MIDAZOLAM- midazolam hydrochloride injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

General Injectables & Vaccines, Inc.

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Midazolam Injection, USP 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 du

Tuoteyhteenveto:

Midazolam Injection, USP is supplied as follows: Storage Conditions 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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

MIDAZOLAM- MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC.
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MIDAZOLAM INJECTION, USP CIV
FOR INTRAVENOUS OR INTRAMUSCULAR USE 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 M