MIDAZOLAM hydrochloride injection

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Caraco Pharmaceutical Laboratories, Ltd.

INN (इंटरनेशनल नाम):

MIDAZOLAM HYDROCHLORIDE

रचना:

MIDAZOLAM 1 mg in 1 mL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

MIDAZOLAM- MIDAZOLAM HYDROCHLORIDE INJECTION
CARACO PHARMACEUTICAL LABORATORIES, LTD.
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MIDAZOLAM INJECTION, USP
CIV
RX ONLY
BOXED WARNING
_Adults and Pediatric:_
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 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, ie., 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.
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 the
1 mg/mL or 5 mg/mL
formulation is recommended to facilitate slower injection. Doses of
sedative medications in
pediatric patients must be calculated on a mg/kg basis, and initial
doses and all subsequent doses
should always be titrated slowly. The initial pediatric dose of
midazolam for sedation
/anxiolysis/amnesia is age, procedure, and route dependent (see DOSAGE
AND
ADMINISTRATION for