Lorazepam
FULL PRESCRIBING INFORMATION: CONTENTS*
- LORAZEPAM DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- LORAZEPAM CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- ESSENTIAL LABORATORY TESTS
- CLINICALLY SIGNIFICANT DRUG INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS
- PREGNANCY
- GERIATRIC USE
- LORAZEPAM ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
LORAZEPAM DESCRIPTION
CLINICAL PHARMACOLOGY
INDICATIONS & USAGE
LORAZEPAM CONTRAINDICATIONS
WARNINGS
PRECAUTIONS, Clinically Significant Drug Interactions)
Use of benzodiazepines, including lorazepam, may lead to physical and psychological dependence.
As with all patients on CNS-depressant 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.
Physical And Psychological Dependence
The use of benzodiazepines, including lorazepam, may lead to physical and psychological dependence. The risk of dependence increases with higher doses and longer term use and is further increased in patients with a history of alcoholism or drug abuse or in patients with significant personality disorders. The dependence potential is reduced when lorazepam is used at the appropriate dose for short-term treatment. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving lorazepam or other psychotropic agents.
In general, benzodiazepines should be prescribed for short periods only (e.g. 2- 4 weeks). Extension of the treatment period should not take place without reevaluation of the need for continued therapy. Continuous long-term use of product is not recommended. Withdrawal symptoms (e.g. rebound insomnia) can appear following cessation of recommended doses after as little as one week of therapy. Abrupt discontinuation of product should be avoided and a gradual dosage-tapering schedule followed after extended therapy.
Abrupt termination of treatment may be accompanied by withdrawal symptoms. Symptoms reported following discontinuation of benzodiazepines include headache, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, rebound phenomena, dysphoria, dizziness, derealization, depersonalization, hyperacusis, numbness/tingling of extremities, hypersensitivity to light, noise, and physical contact/perceptual changes, involuntary movements, nausea, vomiting, diarrhea, loss of appetite, hallucinations/delirium, convulsions/seizures, tremor, abdominal cramps, myalgia, agitation, palpitations, tachycardia, panic attacks, vertigo, hyperreflexia, short-term memory loss, and hyperthermia. Convulsions/seizures may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold such as antidepressants.
There is evidence that tolerance develops to the sedative effects of benzodiazepines.
Lorazepam may have abuse potential, especially in patients with a history of drug and/or alcohol abuse.
PRECAUTIONS
INFORMATION FOR PATIENTS
ESSENTIAL LABORATORY TESTS
CLINICALLY SIGNIFICANT DRUG INTERACTIONS
CARCINOGENESIS & MUTAGENESIS
PREGNANCY
GERIATRIC USE
ADVERSE REACTIONS).Age does not appear to have a significant effect on lorazepam kinetics (seeCLINICAL PHARMACOLOGY).
Clinical circumstances, some of which may be more common in the elderly, such as hepatic or renal impairment, should be considered. Greater sensitivity (e.g., sedation) of some older individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious, and lower doses may be sufficient in these patients (seeDOSAGE AND ADMINISTRATION).
LORAZEPAM ADVERSE REACTIONS
OVERDOSAGE
Symptoms
Overdosage of benzodiazepines is usually manifested by varying degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, paradoxical reactions, dysarthria and lethargy. In more serious cases, and especially when other drugs or alcohol were ingested, symptoms may include ataxia, hypotonia, hypotension, cardiovascular depression, respiratory depression, hypnotic state, coma, and death.
MANAGEMENT
The benzodiazepine antagonist flumazenil may be used in hospitalized patients as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. 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, andPRECAUTIONSshould be consulted prior to use.
DOSAGE & ADMINISTRATION
HOW SUPPLIED
240over0.5on one side andWATSONon the other side, supplied in bottles of 100, 500 and 1000.
1 mg: white, scored, round flat faced beveled edge, debossed with241over1on one side andWATSONon the other side, supplied in bottles of 100, 500 and 1000.
2 mg: white, scored, round flat faced beveled edge, debossed with242over2on one side andWATSONon the other side, supplied in bottles of 100, 500 and 1000.
STORAGE AND HANDLING
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
LorazepamLORAZEPAM TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
