MIDAZOLAM HYDROCHLORIDE injection, solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

INN (International Nazwa):

MIDAZOLAM HYDROCHLORIDE

Skład:

MIDAZOLAM 1 mg in 1 mL

Droga podania:

INTRAMUSCULAR

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 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 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 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 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.

Podsumowanie produktu:

Midazolam Injection, USP is supplied as follows: Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Discard unused portion. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

MIDAZOLAM HYDROCHLORIDE- MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
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MIDAZOLAM INJECTION, USP
CIV
(FOR INTRAVENOUS OR INTRAMUSCULAR USE ONLY)
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 DOSAGEMIDAZOLAM 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 LEAS