Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
midazolam hydrochloride (UNII: W7TTW573JJ) (midazolam - UNII:R60L0SM5BC)
Alvogen Inc.
midazolam hydrochloride
midazolam 5 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Midazolam Injection, USP is indicated: Injectable midazolam hydrochloride 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 hydrochloride; patients with glaucoma have not been studied. Midazolam hydrochloride is not intended for intrathecal or epidural administration due to the presence of the preservative benzyl alcohol in the dosage form. Midazolam hydrochloride is contraindicated for use in premature infants because the formulation contains benzyl alcohol (see WARNINGS and PRECAUTIONS, Pediatric Use ). Midazolam hydrochloride contains midazolam, a Schedule IV control substance. Midazolam was actively self-administered in primate models used to assess the positive
Midazolam Injection, USP is supplied as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex.
Abbreviated New Drug Application
MIDAZOLAM- MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION ALVOGEN INC. ---------- MIDAZOLAM INJECTION, USP CIV (FOR INTRAVENOUS OR INTRAMUSCULAR USE ONLY) NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL RX ONLY WARNINGS PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION _ADULTS AND PEDIATRICS:_ INTRAVENOUS MIDAZOLAM HYDROCHLORIDE 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 HYDROCHLORIDE 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 HYDROCHLORIDE 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 A Διαβάστε το πλήρες έγγραφο