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:

Alvogen Inc.

INN (International Name):

midazolam hydrochloride

Composition:

midazolam 5 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Midazolam Injection, USP is indicated: Injectable midazolam hydrochloride 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 hydrochloride; patients with glaucoma have not been studied. Midazolam hydrochloride is not intended for intrathecal or epidural administration due to the presence of the preservative benzyl alcohol in the dosage form. Midazolam hydrochloride is contraindicated for use in premature infants because the formulation contains benzyl alcohol (see WARNINGS and PRECAUTIONS, Pediatric Use ). Midazolam hydrochloride contains midazolam, a Schedule IV control substance. Midazolam was actively self-administered in primate models used to assess the positive

Product summary:

Midazolam Injection, USP is supplied as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDAZOLAM- MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
ALVOGEN INC.
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MIDAZOLAM INJECTION, USP CIV
(FOR INTRAVENOUS OR INTRAMUSCULAR USE ONLY)
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
RX ONLY
WARNINGS
PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION
_ADULTS AND PEDIATRICS:_ 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, 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 HYDROCHLORIDE 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 A