Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
MIDAZOLAM HYDROCHLORIDE (UNII: W7TTW573JJ) (MIDAZOLAM - UNII:R60L0SM5BC)
Wockhardt USA LLC.
INTRAMUSCULAR
PRESCRIPTION DRUG
Midazolam hydrochloride 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 hydrochloride can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia); - continuous intravenous infusion for sedation of intubated
Package configurations containing preservative-free midazolam hydrochloride equivalent to 1 mg midazolam USP/mL : 64679-764-01 1 mg/mL, 2 mL single-dose vial, carton of 10 vials. 64679-764-02 1 mg/mL, 5 mL single-dose vial, carton of 10 vials. 64679-764-03 1 mg/mL, 2 mL single-dose vial, carton of 25 vials. 64679-764-04 1 mg/mL, 5 mL single-dose vial, carton of 25 vials. Package configurations containing preservative-free midazolam hydrochloride equivalent to 5 mg midazolam USP/mL: 64679-765-01 5 mg/mL, 1 mL single-dose vial, carton of 10 vials. 64679-765-02 5 mg/mL, 2 mL single-dose vial, carton of 10 vials. 64679-765-03 5 mg/mL, 1 mL single-dose vial, carton of 25 vials. 64679-765-04 5 mg/mL, 2 mL single-dose vial, carton of 25 vials. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature]. Discard unused portion.
Abbreviated New Drug Application
MIDAZOLAM HYDROCHLORIDE- MIDAZOLAM HYDROCHLORIDE INJECTION WOCKHARDT USA LLC. ---------- MIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV FOR INTRAVENOUS OR INTRAMUSCULAR USE PRESERVATIVE FREE 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, 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 MINUTES AND ALLOW AN ADDITIONAL 2 OR সম্পূর্ণ নথি পড়ুন