LORazepam 0.5 MG Oral Tablet

Generic Name: LORAZEPAM
Brand Name: Lorazepam
  • Substance Name(s):
  • LORAZEPAM

WARNINGS

Lorazepam is not recommended for use in patients with a primary depressive disorder of psychosis. As with all patients on CNS-acting drugs, patients receiving lorazepam should be warned not to operate dangerous machinery or motor vehicles and that their tolerance for alcohol and other CNS depressants will be diminished.

OVERDOSAGE

In the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. Manifestations of lorazepam overdosage include somnolence, confusion, and coma. Induced vomiting and/or gastric lavage should be undertaken, followed by general supportive care, monitoring of vital signs, and close observation of the patient. Hypotension, though unlikely, usually may be controlled with norepinephrine bitartrate injection. The usefulness of dialysis has not been determined. Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use.

DESCRIPTION

Lorazepam, an antianxiety agent, has the chemical formula, (±)-7-Chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one: It is a nearly white powder almost insoluble in water. Each lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg or 2 mg of lorazepam. This product contains the following inactive ingredients: lactose, magnesium stearate, microcrystalline cellulose and polacrilin potassium. image of chemical structure

HOW SUPPLIED

Lorazepam tablets are available in the following dosage strengths: 0.5 mg: white, scored, round flat faced beveled edge, debossed with 240 over 0.5 on one side and WATSON on the other side, supplied in: Bottles of 10 NDC 54868-2145-0 Bottles of 20 NDC 54868-2145-2 Bottles of 30 NDC 54868-2145-3 Bottles of 50 NDC 54868-2145-5 Bottles of 60 NDC 54868-2145-6 Bottles of 90 NDC 54868-2145-9 Bottles of 100 NDC 54868-2145-4 1 mg: white, scored, round flat faced beveled edge, debossed with 241 over 1 on one side and WATSON on the other side, supplied in: Bottles of 03 NDC 54868-1338-6 Bottles of 10 NDC 54868-1338-7 Bottles of 15 NDC 54868-1338-0 Bottles of 20 NDC 54868-1338-1 Bottles of 30 NDC 54868-1338-3 Bottles of 60 NDC 54868-1338-4 Bottles of 90 NDC 54868-1338-8 Bottles of 100 NDC 54868-1338-2 Bottles of 120 NDC 54868-1338-9 2 mg: white, scored, round flat faced beveled edge, debossed with 242 over 2 on one side and WATSON on the other side, supplied in: Bottles of 30 NDC 54868-0061-3 Bottles of 60 NDC 54868-0061-5 Bottles of 90 NDC 54868-0061-4 Bottles of 100 NDC 54868-0061-2 Bottles of 120 NDC 54868-0061-6 Store at controlled room temperature 15°-30°C (59°-86°F). [See USP.] Dispense in a tight, light-resistant container as defined in the USP. Watson Laboratories, Inc. Corona, CA 92880 USA 30223-3 Rev: February 2004 Repackaging and Relabeling by: Physicians Total Care, Inc. Tulsa, OK 74146

INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

Lorazepam is administered orally. For optimal results, dose, frequency of administration, and duration of therapy should be individualized according to patient response. To facilitate this, 0.5 mg, 1 mg, and 2 mg tablets are available. The usual range is 2 to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the daily dosage may vary from 1 to 10 mg/day. For anxiety, most patients require an initial dose of 2 to 3 mg/day given b.i.d. or t.i.d. For insomnia due to anxiety or transient situational stress, a single daily dose of 2 to 4 mg may be given, usually at bedtime. For elderly or debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated. The dosage of lorazepam should be increased gradually when needed to help avoid adverse effects. When higher dosage is indicated, the evening dose should be increased before the daytime doses.