MIDAZOLAM HYDROCHLORIDE syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ATLANTIC BIOLOGICALS CORP.

INN (International Name):

MIDAZOLAM HYDROCHLORIDE

Composition:

MIDAZOLAM 2 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Midazolam HCl 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 HCl syrup is intended for use in monitored settings only and not for chronic or home use (see ). WARNINGSMIDAZOLAM HCL 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 following induction of genera

Product summary:

NDC:17856-3566-1 in a CUP of 2 SYRUPS NDC:17856-3566-3 in a CUP of 5 SYRUPS

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDAZOLAM HYDROCHLORIDE- MIDAZOLAM HYDROCHLORIDE SYRUP
ATLANTIC BIOLOGICALS CORP.
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MIDAZOLAM HYDROCHLORIDE SYRUP
BOX WARNING
Midazolam HCl syrup has been associated with respiratory depression
and
respiratory arrest, especially when used for sedation in noncritical
care settings.
Midazolam HCl 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 HCl 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 HCl 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. _in situH_
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 with artificial bitterness modifier, cherry-brandy flavor,
citric acid
anhydrous, D&C Red #33, edetate disodium, glycerin, sodium benzoate,
sodium citrate,
1813
sodium saccharin, sorbitol, and water; the pH is adjusted to 2.8 to
3.6 with hydrochloric
acid.
Under the acidic conditi