MIDAZOLAM- midazolam hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MIDAZOLAM HYDROCHLORIDE (UNII: W7TTW573JJ) (MIDAZOLAM - UNII:R60L0SM5BC)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

MIDAZOLAM HYDROCHLORIDE

Composition:

MIDAZOLAM 5 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Midazolam injection is indicated: - intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; - intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants; - intravenously for induction of general anesthesia, before administration of other anesthetic agents.  With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time.  Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia); - continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a

Product summary:

Midazolam Injection, USP, in the Pharmacy Bulk Package, is supplied as midazolam hydrochloride equivalent to 5 mg midazolam per mL : Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDAZOLAM - MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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MIDAZOLAM INJECTION, USP
Rx only
PHARMACY BULK PACKAGE –
NOT FOR DIRECT INFUSION
For intramuscular or intravenous use.
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
WARNING
PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION
_ADULTS AND PEDIATRICS:_ INTRAVENOUS MIDAZOLAM HAS BEEN ASSOCIATED
WITH RESPIRATORY
DEPRESSION AND RESPIRATORY ARREST, ESPECIALLY WHEN USED FOR SEDATION
IN NONCRITICAL CARE
SETTINGS. IN SOME CASES, WHERE THIS WAS NOT RECOGNIZED PROMPTLY AND
TREATED EFFECTIVELY,
DEATH OR HYPOXIC ENCEPHALOPATHY HAS RESULTED. INTRAVENOUS MIDAZOLAM
SHOULD BE USED ONLY
IN HOSPITAL OR AMBULATORY CARE SETTINGS, INCLUDING PHYSICIANS’ AND
DENTAL OFFICES, THAT
PROVIDE FOR CONTINUOUS MONITORING OF RESPIRATORY AND CARDIAC FUNCTION,
E.G., PULSE OXIMETRY.
IMMEDIATE AVAILABILITY OF RESUSCITATIVE DRUGS AND AGE- AND
SIZE-APPROPRIATE EQUIPMENT FOR
BAG/VALVE/MASK VENTILATION AND INTUBATION, AND PERSONNEL TRAINED IN
THEIR USE AND SKILLED IN
AIRWAY MANAGEMENT SHOULD BE ASSURED (SEE WARNINGS). FOR DEEPLY SEDATED
PEDIATRIC
PATIENTS, A DEDICATED INDIVIDUAL, OTHER THAN THE PRACTITIONER
PERFORMING THE PROCEDURE,
SHOULD MONITOR THE PATIENT THROUGHOUT THE PROCEDURE.
RISKS FROM CONCOMITANT USE WITH OPIOIDS
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND
SEDATION,
RESPIRATORY DEPRESSION, COMA, AND DEATH. MONITOR PATIENTS FOR
RESPIRATORY DEPRESSION AND
SEDATION (SEE WARNINGS, PRECAUTIONS, DRUG INTERACTIONS).
INDIVIDUALIZATION OF DOSAGE
MIDAZOLAM MUST NEVER BE USED WITHOUT INDIVIDUALIZATION OF DOSAGE. THE
INITIAL INTRAVENOUS
DOSE FOR SEDATION IN ADULT PATIENTS MAY BE AS LITTLE AS 1 MG, BUT
SHOULD NOT EXCEED 2.5 MG IN A
NORMAL HEALTHY ADULT. LOWER DOSES ARE NECESSARY FOR OLDER (OVER 60
YEARS) OR DEBILITATED
PATIENTS AND IN PATIENTS RECEIVING CONCOMITANT NARCOTICS OR OTHER
CENTRAL NERVOUS SYSTEM
(CNS) DEPRESSANTS. THE INITIAL DOSE AND ALL SUBSEQUENT DOSES SHOULD
ALWAYS BE TITRATED
SLOWLY; ADMINISTER OVER AT LEAST 2 MINUT