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Sedacum 0.1% 5mg/5ml injection

Dexa Medica

Ingredients in every 5 ml

Midazolam 5 mg

Each package contains

10 ampoules of 5 ml

Dosage form

injection

Dosage formInjection

Flavour

None

W.H.O. classification

N01A
N01A

A.T.C. Level 1

Anatomical Main group

N - Nervous system
N01A

A.T.C. Level 2

Therapeutic subgroup

N01 - Anesthetics
N01A

A.T.C. Level 3

Pharmacological subgroup

N01A - Anesthetics; General

Available in

Indonesia

Warnings

Alcohol

NOT RECOMMENDEDThis item should not be used with alcohol.

Machinery

NOT RECOMMENDEDThis item should not be used while operating heavy machinery.

Pregnancy

CAUTIONThis item may not be safe for use during pregnancy. Use with caution and after consultation with your doctor.

Lactation

CAUTIONThis item may not be safe for use during lactation. Use with caution and after consultation with your doctor.

Indication

Sedacum injection is indicated for:
Premedication
before induction of anesthesia (IM)
Basal sedation
before diagnostic or surgical interventions carried out under local anesthesia (IV)
Induction and maintenance of anesthesia
As an induction agent in inhalation anesthesia or a sleep-inducing component in combined anesthesia including total intravenous anesthesia (IV).

Dosage

18 TO 55 YEARS OLD
Premedication before an operation:
– Adults: 0.07-0.1 mg/kg body weight (IM) according to age and general condition of the patient. Usual dosage is about 5 mg.

Intravenous basal sedation:
– Adults: The initial dose should not exceed 2.5 mg IV 5-10 minutes before the beginning of the operation. If necessary, further doses of 1 mg IV can be administered at 2 minutes intervals. However, total dosage should in general not exceed 5 mg IV, in case of concomitant use of other CNS depressants, the dose of midazolam has to be reduced.

Induction and maintenance of anesthesia:
Intravenous injection:
– Induction: The dose is 10 mg IV. A sufficiently deep level of sleep is generally achieved after 2-3 minutes.

55 YEARS OLD AND ABOVE
Premedication before an operation:
– Elderly and debilitated patients: 0.025-0.05 mg/kg body weight (IM). These doses should be administered about 30 minutes before induction of anesthesia.

Intravenous basal sedation:
– Elderly and seriously ill patients: The initial dose must be reduced to 1-1.5 mg IV. The total dose should in general not exceed 3.5 mg IV. The injection must be administered slowly (1 mg in 30 seconds).

Induction and maintenance of anesthesia:
Intravenous injection:
– Induction: Dose should be reduced in elderly patients (above 55 years).

GENERAL
Midazolam is a potent sedative agent which requires slow administration and individualization of dosage according to clinical need, physical status, age and concomitant medication.
The intravenous injection must be given slowly (approximately 2.5 mg in 10 seconds for induction of anesthesia, and 1 mg in 30 seconds for premedication). The onset of effect takes place after approximately 2 minutes.

Premedication before an operation:
Intramuscular administration: in patients suffering from pain before an intervention, it can be administered alone or in combination with anticholinergics and possible analgesics.

Intravenous basal sedation:
For basal sedation in diagnostic or surgical interventions carried out under local anesthesia.

MAINTENANCE DOSE
For maintenance of the desired level of unconsciousness, further small doses should be injected IV. The dose and the intervals between doses vary according to the individual patient's reactions.
These additional doses should be given only after a thorough clinical evaluation clearly indicates the need for additional sedation. 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 analgesics.