MIDAZOLAM injection

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Henry Schein, Inc.

Адміністрація маршрут:

INTRAMUSCULAR

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 sue of narcotic premedications, 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

Огляд продуктів:

Midazolam Injection, USP is available in the following:

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

MIDAZOLAM- MIDAZOLAM INJECTION
HENRY SCHEIN, INC.
----------
MIDAZOLAM
BOXED WARNING
WARNINGS
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. INTRAVENOUSE MIDAZOLAM SHOULD BE USED
ONLY IN HOSPITAL OR AMBULATORY CARE SETTINGS, INCLUDING PHYSICIANS'
AND
DENTAL OFFICES, THAT PROVED FOR CONTINUOUS MONITORING OF RESPIRATORY
AND
CARDIAC FUNCTION, E.G., PULSE OXIMETRY. IMMEDIATED AVAILABILITY OF
RESUSCITATIVE DRUGS AND AGE- AND SIZE-APPROPRIATE 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 SHOULD NEVER BE USED WITHOUT INDIVIDUALIZATION OF DOSAGE.
THE
INITIAL INTRAVENOUSE DOSE FOR SEDATION IN ADULT PATIETNS 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
NERVOUSE 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 FORMUATION OR DILUTION OF THE
1
MG/ML OR 5 MG/ML FORMULATIO