MIDAZOLAM injection

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Cardinal Health

Designación común internacional (DCI):

MIDAZOLAM HYDROCHLORIDE

Composición:

MIDAZOLAM 1 mg in 1 mL

Vía de administración:

INTRAMUSCULAR

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Midazolam Injection, USP is available in the following: 1 mg/mL midazolam hydrochloride equivalent to 1 mg midazolam/mL     2 mL Vial Overbagged with 5 vials per bag, NDC 55154-2889-5

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

MIDAZOLAM- MIDAZOLAM INJECTION
CARDINAL HEALTH
----------
MIDAZOLAM INJECTION, USP
CIV
RX ONLY
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
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. 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 SHOULD 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 TO FULLY
EVALUATE THE SEDATIVE EFFECT. THE USE OF THE