MIDAZOLAM HYDROCHLORIDE syrup

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:

Ranbaxy Pharmaceuticlas Inc

INN (Tên quốc tế):

MIDAZOLAM HYDROCHLORIDE

Thành phần:

MIDAZOLAM 2 mg in 1 mL

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Midazolam hydrochloride syrup is indicated for use in pediatric patients for sedation, anxiolysis and amnesia prior to diagnostic, therapeutic or endoscopic procedures or before induction of anesthesia. Midazolam hydrochloride syrup is intended for use in monitored settings only and not for chronic or home use (see WARNINGS). MIDAZOLAM HYDROCHLORIDE SYRUP MUST BE USED AS SPECIFIED IN THE LABEL. Midazolam is associated with a high incidence of partial or complete impairment of recall for the next several hours (see CLINICAL PHARMACOLOGY). Midazolam hydrochloride syrup is contraindicated in patients with a known hypersensitivity to the drug or allergies to cherries or formulation excipients. 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 of general anest

Tóm tắt sản phẩm:

Midazolam hydrochloride syrup is supplied as a clear, red to purplish-red, cherry-flavored syrup containing midazolam hydrochloride equivalent to 2 mg of midazolam/mL; each amber glass bottle of 118 mL of syrup is supplied with 1 press-in bottle adapter, 4 single-use, graduated, oral dispensers and 4 tip caps (NDC 63304-205-18). Storage: Store at 20 - 25°C (68 - 77°F). (See USP Controlled Room Temperature). 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 exposure to 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) Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32216 USA by: Mikart, Inc. Atlanta, GA 30318 USA

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

MIDAZOLAM HYDROCHLORIDE- MIDAZOLAM HYDROCHLORIDE SYRUP
RANBAXY PHARMACEUTICLAS INC
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MIDAZOLAM HYDROCHLORIDE SYRUP
BOX WARNING
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound
sedation, respiratory
depression, coma, and death _[see WARNINGS and PRECAUTIONS]_.
•
•
•
Midazolam hydrochloride syrup has been associated with respiratory
depression and respiratory arrest,
especially when used for sedation in noncritical care settings.
Midazolam hydrochloride syrup has been
associated with reports of respiratory depression, airway obstruction,
desaturation, hypoxia, and apnea,
most often when used concomitantly with other central nervous system
depressants (eg, opioids).
Midazolam hydrochloride syrup should be used only in hospital or
ambulatory care settings, including
physicians’ and dentists’ offices, THAT CAN PROVIDE FOR CONTINUOUS
MONITORING OF
RESPIRATORY AND CARDIAC FUNCTION. IMMEDIATE AVAILABILITY OF
RESUSCITATIVE DRUGS AND AGE- AND SIZE-APPROPRIATE EQUIPMENT FOR
VENTILATION AND INTUBATION, AND PERSONNEL TRAINED IN THEIR USE AND
SKILLED IN AIRWAY MANAGEMENT SHOULD BE ASSURED (see WARNINGS). For
deeply
sedated patients, a dedicated individual, other than the practitioner
performing the procedure, should
monitor the patient throughout the procedure.
DESCRIPTION
Midazolam is a benzodiazepine available as midazolam hydrochloride
syrup for oral administration.
Midazolam, a white to light yellow crystalline compound, is insoluble
in water, but can be solubilized in
aqueous solutions by formation of the hydrochloride salt _in situ_
under acidic conditions. Chemically,
midazolam HCl is
8-chloro-6-(2-fluorophenyl)-1-methyl-4_H_-imidazo[1,5-a][1,4]benzodiazepine
hydrochloride. Midazolam hydrochloride has the molecular formula C
H ClFN ·HCl, a calculated
molecular weight of 362.25 and the following structural formula:
Each mL of the syrup contains midazolam hydrochloride equivalent to 2
mg midazolam compounded
Reserve concomita