MIDAZOLAM- midazolam hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

The Medicines Company

INN (International Name):

MIDAZOLAM HYDROCHLORIDE

Composition:

MIDAZOLAM 1 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Midazolam Injection, USP, package configurations containing midazolam hydrochloride equivalent to 1 mg midazolam/mL: Product No. NDC No. Fill Volume Vial Size MC410102* 65293-411-25 2 mL 2 mL MC411105* 5 mL 5 mL MC410110 65293-412-10 10 mL 10 mL Midazolam Injection, USP, package configurations containing midazolam hydrochloride equivalent to 5 mg midazolam/mL: Product No. NDC No. Fill Volume Vial Size MC411201* 65293-417-25 1 mL 2 mL MC410202 65293-413-10 2 mL 2 mL MC410205 65293-414-10 5 mL 5 mL MC410210 65293-415-10 10 mL 10 mL Packaged in tens. *Packaged in twenty-fives. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. This container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDAZOLAM- MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
THE MEDICINES COMPANY
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MIDAZOLAM INJECTION, USP
Rx only
BOXED WARNING
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, 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 complete dosing informatio