MIDAZOLAM HYDROCHLORIDE- 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:

Hospira, Inc.

INN (International Name):

MIDAZOLAM HYDROCHLORIDE

Composition:

MIDAZOLAM 1 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 c

Product summary:

Preservative-Free Midazolam Injection, USP is supplied in SLIM-PAK™ tamper detection packages as follows: Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDAZOLAM HYDROCHLORIDE- MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
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MIDAZOLAM INJECTION, USP
_PRESERVATIVE-FREE_
STERILE CARTRIDGE UNIT For Single-dose only.
For intravenous or intramuscular use.
RX ONLY
CIV
WARNINGS
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 AND 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
minutes and allow an additional