DIAZEPAM solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Hikma Pharmaceuticals USA Inc.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

Diazepam Oral Solution The 5 mg per 5 mL oral solution is supplied as a (wintergreen-spice flavored) clear, orange-colored solution. NDC 0054-3188-63: Bottle of 500 mL 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. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50001281/01 Revised November 2022

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

Hikma Pharmaceuticals USA Inc.
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MEDICATION GUIDE
MEDICATION GUIDE
Diazepam Oral Solution, CIV, 5 mg per 5 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 (CNS)
(including street drugs) can
cause severe drowsiness, breathing problems (respiratory depression),
coma and death. Get
emergency help right away if any of the following happens:
o
shallow or slowed breathing
o
breathing stops (which may lead to the heart stopping)
o
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
Diazepam Oral Solution with
opioids affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines, including Diazepam Oral Solution which can lead to
overdose and serious side
effects including coma and death.
o
Serious side effects including coma and death have happened in people
who have abused or
misused benzodiazepines, including Diazepam Oral Solution. These
serious side effects may
also include delirium, paranoia, suicidal thoughts or actions,
seizures, and difficulty
breathing. Call your healthcare provider or go to the nearest hospital
emergency room right
away if you get any of these serious side effects.
o
You can develop an addiction even if you take Diazepam Oral Solution
exactly as prescribed
by your healthcare provider.
o
Take Diazepam Oral Solution exactly as your healthcare provider
prescribed.
o
Do not share your Diazepam Oral Solution with other people.
o
Keep Diazepam Oral Solution in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Diazepam Oral Solution
can cause physical
dependence and withdrawal reactions, especially if you continue to
take Diazepam Oral Solution
for several days to several weeks.
o
Do not suddenly stop taking Diazepam Oral Solution. Stopping

Produktets egenskaber

DIAZEPAM- DIAZEPAM SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
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.
•
•
•
DESCRIPTION
Each 5 mL of Diazepam 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, FD&C Red No. 40, polyethylene glycol, propylene glycol, sodium
citrate, sorbitol,
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, INCLUDING DIAZEPAM, MAY LEAD
TO CLINICALLY SIGNIFICANT PHYSICAL DEPENDENCE. THE RISKS OF
DEPENDENCE AND WITHDRAWAL INCREASE WITH LONGER TREATMENT DURATION
AND HIGHER DAILY DOSE. 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).
water and wintergreen coriander spice blend.
Diazepam