MIDAZOLAM injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

General Injectables and Vaccines, Inc.

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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

제품 요약:

Midazolam Injection, USP, package configurations containing midazolam hydrochloride equivalent to 1 mg midazolam/mL: Midazolam Injection, USP, package configurations containing midazolam hydrochloride equivalent to 5 mg midazolam/mL: Packaged in tens. *Packaged in twenty-fives. 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.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

MIDAZOLAM- MIDAZOLAM INJECTION, SOLUTION
GENERAL INJECTABLES AND VACCINES, INC.
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MIDAZOLAM HYDROCHLORIDE
BOXED WARNING
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
minutes and allow an additional 2 or more minutes to fully evaluate
the sedative
effect. The use of the 1 mg/mL formulation or dilution of