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:

Precision Dose Inc.

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 WARNINGS] . Midazolam HCl 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 anesthesia with injectable midazolam; patients with glaucoma have not been studied. Midazolam HCl syrup is a benzodiazepine and is a Schedule IV controlled substance that can produce drug dependence of the diazepam-type. Therefore, midazolam HCl syrup may be subject to misuse, abuse and addiction. Benzodiazepines can cause physical dependence. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug. Withdrawal symptoms (ie, convulsions, hallucinations, tremors, abdominal and muscle cramps, vomiting and sweating), similar in characteristics to those noted with barbiturates and alcohol have occurred following abrupt discontinuation of midazolam following chronic administration. Abdominal distention, nausea, vomiting, and tachycardia are prominent symptoms of withdrawal in infants. The handling of midazolam HCl syrup should be managed to minimize the risk of diversion, including restriction of access and accounting procedures as appropriate to the clinical setting and as required by law.

Product summary:

Midazolam HCl Syrup is supplied as a clear, red to purplish-red, cherry- brandy flavored syrup containing midazolam hydrochloride equivalent to 2 mg of midazolam/mL. NDC 68094-762-62 2.5 mL per unit dose cup Thirty (30) cups per shipper NDC 68094-764-62 5 mL per unit dose cup Thirty (30) cups per shipper Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MIDAZOLAM HYDROCHLORIDE- MIDAZOLAM HYDROCHLORIDE SYRUP
PRECISION DOSE INC.
----------
MIDAZOLAM HYDROCHLORIDE SYRUP CIV
RX ONLY
For oral use
WARNINGS
PERSONNEL AND EQUIPMENT FOR MONITORING AND DEPRESSION
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. 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 WARNINGS]_. FOR DEEPLY SEDATED 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]_.
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 _in situ_ under
acidic conditions. Chemically, midazolam HCl is
8-chloro-6-(2-fluorophenyl)-1-methyl-_4H_-
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:
18
13
3
Each mL of the syrup contains midazolam hyd