MIDAZOLAM injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

midazolam hydrochloride (UNII: W7TTW573JJ) (midazolam - UNII:R60L0SM5BC)

제공처:

Almaject, Inc.

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Midazolam Injection 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 reinf

제품 요약:

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.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

MIDAZOLAM- MIDAZOLAM INJECTION, SOLUTION
ALMAJECT, INC.
----------
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 OVER AT
LEAST 2 MINUTES AND ALLOW AN ADD