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.

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 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 produced physical dependence of a mild to moderate intensity in cynomolgus monkeys after 5 to 10 weeks of administration. Available data concerning the drug abuse and dependence potential of midazolam suggest that its abuse potential is at least equivalent to that of diazepam. Withdrawal symptoms, similar in ch

Product summary:

Package configurations containing preservative-free midazolam hydrochloride equivalent to 1 mg midazolam/mL : NDC 0409-2305-50 Carton of 10 Single-dose Fliptop Vials 5 mg/5 mL (1 mg/mL) Package configurations containing preservative-free midazolam hydrochloride equivalent to 5 mg midazolam/mL : NDC 0409-2308-49 Carton of 10 Single-dose Fliptop Vials 5 mg/mL NDC 0409-2308-50 Carton of 10 Single-dose Fliptop Vials 10 mg/2 mL (5 mg/mL) Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Discard unused portion.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDAZOLAM HYDROCHLORIDE- MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
----------
PRESERVATIVE-FREE
MIDAZOLAM
Rx only
Injection, USP
For intravenous or intramuscular use.
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 minutes to fully evaluate
the sedative
e