DORMITA 15 (amp)
-
Chemical Name:
Midazolam -
Therapeutic Category:
Central nervous system drugs -
Pharmacologic Category:
Benzodiazepine -
Pharmaceutical Form:
Ampoule -
Composition:
Midazolam 15mg
DORMITA
Injection (Ampoule/Liquid Vial)
Midazolam
1.PHARMACOLOGY:
Midazolam, the active ingredient of DORMITA, is a derivative of the imidazobenzodiazepine group. The free base is a lipophilic substance with low solubility in water.
The basic nitrogen in position 2 of the imidazobenzodiazepine ring system enables the active ingredient of DORMITA to form water soluble salts with acids. These produce a stable and well tolerated injection solution.
The pharmacological action of DORMITA is characterized by rapid onset and short duration because of rapid metabolic inactivation. Because of its very low toxicity, DORMITA has a wide therapeutic range.
DORMITA has a very rapid sedative and sleep-inducing action of pronounced intensity and short duration. It also exerts an anticonvulsant and a muscle –relaxant effect.
2.PHARMACOKINETICS:
Absorption after intramuscular injection: The absorption of Midazolam from the muscle tissue is rapid and complete bioavailability is over 90%.
Metabolism: Midazolam is completely metabolized in the body. The primary metabolite is α-hydroxy-midazolam, which can be traced in the plasma. Its half-life is shorter than that of the parent substance. Immediately after its formation, it is conjugated with glucuronic acid (inactivation) and 60-70% of the dose is then eliminated by the kidneys.
Distribution and elimination: When DORMITA is injected intravenously, the time course of the plasma concentrations shows two distinct phases of distribution as well as the elimination phase. The fraction extracted by the liver is 40-50%, and plasma clearance is in the range of 300-400 ml per minute. The volume of distribution calculated under steady-state conditions is 50-60 liters. 95% of Midazolam becomes bound to plasma proteins. The elimination half-life is between 1½ and 2 ½ hours.
3.INDICATIONS:
- Premedication before an operation.
- Induction of anesthesia.
- Maintenance of anesthesia.
4.CONTRAINDICATIONS:
DORMITA must not be given to patients who are hypersensitive to benzodiazepines.
5.SIDE EFFECTS:
DORMITA is well tolerated.
Respiratory depression and apnea have occurred during intravenous administration of DORMITA. Such life-threatening incidents are more likely to occur in elderly patients and those with preexisting respiratory insufficiency, particularly when the injection is given too rapidly or when a high dosage is administered.
6.PRECAUTIONS:
Caution should be exercised when administering DORMITA parenterally to elderly patients or patients with impaired cardiac and respiratory function. After receiving DORMITA parenterally, patients should not be discharged from hospital or consulting room for at least three hours and then only if accompanied by an attendant. They should be warned not to drive a vehicle or operate a machine for at least twelve hours.
Particular care is needed when administering DORMITA to a patient with myasthenia gravis, owing to preexisting muscle weakness. There are no reports of embryotoxicity, teratogenic or mutagenic effects.
DORMITA like any other drug, should not be used in the first three months of pregnancy unless considered absolutely necessary by the physician.
7.DRUG INTRACTIONS:
DORMITA enhances the central sedative effect of neuroleptics, tranquilizers, antidepressants, sleep-inducing drugs, analgesics and anesthetics. This potentiation can be of advantage therapeutically in certain cases. Special attention must be paid to the possibility of potentiation in patients at particular risk. In some cases the mutual potentiation of alcohol and DORMITA can produce unforeseeable reactions (no alcoholic beverages should be allowed for at least twelve hours after parenteral administration).
8.DOSAGE and ADMINISTRARION:
Injection:
In the case of elderly patients with organic cerebral changes or impaired cardiac and respiratory function, the dosage should be determined with caution, the special factors relating to each patient being taken into consideration.
Intravenous injections must be given slowly (approximately 2.5 mg in ten seconds for induction of anesthesia and 1 mg in 30 seconds for basal sedation). The drug takes effect about two minutes after the injection is started.
Premedication before an operation:
Intravenous administration:
For sedation in diagnostic or surgical interventions carried out under local
anesthesia:
The initial dose is 2.5 mg 5-10 minutes before the beginning of the operation.
Further doses of 1 mg may be given as necessary, in cases of severe illness,
particularly if the patient is in poor general.
Condition or of advanced age, the initial dose must be reduced to 1-1.5 mg.
Intramuscular administration:
In patients suffering from pain before an intervention:
Administration alone or in combination with anticholinergics and possibly analgesics.
Adults: 0.07-0.1mg/kg i.m. according to age and general condition of the patient. Usual dose is about 5 mg.
Children: proportionately higher doses are required than in adult in relation to bodyweight (0.15-0.20mg/kg). These
doses should be administered about 30 minutes before induction of anesthesia.
Induction of anesthesia:
Intravenous administration:
As an induction agent in inhalation anesthesia or a sleep-inducing component in combined anesthesia. The dose is 10-15 mg.
A sufficiently deep level of sleep is generally achieved after 2-3 minutes.
Intramuscular administration in children:
A combination of the sleep-inducing and amnesia-inducing DORMITA with Ketamine (ataralgesia) is recommended.
DORMITA i.m.: 0.15-0.20 mg/kg bodyweight, in combination with ketamine i.m.: 4-8 mg/kg.
A sufficiently deep level of sleep is generally achieved after 2-3 minutes.
Maintenance of anesthesia:
Intravenous administration:
For maintenance of the desired level of unconsciousness further small doses should be injected i.v. The dose and the intervals between doses vary according to the individual reaction of the patient.
9.PACKAGING & COMPOSITION:
- DORMITA 5 - Injection: A Pack of 5 or 25 ampoules of 1mL. Each 1mL ampoule contains Midazolam 5 mg.
- DORMITA 15 - Injection: A Pack of 5 or 25 or 100 ampoules of 3mL. Each 3mL ampoule contains Midazolam 15 mg.
- DORMITA 25 - Injection: A Pack of 1 vial of 5mL. Each 5mL vial contains Midazolam 25 mg.
10.STORAGE CONDITIONS:
Store DORMITA - Injection at temperature between (15-30)°C.
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