MIDAZOLAM injection, solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

HF Acquisition Co LLC, DBA HealthFirst

Vartojimo būdas:

INTRAMUSCULAR

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

MIDAZOLAM INJECTION, USP is supplied in the following dosage forms. NDC 51662-1327-1 MIDAZOLAM INJECTION, USP 5mg/mL 1mL VIAL NDC 51662-1324-1 MIDAZOLAM INJECTION, USP 5mg/5mL (1mg/mL) PF 5mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Package configurations containing preservative-free midazolam hydrochloride equivalent to 1 mg midazolam/mL: Package configurations containing preservative-free midazolam hydrochloride equivalent to 5 mg midazolam/mL: Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature.] Discard unused portion.

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

MIDAZOLAM- MIDAZOLAM INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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MIDAZOLAM INJECTION, USP, VIAL
BOXED WARNING
Personnel and Equipment for Monitoring and Resuscitation - Adults and
Pediatrics - Intravenous
midazolam has been associated with respiratory depression and ...
SPL UNCLASSIFIED
Preservative-Free
For intravenous or intramuscular use.
Rx only
DESCRIPTION
Midazolam hydrochloride injection is a water-soluble benzodiazepine
available as a sterile,
nonpyrogenic parenteral dosage form for intravenous or intramuscular
injection. Each mL contains
midazolam hydrochloride equivalent to 1 mg or 5 mg midazolam
compounded with 0.8% sodium
chloride. The pH is adjusted to approximately 3 with hydrochloric acid
and, if necessary, sodium
hydroxide.
Midazolam is a white to light yellow crystalline compound, insoluble
in water. The hydrochloride salt
of midazolam, which is formed in situ, is soluble in aqueous
solutions. Chemically, midazolam HCl is
8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine
hydrochloride.
Midazolam hydrochloride has the empirical formula C18H13ClFN3·HCl, a
calculated molecular weight
of 362.25 and the following structural formula:
Under the acidic conditions required to solubilize midazolam in the
product, midazolam is present as an
equilibrium mixture (shown below) of the closed-ring form shown above
and an open-ring structure
formed by the acid-catalyzed ring opening of the 4,5-double bond of
the diazepine ring. The amount of
open-ring form is dependent upon the pH of the solution. At the
specified pH of the product, the
solution may contain up to about 25% of the open-ring compound. At the
physiologic conditions under
which the product is absorbed (pH of 5 to 8) into the systemic
circulation, any open-ring form present
reverts to the physiologically active, lipophilic, closed-ring form
(midazolam) and is absorbed as such.
The following chart plots the percentage of midazolam present as the
open-ring form as a function of
pH in aqueous solutions.