Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
Midazolam Hydrochloride (UNII: W7TTW573JJ) (Midazolam - UNII:R60L0SM5BC)
Precision Dose Inc.
Midazolam Hydrochloride
Midazolam 2 mg in 1 mL
ORAL
PRESCRIPTION DRUG
Midazolam HCl syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia. Midazolam HCl syrup is intended for use in monitored settings only and not for chronic or home use [see WARNINGS] . Midazolam HCl syrup is contraindicated in patients with a known hypersensitivity to the drug or allergies to cherries or formulation excipients. 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 of general anesthesia with injectable midazolam; patients with glaucoma have not been studied. Midazolam HCl syrup is a benzodiazepine and is a Schedule IV controlled substance that can produce drug dependence of the diazepam-type. Therefore, midazolam HCl syrup may be subject to misuse, abuse and addiction. Benzodiazepines can cause physical dependence. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug. Withdrawal symptoms (ie, convulsions, hallucinations, tremors, abdominal and muscle cramps, vomiting and sweating), similar in characteristics to those noted with barbiturates and alcohol have occurred following abrupt discontinuation of midazolam following chronic administration. Abdominal distention, nausea, vomiting, and tachycardia are prominent symptoms of withdrawal in infants. The handling of midazolam HCl syrup should be managed to minimize the risk of diversion, including restriction of access and accounting procedures as appropriate to the clinical setting and as required by law.
Midazolam HCl Syrup is supplied as a clear, red to purplish-red, cherry- brandy flavored syrup containing midazolam hydrochloride equivalent to 2 mg of midazolam/mL. NDC 68094-762-62 2.5 mL per unit dose cup Thirty (30) cups per shipper NDC 68094-764-62 5 mL per unit dose cup Thirty (30) cups per shipper Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
MIDAZOLAM HYDROCHLORIDE- MIDAZOLAM HYDROCHLORIDE SYRUP PRECISION DOSE INC. ---------- MIDAZOLAM HYDROCHLORIDE SYRUP CIV RX ONLY For oral use WARNINGS PERSONNEL AND EQUIPMENT FOR MONITORING AND DEPRESSION MIDAZOLAM HCL SYRUP HAS BEEN ASSOCIATED WITH RESPIRATORY DEPRESSION AND RESPIRATORY ARREST, ESPECIALLY WHEN USED FOR SEDATION IN NONCRITICAL CARE SETTINGS. MIDAZOLAM HCL SYRUP HAS BEEN ASSOCIATED WITH REPORTS OF RESPIRATORY DEPRESSION, AIRWAY OBSTRUCTION, DESATURATION, HYPOXIA, AND APNEA, MOST OFTEN WHEN USED CONCOMITANTLY WITH OTHER CENTRAL NERVOUS SYSTEM DEPRESSANTS. MIDAZOLAM HCL SYRUP SHOULD BE USED ONLY IN HOSPITAL OR AMBULATORY CARE SETTINGS, INCLUDING PHYSICIANS' AND DENTISTS' OFFICES, THAT CAN PROVIDE FOR CONTINUOUS MONITORING OF RESPIRATORY AND CARDIAC FUNCTION. IMMEDIATE AVAILABILITY OF RESUSCITATIVE DRUGS AND AGE- AND SIZE-APPROPRIATE EQUIPMENT FOR VENTILATION AND INTUBATION, AND PERSONNEL TRAINED IN THEIR USE AND SKILLED IN AIRWAY MANAGEMENT SHOULD BE ASSURED _[SEE WARNINGS]_. FOR DEEPLY SEDATED 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]_. DESCRIPTION Midazolam is a benzodiazepine available as midazolam HCl syrup for oral administration. Midazolam, a white to light yellow crystalline compound, is insoluble in water, but can be solubilized in aqueous solutions by formation of the hydrochloride salt _in situ_ under acidic conditions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-_4H_- imidazo[1,5-a][1,4]benzodiazepine hydrochloride. Midazolam hydrochloride has the molecular formula C H ClFN ∙HCl, a calculated molecular weight of 362.25 and the following structural formula: 18 13 3 Each mL of the syrup contains midazolam hyd Lugege kogu dokumenti