MIDAZOLAM- midazoalm injection, solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

General Injectables and Vaccines, Inc.

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Midazolam Injection, USP 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 crit

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

MIDAZOLAM- MIDAZOALM INJECTION, SOLUTION
GENERAL INJECTABLES AND VACCINES, INC.
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MIDAZOLAM
Rx only
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
BOXED WARNING
WARNINGS
Personnel and Equipment for Monitoring and Resuscitation
Adults and Pediatrics: Intravenous midazolam hydrochloride 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 hydrochloride 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 hydrochloride 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