- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Capsules containing danazol
Benign fibrocystic breast disease - unresponsive to other treatment
Endometriosis - unresponsive to other treatment
Thinning of uterine endometrium before or instead of surgery
Treatment of severe cyclical mastalgia with/without nodularity
Danazol should be given as a continuous course, dosage being adjusted according to the severity of the condition and the patient's response.
A dosage reduction may be possible once a satisfactory response has been achieved.
In fertile females, who should employ non-hormonal contraception throughout treatment, danazol should be started during menstruation, preferably on the first day. Appropriate checks to exclude pregnancy should be made prior to treatment, if necessary.
The recommended dosage is 200 mg to 800 mg daily in a course of treatment lasting normally 3 to 6 months. 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.
Benign fibrocystic breast disease
Initially 300 mg daily in a course of treatment lasting normally 3 to 6 months.
200 mg daily in a course of treatment lasting normally 3 months.
400 mg daily in up to four divided doses for 6 months.
Severe cyclical mastalgia
Initially 200 mg to 300 mg daily, according to the severity of the symptoms, a course of treatment normally lasting 3 to 6 months.
Pre-operative thinning of the endometrium
400 mg to 800 mg daily in up to four divided doses for 3 to 6 weeks.
Hereditary Angioedema (Unlicensed Use)
Initially 100 to 200 mg daily then reducing dose according to response.
200 mg daily, increased to 400 mg daily if no response after two months.
Children under 12 years
History of thrombosis
Severe cardiac dysfunction
Severe hepatic impairment
Severe renal impairment
Undiagnosed gynaecological haemorrhage
Precautions and Warnings
Children aged 12 to 18 years
Disorders aggravated by fluid retention
Females of childbearing potential
Marked or persistent androgenic reaction to previous gonadal steroids
Disorder of lipoprotein metabolism
Glucose-galactose malabsorption syndrome
Diabetes mellitus: May cause insulin resistance
Exclude malignancy before treatment
Not all available brands are licensed for all indications
During treatment > than 6 months, perform biannual hepatic ultra sonography
Monitor haematological parameters periodically
Monitor hepatic function
Exclude cancer if breast nodules persist/enlarge during therapy
May increase baseline risk of ovarian carcinoma
May affect results of some laboratory tests
Advise patient to seek advice at first indications of pregnancy
Discontinue at first signs of thrombophlebitis or thromboembolism
Discontinue if jaundice or other evidence of hepatic impairment occurs
Discontinue if signs of raised intracranial pressure
Discontinue treatment if evidence of virilisation appears
Female: Barrier or non-hormonal contraception advised during treatment
Monitor hepatic function and haematological parameters periodically.
The long term risks of repeated courses of treatment should be considered as danazol is chemically related to steroids which have known long term risks of benign hepatic adenomata, peliosis hepatis and hepatic carcinoma. If treatment extends beyond 6 months, or repeated courses are given, biannual hepatic ultrasonography is recommended.
Pregnancy and Lactation
Danazol is contraindicated during pregnancy.
Danazol should not be used during pregnancy as there is epidemiological and toxicological evidence of hazard. Danazol is known to be associated with a risk of virilisation of the female foetus if administered during pregnancy. If the patient conceives during pregnancy, danazol should be discontinued.
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 ).
Danazol is contraindicated in breastfeeding.
Danazol has the theoretical potential for androgenic effects in breast-fed infants and therefore either danazol therapy or breast-feeding should be discontinued.
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
Altered glucose tolerance
Altered thyroid hormone levels
Amenorrhoea during and after treatment
Benign hepatic adenomata
Benign raised intracranial pressure
Breast size reduction
Carpal tunnel syndrome
Changes in libido
Creatine phosphokinase increased
Exacerbation of epilepsy
Increase in serum glucose
Increase in serum transaminases
Inflammatory erythematous nodules
Reduction in spermatogenesis (in male)
Skin pigmentation changes
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: December 2013
Joint Formulary Committee. British National Formulary. 66th ed. London: BMJ Group and Pharmaceutical Press; 2013. Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com [Accessed on December 16, 2013]
Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.
Paediatric Formulary Committee. BNF for Children 2013-2014. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2013. Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications https://www.medicinescomplete.com [Accessed on December 16, 2013].
Summary of Product Characteristics: Danol 200mg capsules.Sanofi. Revised August 2013.
Summary of Product Characteristics: Danazol 200mg capsules. Generics UK Ltd. Revised February 2013.
Already a member? Log in
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.