MIDAZOLAM- midazolam hydrochloride injection, solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Fresenius Kabi USA, LLC

INN (इंटरनेशनल नाम):

MIDAZOLAM HYDROCHLORIDE

रचना:

MIDAZOLAM 1 mg in 1 mL

प्रशासन का मार्ग:

INTRAVENOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 treatment in a c

उत्पाद समीक्षा:

Midazolam Injection, USP, package configurations containing midazolam hydrochloride equivalent to 1 mg midazolam/mL : Midazolam Injection, USP, package configurations containing midazolam hydrochloride equivalent to 5 mg midazolam/mL : Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The container closure is not made with natural rubber latex.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

MIDAZOLAM - MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
MIDAZOLAM INJECTION, USP
Rx only
For intramuscular or intravenous use only.
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
WARNING
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, 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 T