DIAZEPAM- diazepam oral solution DIAZEPAM (diazepam oral solution- concentrate solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Chartwell RX, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Diazepam Oral Solution, 5 mg per 5 mL (Orange-colored, peppermint flavored solution) is supplied as follows: NDC 62135-767-47: Bottle of 473 mL. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP/NF. Diazepam Oral Solution (Concentrate), 5 mg per mL (Clear, yellow solution) is supplied as follows: NDC 62135-768-43: Bottle of 30 mL Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard opened bottle after 90 days. PROTECT FROM LIGHT. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71008 Rev. 08/2022-01

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Chartwell RX, LLC
----------
MEDICATION GUIDE
Diazepam Oral Solution, CIV, 5 mg per 5 mL and
Diazepam Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
(dye az’ e pam)
What is the most important information I should know about Diazepam
Oral Solution and Diazepam
Oral Solution (Concentrate)?
•
Diazepam Oral Solution and Diazepam Oral Solution (Concentrate) are
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:
•
shallow or slowed breathing
•
breathing stops (which may lead to the heart stopping)
•
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
Diazepam Oral Solution and
Diazepam Oral Solution (Concentrate) with opioids affects you.
•
Riskofabuse,misuse,andaddiction.There is a risk of abuse, misuse, and
addiction with
benzodiazepines, including Diazepam Oral Solution and Diazepam Oral
Solution (Concentrate),
which can lead to overdose and serious side effects including coma and
death.
•
Serious side effects including coma and death have happened in people
who have abused
or misused benzodiazepines, including Diazepam Oral Solution and
Diazepam Oral
Solution (Concentrate). 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.
•
You can develop an addiction even if you take Diazepam Oral Solution
and Diazepam
Oral Solution (Concentrate) exactly as prescribed by your healthcare
provider.
•
Take Diazepam Oral Solution and Diazepam Oral Solution (Concentrate)
exactly as your
healthcare provider prescribed.
•
Do not share your Diazepam Oral Solution and Diazepam Oral Solution
(Concentra

Summary of Product characteristics

DIAZEPAM- DIAZEPAM ORAL SOLUTION
CHARTWELL RX, LLC
----------
DIAZEPAM ORAL SOLUTION, CIV,
5 MG PER 5 ML
DIAZEPAM ORAL SOLUTION (CONCENTRATE), CIV,
25 MG PER 5 ML (5 MG/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 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).
DESCRIPTION
Each 5 mL of Diazepam Oral Solution contains:
diazepam USP ....................................................... 5
mg
Each mL of Diazepam Oral Solution (Concentrate) contains:
diazepam USP ....................................................... 5
mg
alcohol
.................................................................. 19%
_I