MIDAZOLAM injection

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

A-S Medication Solutions

INN (Alþjóðlegt nafn):

MIDAZOLAM HYDROCHLORIDE

Samsetning:

MIDAZOLAM 5 mg in 1 mL

Stjórnsýsluleið:

INTRAMUSCULAR

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Midazolam Injection is indicated: - intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; - intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants; - intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia); - continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a c

Vörulýsing:

Product: 50090-0683 NDC: 50090-0683-0 10 mL in a VIAL / 10 in a CARTON NDC: 50090-0683-1 10 mL in a VIAL / 1 in a CARTON Product: 50090-0738 NDC: 50090-0738-0 10 mL in a VIAL / 10 in a CARTON

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

MIDAZOLAM- MIDAZOLAM INJECTION
A-S MEDICATION SOLUTIONS
----------
MIDAZOLAM INJECTION, USP
CIV
RX ONLY
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
BOXED WARNING
WARNINGS
PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION
_ADULTS AND PEDIATRICS: _INTRAVENOUS MIDAZOLAM 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
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, PRECAUTIONS; DRUG INTERACTIONS).
INDIVIDUALIZATION OF DOSAGE
MIDAZOLAM SHOULD 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 SEDATIVE EFFECT. THE US