MIDAZOLAM HYDROCHLORIDE injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

General Injectables & Vaccines, Inc

DCI (Dénomination commune internationale):

Midazolam Hydrochloride

Composition:

Midazolam 5 mg in 1 mL

Mode d'administration:

INTRAMUSCULAR

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

Package configurations containing preservative-free midazolam hydrochloride equivalent to 1 mg midazolam/mL: Package configurations containing preservative-free midazolam hydrochloride equivalent to 5 mg midazolam/mL: Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.] Discard unused portion.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

MIDAZOLAM HYDROCHLORIDE- MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
----------
PRESERVATIVE-FREE
MIDAZOLAM INJECTION, USP
CIV
RX ONLY
BOXED 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 PROCEDURES.
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 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 TO FULLY EVALUATE THE SEDATIVE
EFFECT.