Fulsed (Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

N05CD08 (Midazolam)

Active Substance

Midazolam (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Hypnotic and sedative drug for premedication and induction anesthesia

Pharmacotherapeutic Group

Hypnotic agent

Pharmacological Action

A hypnotic agent from the group of benzodiazepine derivatives. It has anxiolytic, sedative, central muscle relaxant, and anticonvulsant effects.

It is characterized by a short latent period (induces sleep within 20 minutes after oral administration); it has little effect on sleep structure. A hangover effect is not typical.

Indications

Sleep disorders. Premedication before surgical operations and diagnostic procedures. Induction of anesthesia and its maintenance.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
F51.2	Nonorganic disorders of the sleep-wake schedule
Z51.4	Preparatory procedures for subsequent treatment or examination, not elsewhere classified

ICD-11 code	Indication
7B2Z	Sleep-wake cycle disorders, unspecified
QB9A	Preparatory procedures for subsequent treatment

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Solution

Orally, the dose for adults is 7.5-15 mg. It is taken immediately before bedtime.

For premedication, it is administered intramuscularly at 10-15 mg (100-150 mcg/kg) 20-30 minutes before the start of anesthesia or intravenously at 2.5-5 mg (50-100 mcg/kg of body weight) 5-10 minutes before the start of surgery. In elderly patients, half the usual dose is used.

For induction of anesthesia, it is administered intravenously at 10-15 mg (150-200 mcg/kg) in combination with analgesics.

To maintain the desired depth of narcotic sleep, additional intravenous injections in small doses are administered.

Adverse Reactions

From the central nervous system: weakness, drowsiness, fatigue. In patients awakened in the first hours after taking midazolam, amnesia may be observed. With prolonged use, the development of drug dependence is possible.

Allergic reactions: skin rash, urticaria, angioedema.

Contraindications

Myasthenia gravis, pregnancy, hypersensitivity to benzodiazepines.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy.

Geriatric Use

For premedication in elderly patients, half the usual dose is used.

Special Precautions

Not used for the treatment of sleep disorders in psychoses and severe forms of depression.

Use with caution in patients with organic brain damage, severe forms of respiratory failure.

Effect on the ability to drive vehicles and operate machinery

Patients taking Midazolam should refrain from engaging in potentially hazardous activities that require increased attention and high speed of psychomotor reactions.

Drug Interactions

Midazolam should not be combined with drugs that have a depressant effect on the functions of the central nervous system.

Midazolam enhances the effect of anesthetic agents and analgesics.

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.

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