MIDAZOLAM HYDROCHLORIDE injection, solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

Midazolam Hydrochloride (UNII: W7TTW573JJ) (Midazolam - UNII:R60L0SM5BC)

MAH:

Gland Pharma Limited

INN:

Midazolam Hydrochloride

composition:

Midazolam 5 mg in 1 mL

administration_route:

INTRAVENOUS

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Midazolam Injection 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 during tr

leaflet_short:

Midazolam Injection, USP is supplied as follows:   Storage Conditions 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

SPC

MIDAZOLAM HYDROCHLORIDE - MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
GLAND PHARMA LIMITED
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MIDAZOLAM INJECTION, USP
CIV
(FOR INTRAVENOUS OR INTRAMUSCULAR USE ONLY)
RX ONLY
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
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 OVE