MIDAZOLAM injection, solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

midazolam hydrochloride (UNII: W7TTW573JJ) (midazolam - UNII:R60L0SM5BC)

Sẵn có từ:

Almaject, Inc.

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Midazolam Injection 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 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. W

Tóm tắt sản phẩm:

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. Discard unused portion. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

MIDAZOLAM- MIDAZOLAM INJECTION, SOLUTION
ALMAJECT, INC.
----------
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 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 ALLOW AN ADDITIONAL 2 OR MORE MINUTES TO FULLY
EVALUATE THE