Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
MIDAZOLAM HYDROCHLORIDE (UNII: W7TTW573JJ) (MIDAZOLAM - UNII:R60L0SM5BC)
Dispensing Solutions, Inc.
MIDAZOLAM HYDROCHLORIDE
MIDAZOLAM 5 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
Midazolam injection is indicated: - intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; 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 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 anes
Package configurations containing midazolam hydrochloride equivalent to 1 mg midazolam/mL : NDC No. Container Description Fill Volume Total Midazolam (per container) 0409–2587–05 Fliptop Vial 10 mL 10 mg Package configurations containing midazolam hydrochloride equivalent to 5 mg midazolam/mL : NDC No. Container Description Fill Volume Total Midazolam (per container) 0409–2596–03 Fliptop Vial 5 mL 25 mg 0409–2596–05 Fliptop Vial 10 mL 50 mg Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: September, 2009 Printed in USA EN-2248 Hospira, Inc., Lake Forest, IL 60045 USA
Abbreviated New Drug Application
MIDAZOLAM HYDROCHLORIDE - MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION DISPENSING SOLUTIONS, INC. ---------- MIDAZOLAM INJECTION, USP CIV R only WARNING _Adult and Pediatric:_ 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, ie, 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. 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 use of the 1 mg/mL formulation or dilution of the 1 mg/mL or 5 mg/mL formulation is recommended to facilitate slower injection. Doses of sedative medications in pediatric patients must be calculated on a mg/kg basis, and initial doses and all subsequent doses should always be titrated slowly. The initial pediatric dose of midazolam for sedation/anxiolysis/amnesia is age, procedure, and route dependent (see _DOSAGE AND_ _ADMINISTRATION_ for co Belgenin tamamını okuyun