Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
MIDAZOLAM HYDROCHLORIDE (UNII: W7TTW573JJ) (MIDAZOLAM - UNII:R60L0SM5BC)
Fresenius Kabi USA, LLC
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
Midazolam Injection, USP, in the Pharmacy Bulk Package, is supplied as midazolam hydrochloride equivalent to 5 mg midazolam per mL : Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The container closure is not made with natural rubber latex.
Abbreviated New Drug Application
MIDAZOLAM - MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION FRESENIUS KABI USA, LLC ---------- MIDAZOLAM INJECTION, USP Rx only PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION For intramuscular or intravenous use. NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL 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 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 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 MINUT Lestu allt skjalið