Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
MIDAZOLAM HYDROCHLORIDE (UNII: W7TTW573JJ) (MIDAZOLAM - UNII:R60L0SM5BC)
The Medicines Company
MIDAZOLAM HYDROCHLORIDE
MIDAZOLAM 1 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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 during treatment
Midazolam Injection, USP, package configurations containing midazolam hydrochloride equivalent to 1 mg midazolam/mL: Product No. NDC No. Fill Volume Vial Size MC410102* 65293-411-25 2 mL 2 mL MC411105* 5 mL 5 mL MC410110 65293-412-10 10 mL 10 mL Midazolam Injection, USP, package configurations containing midazolam hydrochloride equivalent to 5 mg midazolam/mL: Product No. NDC No. Fill Volume Vial Size MC411201* 65293-417-25 1 mL 2 mL MC410202 65293-413-10 2 mL 2 mL MC410205 65293-414-10 5 mL 5 mL MC410210 65293-415-10 10 mL 10 mL Packaged in tens. *Packaged in twenty-fives. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. This container closure is not made with natural rubber latex.
Abbreviated New Drug Application
MIDAZOLAM- MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION THE MEDICINES COMPANY ---------- MIDAZOLAM INJECTION, USP Rx only BOXED WARNING 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, 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 procedure. 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 complete dosing informatio Les hele dokumentet