Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
MIDAZOLAM HYDROCHLORIDE (UNII: W7TTW573JJ) (MIDAZOLAM - UNII:R60L0SM5BC)
Hospira, Inc.
MIDAZOLAM HYDROCHLORIDE
MIDAZOLAM 1 mg in 1 mL
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 not intended for intrathecal or epidural administration due to the presence of the preservative benzyl alcohol in the dosage form. Midazolam injection is contraindicated for use in premature infants because the formulation contains benzyl alcohol (see WARNINGS and PRECAUTIONS, Pediatric Use ). Midazolam Injection contains midazolam a Schedule IV control substance. Midazolam was actively self-administered in primate models used to assess the positive reinforcing effects of psychoactive drugs. Midazolam p
Package configurations containing midazolam hydrochloride equivalent to 1 mg midazolam/mL : Unit of Sale Concentration NDC 0409-2587-05 10 mg/10 mL (1 mg/mL) Carton of 10 Multiple-dose Fliptop Vials Package configurations containing midazolam hydrochloride equivalent to 5 mg midazolam/mL : Unit of Sale Concentration NDC 0409-2596-03 25 mg/5 mL (5 mg/mL) Carton of 10 Multiple-dose Fliptop Vials NDC 0409-2596-05 50 mg/10 mL (5 mg/mL) Carton of 10 Multiple-dose Fliptop Vials Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
MIDAZOLAM HYDROCHLORIDE- MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION HOSPIRA, INC. ---------- MIDAZOLAM INJECTION, USP R ONLY For intravenous or intramuscular use. NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL X WARNINGS 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 _and_ 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 minutes and allow an additional 2 or more Lesen Sie das vollständige Dokument