Midanest

Composition:

Each ml of injection contains:

  • Midazolam HCl is equivalent to Midazolam 1 mg (Ampoule 5 ml)
  • Midazolam HCl is equivalent to Midazolam 5 mg (Ampoule 3 ml)

 

Efficacy and Effect

Midazolam, the active ingredient of Midanest, is an imidazobenzodiazepine derivative. This free base is a lipophilic substance with low water solubility. The nitrogen base at position 2 of the imidazobenzodiazepine ring system allows the active substance from Midanest to form a solution of salt with acid dissolved in water. This substance produces a stable injection solution and is well tolerated. Midanest pharmacologically works fast and because the transformation of its metabolites is fast, its duration is short. Midanest works strongly causing sedation and induction of sleep. Anxiolytic, anticonvulsant and muscle relaxation are also seen. After intramuscular or intravenous administration there is anterograde amnesia in a short time (the patient does not tell the events that occurred during the component is in its peak activity).

 

Pharmacokinetics :

Absorption after intramuscular injection

Midazolam is absorbed from muscle tissue quickly and perfectly. Maximum plasma concentration is reached in 30 minutes. Bioavailability is more than 90%.

Distribution

When Midanest is given intravenously, the time curve for plasma levels shows 2 phases of distribution. The distribution volume is calculated on the condition of steady state is 50 – 60 L. Study shows, plasma protein bond Midazolam 96 – 98%.

Metabolism

Midazolam is metabolized in the body almost completely. The main metabolite is α hydroximidazolam, which can be observed in plasma. This fraction is excreted through the liver as much as 40-50%.

Elimination

In healthy people, the elimination half-life is between 1½ hours and 3 hours. Plasma clearance between 300 – 500 ml / min. If midazolam is given by intravenous infusion, the elimination kinetics is no different from bolus injection.

The elimination half-life of the hydroxi-midazolam main alpha metabolite, which is shorter than the parent substance. After the formation of hydroxide-midazolam α is immediately bound to glucuronic acid (inactive), and 50-70% of the dose is then eliminated through the kidneys.

 

Indication

  • Premedication before induction of anesthesia (giving i.m.)
  • Basal sedation before diagnostic action or surgery is performed through local anesthesia

(administration of i.v.)

  • Induction and conscious anesthesia. As an inducing agent in inhalation anesthesia or a sleep inducing

component in a combination of anesthesia, including intravenous total anesthesia (i.v. injection)

 

Dosage and Usage

In elderly patients with organic brain changes or impaired heart and respiratory function, the dosage must be carefully determined, special factors related to each patient must be considered: intravenous injection is given slowly (2.5 mg in 10 seconds for induction of anesthesia and 1 mg in 30 seconds for basal sedation). Drug effects occur within 2 minutes after injection.

Premedication before surgery:

Intramuscular administration:

In patients who experience pre-surgical pain, a single or combination with anticholinergics and possibly analgesics.

Adult: 0.07 – 0.10 mg / kg body weight by i.m. adjusted for age and circumstances. The usual dose is 5 mg.

Weak parents and patients: 0.025 – 0.05 mg / kg body weight by i.m. This dose should be given ± 30 minutes before induction of anesthesia.

Intravenous basal sedation

For basal sedation in diagnostic or surgical procedures performed under local anesthesia.

Initial dose: 2.5 mg, 5-10 minutes before the start of surgery. Then a dose of 1 mg can be given if needed. A total dose of more than 5 mg is not usually necessary to achieve the desired effect. In cases of severe illness, especially if the patient’s general condition is weak or elderly, the initial dose should be reduced to 1-1.5 mg. A total dose greater than 3.5 mg is usually not needed.

Induction of anesthesia and conscious anesthesia:

Intravenous injection

Induction of anesthesia: Dosage is ± 10 mg i.v

An adequate level of sleep can generally be achieved after 2-3 minutes. Dosage is reduced in elderly patients (over 55 years).

Maintenance dose

For maintenance of the desired level of unconsciousness should be continued with a low dose injection i.v. The dose and interval between doses differ, depending on the individual patient’s reaction. This additional dose is given only if a thorough evaluation has been carried out and shows the need for sedation effects. If Midanest is given together with strong analgesics, analgesics must be given first, so that the sedative effect of Midanest can be safely determined at the peak of sedation caused by analgesics.

 

Presentation and Registration Number :

MIDANEST® 5 mg   Box, 5 ampoules @ 5 ml; DPL1708024543A1

MIDANEST® 15 mg Box, 5 ampoules @ 3 ml; DPL1708024543B1

 

ON MEDICAL PRESCRIPTION ONLY

 

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