DIAZEPAM solution, concentrate DIAZEPAM solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lannett Company, Inc.

INN (International Name):

DIAZEPAM

Composition:

DIAZEPAM 5 mg in 5 mL

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, mint-peppermint flavored solution) is supplied as follows: NDC 0527-1767-65:      Bottle of 500 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 0527-1768-36:      Bottle of 30 mL with calibrated dropper [graduations of 0.2 mL (1 mg), 0.4 mL (2 mg), 0.6 mL (3 mg), 0.8 mL (4 mg), and 1 mL (5 mg) on the dropper]. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Discard opened bottle after 90 days. PROTECT FROM LIGHT. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 10-393 Rev.01/21

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DIAZEPAM- DIAZEPAM SOLUTION, CONCENTRATE
Lannett Company, Inc.
----------
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.
•
Risk of abuse, misuse, and addiction. 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

Summary of Product characteristics

DIAZEPAM- DIAZEPAM SOLUTION
DIAZEPAM- DIAZEPAM SOLUTION, CONCENTRATE
LANNETT COMPANY, INC.
----------
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
.................................