MIDAZOLAM- midazolam hydrochloride injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

MIDAZOLAM HYDROCHLORIDE (UNII: W7TTW573JJ) (MIDAZOLAM - UNII:R60L0SM5BC)

Disponible desde:

Fresenius Kabi USA, LLC

Designación común internacional (DCI):

MIDAZOLAM HYDROCHLORIDE

Composición:

MIDAZOLAM 2 mg in 2 mL

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Midazolam injection 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 in a critical care setting. 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 a Schedule IV control substance. 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 symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, hallucinations, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuation of benzodiazepines, including midazolam. Abdominal distention, nausea, vomiting, and tachycardia are prominent symptoms of withdrawal in infants. The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at the therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. There is no consensus in the medical literature regarding tapering schedules; therefore, practitioners are advised to individualize therapy to meet patient's needs. In some case reports, patients who have had severe withdrawal reactions due to abrupt discontinuation of high-dose long-term midazolam, have been successfully weaned off of midazolam over a period of several days. Figure 1: Outer Packaging and Prefilled Syringe NOTES: - Inspect the outer packaging (blister pack) to confirm the integrity of the packaging. Do not use if the blister pack or the prefilled syringe has been damaged. - Remove the syringe from the outer packaging. (See Figure 2) Figure 2 Figure 2 - Visually inspect the syringe. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. - Twist off the syringe tip cap. Do not remove the label around the luer lock collar. (See Figure 3) Figure 3 Figure 3 - Expel air bubble(s). Adjust the dose (if applicable). - Administer the dose ensuring that pressure is maintained on the plunger rod during the entire administration. - Discard the used syringe into an appropriate receptacle. For more information concerning this drug, please call Fresenius Kabi USA, LLC at 1-800-551-7176. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The brand names mentioned in this document are the trademarks of their respective owners. U.S. Patent 9,731,082; 10,661,018 www.fresenius-kabi.com/us 451524E Revised: February 2023

Resumen del producto:

Midazolam Injection, USP (Preservative-Free) is supplied as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Do not place syringe on a sterile field. Published studies in animals demonstrate that the use of anesthetic agents during the period of rapid brain growth or synaptogenesis results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. Based on comparisons across species, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester through the first several months of life, but may extend out to approximately 3 years of age in humans. In primates, exposure to 3 hours of an anesthetic regimen that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer increased neuronal cell loss. Data in rodents and in primates suggest that the neuronal and oligodendrocyte cell losses are associated with subtle but prolonged cognitive deficits in learning and memory. The clinical significance of these nonclinical findings is not known, and healthcare providers should balance the benefits of appropriate anesthesia in neonates and young children who require procedures against the potential risks suggested by the nonclinical data. (see WARNINGS, Pediatric Neurotoxicity and PRECAUTIONS, Pregnancy and Pediatric Use )

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

MIDAZOLAM - MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
MIDAZOLAM INJECTION, USP CIV
PRESERVATIVE-FREE
RX ONLY
WARNING
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, 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 MINUTES TO FULLY EVALUATE THE SEDATIVE
EFFECT. THE USE OF THE 1 MG/ML FORMULATI