国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
MIDAZOLAM HYDROCHLORIDE (UNII: W7TTW573JJ) (MIDAZOLAM - UNII:R60L0SM5BC)
A-S Medication Solutions
MIDAZOLAM HYDROCHLORIDE
MIDAZOLAM 5 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
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
Product: 50090-0683 NDC: 50090-0683-0 10 mL in a VIAL / 10 in a CARTON NDC: 50090-0683-1 10 mL in a VIAL / 1 in a CARTON Product: 50090-0738 NDC: 50090-0738-0 10 mL in a VIAL / 10 in a CARTON
Abbreviated New Drug Application
MIDAZOLAM- MIDAZOLAM INJECTION A-S MEDICATION SOLUTIONS ---------- 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 US 完全なドキュメントを読む