MIDAZOLAM HYDROCHLORIDE injection, solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Dispensing Solutions, Inc.

INN (International Nazwa):

MIDAZOLAM HYDROCHLORIDE

Skład:

MIDAZOLAM 5 mg in 1 mL

Droga podania:

INTRAMUSCULAR

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Midazolam injection is indicated: - intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; 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 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 anes

Podsumowanie produktu:

Package configurations containing midazolam hydrochloride equivalent to 1 mg midazolam/mL : NDC No. Container Description Fill Volume Total Midazolam (per container) 0409–2587–05 Fliptop Vial 10 mL 10 mg Package configurations containing midazolam hydrochloride equivalent to 5 mg midazolam/mL : NDC No. Container Description Fill Volume Total Midazolam (per container) 0409–2596–03 Fliptop Vial 5 mL 25 mg 0409–2596–05 Fliptop Vial 10 mL 50 mg Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: September, 2009 Printed in USA EN-2248 Hospira, Inc., Lake Forest, IL 60045 USA

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

MIDAZOLAM HYDROCHLORIDE - MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
DISPENSING SOLUTIONS, INC.
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MIDAZOLAM
INJECTION, USP
CIV
R only
WARNING
_Adult and Pediatric:_ 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, 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 procedures.
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 co