MIDAZOLAM KALCEKS SOLUTION FOR INJECTION/INFUSION 1 MG/ML [SIN16967P]

Product Info

MIDAZOLAM KALCEKS SOLUTION FOR INJECTION/INFUSION 1 MG/ML

[SIN16967P]

4.1 Therapeutic indications

Conscious sedation before diagnostic or therapeutic procedures with or without local anaesthesia (i.v. administration).

Premedication before induction of anaesthesia (i.m. or rectal administration in children).

Induction and maintenance of anaesthesia. As an induction agent in inhalation anaesthesia or a sedative component in combined anaesthesia, including total intravenous anaesthesia (i.v. injection, i.v. infusion).

Ataranalgesia in combination with ketamine in children (i.m. administration).

Long-term sedation in intensive care units (i.v. administration as bolus injection or continuous infusion).

4.2 Posology and method of administration

Posology

Standard dosage
Midazolam is potent sedative agent which requires slow administration and individualization of dosage.
The dose should be individualized and titrated to the desired state of sedation according to the clinical need, physical status, age and concomitant medication.
In adults over 60 years of age, debilitated or chronically ill patients the dose should be determined with caution, the special factors relating to each patient being taken into consideration.

a) Intravenous conscious sedation

For basal (conscious) sedation prior to diagnostic or surgical intervention, midazolam is administered i.v. The dose must be individualized and titrated and should not be administered by rapid or single bolus injection. The onset of sedation may vary individually depending on the physical status of the patient and the detailed circumstances of dosing (e.g. speed of administration, amount of dose). If necessary, subsequent doses may be administered according to the individual need.

The intravenous injection of midazolam should be given slowly at a rate of approximately 1 mg in 30 seconds. The drug takes effect in about 2 minutes after the injection has been given.

In adults below 60 years of age the initial dose is 2.5 mg given 5–10 minutes before the beginning of the procedure.
Further doses of 1 mg may be given as necessary. Mean total doses have been found to range from 3.5–7.5 mg.
A total dose greater than 5 mg is usually not necessary.

In adults over 60 years of age, debilitated or chronically ill patients the initial dose must be reduced to 1–1.5 mg and given 5–10 minutes before the beginning of the procedure.
Further doses of 0.5–1 mg may be given as necessary. Since in these patients the peak effect may be reached less rapidly, additional midazolam should be titrated very slowly and carefully.
A total dose greater than 3.5 mg is usually not necessary.

b) Anaesthesia

Premedication: Premedication with midazolam given shortly before a procedure does produce sedation (induction of sleepiness or drowsiness and relief of apprehension) and preoperative impairment of memory.
Midazolam can also be administered in combination with anticholinergics.
The premedication is usually administered 20–60 minutes before induction of anaesthesia.

Intramuscular administration: In adults below 60 years of age the dose of midazolam ranges from 0.07–0.1 mg/kg according to the general condition of the patient.

The usual dose is 5 mg.

In adults over 60 years of age, debilitated and chronically ill, the dose ranges from 0.025–0.05 mg/kg.
The usual dose is 2–3 mg. In patients over 70 years i.m. midazolam should be administered cautiously, under continuous observation, because excessive drowsiness may occur.

Children
In children between ages of 1 and 15 years proportionally higher doses are required than in adults in relation to bodyweight. The dose range from 0.08 to 0.2 mg/kg bodyweight has been shown to be effective and safe.
Midazolam should be administered deep into a large muscle mass 30–60 minutes prior to the induction of anaesthesia.

Rectal administration in children: The total dose of midazolam ranging from 0.3–0.5 mg/kg bodyweight should be administered 20-30 minutes before induction of anaesthesia.
Rectal administration of the ampoule solution is performed by means of a plastic applicator fixed on the end of the syringe.
If the volume to be administered is too small, water may be added up to a total volume of 10 ml.

Induction: If midazolam is used for induction of anaesthesia before other anaesthetic agents have been administered, the individual response is variable. The dose should be titrated to the desired effect according to the patient’s age and clinical status. When midazolam is used before other i.v. agents for induction of anaesthesia, the initial dose of each agent may be significantly reduced, at times to as low as 25% of the usual initial dose of the individual agents.
The desired level of anaesthesia is reached by stepwise titration.

The intravenous induction dose of midazolam should be given slowly in increments.
Each increment of not more than 5 mg should be injected over 20–30 seconds allowing 2 minutes between successive increments.

In premedicated adults below 60 years of age, the dose can range from 0.15–0.2 mg/kg but a total dose greater than 15 mg is usually not necessary.

In non-premedicated adults below 60 years of age, the dose may be higher (0.3–0.35 mg/kg bodyweight), but a total dose greater than 20 mg is usually not necessary. If needed to complete induction, increments of approximately 25% of the patient’s initial dose may be used. Induction may instead be completed with volatile liquid inhalational anaesthetics. In resistant cases, a total dose of up to 0.6 mg/kg may be used for induction, but such larger doses may prolong recovery.

In adults over 60 years of age, debilitated and chronically ill patients, lower doses will be required.
Midazolam is not recommended for the induction of anaesthesia in children, as experience is limited.

Maintenance: The maintenance of the desired level of unconsciousness can be achieved by either further intermittent doses or continuous infusion of intravenous midazolam typically in combination with analgesics.
The maintenance dose usually ranges from 0.03–0.1 mg/kg/hr when used in combination with narcotics or ketamine.
In adults over 60 years of age, debilitated or chronically ill patients, lower maintenance doses will be required.

In children receiving ketamine for anaesthesia (ataranalgesia), an intramuscular dose of midazolam of 0.15–0.20 mg/kg is recommended.

A sufficiently deep level of sleep is generally achieved after 2–3 minutes.

c) Intravenous sedation in the intensive care unit (ICU)

The desired level of sedation is reached by stepwise titration of midazolam followed by either continuous infusion or intermittent bolus.

The intravenous loading dose should be given slowly in increments.
Each increment of 1–2.5 mg should be injected over 20–30 seconds allowing 2 minutes between successive increments.
The intravenous loading dose can range from 0.03–0.3 mg/kg but a total dose greater than 15 mg is usually not necessary.
In hypovolemic, vasoconstricted or hypothermic patients the loading dose should be reduced or omitted.

The maintenance dose can range from 0.03–0.2 mg/kg/hr.

The level of sedation should be assessed regularly if permitted by patient's condition.
In hypovolemic, vasoconstricted or hypothermic patients the maintenance dose should be reduced, at times to as low as 25 % of the usual dose.

When midazolam is given with potent analgesics, the latter should be administered first so that the sedative effects of midazolam can be safely titrated on top of any sedation caused by the analgesic.

Renal impairment
In patients with severe renal impairment, midazolam may be accompanied by more pronounced and prolonged sedation possibly including clinically relevant respiratory and cardiovascular depression. Midazolam should therefore be dosed carefully in the patient population and titrated for the desired effect.

Hepatic impairment
The clinical effects in patients with hepatic impairment may be stronger and prolonged. The dose of midazolam may have to be reduced and vital signs should be monitored.

Method of administration

For intravenous, intramuscular and rectal use.
For instructions on dilution of the medicinal product before administration, see section 6.7 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

Midazolam must not be used in patients with known hypersensitivity to benzodiazepines or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.