Instructions for use Mizo oral drops 60mg/ml 15 ml
Composition
Active ingredient: 1 drop contains 3 mg of the active ingredient cyanamide;
1 ml of drops contains 60 mg of the active substance cyanamide;
Excipients: sorbic acid, glacial acetic acid, sodium acetate trihydrate, water for injections.
Dosage form
colorless, clear liquid with a faint odor of acetic acid.
Pharmacotherapeutic group
A remedy used for alcohol addiction.
ATX code N07B B.
Pharmacological properties
Pharmacodynamics
The action of cyanamide is based on the blockade of the enzymatic biotransformation of ethyl alcohol (acetaldehyde dehydrogenase). This leads to an increase in the concentration of the metabolite of ethyl alcohol - acetaldehyde, which causes negative sensations (flushing of blood to the face, nausea, tachycardia, shortness of breath), which make drinking alcohol after taking the drug extremely unpleasant. This causes a conditioned reflex aversion to the taste and smell of alcohol. The sensitizing effect of cyanamide on alcohol appears earlier (after approximately 45-60 minutes) and lasts less (about 12 hours) than the effect of disulfiram. Unlike disulfiram, cyanamide does not have a hypotensive effect.
Indication
Treatment of chronic alcoholism and prevention of relapse.
Contraindication
Severe heart disease, respiratory tract diseases with decreased function, respiratory, cardiac, hepatic, renal failure, increased individual sensitivity to the drug. Hepatic encephalopathy.
Interaction with other medicinal products and other types of interactions
It is necessary to avoid prescribing MIDZO® together with metronidazole, isoniazid, phenytoin and other aldehyde dehydrogenase inhibitors, which may increase the interaction reaction with alcohol. After taking disulfiram, a break of at least 10 days should be allowed before using MIDZO®.
MIDZO® is incompatible with aldehyde group drugs (with paraldehyde and chloral derivatives).
Application features
MIDZO® should only be started under the supervision of a physician and with the patient's consent. Reactions to alcohol, which is found in some medications and foods, may occur.
Treatment with MIDZO® can be started only 12 hours after the last alcohol intake. The drug is used with caution in cases where the reaction to simultaneous administration with alcohol may pose a risk to the patient's health: with hyperthyroidism, diabetes mellitus, epilepsy, cardiovascular diseases, bronchial asthma, acute and chronic nephritis. Long-term treatment should be avoided. However, if necessary, thyroid function should be monitored, since cases of hypothyroidism have been described. It is recommended to evaluate the patient every 6 months.
Reaction to alcohol. When taken simultaneously with alcohol, the following symptoms occur: hyperemia of the skin, a feeling of "pulsation" in the head and neck, nausea, tachycardia, difficulty breathing, weakness, blurred vision, profuse sweating, chest pain. In more severe cases - vomiting, decreased blood pressure, respiratory depression, collaptoid state. The nature and severity of the symptoms depend on the amount of alcohol consumed and the drug taken. In severe cases, it is necessary to carry out symptomatic therapy aimed at supporting the functions of the respiratory and cardiovascular systems, intravenous administration of antihistamines.
Use during pregnancy or breastfeeding
The use of the drug is contraindicated during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Caution should be exercised when driving or operating other machinery, as the drug may cause drowsiness and fatigue.
Method of administration and doses
It is used strictly as prescribed by a doctor. Treatment is prescribed after examining the patient and warning about possible consequences and complications. The drug is used internally, 36-75 mg (12-25 drops 2 times a day with an interval of 12 hours) according to an individual regimen.
Children
Do not use the drug in children.
Overdose
Symptoms are not described. Possible increase in side effects. In case of taking large doses, it is necessary to wash the stomach, treatment - detoxification and symptomatic therapy aimed at supporting the function of the liver, respiration, cardiovascular system, monitoring the hematocrit and, if necessary, blood transfusion.
Side effects
The drug is usually well tolerated if the patient does not drink alcohol. Side effects are usually mild and disappear without stopping treatment.
Nature and frequency of adverse reactions:
From the endocrine system
Rare: hypothyroidism.
From the nervous system
Very rare: depression, drowsiness.
Genital and breast disorders
Rare: impotence.
From the sensory organs
Rare: ringing in the ears.
From the digestive tract
Common: nausea, stomach discomfort.
Renal and urinary disorders
Skin and subcutaneous tissue disorders
Rare: skin rashes, allergic dermatitis (due to accidental contact with the drug).
General disorders
Common: fatigue, dizziness, decreased appetite.
Impact on laboratory test results
Very rare: transient leukocytosis, granulocytopenia, aplastic anemia, which disappear after the end of treatment.
Cases of hepatocyte inclusions similar to those seen in Lafort disease have been described. Such abnormalities are usually associated with the administration of large doses of cyanamide over a long period (more than 3 months) and resolve after discontinuation of treatment.
Expiration date
2 years. Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in a place protected from light, in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
15 ml in a brown glass bottle with a dropper; 4 bottles in a cardboard box.
Vacation category
According to the recipe.
Producer
SPECIAL PRODUCTS LINE S.P.A., ITALY.
Address
Ukraine, 04114, Kyiv,
Avtozavodskaya St., Building 54/19 Lit. A, office.
Tel. +380(44) 503 7868.
Applicant
LLC "ZDRAVO".
