MIDAZOLAM injection

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Hikma Pharmaceuticals USA 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 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 Injection 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 controlled 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 available in the following: 1 mg/mL midazolam hydrochloride equivalent to 1 mg midazolam/mL     2 mL Vial packaged in 10s (NDC 0641-6057-10) and in 25s (NDC 0641-6057-25)     5 mL Vial packaged in 10s (NDC 0641-6059-10)     10 mL Vial packaged in 10s (NDC 0641-6056-10) 5 mg/mL midazolam hydrochloride equivalent to 5 mg midazolam/mL     1 mL Vial packaged in 10s (NDC 0641-6061-10) and in 25s (NDC 0641-6061-25)     2 mL Vial packaged in 10s (NDC 0641-6063-10) and in 25s (NDC 0641-6063-25)     10 mL Vial packaged in 10s (NDC 0641-6060-10)

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

MIDAZOLAM- MIDAZOLAM INJECTION
HIKMA PHARMACEUTICALS USA INC.
----------
MIDAZOLAM INJECTION, USP
CIV
RX ONLY
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
BOXED WARNING
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, PRECAUTIONS;
DRUG INTERACTIONS).
INDIVIDUALIZATION OF DOSAGE
MIDAZOLAM SHOULD 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.