MIDAZOLAM HYDROCHLORIDE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Wockhardt Limited

INN (International Name):

MIDAZOLAM HYDROCHLORIDE

Composition:

MIDAZOLAM 1 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Midazolam hydrochloride 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 duri

Product summary:

Package configurations containing midazolam hydrochloride equivalent to 1 mg midazolam USP/mL : 64679-762-01            1 mg/mL, 2 mL vial, carton of 10 vials. 64679-762-02            1 mg/mL, 5 mL vial, carton of 10 vials. 64679-762-03            1 mg/mL, 10 mL vial, carton of 10 vials. 64679-762-04            1 mg/mL, 2 mL vial, carton of 25 vials. 64679-762-05            1 mg/mL, 5 mL vial, carton of 25 vials. 64679-762-06            1 mg/mL, 10 mL vial, carton of 25 vials. Package configurations containing midazolam hydrochloride equivalent to 5 mg midazolam USP/mL : 64679-763-01            5 mg/mL, 1 mL vial, carton of 10 vials. 64679-763-02            5 mg/mL, 2 mL vial, carton of 10 vials. 64679-763-03            5 mg/mL, 5 mL vial, carton of 10 vials. 64679-763-04            5 mg/mL, 10 mL vial, carton of 10 vials. 64679-763-05            5 mg/mL, 1 mL vial, carton of 25 vials. 64679-763-06            5 mg/mL, 2 mL vial, carton of 25 vials. 64679-763-07            5 mg/mL, 5 mL vial, carton of 25 vials. 64679-763-08            5 mg/mL, 10 mL vial, carton of 25 vials. Store at 20°-25°C (68°-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
WOCKHARDT LIMITED
----------
MIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV
RX ONLY
WARNING
_Adult and Pediatric_: Intravenous midazolam hydrochloride 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 hydrochloride
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
ADMI