Medicinal Products

DANATROL 200 mg

Generic drug of the therapeutic class: Gynecology
Active ingredients: Danazol
laboratory: Sanofi-Aventis France

capsule
Box of 40
All forms

Indication

· Endometriosis: treatment of symptoms associated with endometriosis and / or treatment to reduce the importance of endometriotic foci. Danazol can be used either in combination with surgery or as a sole hormonal therapy in non-responders to other treatments.

· Hereditary angioneurotic edema.

Dosage DANATROL 200 mg Capsule Box of 40

Danazol is reserved for the oral route.

The effective dosage is variable from one subject to another; it must be individually adjusted to obtain the minimum effective dose in each patient. In some cases, it is possible to reduce the dose after improvement of the functional and anatomo-clinical signs.

It is recommended to start treatment during the first or second day of the menstrual cycle. In women with amenorrhea before starting treatment, the possibility of pregnancy should be sought.

Endometriosis : the dosage is generally 2 to 4 capsules / day in 2 or 3 doses, this dosage may be modulated secondarily.

A continuous treatment period is normally 3 to 6 months.

Angioneurotic edema : The dosage will be adjusted according to the results and varies from one subject to another.

Following the favorable response to danazol, the lowest effective maintenance dose should be prescribed for continuous preventive treatment.

Against indications

· Progressive thrombosis or history of thromboembolic disease.

· Porphyria.

· Hepatic insufficiency, chronic or recent hepatitis.

· Severe renal or cardiac insufficiency (NYHA stage III or IV).

· Androgen-dependent tumor.

· Pathological genital haemorrhage of unspecified etiology.

Pregnancy: Prolonged administration of danazol beyond 8 weeks of amenorrhea is contraindicated. (see section on Pregnancy and breastfeeding ).

· Breastfeeding (see section on Pregnancy and breastfeeding ).

Danatrol side effects

Androgenic effects

· Frequent :

o Menstrual disorders, intermenstrual hemorrhages, amenorrhea, flushing, vaginal dryness, vaginal irritation.

o Acne, weight gain, seborrhea, hirsutism, hair loss, change of tone of voice.

o Increased appetite.

o Modification of the libido.

· Uncommon :
Decreased breast volume

· Rare :
Clitoral hypertrophy, water-soluble retention, spermatogenic disorder.

Other endocrine and metabolic disorders:

· An increase in insulin resistance and elevation of plasma glucagon, glucose intolerance, increased LDL cholesterol, decreased HDL cholesterol affecting all subfractions and decreased apolipoproteins AI and AII have been reported .

· Induction of aminolevulinic acid (ALA) hepatic synthetase.

· A reduction in TBG and T4 with increased T3 but no change in TSH or free thyroxine index (FTI).

Dermatological effects:

· Frequent :
pruritus, maculopapular, petechial, purpuric rash with or without fever, facial edema, photosensitivity reaction;

· Very rare :
erythema multiforme

Muscle and bone effects:

Myalgia with sometimes elevated levels of creatine phosphokinase (CPK), muscle fasciculations, arthralgia.

Cardiovascular effects:

· Rare :
hypertension, palpitations, tachycardia and myocardial infarction. Thrombotic effects have also been observed, including deep vein thrombosis and arterial thrombosis.

Effects on the central nervous system:

· Frequent :
emotional lability, anxiety, depressed mood, nervousness, headache;

· Rare :
visual disturbances, dizziness, vertigo, benign intracranial hypertension;

· Very rare :
aggravation of epilepsy.

Hematological effects:

· Rare :
thrombocythemia, polycythemia or leucopenia and thrombocytopenia;

· Very rare :
hypereosinophilia, splenic peliosis.

Hepato-pancreatic effects:

· Frequent :
isolated increase in serum transaminase levels;
pancreatitis;

· Uncommon :
cholestatic jaundice;
hepatitis;

· Rare :
hepatic adenomas;

· Very rare :
malignant hepatic tumors and hepatic pelioses observed during long-term treatments.

Other effects:

· Rare :
nausea, dyspepsia, asthenia;

· Very rare :
hematuria with prolonged use in hereditary angioedema, carpal tunnel syndrome, interstitial pneumonitis.

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