 3 to 6 months or continued for up to 9 months if necessary. In the treatment of benign breast disorders the usual initial dose is to mg daily in 2 divided doses, adjusted according to response, and continued for 3 to 6 months.
For gynaecomastia mg daily has been given to male adolescents, increased after 2 months to mg daily if no response occurs; adult men have been given mg daily initially, in up to 4 divided doses. Therapy is usually tried for 6 months. In the management of hereditary angioedema initial doses of mg two or three times daily are given, and then reduced according to the patient's response. For pre-operative thinning of the endometrium danazol has been given in a dose of to mg daily in up to 4 divided doses, for 3 to 6 weeks. Although danazol may produce thrombocytopenia and leucopenia its use has also been investigated in some blood disorders.
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Increased platelet counts have been reported in patients with idiopathic thrombocytopenic purpura Corticosteroids , although in one study3 7 of 10 patients derived no benefit. A study on its action in this disorder7 indicated that danazol may influence the number of available binding sites for monomeric immunoglobulin G Fc receptors on monocytes. Another study8 showed that sex, age in women only , and the status of the spleen influenced the response of auto-immune thrombocytopenia to danazol.
Thrombocytopenia associated with rheumatic disorders, such as systemic lupus erythematosus, the antiphospholipid antibody syndrome, and rheumatoid arthritis has also been reported to respond to treatment with danazol. Additionally there have been reports of response to danazol therapy in patients with auto-immune haemolytic anaemia10,11 Blood Products Plasma Expanders and Haemostatics , paroxysmal nocturnal haemoglobinuria,12 hereditary haemorrhagic telangiectasia,13 and Evan's syndrome due to systemic lupus erythematosus,14 and conflicting reports in patients with myelodysplastic syndromes.
Ahn YS, et al. Danazol for the treatment of idiopathic thrombocytopenic purpura. N Engl J Med ; Buelli M, et al. Acta Haematol Basel ; McVerry BA, et al. The use of danazol in the management of chronic immune thrombocytopenic purpura. Br J Haematol ; Mylvaganam R, et al. Very low dose danazol in idiopathic thrombocytopenic purpura and its role as an immune modulator. Am J Med Sci ; Edelmann DZ, et al.
Danazol in non-splenectomised patients with refractory idiopathic thrombocytopenic purpura. Maloisel F, et al. Danazol therapy in patients with chronic idiopathic thrombocytopenic purpura: long-term results. PubMed id 7. Schreiber AD, et al. Effect of danazol in immune thrombocytopenic purpura. PubMed id 8. Long-term danazol therapy in autoimmune thrombocytopenia: unmaintained remission and age-dependent response in women.
PubMed id 9. Blanco R, et al. Successful therapy with danazol in refractory autoimmune thrombocytopenia associated with rheumatic diseases. Br J Rheumatol ; PubMed id Danazol therapy for autoimmune hemolytic anemia. Tan AM, et al. Ann Acad Med Singapore ; Harrington WJ, et al. Danazol for paroxysmal nocturnal hemoglobinuria. Am J Hematol ; Haq AU, et al. Hereditary hemorrhagic telangiectasia and danazol.