Product Elements:
Lorazepam lorazepam lorazepam lorazepam lactose monohydrate magnesium stearate cellulose, microcrystalline polacrilin potassium ip;15 lorazepam lorazepam lorazepam lorazepam lactose monohydrate magnesium stearate cellulose, microcrystalline polacrilin potassium ip;16 lorazepam lorazepam lorazepam lorazepam lactose monohydrate magnesium stearate cellulose, microcrystalline polacrilin potassium ip;17
Boxed Warning:
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 patientâs 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 ( dosage and administration and warnings ).
Indications and Usage:
Indications and usage lorazepam tablets, are 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 tablets, 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 risks from concomitant use with opioids 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 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, p
Read more...rescribe a lower initial dose of 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 : drug interactions ). abuse, misuse, and addiction the use of benzodiazepines, including lorazepam, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death (see drug abuse and dependence : abuse ). before prescribing lorazepam and throughout treatment, assess each patientâs risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). use of lorazepam, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of lorazepam along with monitoring for signs and symptoms of abuse, misuse, and addiction. prescribe the lowest effective dosage; avoid or minimize concomitant use of cns depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. if a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate. dependence and withdrawal reactions to reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam or reduce the dosage (a patient-specific plan should be used to taper the dose) (see dosage and adminstration : discontinuation or dosage reduction of lorazepam ). patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use. acute withdrawal reactions the continued use of benzodiazepines, including lorazepam, may lead to clinically significant physical dependence. abrupt discontinuation or rapid dosage reduction of lorazepam after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see drug abuse and dependence : dependence ) . protracted withdrawal syndrome in some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months (see drug abuse and dependence : dependence ). 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 : drug interacti ons ). 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.
Dosage and Administration:
Dosage and administration lorazepam tablets, 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 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 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 day
Read more...time doses. discontinuation or dosage reduction of lorazepam to reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam or reduce the dosage. if a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. subsequently decrease the dosage more slowly (see warnings : dependence and withdrawal reactions and drug abuse and dependence : dependence ).
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 obstruct
Read more...ive pulmonary disease; gastrointestinal symptoms including nausea, change in appetite, constipation, jaundice, increase in bilirubin, increase in liver transaminases, increase in alkaline phosphatase; hypersensitivity reactions, anaphylactoid reactions; dermatological symptoms, allergic skin reactions, alopecia; syndrome of inappropriate antidiuretic hormone (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. to report suspected adverse reactions, contact amneal pharmaceuticals at 1-877-835-5472 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.
Overdosage:
Overdosage in post-marketing 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 contraindications , warnings , and precautions sections should be consulted prior to use.
Description:
Description lorazepam usp, an antianxiety agent, has the chemical formula, 7-chloro-5-( o -chlorophenyl)-1,3-dihydro-3-hydroxy-2 h -1,4-benzodiazepin-2-one: c 15 h 10 c l2 n 2 o 2 m.w. 321.16 it is a nearly white powder almost insoluble in water. each lorazepam tablet, usp to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam, usp. the inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polacrilin potassium. 1
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 central nervous system (cns) activity in animals. the plasma levels of lorazepam are proportional to the dose given. there is no evidence
Read more...of accumulation of lorazepam 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, 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 of 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 âipâ on one side and â15â on the other side. they are available as follows: bottles of 100: ndc 65162-015-10 bottles of 500: ndc 65162-015-50 bottles of 1000: ndc 65162-015-11 1 mg white, round, flat face, beveled edge tablets, debossed âipâ scored â16â on one side and plain on the other side. they are available as follows: bottles of 100: ndc 65162-018-10 bottles of 500: ndc 65162-018-50 bottles of 1000: ndc 65162-018-11 2 mg white, round, flat face, beveled edge tablets, debossed âipâ scored â17â on one side and plain on the other side. they are available as follows: bottles of 100: ndc 65162-017-10 bottles of 500: ndc 65162-017-50 bottles of 1000: ndc 65162-017-11 keep bottles tightly closed. keep out of reach of children. store at 20° to 25°c (68° to 77°f); excursio
Read more...ns permitted between 15° to 30°c (59° to 86°f) [see usp controlled room temperature]. dispense in a tight container. manufactured by: amneal pharmaceuticals of ny, llc hauppauge, ny 11788 distributed by: amneal pharmaceuticals llc glasgow, ky 42141 rev. 03-2021-01
Package Label Principal Display Panel:
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