Product Elements:
Lorazepam lorazepam lorazepam lorazepam anhydrous lactose microcrystalline cellulose polacrilin potassium magnesium stearate ep;904
Indications and Usage:
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.
Warnings:
Warnings pre-existing depression may emerge or worsen during use of benzodiazepines including lorazepam. lorazepam is not recommended for use in patients with a primary depressive disorder or psychosis. use of benzodiazepines, including lorazepam, both used alone and in combination with other cns depressants may lead to potentially fatal respiratory depression. (see 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
Read more... 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 to 4 weeks). extension of the treatment period should not take place without reevaluation of the need for continued therapy. continuous long-term use of the 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.
Dosage and Administration:
Dosage and administration lorazepam tablets, usp are 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 dose 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 tablets 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.
Contraindications:
Contraindications lorazepam is contraindicated in patients with ⢠hypersensitivity to benzodiazepines or to any components of the formulation. ⢠acute narrow-angle glaucoma.
Adverse Reactions:
Adverse reactions most adverse reactions to benzodiazepines, including cns effects and respiratory depression, are dose dependent, with more severe effects occurring with high doses. in a sample of about 3500 patients treated for anxiety, the most frequent adverse reaction to lorazepam was sedation (15.9%), followed by dizziness (6.9%), weakness (4.2%), and unsteadiness (3.4%). the incidence of sedation and unsteadiness increased with age. other adverse reactions to benzodiazepines, including lorazepam are fatigue, drowsiness, amnesia, memory impairment, confusion, disorientation, depression, unmasking of depression, disinhibition, euphoria, suicidal ideation/attempt, ataxia, asthenia, extrapyramidal symptoms, convulsions/seizures, tremor, vertigo, eye-function/visual disturbance (including diplopia and blurred vision), dysarthria, slurred speech, change in libido, impotence, decreased orgasm; headache, coma; respiratory depression, apnea, worsening of sleep apnea, worsening of obstruc
Read more...tive pulmonary disease; gastrointestinal symptoms including nausea, change in appetite, constipation, jaundice, increase in bilirubin, increase in liver transaminases, increase in alkaline phosphatase; hypersensitivity reactions, anaphylactic/oid reactions; dermatological symptoms, allergic skin reactions, alopecia; siadh, hyponatremia, thrombocytopenia, agranulocytosis, pancytopenia; hypothermia; and autonomic manifestations. paradoxical reactions, including anxiety, excitation, agitation, hostility, aggression, rage, sleep disturbances/insomnia, sexual arousal, and hallucinations may occur. small decreases in blood pressure and hypotension may occur but are usually not clinically significant, probably being related to the relief of anxiety produced by lorazepam.
Overdosage:
Overdosage in postmarketing experience, overdose with lorazepam has occurred predominantly in combination with alcohol and/or other drugs. therefore, in the management of overdosage, it should be borne in mind that multiple agents may have been taken. 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 general supportive and symptomatic measures are recommended; vital signs must be monitored and the patient closely observed. when there is a risk of aspiration, induction of emesis is not recommended. gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients. administration of activated charcoal may also limit drug absorption. hypotension, though unlikely, usually may be controlled with norepinephrine bitartrate injection. lorazepam is poorly dialyzable. lorazepam glucuronide, the inactive metabolite, may be highly dialyzable. 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 âcontraindicationsâ , âwarningsâ , and âprecautionsâ should be consulted prior to use.
Description:
Description lorazepam, an antianxiety agent, has the chemical formula, 7-chloro-5-( o -chlorophenyl)-1,3-dihydro-3-hydroxy-2 h -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. the inactive ingredients present are lactose anhydrous, microcrystalline cellulose, polacrilin potassium and magnesium stearate. lorazepam structure
Clinical Pharmacology:
Clinical pharmacology studies in healthy volunteers show that in single high doses lorazepam has a tranquilizing action on the central nervous system with no appreciable effect on the respiratory or cardiovascular systems. lorazepam is readily absorbed with an absolute bioavailability of 90 percent. peak concentrations in plasma occur approximately 2 hours following administration. the peak plasma level of lorazepam from a 2 mg dose is approximately 20 ng/ml. the mean half-life of unconjugated lorazepam in human plasma is about 12 hours and for its major metabolite, lorazepam glucuronide, about 18 hours. at clinically relevant concentrations, lorazepam is approximately 85% bound to plasma proteins. lorazepam is rapidly conjugated at its 3-hydroxy group into lorazepam glucuronide which is then excreted in the urine. lorazepam glucuronide has no demonstrable cns activity in animals. the plasma levels of lorazepam are proportional to the dose given. there is no evidence of accumulation of
Read more... lorazepam on administration up to six months. studies comparing young and elderly subjects have shown that advancing age does not have a significant effect on the pharmacokinetics of lorazepam. however, in one study involving single intravenous doses of 1.5 to 3 mg of lorazepam, mean total body clearance of lorazepam decreased by 20% in 15 elderly subjects of 60 to 84 years of age compared to that in 15 younger subjects 19 to 38 years of age.
How Supplied:
How supplied lorazepam tablets, usp are available in the following dosage strengths: 0.5 mg white, round, flat face, beveled edge tablets, debossed âep 904â on one side and plain on the other side. they are available as follows: bottles of 100 tablets ndc# 0904-6007-60 bottles of 500 tablets ndc# 0904-6007-40 cartons of 100 tablets (10 tablets each blister pack x 10) ndc 0904-6007-61 1 mg white, round, flat face, beveled edge tablets, debossed âep 905â and scored on one side and "1" on the other side. they are available as follows: bottles of 100 tablets ndc# 0904-6008-60 cartons of 100 tablets (10 tablets each blister pack x 10) ndc 0904-6008-61 2 mg white, round, flat face, beveled edge tablets, debossed âep 906â and scored on one side and "2" on the other side. they are available as follows: bottles of 100 tablets ndc# 0904-6009-60 cartons of 100 tablets (10 tablets each blister pack x 10) ndc 0904-6009-61 store at 20° to 25°c (68° to 77°f)
Read more...[see usp controlled room temperature]. dispense in a tight container. bottles: keep tightly closed store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. dispense in a tight container.
Package Label Principal Display Panel:
Principal display panel - 0.5mg ndc 71610-008 - lorazepam 0.5mg - rx only bottle label 0.5mg