DIAZEPAM- diazepam injection, solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

Diazepam (UNII: Q3JTX2Q7TU) (Diazepam - UNII:Q3JTX2Q7TU)

Saadav alates:

General Injectables and Vaccines, Inc.

INN (Rahvusvaheline Nimetus):

Diazepam

Koostis:

Diazepam 5 mg in 1 mL

Manustamisviis:

INTRAVENOUS

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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

Toote kokkuvõte:

Diazepam Injection, USP is supplied as follows: 10 mL multiple dose vials containing 50 mg (5 mg/mL) Box of 10 Fliptop Vial               NDC 0409-3213-12 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

DIAZEPAM - DIAZEPAM INJECTION, SOLUTION
GENERAL INJECTABLES AND VACCINES, INC.
----------
DIAZEPAM INJECTION, USP
5MG/ML
FLIPTOP VIAL
RX ONLY
CIV
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND
SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH [SEE WARNINGS,
PRECAUTIONS; DRUG INTERACTIONS].
RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS FOR USE IN PATIENTS
FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED.
FOLLOW PATIENTS FOR SIGNS AND SYMPTOMS OF RESPIRATORY DEPRESSION AND
SEDATION.
_Diazepam is indicated:_
_For relief of acute anxiety when rapid action is required_
_In acute alcohol withdrawal_
_As a useful adjunct in_
_endoscopic procedures_
_skeletal muscle spasm associated with local pathology, cerebral
palsy, athetosis, stiff-_
_man syndrome, tetanus_
_status epilepticus and severe recurrent convulsive seizures_
_As premedication in patients undergoing_
_surgical procedures_
_cardioversion_
_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.