MIDAZOLAM HYDROCHLORIDE injection, solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
03-03-2021

Viambatanisho vya kazi:

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

Inapatikana kutoka:

A-S Medication Solutions

Njia ya uendeshaji:

INTRAMUSCULAR

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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

Bidhaa muhtasari:

Product: 50090-5472 NDC: 50090-5472-0 10 mL in a VIAL / 10 in a BOX

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

                                MIDAZOLAM HYDROCHLORIDE- MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
A-S MEDICATION SOLUTIONS
----------
MIDAZOLAM
INJECTION, USP
CIV
R ONLY
For intravenous or intramuscular use.
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
X
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 AND PRECAUTIONS; DRUG_
_INTERACTIONS_).
INDIVIDUALIZATION OF DOSAGE
Midazolam must 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
                                
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