DORMICUM INJECTION 15 MG/3 ML [SIN00478P]

Product Info

DORMICUM INJECTION 15 MG/3 ML

[SIN00478P]

Indications and usage
Conscious sedation before diagnostic or therapeutic procedures with or without local anesthesia (i.v. administration).

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

Induction and maintenance of anesthesia. As an induction agent in inhalation anesthesia or a sedative component in combined anesthesia, including total intravenous anesthesia (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).

Dosage and administration
Standard dosage
Midazolam is a 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, Dormicum 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 Dormicum 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 the age of 60 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 Dormicum should be titrated very slowly and carefully.

A total dose greater than 3.5 mg is usually not necessary.

b) Anesthesia
Pre-medication: Pre-medication with Dormicum given shortly before a procedure does produce sedation (induction of sleepiness or drowsiness and relief of apprehension) and preoperative impairment of memory.

Dormicum can also be administered in combination with anticholinergics.

The pre-medication is usually administered 20–60 minutes before induction of anesthesia.

Intramuscular administration: In adults below the age of 60 the dose of Dormicum 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. Dormicum should be administered cautiously, under continuous observation, because excessive drowsiness may occur.

Children
In children between ages of 1 and 15 proportionally higher doses are required than in adults in relation to body weight. The dose range from 0.08–0.2 mg/kg bodyweight has been shown to be effective and safe.

Dormicum should be administered deep into a large muscle mass 30– 60 minutes prior to the induction of anesthesia.

Rectal administration in children: The total dose of Dormicum ranging from 0.3–0.5 mg/kg bodyweight should be administered 20– 30 minutes before induction of anesthesia.

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 Dormicum is used for induction of anesthesia before other anesthetic 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 Dormicum is used before other i.v. agents for induction of anesthesia, 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 anesthesia is reached by stepwise titration.

The intravenous induction dose of Dormicum 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 pre-medicated adults below the age of 60 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 pre-medicated adults below the age of 60 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 anesthetics. 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.

Dormicum is not recommended for the induction of anesthesia 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 Dormicum 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 anesthesia (ataranalgesia), an intramuscular dose of Dormicum 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
The desired level of sedation is reached by stepwise titration of Dormicum 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 Dormicum is given with potent analgesics, the latter should be administered first so that the sedative effects of Dormicum can be safely titrated on top of any sedation caused by the analgesic.

Special dosage instructions
Compatibility with infusion solutions: The Dormicum ampoule solution can be diluted with sodium chloride 0.9 %, dextrose 5 % and 10 %, levulose 5 %, Ringer’s solution and Hartmann’s solution in a mixing ratio of 15 mg midazolam per 100-1000 ml infusion solution. These solutions remain physically and chemically stable for 24 hours at room temperature, or 3 days at 5 °C (see also Special remarks – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The Dormicum Ampoule solution should not be diluted with Macrodex 6 % in Dextrose or mixed with alkaline injections.

Patients with renal impairment

In patients with severe renal impairment, Dormicum may be accompanied by more pronounced and prolonged sedation possibly including clinically relevant respiratory and cardiovascular depression. Dormicum 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.

Contraindications
Dormicum must not be used in patients with known hypersensitivity to benzodiazepines or any of their formulation excipients.