Product Elements:
Oxazepam oxazepam oxazepam oxazepam croscarmellose sodium d&c yellow no. 10 fd&c blue no. 1 fd&c blue no. 2 fd&c red no. 40 ferrosoferric oxide gelatin lactose monohydrate magnesium stearate microcrystalline cellulose butyl alcohol propylene glycol alcohol shellac sodium lauryl sulfate titanium dioxide fbp660 oxazepam oxazepam oxazepam oxazepam croscarmellose sodium d&c yellow no. 10 fd&c blue no. 1 fd&c blue no. 2 fd&c red no. 40 ferrosoferric oxide gelatin lactose monohydrate magnesium stearate microcrystalline cellulose butyl alcohol propylene glycol alcohol shellac sodium lauryl sulfate titanium dioxide fd&c yellow no. 6 fbp661 oxazepam oxazepam oxazepam oxazepam croscarmellose sodium d&c yellow no. 10 fd&c blue no. 1 fd&c blue no. 2 fd&c red no. 40 ferrosoferric oxide gelatin lactose monohydrate magnesium stearate microcrystalline cellulose butyl alcohol propylene glycol alcohol shellac sodium lauryl sulfate titanium dioxide d&c red no. 28 fbp662
Drug Interactions:
Drug interactions: the concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the cns that control respiration. benzodiazepines interact at gabaa sites and opioids interact primarily at mu receptors. when benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid- related respiratory depression exists. limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.
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 sedati on, respiratory depression, coma, and death reserve concomitant prescribing of these drugs in patients for whom alternati ve 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 oxazepam, exposes users to risks of abuse, misu se, 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 oxazepam and throughout treatment, assess each patientâs risk for abuse, misuse, and addiction (see warnings ). ⢠the continued use of benzodiazepines, including oxazepam, 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 oxazepam after continued use may precipitate acute withdrawa l reactions, which can be life-threatening. to reduce the risk of withdrawal reactions, use a gradual taper to discontinue oxazepam or reduce the dosage (see dosage and administration and warnings ).
Warnings:
Warnings risks from concomitant use with opioids: concomitant use of benzodiazepines, including oxazepam, 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 oxazepam 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 oxazepam than indicated in the absence of an opioid and titrate based on clinical response. if an opioid is initiated in a patient already taking oxazepam, pres
Read more...cribe 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 oxazepam 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 oxazepam, 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 oxazepam and throughout treatment, assess each patientâs risk for abuse, misuse, and addiction (e.g., using a standardized screening tool). use of oxazepam, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of oxazepam 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 oxazepam or reduce the dosage (a patient-specific plan should be used to taper the dose) (see dosage and administration : discontinuation or dosage reduction of oxazepam). 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 oxazepam, may lead to clinically significant physical dependence. abrupt discontinuation or rapid dosage reduction of oxazepam 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 ). as with other cns-acting drugs, patients should be cautioned against driving automobiles or operating dangerous machinery until it is known that they do not become drowsy or dizzy on oxazepam therapy. patients should be warned that the effects of alcohol or other cns-depressant drugs may be additive to those of oxazepam, possibly requiring adjustment of dosage or elimination of such agents.
General Precautions:
General: although hypotension has occurred only rarely, oxazepam should be administered with caution to patients in whom a drop in blood pressure might lead to cardiac complications. this is particularly true in the elderly patient.
Dosage and Administration:
Dosage and administration because of the flexibility of this product and the range of emotional disturbances responsive to it, dosage should be individualized for maximum beneficial effects. oxazepam usual dose mild-to-moderate anxiety, with associated tension, irritability, agitation, or related symptoms of functional origin secondary to organic 10 to 15 mg. 3 or 4 times daily severe anxiety syndromes, agitation, or anxiety associated with depression 15 to 30 mg. 3 or 4 times daily older patients with anxiety, tension, irritability, and agitation initial dosage: 10 mg, 3 times daily. if necessary, increase cautiously to 15 mg, 3 or 4 times daily. alcoholics with acute inebriation, tremulousness, or anxiety on withdrawal 15 to 30 mg, 3 or 4 times daily this product is not indicated in pediatric patients under 6 years of age. absolute dosage for pediatric patients 6 to 12 years of age is not established. discontinuation or dosage reduction of oxazepam to reduce the risk of withdrawal re
Read more...actions, use a gradual taper to discontinue oxazepam 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 history of previous hypersensitivity reaction to oxazepam. oxazepam is not indicated in psychoses.
Adverse Reactions:
Adverse reactions the necessity for discontinuation of therapy due to undesirable effects has been rare. transient, mild drowsiness is commonly seen in the first few days of therapy. if it persists, the dosage should be reduced. in few instances, dizziness, vertigo, headache, and rarely syncope have occurred either alone or together with drowsiness. mild paradoxical reactions, i.e., excitement, stimulation of affect, have been reported in psychiatric patients; these reactions may be secondary to relief of anxiety and usually appear in the first two weeks of therapy. other side effects occurring during oxazepam therapy include rare instances of minor diffuse skin rashes-morbilliform, urticarial, and maculopapular nausea, lethargy, edema, slurred speech, tremor and altered libido. such side effects have been infrequent and are generally controlled with reduction of dosage. a case of an extensive fixed drug eruption also has been reported. although rare, leukopenia and hepatic dysfunction
Read more... including jaundice have been reported during therapy. periodic blood counts and liver-function tests are advisable. ataxia with oxazepam has been reported in rare instances and does not appear to be specifically related to dose or age. although the following side reactions have not as yet been reported with oxazepam, they have occurred with related compounds (chlordiazepoxide and diazepam): paradoxical excitation with severe rage reactions, hallucinations, menstrual irregularities, change in eeg pattern, blood dyscrasias including agranulocytosis, blurred vision, diplopia, incontinence, stupor, disorientation, fever, and euphoria. transient amnesia or memory impairment has been reported in association with the use of benzodiazepines.
Drug Interactions:
Drug interactions: the concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the cns that control respiration. benzodiazepines interact at gabaa sites and opioids interact primarily at mu receptors. when benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid- related respiratory depression exists. limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.
Pediatric Use:
Pediatric use: safety and effectiveness in pediatric patients under 6 years of age have not been established. absolute dosage for pediatric patients 6 to 12 years of age is not established.
Geriatric Use:
Geriatric use: clinical studies of oxazepam were not adequate to determine whether subjects aged 65 and over respond differently than younger subjects. age (<80 years old) does not appear to have a clinically significant effect on oxazepam kinetics [see clinical pharmacology ]. clinical circumstances, some of which may be more common in the elderly, such as hepatic or renal impairment, should be considered. greater sensitivity of some older individuals to the effects of oxazepam (e.g., sedation, hypotension, paradoxical excitation) cannot be ruled out [see precautions: general ; see adverse reactions ]. in general, dose selection for oxazepam for elderly patients should be cautious, usually starting at the lower end of the dosing range (see dosage and administration ).
Overdosage:
Overdosage in the management of overdosage with any drug, 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 and lethargy. in more serious cases, and especially when other drugs or alcohol were ingested, symptoms may include ataxia, hypotonia, hypotension, hypnotic state, stage one (1) to three (3) coma, and very rarely, death. management 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 value of dialysis has not been adequately determined for oxazepam. 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 flurnazenil package insert including â contraindications , â â warnings , â and â precautions â should be consulted prior to use.
dependence:
Dependence physical dependence oxazepam may produce physical dependence from continued therapy. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see warnings - dependence and withdrawal reactions). to reduce the risk of withdrawal reactions, use a gradual taper to discontinue oxazepam or reduce the dosage (see dosage and dministration -discontinuation or dosage reduction of oxazepam and warnings - dependence and withdrawal reactions). acute withdrawal signs and symptoms acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. more severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality. protracted withdrawal syndrome protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. protracted withdrawal symptoms may last weeks to more than 12 months. as a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. tolerance tolerance to oxazepam may develop from continued therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). tolerance to the therapeutic effect of oxazepam may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.
Description:
Description oxazepam, usp is the first of a chemical series of compounds known as the 3- hydroxybenzodiazepinones. a therapeutic agent providing versatility and flexibility in control of common emotional disturbances, this product exerts prompt action in a wide variety of disorders associated with anxiety, tension, agitation, and irritability, and anxiety associated with depression. in tolerance and toxicity studies on several animal species, this product reveals significantly greater safety factors than related compounds (chlordiazepoxide and diazepam) and manifests a wide separation of effective doses and doses inducing side effects. oxazepam, is 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2 h -1,4-benzodiazepin-2-one and has the following structural formula: mw 286.72 oxazepam is a white-crystalline powder. each capsule for oral administration contain 10 mg, 15 mg or 30 mg of oxazepam. inactive ingredients: croscarmellose sodium, d&c yellow #10, fd&c blue #1, fd&c blue # 2, fd&c red # 40, ferric oxide black, gelatin, lactose monohydrate, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, propylene glycol, sda-3a alcohol, shellac, sodium lauryl sulfate, titanium dioxide and other inert ingredients. the 15 mg capsule also contains: fd&c yellow # 6. the 30 mg capsule also contains: d&c red # 28. the following structural formula for oxazepam, is 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2h-1,4-benzodiazepin-2-one
Clinical Pharmacology:
Clinical pharmacology pharmacokinetic testing in 12 volunteers demonstrated that a single 30 mg dose of a capsule, tablet or suspension will result in equivalent extent of absorption. for the capsule and tablet, peak plasma levels averaged 450 mg/ml and were observed to occur about 3 hours after dosing. the mean elimination half-life for oxazepam was approximately 8.2 hours (range 5.7 to 10.9 hours). this product has a single, major inactive metabolite in man, a glucuronide excreted in the urine. age (<80 years old) does not appear to have a clinically significant effect on oxazepam kinetics. a statistically significant increase in elimination half-life in the very elderly (> 80 years of age) as compared to younger subjects has been reported, due to a 30% increase in volume of distribution, as well as a 50% reduction in unbound clearance of oxazepam in the very elderly (see precautions, geriatric use ) .
How Supplied:
How supplied oxazepam capsules, usp are available as: 10 mg - each #4 white opaque/white opaque gelatin capsule, printed fbp660 in black ink on the cap and body contains 10 mg of oxazepam, usp. oxazepam capsules are supplied in bottles of 100 (ndc 52817-290-10) 15 mg - each #4 red opaque/red opaque gelatin capsule, printed fbp661in black ink on the cap and body, contains 15 mg of oxazepam, usp. oxazepam capsules are supplied in bottles of 100 (ndc 52817-291-10) 30 mg - each #4 maroon opaque/maroon opaque gelatin capsule, printed fbp662 in black ink on the cap and body, contains 30 mg of oxazepam, usp. oxazepam capsules are supplied in bottles of 100 (ndc 52817-292-10) store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. protect from moisture. dispense in a tight, light-resistant container.
Information for Patients:
Information for patients advise the patient to read the fda-approved patient labeling (medication guide)
Package Label Principal Display Panel:
Principal display panel 52817-290-10 oxazepam capsules, usp 10 mg 100 capsules rx only principal display panel 52817-290-10 oxazepam capsules, usp 10 mg 100 capsules rx only
Principal display panel 52817-291-10 oxazepam capsules, usp 15 mg 100 capsules rx only principal display panel 52817-291-10 oxazepam capsules, usp 15 mg 100 capsules rx only
Principal display panel 52817-292-10 oxazepam capsules, usp 30 mg 100 capsules rx only principal display panel 52817-292-10 oxazepam capsules, usp 30 mg 100 capsules rx only