Danazol


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Endometriosis 200-800 mg/day in 2-4 divided doses for 3-6 mth, up to 9 mth if necessary. Benign breast disorders Initial: 100-400 mg/day in 2 divided doses for 3-6 mth. Hereditary angioedema Initial: 200 mg bid or tid, reduce after an initial response is obtained.
Dosage Details
Oral
Benign breast disorders
Adult: Initially, 100-400 mg daily in 2 divided doses, adjust according to response. Duration of therapy: 3-6 mth.

Oral
Hereditary angioedema
Adult: Initially, 200 mg bid or tid. After an initial response is obtained, reduce by ≤50% at intervals of 1-3 mth or longer depending on the frequency of attack prior to initiation; if an attack occurs during treatment, may increase by up to 200 mg daily.

Oral
Endometriosis
Adult: 200-800 mg daily in 2-4 divided doses, adjust according to response. Duration of treatment: 3-6 mth, up to 9 mth if necessary.
Renal Impairment
Severe: Contraindicated.
Hepatic Impairment
Severe: Contraindicated.
Administration
May be taken with or without food. Take consistently either always w/ or always w/o meals.
Contraindications
Undiagnosed abnormal genital bleeding, androgen-dependent tumour, thromboembolic disease or history of thrombosis, severe cardiac impairment. Severe hepatic and renal impairment. Pregnancy and lactation.
Special Precautions
Patient w/ epilepsy, migraine, DM, polycythaemia, HTN and other CV disease, porphyria, lipoprotein disorder. Hepatic or renal impairment.
Adverse Reactions
Significant: Androgenic effects (e.g. acne, seborrhoea, wt gain, hair loss, voice change, clitoral hyperthrophy), peliosis hepatis, benign hepatic adenoma, cholestatic jaundice, benign intracranial HTN.
Nervous: Nervousness, emotional lability, headache.
CV: Palpitations, tachycardia.
Resp: Interstitial pneumonitis.
Genitourinary: Vaginal dryness and irritation; abnormal semen volume, sperm count, viscosity and motility.
Endocrine: Menstrual disturbances.
Dermatologic: Rash, Steven-Johnsons syndrome, erythema multiforme.
Potentially Fatal: Thromboembolism, thrombotic and thrombophlebitic events, including sagittal sinus thrombosis and stroke.
MonitoringParameters
Perform LFT and renal function test periodically. Monitor haematologic parameters, lipid panel, signs and symptoms of intracranial HTN, androgenic changes, and/or fluid retention.
Drug Interactions
May prolong prothrombin time when used w/ warfarin. May increase serum concentrations of carbamazepine, ciclosporin, tacrolimus. Increased risk of myopathy and rhabdomyolysis when concurrently administered w/ statins (e.g. simvastatin, atorvastatin, lovastatin). May increase calcaemic response to synthetic vit D analogs. May cause insulin resistance.
Food Interaction
Food, particularly high-fat meal, increases plasma concentration and extent of availability.
Lab Interference
May interfere w/ determination of testosterone, androstenedione, dehydroepiandrosterone or plasma proteins.
Action
Description: Danazol is an antigonadotropic agent which suppresses the pituitary-ovarian axis by inhibiting the pituitary output of FSH and LH, resulting in regression and atrophy of normal and ectopic endometrial tissue. It decreases growth rate of abnormal breast tissues, and also reduces attacks in hereditary angioedema by increasing C4 levels of the complement system.
Onset: Benign breast disorder: 1 mth (pain relief); 4-6 mth (nodule elimination).
Pharmacokinetics:
Absorption: Absorbed from in the GI tract. Increased absorption w/ food. Time to peak plasma concentration: 4 hr.
Metabolism: Extensively metabolised in the liver to 2-hydroxymethyl danazol and ethisterone.
Excretion: Via urine and faeces. Elimination half-life: Approx 10 hr.
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Database. Danazol, CID=28417, https://pubchem.ncbi.nlm.nih.gov/compound/Danazol (accessed on Jan. 20, 2020)

Storage
Store between 20-25°C. Protect from light.
ATC Classification
G03XA01 - danazol ; Belongs to the class of antigonadotropins and similar agents.
References
Anon. Danazol. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/09/2016.

Buckingham R (ed). Danazol. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com . Accessed 19/09/2016.

Danazol Capsule (Teva Pharmaceuticals USA, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 19/09/2016.

Joint Formulary Committee. Danazol. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 19/09/2016.

McEvoy GK, Snow EK, Miller J et al (eds). Danazol. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 19/09/2016.

Disclaimer: This information is independently developed by MIMS based on Danazol from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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