LORAZEPAM concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LORAZEPAM (UNII: O26FZP769L) (LORAZEPAM - UNII:O26FZP769L)

Available from:

Amneal Pharmaceuticals LLC

INN (International Name):

LORAZEPAM

Composition:

LORAZEPAM 2 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam 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 for the individual patient. Lorazepam is contraindicated in patients with: - hypersensitivity to benzodiazepines or to any components of the formulation. - acute narrow-angle glaucoma. Lorazepam contains lorazepam, a Schedule IV controlled substance. Lorazepam is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug

Product summary:

Lorazepam Oral Concentrate USP, 2 mg per mL , is available as a clear, colorless solution. It is supplied as follows: NDC 65162-687-84: Bottles of 30 mL with calibrated dropper (graduations of 0.25 mL [0.5 mg], 0.5 mL [1 mg], 0.75 mL [1.5 mg] and 1 mL [2 mg] on the dropper). PROTECT FROM LIGHT Keep bottles tightly closed. Keep out of reach of children. Store at cold temperature. Refrigerate at 2° to 8°C (36° to 46°F). Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days. Manufactured by: Amneal Pharmaceuticals LLC Branchburg, NJ 08876 Distributed by: Amneal Pharmaceuticals LLC Glasgow, KY 42141 Rev. 07-2023-04

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Amneal Pharmaceuticals LLC
----------
MEDICATION GUIDE
Lorazepam (lor az’ e pam) Oral Concentrate USP, CIV
What is the most important information I should know about lorazepam?
•
Lorazepam 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. 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
lorazepam with opioids affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines including lorazepam 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 lorazepam. 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 lorazepam exactly as
prescribed by your healthcare
provider.
•
Take lorazepam exactly as your healthcare provider prescribed.
•
Do not share your lorazepam with other people.
•
Keep lorazepam in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Lorazepam can cause
physical dependence and
withdrawal reactions.
•
Do not suddenly stop taking lorazepam. Stopping lorazepam suddenly can
cause serious and life-
threatening side effects, including, unusual movements, responses or
expressions, seizures, sudden
and severe mental or nervous system changes, depression, seeing or
hearing things that others do not
see or

Summary of Product characteristics

LORAZEPAM- LORAZEPAM CONCENTRATE
AMNEAL PHARMACEUTICALS LLC
----------
LORAZEPAM ORAL CONCENTRATE USP, 2 MG PER ML, CIV
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 FOR 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 LORAZEPAM, 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 LORAZEPAM AND
THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE,
AND ADDICTION (SEE WARNINGS).
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING LORAZEPAM 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
LORAZEPAM 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 LORAZEPAM OR
REDUCE THE DOSAGE (DOSAGE AND ADMINISTRATION AND WARNINGS).
DESCRIPTION
Lorazepam USP, an antianxiety agent, has the chemical formula,
2_H_-1,4-benzodiazepin-
2-one, 7-chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-, (±)-:
C
H
C N O M.W. 321.16
Lorazepam, USP is a white to almost white powder, practically
insoluble in water. Each
mL of lorazepam oral concentrate, USP contains 2 mg of lorazepam. The
inactive
ingredients are polyethylene glycol, propyle