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:

Hospira, Inc.

INN (International Name):

MIDAZOLAM HYDROCHLORIDE

Composition:

MIDAZOLAM 1 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Midazolam injection is indicated: Injectable midazolam is contraindicated in patients with a known hypersensitivity to the drug. Benzodiazepines are contraindicated in patients with acute narrow-angle glaucoma. Benzodiazepines may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. Measurements of intraocular pressure in patients without eye disease show a moderate lowering following induction with midazolam; patients with glaucoma have not been studied. Midazolam is not intended for intrathecal or epidural administration due to the presence of the preservative benzyl alcohol in the dosage form. Midazolam injection is contraindicated for use in premature infants because the formulation contains benzyl alcohol (see WARNINGS and PRECAUTIONS, Pediatric Use ). Midazolam Injection contains midazolam a Schedule IV control substance. Midazolam was actively self-administered in primate models used to assess the positive reinforcing effects of psychoactive drugs. Midazolam p

Product summary:

Package configurations containing midazolam hydrochloride equivalent to 1 mg midazolam/mL : Unit of Sale Concentration NDC 0409-2587-05 10 mg/10 mL (1 mg/mL) Carton of 10 Multiple-dose Fliptop Vials Package configurations containing midazolam hydrochloride equivalent to 5 mg midazolam/mL : Unit of Sale Concentration NDC 0409-2596-03 25 mg/5 mL (5 mg/mL) Carton of 10 Multiple-dose Fliptop Vials NDC 0409-2596-05 50 mg/10 mL (5 mg/mL) Carton of 10 Multiple-dose Fliptop Vials Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDAZOLAM HYDROCHLORIDE- MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
----------
MIDAZOLAM
INJECTION, USP
R ONLY
For intravenous or intramuscular use.
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
X
WARNINGS
Personnel and Equipment for Monitoring and Resuscitation
_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, 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 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