Danol
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Danol is a drug with antigonadotropic action.
Release form and composition
Danol dosage form - capsules: gelatinous solid, opaque; the capsules contain an almost white or white powder, almost odorless; 100 mg each - size No. 3, white body and gray lid, marking on the body and lid - "DANOL 100"; 200 mg each - size No. 1, white body and brownish-pink cap; marking on the body and lid - "DANOL 200" (in blisters of 10 pcs., in a cardboard box 6 or 10 blisters).
Composition of 1 capsule:
- active substance: danazol (micronized) - 100 or 200 mg;
- auxiliary components: corn starch, talc, lactose monohydrate, magnesium stearate;
- capsule: body - gelatin, titanium dioxide (E171); cap - gelatin, titanium dioxide (E171), black iron oxide dye (E172);
- ink: Opacode S-1-8100HV Black 1007 [shellac, soy lecithin, dimethylpolysiloxane, black iron oxide (E172) dye].
Indications for use
- endometriosis with infertility;
- benign neoplasms of the mammary gland (fibrocystic mastopathy);
- hereditary angioedema;
- premature puberty, primary menorrhagia and premenstrual syndrome, gynecomastia.
Contraindications
Absolute:
- androgen-dependent tumors;
- porphyria;
- carcinoma;
- mammary cancer;
- bleeding from the vagina of unknown origin;
- renal / hepatic impairment;
- thromboembolism;
- chronic heart failure;
- pregnancy and lactation;
- individual intolerance to the components of the drug.
Relative (diseases / conditions in which the appointment of Danol requires caution):
- migraine;
- epilepsy;
- violations of the plasma mechanisms of hemostasis;
- diabetes.
For children, Danol can be prescribed only in case of premature puberty.
Method of administration and dosage
Danol is taken orally.
It is desirable to use the minimum effective dose.
Adults
The average daily dose is 200-800 mg, divided into 2-4 doses.
The scheme of application is determined by the indications:
- endometriosis: the initial daily dose is 400 mg. It can be decreased or increased depending on the effectiveness / tolerance. Course duration - 4-6 months;
- primary menorrhagia and premenstrual syndrome: the average daily dose is 100-400 mg (usually 200 mg). Course duration - 3 months;
- benign breast diseases, severe cyclical mastalgia: the average daily dose is 100-400 mg (usually 300 mg). The duration of the course is 3–6 months;
- gynecomastia (in men): the average daily dose is 200-600 mg (usually 400 mg). Course duration - no longer than 6 months;
- angioedema (for the purpose of prevention): the initial daily dose is 200 mg, then it is reduced (in the absence of exacerbations). The duration of the course is 1–3 months.
Children
Danol is prescribed only for precocious puberty in a daily dose of 100-400 mg (determined by the age and severity of the disease).
Side effects
- hematopoietic system: thrombocytopenia or leukopenia, leukocytosis, increased platelet / erythrocyte count;
- endocrine system: menstrual irregularities, vaginitis, absence of menstruation, decrease in the size of the mammary glands, acne, hypersecretion of the sebaceous glands, edema, hirsutism, viril syndrome, coarsening of the voice, weight gain, hair loss (alopecia), impaired spermatogenesis, changes in libido, hot flashes blood to the skin of the face, profuse sweat, increased nervous excitability, increased sweating, dysmenorrhea, emotional lability, migraine-like headache;
- cardiovascular system: tachycardia, worsening of the course of arterial hypertension;
- blood coagulation system: bleeding (with hemophilia);
- digestive system: increased activity of liver enzymes; rarely - cholestatic jaundice / cholestasis, dyslipidemia, hepatitis, increased insulin requirements, nausea, increased creatine kinase activity, hypoglycemia;
- central nervous system: increased intracranial pressure.
In rare cases, during Danol therapy, the following disorders develop: nausea, visual impairment, increased appetite, skeletal muscle spasm, lumbodynia, fluid retention, photosensitivity, paresthesia, skin rash, sleep disturbances, dizziness, increased fatigue, worsening of the course of epilepsy and depressive conditions …
special instructions
During therapy with Danol, careful monitoring of the condition of patients is required, especially in cases of liver and kidney disease, arterial hypertension and / or other cardiovascular diseases, conditions that are accompanied by epilepsy, fluid retention, impaired lipoprotein metabolism, as well as thrombosis (including the presence of anamnestic data) and migraine.
All patients should have regular liver function tests that include peripheral blood cell counts and liver enzymes. With a long course (6 months) and with repeated courses of therapy, it is recommended to conduct an ultrasound examination of the pelvic organs and liver (at least 2 times a year). Care must be taken when prescribing Danol to patients with a previous androgenic reaction to the use of sex hormones. It should be taken into account that the drug affects the results of some laboratory indicators of sex hormones (in particular, it increases testosterone levels).
Danol should not be prescribed during pregnancy, therefore, in all cases, therapy can be started after excluding pregnancy on the first day of menstruation. With amenorrhea, a pregnancy test should be performed before prescribing the drug.
In cases of prescribing the drug to patients with diabetes mellitus, it is necessary to adjust the dose of insulin.
Prescribing high doses of Danol prevents ovulation. However, at low doses, ovulation is possible, therefore, non-hormonal methods of contraception should be used during therapy.
Drug interactions
With the combined use of Danol with certain drugs / substances, the following effects may develop:
- insulin and oral hypoglycemic drugs: weakening their action;
- coumarin anticoagulants and indandione derivatives: increasing their effect (the likelihood of bleeding increases);
- antihypertensive drugs: decrease in their effectiveness;
- glucagon: an increase in its plasma concentration;
- cyclosporine, tacrolimus: an increase in their plasma concentration (the likelihood of nephrotoxicity increases);
- antiepileptic drugs, including phenobarbital, carbamazepine, phenytoin: suppression of their metabolism and an increase in their concentration in the blood;
- alfacalcidol: an increase in the calcemic response in primary hypoparathyroidism (a decrease in its dose is required).
Analogs
Danol's analogues are: Danoval, Danazol, Danodiol.
Terms and conditions of storage
Store in a place protected from moisture at temperatures up to 25 ° C. Keep out of the reach of children.
The shelf life is 5 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
