MIDAZOLAM HYDROCHLORIDE injection

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Physicians Total Care, Inc.

INN (International Name):

MIDAZOLAM HYDROCHLORIDE

Sammensætning:

MIDAZOLAM HYDROCHLORIDE 1 mg in 1 mL

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

Midazolam Injection, USP, is available in the following: 1 mg/mL midazolam hydrochloride equivalent to 1 mg midazolam/mL 2 mL Vial  x   Packaged in 10s      NDC 54868-5711-0 Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

MIDAZOLAM HYDROCHLORIDE - MIDAZOLAM HYDROCHLORIDE INJECTION
PHYSICIANS TOTAL CARE, INC.
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MIDAZOLAM HYDROCHLORIDE INJECTION
CIV
RX ONLY
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, i.e., 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 complete dosing