LORAZEPAM liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

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

Available from:

Pharmaceutical Associates, Inc.

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 the benzodiazepines or to any components of the formulation - acute narrow-angle glaucoma. Controlled Substance Lorazepam Oral Concentrate USP is a Schedule IV controlled substance. Abuse 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, fo

Product summary:

2 mg per mL Lorazepam Oral Concentrate USP PROTECT FROM LIGHT Keep bottles tightly closed. Keep out of the reach of children. Store at Cold Temperature. Refrigerate 2° - 8°C (36° - 46°F) Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

                                LORAZEPAM- LORAZEPAM LIQUID
PHARMACEUTICAL ASSOCIATES, INC.
----------
LORAZEPAM ORAL CONCENTRATE USP, 2 MG PER ML, CIV
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 (see DOSAGE AND ADMINISTRATION and WARNINGS).
DESCRIPTION
Lorazepam, an antianxiety agent, has the chemical formula,
2H-1,4-benzodiazepin-2-
one, 7-chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-, (±)-:
C
H
CL
N
O M.W. 321.16
It is a nearly white powder almost insoluble in water. The inactive
ingredients present are
15
10
2
2
2
polyethylene glycol and propylene glycol.
CLINICAL PHARMACOLOGY
Studies in healthy volunteers show that
                                
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