INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
LADAZOL* 100 mg Capsules
LADAZOL* 200 mg Capsules

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

LADAZOL* 100 mg Capsules
LADAZOL* 200 mg Capsules

COMPOSITION:
Danazol (17 alpha-pregna-2,4-dien-20-yno(2,3-d) isoxazol-17-ol), is a synthetic hormone derived from ethisterone. Each 100 mg capsule contains danazol 100 mg. Each 200 mg capsule contains danazol 200 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 21.12 Hormone Inhibitors

PHARMACOLOGICAL ACTION:
LADAZOL* suppresses the pituitary-ovarian axis by inhibiting the output of both follicle-stimulating hormone (FSH) and luteinizing hormone (LH) from the pituitary gland in females.
For the treatment of endometriosis, LADAZOL* renders the endometrium inactive and atrophic while causing regression of ectopic endometrial tissue. Changes in vaginal cytology and cervical mucous reflect the suppressive effect of LADAZOL* on the pituitary-ovarian axis.
After institution of therapy with LADAZOL*, patients may have one or two additional menstrual periods depending on the dosage used. They then become anovulatory and amenorrhoeic with occasional spotting for the duration of treatment.
The effects of LADAZOL* on cyclical breast pain and nodularity are believed to be due to suppression of the ovarian function resulting from the inhibitory action on the gonadotropic function of the anterior pituitary gland.

INDICATIONS:
LADAZOL* is indicated for the treatment of:
Females:

1.	Endometriosis.
2.	Severe cyclical breast pain and nodularity.

Males and Females:
        Hereditary angioneurotic oedema.

CONTRA-INDICATIONS:
Safe use of the drug in pregnancy has not been established. Therefore, LADAZOL* should not be administered to pregnant women. If a patient becomes pregnant during treatment, administration of the drug should be discontinued. Continuing treatment may result in an androgenic effect on the foetus.

DOSAGE AND DIRECTIONS FOR USE:
Dysmenorrhoea and pelvic pain are usually relieved within the first few weeks after initiation of therapy, and dyspareunia and induration of the posterior fornix in a somewhat longer time.
The action of LADAZOL* is reversible. Ovulation and predictable cyclic bleeding return with discontinuation of therapy, usually within sixty to ninety days, which results in a rebound in FSH and LH.
Females:

1.	Endometriosis :
	Dosage depends on the patient's response and is usually within the range of 200 mg to 800 mg LADAZOL* daily in two to four divided doses. If, at lower doses (200 mg to 400 mg) the symptomatology is not relieved in thirty to sixty days, the dosage should be increased.
	Once a satisfactory response has been obtained, in some patients, it may be possible to maintain improvement with a reduced dosage. The maximum recommended daily dose is 800 mg. If necessary treatment with LADAZOL* may be continued for up to nine months. After termination of therapy, if symptoms recur, treatment can be re-instituted.
2.	Cyclical breast pain and nodularity:
	A dosage of 200 mg daily (100 mg twice daily) is recommended for a maximum period of three months.

THERAPY SHOULD BEGIN DURING MENSTRUATION AND APPROPRIATE TESTS SHOULD BE PERFORMED TO ENSURE THAT THE PATIENT IS NOT PREGNANT WHILE ON LADAZOL* THERAPY.

Males and Females:
Hereditary angioneurotic oedema:
Initial adult dose is 400 mg daily. After a two month attack- free period dosage should be reduced and individualized to the lowest effective dose.
For all above conditions, twice daily administration is recommended. If symptoms recur after termination of therapy, treatment may be re-instituted.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Androgenic side-effects may be expected especially with higher doses.
Side-effects such as acne and oily skin, fluid retention, flushing, mild hirsutism, changes in breast size, breast tenderness, deepening of the voice, sweating and mass gain could be attributed to the androgenic activity of LADAZOL*. Virilization is not necessarily reversible.
Other effects which have been reported are skin rashes, muscle cramps, CPK elevations, testicular atrophy, haematuria, dizziness, headache, nervousness, emotional liability, backache and hair loss. LADAZOL* has little overall effects on libido. LADAZOL* may potentiate the action of anticoagulants.
Because LADAZOL* may cause some degree of fluid retention, conditions that might be influenced by this factor, such as epilepsy, migraine, cardiac or renal dysfunction, require careful observation. LADAZOL* may cause liver damage. Care is needed in patients with severe hepatic dysfunction since the drug is metabolised in the liver.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects. Treatment is supportive and symptomatic.

IDENTIFICATION:

100 mg Capsules:	Yellow opaque body and cap imprinted with LADAZOL 100.
200 mg Capsules:	Orange opaque body and cap imprinted with LADAZOL 200.

PRESENTATION:
100 mg and 200 mg capsules in "Securitainers" of 60 capsules each.

STORAGE INSTRUCTIONS:
Store below 25°C. Keep out of reach of children.

REGISTRATION NUMBERS:
100 mg Capsules: H/21.12/95
200 mg Capsules: H/21.12/96

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext 77
Private Bag X69
Bryanston 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
August 1986

*         Registered Trade Mark

New addition to this site: April 2004
Source: Pharmaceutical Industry
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