MIDAZOLAM HYDROCHLORIDE- 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:

Cardinal Health

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 subject to Schedule IV control under the Controlled Substances Act of 1970. 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 sympto

Product summary:

Package configurations containing preservative-free midazolam hydrochloride equivalent to 1 mg midazolam/mL : NDC No. Container Description Fill Volume Total Midazolam (per container) 55154-7831-5 Fliptop Vial (Overbagged with 5 vials per bag) 2 mL 2 mg Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Discard unused portion. Revised: 02/2012                                                                             EN-3008 Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA Novation and NOVAPLUS are trademarks of Novation, LLC. Distributed by: Cardinal Health Dublin, OH 43017 LC1707741118

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDAZOLAM HYDROCHLORIDE- MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
CARDINAL HEALTH
----------
PRES ERVATIVE-FREE
MIDAZOLAM
Rx only
Injection, USP
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 comple