Danol

Danol refers to drugs that contain sex hormones and affect the sexual sphere. 

[1], [2], [3]

Indications Danol

Danol is indicated for the treatment of endometriosis symptoms. The drug well helps to stop or significantly reduce lesions on the uterine mucosa during enedometriosis.

In addition, the drug is prescribed in operational treatment as a hormonal monotherapy, when other types of treatment does not show the proper effect.

Danol is used to reduce the unpleasant symptoms of cystic fibrosis mastopathy.

The medication is prescribed only to those patients who do not respond to other treatments or in those conditions where another therapy is not recommended. 

[4],

Release form

The medication is available in the form of gelatin capsules of 100 mg and 200 mg. 

[5]

Pharmacodynamics

Danol has a moderate affinity with androgen receptors, to a lesser extent, kinship with the receptors of progesterone, minimal kinship is observed with estrogen receptors.

The active substance of the drug is danazol, which is a weak steroid hormone, which possesses antiandrogenic, progestagenic, anti-progestagenic, estrogenic and anti-estrigenic properties. Danol interferes with the synthesis of sex steroids, the accumulation of cAMP in the yellow body and granulosis in response to the influence of gonadotropic hormones.

Danazol is able to change the level of protein in the plasma, increase the level of plasminogen, antithrombin III, inhibitor C1-esterase and erythropoietin, reduces the level of globulins (which bind to sex hormones and thyroid hormones), fibrinogen. Danol increases the proportions and concentration of testosterone, which remains unbound in the plasma.

[6],

Pharmacokinetics

Danol after intake is absorbed in the body, depending on the dosage, has an almost linear character with repeated admission (100-400 mg twice daily).

The intake of food has a significant effect on the degree of absorption of the drug. After meals, there is an almost double increase in absorption compared to taking Danol two hours before meals.

The main product of the metabolism of danazol is etisterone and 17-hydroxymethyl-leu- testerone. The half-life of the drug from the plasma is about one day. 

[7], [8], [9]

Dosing and administration

Danol is given only by mouth. The course of treatment should be started during menstruation. Throughout the treatment it is important to use non-hormonal contraceptives.

Always take a minimally effective dose. When endometriosis is recommended to take 200-800 mg per day, usually the duration of treatment is 3 - 6 months.

With benign cystic fibrosis mastopathy (as well as cyclic mastalgia) take 100 - 400 mg per day, the duration of treatment - 3 - 6 months.

With hereditary angioedema, the initial dose is 200 mg 2-3 times a day. With a favorable reaction, it is necessary to find a minimally effective dosage for maintenance preventive therapy. In this case, the drug is taken without interruption.  

[16], [17]

Use Danol during pregnancy

Danol is not recommended for pregnant women, as studies have shown that delayed fetal development is possible when taking danazol.

 

Contraindications

Danol is contraindicated in pregnant women, during lactation, in the elderly and in children.

Also, a contraindication to the prescription of a medication is marked disturbances of the hepatic, renal or cardiac function, porphyrin disease, androgen-dependent tumor, abnormal genital bleeding of an unidentified nature, occlusion of blood vessels (in the present or in the past). 

[10], [11], [12]

Side effects Danol

Danol can lead to acne, weight gain, increased appetite, increased sebum secretion, increased hairiness in the male type, hair loss, voice changes, in rare cases, fluid retention in the body, increased sexual activity, hypertrophy of the clitoris.

In addition, there may be a violation of the menstrual cycle, bleeding between menstruation, the absence of menstruation, tidal attacks, vaginal dryness, vaginal irritation, changes in sexual desire. In some cases, there is a change in breast size.

There may be a change in susceptibility to insulin, an increase in glucagon levels or an abnormal glucose tolerance, a change in cholesterol level, and other changes in blood counts.

Medication can lead to skin rashes, increased body temperature, swelling of the face, increased light resistance, in rare cases, hives, skin discoloration, erythema multiforme, exfoliative dermatitis.  

In some cases, there is pain in the back, cramps or muscle tremors, increased levels of creatine phosphokinase (the enzyme of skeletal and smooth muscle), which can lead to various muscle damage, muscle fibers (one or a whole group), pain in the limbs, swelling of the joints.

Medication can cause heart palpitations, increased blood pressure, thrombotic events (thrombosis of the arteries, cerebral vessels, myocardial infarction, etc.).

In rare cases, visual impairment is possible (turbidity, focus problems, etc.) that require treatment.  

From the central nervous system is possible emotional imbalance, anxiety, depression, irritation, headaches. In rare cases, dizziness, increased intracranial pressure, worsening of epilepsy, migraine.

In some cases, there may be cholestatic jaundice, benign adenoma of the liver, pancreatitis, rarely, usually with prolonged medication, a malignant liver tumor, hemorrhages in the hepatic tissue.

Vomiting, fatigue, with prolonged admission - impurity of blood in the urine, pain in the chest, interstitial pneumonitis are not excluded. 

[13], [14], [15]

Overdose

Danol at reception in the raised doses practically does not cause serious negative reactions. Despite the research data, overdose should take all the necessary measures to reduce the degree of absorption (take adsorbents). When taking in elevated doses, the patient should be under the supervision of a specialist in case of late negative reactions. 

[18], [19]

Interactions with other drugs

Danol has the ability to increase the level of carbamazepine in plasma (anticonvulsant and antiepileptic drugs), which can influence the patient's response to drugs. A similar reaction is possible with simultaneous admission to phenobarbital.

With simultaneous admission with antidiabetic drugs, a change in susceptibility to insulin is possible.

When taking drugs that inhibit blood clotting and Danol, it is possible to increase the therapeutic effect.

Danol reduces the effectiveness of drugs from high blood pressure.

The drug increases the toxic effect of tacrolimus and cyclosporine.

Combination therapy with steroids leads to the interaction of danol and sex hormones. 

[20], [21]

Storage conditions

Danol should be stored in a place that is protected from moisture, at room temperature (not above 25 ° C). The drug should be kept away from small children. 

[22]

Shelf life

Danol is suitable for five years from the date of manufacture. The drug can not be used in violation of storage conditions. 

[23], [24]