DIAZEPAM injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Hospira, Inc.

INN (mednarodno ime):

DIAZEPAM

Sestava:

DIAZEPAM 5 mg in 1 mL

Pot uporabe:

INTRAMUSCULAR

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 Injection is a useful adjunct in status epilepticus and severe recurrent convulsive seizures. Diazepam is a useful preme

Povzetek izdelek:

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

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

DIAZEPAM- DIAZEPAM INJECTION, SOLUTION
HOSPIRA, INC.
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DIAZEPAM INJECTION, USP
RX ONLY
5 MG/ML
Fliptop Vial
CIV
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
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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%
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH (SEE
WARNINGS).
RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS 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 (SEE WARNINGS AND PRECAUTIONS).
THE USE OF BENZODIAZEPINES, INCLUDING DIAZEPAM, EXPOSES USERS TO
RISKS OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR
DEATH. ABUSE AND MISUSE OF BENZODIAZEPINES COMMONLY INVOLVE
CONCOMITANT USE OF OTHER MEDICATIONS, ALCOHOL, AND/OR ILLICIT
SUBSTANCES, WHICH IS ASSOCIATED WITH AN INCREASED FREQUENCY OF
SERIOUS ADVERSE OUTCOMES. BEFORE PRESCRIBING DIAZEPAM AND
THROUGHOUT TREATMENT, ASSESS EACH PATIENT'S RISK FOR ABUSE, MISUSE,
AND ADDICTION (SEE WARNINGS).
THE CONTINUED USE OF BENZODIAZEPINES MAY LEAD TO CLINICALLY
SIGNIFICANT PHYSICAL DEPENDENCE. THE RISKS OF DEPENDENCE AND
WITHDRAWAL INCREASE WITH LONGER TREATMENT DURATION AND HIGHER DAILY
DOSE. ALTHOUGH DIAZEPAM IS INDICATED ONLY FOR INTERMITTENT USE (SEE
INDICATIONS AND USAGE AND DOSAGE AND ADMINISTRATION), IF
USED MORE FREQUENTLY THAN RECOMMENDED, ABRUPT DISCONTINUATION OR
RAPID DOSAGE REDUCTION OF DIAZEPAM MAY PRECIPITATE ACUTE
WITHDRAWAL REACTIONS, WHICH CAN BE LIFE-THREATENING. FOR PATIENTS
USING DIAZEPAM MORE FREQUENTLY THAN RECOMMENDED, TO REDUCE THE
RISK OF WITHDRAWAL REACTIONS, USE A GRADUAL TAPER TO DISC