MIDAZOLAM HYDROCHLORIDE injection, solution

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Cardinal Health 107, LLC

INN (International ime):

MIDAZOLAM HYDROCHLORIDE

Sastav:

MIDAZOLAM 1 mg in 1 mL

Administracija rute:

INTRAMUSCULAR

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Midazolam injection is indicated: Injectable midazolam is contraindicated in patients with a known hypersensitivity to the drug. 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 with midazolam; patients with glaucoma have not been studied. Midazolam Injection contains midazolam a Schedule IV control substance. Midazolam was actively self-administered in primate models used to assess the positive reinforcing effects of psychoactive drugs. Midazolam produced physical dependence of a mild to moderate intensity in cynomolgus monkeys after 5 to 10 weeks of administration. Available data concerning the drug abuse and dependence potential of midazolam suggest that its abuse potential is at least equivalent to that of diazepam. Withdrawal symptoms, similar in ch

Proizvod sažetak:

Package configurations containing preservative-free midazolam hydrochloride equivalent to 1 mg midazolam/mL : Overbagged with 5 vials in each bag, NDC 55154-4743-5 2 mg/2 mL (1 mg/mL) Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.] Discard unused portion.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

MIDAZOLAM HYDROCHLORIDE- MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
CARDINAL HEALTH 107, LLC
----------
MIDAZOLAM CIV
INJECTION, USP
PRESERVATIVE-FREE
For intravenous or intramuscular use.
RX ONLY
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 procedures.
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 2 or more minutes to fully evaluate