MIDAZOLAM HYDROCHLORIDE syrup

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Atlantic Biologicals Corps

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 ). WARNINGSMIDAZOLAM 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 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

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

MIDAZOLAM HYDROCHLORIDE- MIDAZOLAM HYDROCHLORIDE SYRUP
ATLANTIC BIOLOGICALS CORPS
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MIDAZOLAM HYDROCHLORIDE SYRUP
RX ONLY
BOX WARNING
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 ). For deeply sedated patients, a dedicated
individual, other than the
practitioner performing the procedure, should monitor the patient
throughout the procedure.
WARNINGS
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 under acidic
conditions. Chemically,
midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4
-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: _in
situH_
Each mL of the syrup contains midazolam hydrochloride equivalent to 2
mg midazolam compounded
with artificial bitterness modifier, cherry flavor, citric acid, D&C
Red #33, edetate disodium, glycerin,
saccharin sodium, sodium benzoate, sodium citrate, sorbitol and water;
the pH is adjusted between 3.1 -
3.3 with hydrochloric a