Product Elements:
Lorazepam lorazepam lorazepam lorazepam anhydrous lactose microcrystalline cellulose polacrilin potassium magnesium stearate ep;904 lorazepam lorazepam lorazepam lorazepam anhydrous lactose microcrystalline cellulose polacrilin potassium magnesium stearate ep;905;1 lorazepam lorazepam lorazepam lorazepam anhydrous lactose microcrystalline cellulose polacrilin potassium magnesium stearate ep;906;2
Boxed Warning:
Warning: risks from concomitant use with opioids concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death ( see warnings; precautions, clinically significant drug interactions ). ⢠reserve concomitant prescribing of these drugs for use in 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.
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 concomitant use of benzodiazepines, including lorazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. if a decision is made to prescribe lorazepam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. in patients already receiving an opioid analgesic, prescribe a lower initial dose of lorazepam than indicated in the absence of an opioid and titrate based on clinical response. if an opioid is initiated in a patient already taking lorazepam, prescribe a lower initial dose of
Read more... the opioid and titrate based upon clinical response. advise both patients and caregivers about the risks of respiratory depression and sedation when lorazepam is used with opioids. advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined ( see precautions , clinically significant drug interactions ). 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 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 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 two times a day or three times a day. 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.
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. call your doctor for medical advice about side effects. you may report side effects to the fda at phone # 1-800-fda-1088 or leading pharma, llc at 1-844-740-7500.
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 cns 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 contraindication, warnings , and precautions 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, magnesium stearate, microcrystalline cellulose and polacrilin potassium. 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%. 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 loraze
Read more...pam on administration up to 6 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 injection, 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 0.5 mg white color, round, flat face beveled edge compressed tablets, debossed "ep" and "904" on one side, and plain on the other side. bottles of 100 tablets ndc# 0904-6007-60 cartons of 100 tablets (10 tablets each blister pack x 10) ndc 0904-6007-61 1 mg white color, round, bisected flat face beveled edge compressed tablets, debossed "ep" above bisect and "905" below bisect on one side, and "1" on the other side. 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 color, round, bisected flat face beveled edge compressed tablets, debossed "ep" above bisect and "906" below bisect on one side, and "2" on the other side. bottles of 100 tablets ndc# 0904-6009-60 cartons of 100 tablets (10 tablets each blister pack x 10) ndc 0904-6009-61 bottles: dispense in a tight, light-resistant container as defined in the usp, using a child-resistant closure. keep this and all medications out of the reach of chil
Read more...dren. store at 20°-25°c (68°-77°f) [see usp controlled room temperature]. excursions permitted to 59Ë to 86Ëf (15Ë to 30Ëc).
Package Label Principal Display Panel:
Package/label display panel lorazepam tablets, usp civ 0.5 mg 100 tablets carton label
Package/label display panel lorazepam tablets, usp civ 1 mg 100 tablets carton label
Package/label display panel lorazepam tablets, usp civ 2 mg 100 tablets carton label