Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
MIDAZOLAM HYDROCHLORIDE (UNII: W7TTW573JJ) (MIDAZOLAM - UNII:R60L0SM5BC)
Cardinal Health
INTRAMUSCULAR
PRESCRIPTION DRUG
Midazolam injection is indicated: Injectable midazolam is contraindicated in patients with a known hypersensitivity to the drug. Benzodiazepines are contraindicated in patients with acute narrow-angle glaucoma. Benzodiazepines may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. Measurements of intraocular pressure in patients without eye disease show a moderate lowering following induction with midazolam; patients with glaucoma have not been studied. Midazolam is subject to Schedule IV control under the Controlled Substances Act of 1970. Midazolam was actively self-administered in primate models used to assess the positive reinforcing effects of psychoactive drugs. Midazolam produced physical dependence of a mild to moderate intensity in cynomolgus monkeys after 5 to 10 weeks of administration. Available data concerning the drug abuse and dependence potential of midazolam suggest that its abuse potential is at least equivalent to that of diazepam. Withdrawal sympto
Package configurations containing preservative-free midazolam hydrochloride equivalent to 1 mg midazolam/mL : NDC No. Container Description Fill Volume Total Midazolam (per container) 55154-7831-5 Fliptop Vial (Overbagged with 5 vials per bag) 2 mL 2 mg Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Discard unused portion. Revised: 02/2012 EN-3008 Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA Novation and NOVAPLUS are trademarks of Novation, LLC. Distributed by: Cardinal Health Dublin, OH 43017 LC1707741118
Abbreviated New Drug Application
MIDAZOLAM HYDROCHLORIDE- MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION CARDINAL HEALTH ---------- PRES ERVATIVE-FREE MIDAZOLAM Rx only Injection, USP 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 comple read_full_document