Midzo^® (Drops) Instructions for Use

Marketing Authorization Holder

LASA Laboratorios, LLC (Russia)

Manufactured By

Special Product's Line, S.P.A. (Italy)

ATC Code

N07BB02 (Calcium carbimide)

Active Substance

Cyanamid (Grouping name)

Dosage Form

Midzo®

Oral drops 60 mg/1 ml: bottle 15 ml 1 or 4 pcs.

Dosage Form, Packaging, and Composition

Oral drops in the form of a transparent, colorless solution with a faint odor of acetic acid.

Excipients: sorbic acid – 0.2 mg, acetic acid – 0.47 mg, sodium acetate trihydrate – 0.47 mg, purified water – up to 1 ml.

15 ml – bottles (1) – cardboard packs.
15 ml – bottles (4) – cardboard packs.

Clinical-Pharmacological Group

Drug for the treatment of alcohol dependence

Pharmacotherapeutic Group

Other agents for the treatment of nervous system diseases; agents used for addictive disorders; agents used for alcohol dependence

Pharmacological Action

A drug for the treatment of chronic alcoholism. The mechanism of action is due to the blockade of aldehyde dehydrogenase, which is involved in the metabolism of ethanol.

Blockade of this enzyme leads to an increase in the concentration of an ethanol metabolite – acetaldehyde, which causes negative sensations (including facial flushing, nausea, tachycardia, shortness of breath) that make alcohol consumption extremely unpleasant after taking cyanamide. This leads to a conditioned reflex aversion to the taste and smell of alcoholic beverages.

The sensitizing effect of cyanamide on alcohol appears earlier (approximately after 45-60 minutes) and lasts shorter (about 12 hours) than the effect of disulfiram.

Unlike disulfiram, Cyanamid does not have a hypotensive effect and has lower intrinsic toxicity. In addition, Cyanamid has greater specificity of action: unlike disulfiram, it blocks only aldehyde dehydrogenase and does not affect other enzymes, in particular dopamine-beta-hydroxylase.

Indications

Treatment of patients with chronic alcoholism; prevention of relapses of chronic alcoholism after treatment.

ICD codes

Dosage Regimen

Administer Midzo^® (Cyanamid) only after a comprehensive patient examination and receipt of informed consent.

Warn the patient unequivocally about the severe adverse reactions and potential complications of therapy, including the disulfiram-like reaction upon alcohol consumption.

Initiate treatment no sooner than 12 hours after the patient’s last intake of any alcoholic beverage.

Prescribe the oral drops twice daily according to an individualized regimen established by the physician.

Use the supplied dropper for precise dosage measurement. Dilute the required number of drops in a small amount of water or juice immediately before administration.

Adhere strictly to the prescribed dosing schedule. Do not exceed the recommended dosage.

Monitor the patient’s compliance and clinical status continuously throughout the treatment course.

Exercise extreme caution in patients with hyperthyroidism, diabetes mellitus, epilepsy, or mild to moderate cardiovascular or renal impairment.

Perform regular monitoring of thyroid function at a minimum of 6-month intervals during long-term therapy.

Immediately discontinue administration if a severe reaction to alcohol occurs and seek urgent medical attention.

Adverse Reactions

Sometimes feeling of fatigue, drowsiness, skin rash, tinnitus, transient leukocytosis.

Cyanamid is generally well tolerated if the patient does not consume alcohol.

Contraindications

Severe diseases of the cardiovascular system; diseases of the respiratory system; kidney diseases accompanied by impaired function; severe liver diseases; pregnancy, breastfeeding; hypersensitivity to cyanamide.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated in severe liver diseases.

Use in Renal Impairment

Contraindicated in kidney diseases accompanied by impaired function.

Special Precautions

Cyanamid should be used only under medical supervision and with the patient’s consent to the therapy. The possibility of a reaction to ethanol contained in some medicines and food products should be taken into account.

Treatment with cyanamide should be started only after 12 hours have passed since the last alcohol consumption.

When alcohol is taken simultaneously, pronounced skin hyperemia, sensation of pulsation in the head and neck, nausea, tachycardia, difficulty breathing, weakness, blurred vision, increased sweating, chest pain may occur. In the most severe cases: vomiting, decreased blood pressure, respiratory depression, collapse-like state. The manifestations and their severity depend on the dose of cyanamide and the amount of alcohol consumed. In severe cases, symptomatic therapy aimed at maintaining the functions of the respiratory and cardiovascular systems, intravenous administration of antihistamines is carried out.

Cyanamid should be used with caution in cases where the patient’s reaction to simultaneous alcohol consumption may pose a risk to the patient’s health: in hyperthyroidism, diabetes mellitus, epilepsy, cardiovascular diseases, kidney diseases.

With long-term use of cyanamide, it is recommended to monitor thyroid function at least once every 6 months.

Drug Interactions

Cyanamid should not be used simultaneously with metronidazole, isoniazid, phenytoin and other aldehyde dehydrogenase inhibitors – this may enhance the reaction to alcohol consumption.

There should be a break of at least 10 days between the use of disulfiram and the prescription of cyanamide.

Cyanamid is incompatible with drugs of the aldehyde group (paraldehyde and chloral products).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.