देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
LORAZEPAM (UNII: O26FZP769L) (LORAZEPAM - UNII:O26FZP769L)
Pharmaceutical Associates, Inc.
Lorazepam
Lorazepam 2 mg in 1 mL
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
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 पूरा दस्तावेज़ पढ़ें