DIAZEPAM solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Pharmaceutical Associates, Inc.

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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. 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; and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug

產品總結:

Diazepam Oral Solution The 5 mg per 5 mL oral solution is supplied as a (wintergreen-spice flavored) clear, orange-colored solution. NDC 0121-0905-05: 5 mL unit dose cup, in a tray of ten cups. STORAGE Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP/NF.

授权状态:

Abbreviated New Drug Application

资料单张

DIAZEPAM- diazepam solution
Pharmaceutical Associates, Inc.
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MEDICATION GUIDE
Diazepam Oral Solution, CIV, (5
mg/mL)
(dye az’ e pam)
What is the most important information I should know about Diazepam
Oral Solution?
• Diazepam Oral Solution is a benzodiazepine medicine. Taking
benzodiazepines with opioid medicines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe drowsiness,
breathing problems (respiratory depression), coma and death.
• Diazepam Oral Solution can make you sleepy or dizzy, and can slow
your thinking and motor skills.
o Do not drive, operate heavy machinery, or do other dangerous
activities until you know how Diazepam
Oral Solution affects you.
o Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking Diazepam Oral
Solution without first talking to your healthcare provider. When taken
with alcohol or drugs that cause
sleepiness or dizziness, Diazepam Oral Solution may make your
sleepiness or dizziness much worse.
• Do not take more Diazepam Oral Solution than prescribed.
What is Diazepam Oral Solution?
• Diazepam Oral Solution is a prescription medicine used:
o to treat anxiety disorders
o for the short-term relief of the symptoms of anxiety
o to relieve the symptoms of alcohol withdrawal including agitation,
shakiness (tremor), sudden and severe
mental or nervous system changes (delirium tremens) and seeing or
hearing things that others do not see or
hear (hallucinations)
o along with other medicines for the relief of muscle spasms
o along with other medicines to treat seizure disorders
• Diazepam Oral Solution is a federal controlled substance (C-IV)
because it can be abused or lead to
dependence. Keep Diazepam Oral Solution in a safe place to prevent
misuse and abuse. Selling or giving
away Diazepam Oral Solution may harm others, and is against the law.
Tell your healthcare provider if you
have abused or been dependent on alcohol, prescription medicines or
street drugs.
• It is not known if Diaz

产品特点

DIAZEPAM- DIAZEPAM SOLUTION
PHARMACEUTICAL ASSOCIATES, INC.
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DIAZEPAM ORAL SOLUTION, CIV
5 MG PER 5 ML
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND
SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH.
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 PATIENTS RISK FOR ABUSE, MISUSE,
AND ADDICTION (SEE WARNINGS).
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING DIAZEPAM, FOR SEVERAL
DAYS TO WEEKS MAY LEAD TO CLINICALLY SIGNIFICANT PHYSICAL DEPENDENCE.
ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF DIAZEPAM AFTER
CONTINUED USE MAY PRECIPITATE ACUTE WITHDRAWAL REACTIONS, WHICH CAN
BE LIFE-THREATENING. TO REDUCE THE RISK OF WITHDRAWAL REACTIONS, USE A
GRADUAL TAPER TO DISCONTINUE DIAZEPAM OR REDUCE THE DOSAGE (SEE
DOSAGE AND ADMINISTRATION AND WARNINGS).
DESCRIPTION
Diazepam is a benzodiazepine derivative. Chemically, diazepam is
7-chloro-1,3-dihydro-1-
methyl-5-phenyl-2 _H_-1,4-benzodiazepin-2-one. It is a white to
practically white crystalline
powder, insoluble in water and has a molecular weight of 284.74. Its
structural formula
is as follows:
C
H
CIN
O
Each 5 mL of Oral Solution contains:
diazepam USP 5 mg
_Inactive Ingredients_
The flavored 5 mg/5 mL Oral Solution contains bitterness modifier,
citric acid, D&C Yellow
No. 10,