DIAZEPAM injection, solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

DIAZEPAM (UNII: Q3JTX2Q7TU) (DIAZEPAM - UNII:Q3JTX2Q7TU)

Beschikbaar vanaf:

Physicians Total Care, Inc.

INN (Algemene Internationale Benaming):

DIAZEPAM

Samenstelling:

DIAZEPAM 5 mg in 1 mL

Toedieningsweg:

INTRAMUSCULAR

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient’s recall of the procedures. (See WARNINGS.) Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma); spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia); athetosis; stiff-man syndrome; and tetanus. Diazepam is a useful adjunct in status epilepticus and severe recurrent convulsive seizures. Diazepam is a useful premedication (t

Product samenvatting:

Diazepam Injection, USP is supplied as follows: 10 mL multiple dose vials containing 50 mg (5 mg/mL) Box of 10      NDC 54868-0617-2 10 mL multiple dose vials containing 50 mg (5 mg/mL) Carton of 5    NDC 54868-0617-1 Protect from light.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

DIAZEPAM - DIAZEPAM INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
----------
5 MG/ML
CIV
Fliptop Vial
Rx only
DESCRIPTION
Diazepam Injection, USP is a sterile, nonpyrogenic solution intended
for intramuscular or intravenous
administration. Each milliliter (mL) contains 5 mg diazepam; 40%
propylene glycol; 10% alcohol; 5%
sodium benzoate and benzoic acid added as buffers; and 1.5% benzyl
alcohol added as a preservative.
pH 6.6 (6.2 to 6.9). Note: Solution may appear colorless to light
yellow.
Diazepam is a benzodiazepine derivative chemically designated as
7-chloro-1,3-dihydro-1-methyl-5-
phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless crystalline
compound, insoluble in water, with the
following molecular structure:
CLINICAL PHARMACOLOGY
In animals, diazepam appears to act on parts of the limbic system, the
thalamus and hypothalamus, and
induces calming effects. Diazepam, unlike chlorpromazine and
reserpine, has no demonstrable
peripheral autonomic blocking action, nor does it produce
extrapyramidal side effects; however,
animals treated with diazepam do have a transient ataxia at higher
doses. Diazepam was found to have
transient cardiovascular depressor effects in dogs. Long-term
experiments in rats revealed no
disturbances of endocrine function. Injections into animals have
produced localized irritation of tissue
surrounding injection sites and some thickening of veins after
intravenous use.
INDICATIONS AND USAGE
Diazepam is indicated for the management of anxiety disorders or for
the short-term relief of the
symptoms of anxiety. Anxiety or tension associated with the stress of
everyday life usually does not
require treatment with an anxiolytic.
In acute alcohol withdrawal, diazepam may be useful in the symptomatic
relief of acute agitation,
tremor, impending or acute delirium tremens and hallucinosis.
As an adjunct prior to endoscopic procedures if apprehension, anxiety
or acute stress reactions are
present, and to diminish the patient’s recall of the procedures.
(See WARNINGS.)
Diazepam is a useful a