Midasan

Midazolam.

Each mL contains: Midazolam Hydrochloride equivalent to Midazolam 1 mg or 5 mg.
Water for injection ad 1 mL.
Product is preservative free.

Pharmacology: Midazolam is a relatively short-acting benzodiazepine central nervous system (CNS) depressant, sleep inducting agent for premedication as well as for induction and maintenance of anesthesia. Midazolam has anxiolytic, hypnotic, anticonvulsant, muscle relaxant and anterograde amnestic effect, which are characteristic of benzodiazepines. The mechanism of action of Midazolam is not clearly understood. However, it is probably similar to that of other benzodiazepines. Midazolam activity is primarily due to the parent drug. Elimination of the parent takes places via hepatic metabolism of Midazolam to hydroxylated metabolites that are conjugated and excreted in the urine.

Premedication before induction of anesthesia (i.m. administration).
Basal sedation before diagnostic or surgical interventions carried out under local anesthesia (i.v. administration).
Induction and conscious sedation. As in induction agent in inhalation anesthesia or a sleep induction component in combined anesthesia, including total intravenous (i.v. injection).

Standard dosage and mode of administration: 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.
i.v. injection must be given slowly (approximately 2.5 mg in 10 seconds for induction of anesthesia and 1 mg in 30 seconds for basal sedation). The drug takes effects about 2 minutes after the injection is started.
Premedication before an operation: i.m. administration: In patients suffering from pain before an intervention: Administration MIDASAN alone or in combination with anticholinergics and possibly analgesics. Usual doses about 5 mg.
Elderly and debilitated patients: 0.025-0.05 mg/Kg Body Weight i.m. These doses should be administered about 30 minutes before induction anesthesia.
Adult: 0.07-0.1 mg/Kg i.m. standard dosage about 5 mg, according to age and general condition of patients.
Induction of anesthesia and conscious sedation: i.v. administration: As an induction agent in inhalation of anesthesia and conscious sedation.
The dose is ±10 mg i.v.
A sufficiently deep level of sleep is generally achieved after 2-3 minutes. Dose should be reduced in elderly patients (above 55 years).
Maintenance of anesthesia: i.v. administration: For maintenance of 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 patients. These additional doses should be given only after through clinical evaluation clearly indicates the need for additional sedation.
When MIDASAN is given with potent analgesics, the latter should be administered first so that sedative effects of MIDASAN can be safely titrated on top any sedation caused by analgesics.
Basal sedation: Intravenous basal sedation: For basal sedation in diagnostic or surgical carried out under local anesthesia: The initial dose is 2.5 mg 5-20 minutes before the beginning of the operation. Further dose 1 mg may be given as necessary. A total dose greater than 5 mg is not usually necessary to reach the desired end point.
In case 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. Total doses greater than 3.5 mg are not usually necessary.

Patients who are hypersensitive to benzodiazepines.
Patients with acute narrow-angle glaucoma.
Also contraindicated in premature infants.
Myasthenia gravis, shock or coma, or in acute alcoholic intoxication depression of vital signs.

When used for sedation should always be titrated slowly in adult or pediatric patients.
Injectable Midazolam should not be administered to adult or pediatric patients in shock or coma, or in acute alcohol intoxication with depression of vital signs.
When Midazolam is given along with central nervous system depressants, such as potent analgesics, the sedative effect may be intensified and the possibility of severe respiratory or cardiovascular depression should be considered.
Patients should be instructed to avoid alcohol before and for at least 8 hours after administration of Midazolam since the individual response cannot be foreseen.
After prolonged i.v. administration of Midazolam, abrupt discontinuation may be accompanied by withdrawal symptoms, therefore a gradual reduction of Midazolam is recommended.
Midazolam should be given with caution for patients with pulmonary insufficiency, impairment of renal or hepatic function, to elderly or debilitated patients and patients with myasthenia gravis.
During bolus sedation for operative procedures extreme cautions should be exercised in patients with acute pulmonary insufficiency or respiratory depression.
Disinhibiting effects have been noted, even after a single dose. This possibility should be borne in mind if treating patients with a history of personality disorders.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.
Use in Children: Usage in preterm infants and neonatal: Rapid injection should be avoided in the neonatal population. Midazolam administered rapidly as an intravenous injection (less than 2 minutes) has been associated with severe hypotension in neonates, particularly when the patients has also received Fentanyl.
Use in the Elderly: Caution should be exercised when administering Midazolam parenterally to elderly patients or patients with impaired cardiac and respiratory function. After receiving Midazolam parenterally, patients should not be discharged from hospital or consulting room for at least 3 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 12 hours.

Usage in pregnancy: Midazolam should not be used in the first 3 months of pregnancy unless considered absolutely necessary by the physician.
An increased risk of congenital malformations associated with the use of benzodiazepine drugs (Diazepam and Chlordiazepoxide) has been suggested in several study. If this drug is used during pregnancy the patients should be apprised of the potential hazard to the fetus.
Nursing mother: Midazolam is excreted in human milk. Caution should be exercised when Midazolam is administered to a nursing mother.

Concerning serious cardiorespiratory events and possible paradoxical reactions.
Fluctuations in vital signs were the most frequently seen findings following parenteral administration of Midazolam in adults and included decreased tidal volume and/or respiratory rate decrease and apnea, as well as variations in blood pressure and pulse rate.
The majority of serious adverse effects, particularly those associated with oxygenation and ventilation, have been reported when Midazolam is administered with other medications capable of depressing the central nervous system.
Headache and local effects at i.m. injection, e.g. pain, induration, redness and muscle stiffness.
Following intravenous application of Midazolam, respiratory depression and respiratory arrest have occurred. These life-threatening incidents may occur especially in elder patients or patients with preexisting respiratory insufficiency, particularly if excessive or to rapidly injected doses are administered.
The following additional adverse reactions were reported subsequent to intravenous administration is hiccoughs, nausea, vomiting, coughing, oversedation, headache, drowsiness.
Hallucinations, some of a sexual nature, have been reported.
Change in cardiovascular parameter are slight but can include a decrease in mean arterial pressure, cardiac output, stroke volume and systemic vascular resistance. Such changes may be important in patients with impaired myocardial oxygen delivery capacity and hypovolemia.

The sedative effect of intravenous Midazolam is accentuated by any concomitantly administered medication, which depresses the central nervous system, particularly narcotics (e.g. Morphine, Meperidine and Fentanyl) and also Secobarbital and Droperidol.
With drugs that are known to inhibit the P450 3A4 enzyme system such as Cimetidine (not Ranitidine), Erythromycin, Diltiazem, Verapamil, Ketoconazole, and Itraconazole may result in prolonged sedation due to a decrease in plasma clearance of Midazolam.
Midazolam enhances the central sedative effect of neuroleptics, tranquilizers, antidepressants, sleep-inducing drugs, analgesics and anesthetics. This potentiation can be of advantage therapeutically.

Store at temperature between 15°C and 30°C, away from light.

Hypnotics & Sedatives

N05CD08 - midazolam ; Belongs to the class of benzodiazepine derivatives. Used as hypnotics and sedatives.

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