|fdaLIADPed=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.
|fdaLIADPed=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.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Oxazepam in pediatric patients.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Oxazepam in pediatric patients.
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====Physical and Psychological Dependence====
====Physical and Psychological Dependence====
*[[Withdrawal symptoms]], similar in character to those noted with [[barbiturates]] and [[alcohol]] ([[convulsions]], [[tremor]], abdominal and [[muscle cramps]], [[vomiting]], and [[sweating]]), have occurred following abrupt discontinuance of oxazepam.
*[[Withdrawal symptoms]] ([[Benzodiazepine withdrawal syndrome]]), similar in character to those noted with [[barbiturates]] and [[alcohol]] ([[convulsions]], [[tremor]], abdominal and [[muscle cramps]], [[vomiting]], and [[sweating]]), have occurred following abrupt discontinuance of oxazepam.
*The more severe [[withdrawal symptoms]] have usually been limited to those patients who received excessive doses over an extended period of time.
*The more severe [[withdrawal symptoms]] have usually been limited to those patients who received excessive doses over an extended period of time.
*Generally milder [[withdrawal symptoms]] (e.g., [[dysphoria]] and [[insomnia]]) have been reported following abrupt discontinuance of [[benzodiazepines]] taken continuously at therapeutic levels for several months.
*Generally milder [[withdrawal symptoms]] (e.g., [[dysphoria]] and [[insomnia]]) have been reported following abrupt discontinuance of [[benzodiazepines]] taken continuously at therapeutic levels for several months.
*Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage-tapering schedule followed.
*Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage-tapering schedule followed.
*Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving oxazepam or other [[psychotropic]] agents because of the predisposition of such patients to habituation and dependence.
*Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving oxazepam or other [[psychotropic]] agents because of the predisposition of such patients to habituation and dependence.
|clinicalTrials=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]] 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.
|useInPregnancyFDA=An increased risk of congenital malformations associated with the use of minor tranquilizers ([[chlordiazepoxide]], [[diazepam]], and [[meprobamate]]) during the first trimester of [[pregnancy]] has been suggested in several studies. Oxazepam, a [[benzodiazepine]] derivative, has not been studied adequately to determine whether it, too, may be associated with an increased risk of fetal abnormality. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physician about the desirability of discontinuing the drug.
|AUSPregCat=C
|useInPed=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.
|useInPed=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.
|useInGeri=*Clinical studies of oxazepam were not adequate to determine whether subjects aged 65 and over respond differently than younger subjects.
|useInGeri=*Clinical studies of oxazepam were not adequate to determine whether subjects aged 65 and over respond differently than younger subjects.
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*In general, dose selection for oxazepam for elderly patients should be cautious, usually starting at the lower end of the dosing range.
*In general, dose selection for oxazepam for elderly patients should be cautious, usually starting at the lower end of the dosing range.
|administration=*Oral
|administration=*Oral
|monitoring=Although rare, leukopenia and hepatic dysfunction including jaundice have been reported during therapy. Periodic blood counts and liver-function tests are advisable.
|overdose=In the management of overdosage with any drug, it should be born in mind that multiple agents may have been taken.
|overdose=In the management of overdosage with any drug, it should be born in mind that multiple agents may have been taken.
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| Excretion = Renal
| Excretion = Renal
}}
}}
|alcohol=Alcohol-Oxazepam interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|mechAction=There is limited information regarding mechanism of action of oxazepam in the drug label.
|structure=*Oxazepam is the first of a chemical series of compounds, the 3-hydroxybenzodiazepinones.
*Oxazepam is 7 chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one, and has the following structural formula:
[[File:Oxazepam structure.png|thumb|none|400px]]
*Oxazepam is a white crystalline powder.
|PD=There is limited information regarding Pharmacodynamics of oxazepam in the drug label.
|PK=*[[Pharmacokinetic]] testing in 12 volunteers demonstrated that a single 30 mg dose of a capsule, tablet or suspension will result in an 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 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 ofoxazepam in the very elderly.
|nonClinToxic=There is limited information regarding nonclinical toxicology of oxazepam in the drug label.
|howSupplied=Oxazepam capsules are available as follows:
*10 mg — Each pink opaque gelatin #4 capsule printed with[[File:Oxazepam capsule symbol.jpg|none|10px]]and 067 in black ink on both cap and body contains 10 mg of Oxazepam, USP. Capsules are supplied in bottles of 100 (NDC 0228-2067-10) and 500 (NDC 0228-2067-50).
*15 mg — Each red opaque gelatin #4 capsule printed with[[File:Oxazepam capsule symbol.jpg|none|10px]]and 069 in black ink on both cap and body contains 15 mg of Oxazepam, USP. Capsules are supplied in bottles of 100 (NDC 0228-2069-10) and 500 (NDC 0228-2069-50).
*30 mg — Each maroon opaque gelatin #4 capsule printed with[[File:Oxazepam capsule symbol.jpg|none|10px]] and 073 in blue ink on both cap and body contains 30 mg of Oxazepam, USP. Capsules are supplied in bottles of 100 (NDC 0228-2073-10).
|storage=*Store at 25(C (77(F); excursions permitted to 15( to 30(C (59( to 86(F).
*Keep tightly closed.
*Dispense in a tight, light-resistant container as defined in the USP.
|packLabel=[[File:Oxazepam FDA package label.png|none|550px]]
[[File:Oxazepam FDA package label 2 .png|none|550px]]
|alcohol=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.
| legal_status = [[Schedule IV controlled substance|Schedule IV]](US)
| routes_of_administration = Oral
}}
}}
'''Oxazepam''' (marketed under brand names '''Alepam''', '''Murelax''', '''Oxascand''', '''Serax''', '''Serepax''', '''Seresta''', '''Sobril''') is a drug which is a [[benzodiazepine]] derivative. It possesses relatively weak [[anxiolytic]], [[anticonvulsant]], [[sedative]] and [[skeletal muscle relaxant]] properties.
==Pharmacology==
Oxazepam is an intermediate acting benzodiazepine. Oxazepam acts on benzodiazepine receptors resulting in an enhancement of the binding of [[GABA]] to the GABA<sub>A</sub> receptor which results in inhibitory effects on the [[central nervous system]].<ref>{{cite journal | author = Skerritt JH | coauthors = Johnston GA. | year = 1983 | month = May | date = 6 | title = Enhancement of GABA binding by benzodiazepines and related anxiolytics. | journal = Eur J Pharmacol. | volume = 89 | issue = 3-4 | pages = 193-8 | pmid = 6135616 }}</ref><ref>{{cite journal | author = Oelschläger H. | coauthors = | year = 1989 | month = Jul | date = 4 | title = [Chemical and pharmacologic aspects of benzodiazepines] | journal = Schweiz Rundsch Med Prax. | volume = 78 | issue = 27-28 | pages = 766-72 | pmid = 2570451 }}</ref> The half life of oxazepam is 4-15 hours.<ref>{{cite web | url = http://www.bcnc.org.uk/equivalence.html | title = BENZODIAZEPINE EQUIVALENCY TABLE | accessmonthday = Sept 23 | accessyear = 2007 | author = Professor heather Ashton | year = 2007 | month = April }}</ref> Oxazepam has been shown to suppress cortisol levels.<ref>{{cite journal | author = Christensen P | coauthors = Lolk A, Gram LF, Kragh-Sørensen P. | year = 1992 | title = Benzodiazepine-induced sedation and cortisol suppression. A placebo-controlled comparison of oxazepam and nitrazepam in healthy male volunteers. | journal = Psychopharmacology. | volume = 106 | issue = 4 | pages = 511-6 | pmid = 1349754 }}</ref>
Oxazepam is an active metabolite formed during the breakdown of [[diazepam]], [[nordazepam]], and certain similar drugs. Oxazepam may be safer than many other benzodiazepines in patients with impaired liver function because it does not require hepatic oxidation, but rather it is simply metabolized via [[glucuronidation]]. This means that oxazepam is less likely to accumulate and cause adverse reactions in the elderly or people with liver disease. Oxazepam is similar to [[lorazepam]] in this respect. [http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=8700792&itool=iconabstr&query_hl=14&itool=pubmed_DocSum (1)]
There is preferential storage of oxazepam in some organs including the heart. Absorption by any administered route and the risk of accumulation is significantly increased in the neonate and there is clinical justification to recommend the withdrawal of oxazepam during pregnancy and breast feeding as oxazepam is excreted in breast milk.<ref>{{cite journal | author = Olive G | coauthors = Dreux C. | year = 1977 | month = Jan | title = Pharmacologic bases of use of benzodiazepines in peréinatal medicine. | journal = Arch Fr Pediatr. | volume = 34(1) | pages = 74-89 | pmid = 851373 }}</ref>
==Indications==
It is an intermediate acting benzodiazepine with a slow onset of action, so it is usually prescribed to individuals who have trouble staying asleep, rather than falling asleep. It is commonly prescribed for anxiety disorders with associated tension, irritability, and agitation. It is also prescribed for drug and [[Delirium tremens|alcohol withdrawal]], and for anxiety associated with [[clinical depression|depression]]. Also prescribed for sleepwalking before a neurologist is involved when the sleepwalker may be a problem or danger to themselves.
[[Image:Oxazepam_DOJ.jpg|frame|right]]
==Tolerance==
When tolerance and [[habituation]] occurs brain concentration of oxazepam increase according to degree of tolerance.<ref>{{cite journal | author = Chodera A | coauthors = Szczawińska K, Cenajek D, Nowakowska E. | year = 1984 | month = Jul-Aug | date = | title = Pharmacokinetic aspects of habituation to benzodiazepines. | journal = Pol J Pharmacol Pharm. | volume = 36 | issue = 4 | pages = 353-60 | pmid = 6152051 }}</ref>
==Dependence==
Oxazepam as with other [[benzodiazepine]] drugs can cause [[physical dependence]], [[addiction]] and what is known as the [[benzodiazepine withdrawal syndrome]]. Withdrawal from oxazepam or other benzodiazepines often leads to withdrawal symptoms which are similar to those seen during alcohol and [[barbiturate]] withdrawal. The higher the dose and the longer the drug is taken the greater the risk of experiencing unpleasant withdrawal symptoms. Withdrawal symptoms can however occur at standard dosages and also after short term use. Benzodiazepine treatment should be discontinued as soon as possible via a slow and gradual dose reduction regime.<ref>{{cite journal | author = MacKinnon GL | coauthors = Parker WA. | year = 1982 | month = | title = Benzodiazepine withdrawal syndrome: a literature review and evaluation. | journal = The American journal of drug and alcohol abuse. | volume = 9 | issue = 1 | pages = 19-33 | pmid = 6133446 }}</ref>
====The Committee on the Review of Medicines====
The Committee on the Review of Medicines (UK) carried out a review into benzodiazepines due to significant concerns of tolerance, [[drug dependence]] and [[benzodiazepine withdrawal]] problems and other adverse effects. The committee found that benzodiazepines do not have any [[antidepressant]] or [[analgesic]] properties and are therefore unsuitable treatments for conditions such as depression, [[tension headaches]] and [[dysmenorrhoea]]. Benzodiazepines are also not beneficial in the treatment of [[psychosis]] due to a lack of efficacy. The committee also recommended against benzodiazepines being used in the treatment of [[anxiety]] or [[insomnia]] in children. The committee was in agreement with the [[Institute of Medicine]] (USA) and the conclusions of a study carried out by the White House Office of Drug Policy and the [[National Institute on Drug Abuse]] (USA) that there was little evidence that long term use of benzodiazepine hypnotics were beneficial in the treatment of insomnia due to the development of tolerance. Benzodiazepines tended to lose their sleep promoting properties within 3 - 14 days of continuous use and in the treatment of anxiety the committee found that there was little convincing evidence that benzodiazepines retained efficacy in the treatment of anxiety after 4 months continuous use due to the development of tolerance. The committee found that the regular use of benzodiazepines caused the development of dependence characterised by tolerance to the therapeutic effects of benzodiazepines and the development of the [[benzodiazepine withdrawal syndrome]] including symptoms such as [[anxiety]], [[apprehension]], [[tremor]], [[insomnia]], [[nausea]], and [[vomiting]] upon cessation of benzodiazepine use. Withdrawal symptoms tended to develop within 24 hours on the cessation of a short acting benzodiazepine and within 3 - 10 days after the cessation of a more short acting benzodiazepine. Withdrawal effects could occur after treatment lasting only 2 weeks at therapeutic dose levels however withdrawal effects tended to occur with habitual use beyond 2 weeks and were more likely the higher the dose. The withdrawal symptoms may appear to be similar to the original condition. The committee recommended that all benzodiazepine treatment be withdrawn gradually and recommended that benzodiazepine treatment be used only in carefully selected patients and that therapy be limited to short term use only. It was noted in the review that alcohol can potentiate the [[central nervous system]] depressant effects of benzodiazepines and should be avoided. The central nervous system depressant effects of benzodiazepines may make driving or operating machinery dangerous and the elderly are more prone to these adverse effects. In the [[neonate]] high single doses or repeated low doses have been reported to produce [[hypotonia]], poor sucking, and [[hypothermia]] in the [[neonate]] and irregularities in the [[fetal]] heart. Benzodiazepines should be avoided in [[lactation]]. Withdrawal from benzodiazepines should be gradual as abrupt withdrawal from high doses of benzodiazepines may cause [[confusion]], [[toxic psychosis]], [[convulsions]], or a condition resembling [[delirium tremens]]. Abrupt withdrawal from lower doses may cause depression, [[nervousness]], [[rebound insomnia]], [[irritability]], [[sweating]], and [[diarrhoea]].<ref>{{cite journal | author = Committee on the Review of Medicines | year = 1980 | month = Mar | date = 29 | title = Systematic review of the benzodiazepines. Guidelines for data sheets on diazepam, chlordiazepoxide, medazepam, clorazepate, lorazepam, oxazepam, temazepam, triazolam, nitrazepam, and flurazepam. Committee on the Review of Medicines. | journal = Br Med J. | volume = 280 | issue = 6218 | pages = 910-2 | pmid = 7388368 | url = http://www.pubmedcentral.nih.gov/picrender.fcgi?artid=1601049&blobtype=pdf | format = pdf }}</ref>
==Dosage==
* Mild/moderate anxiety - 10 to 15mg, 3 to 4 times daily
* Severe anxiety - 15 to 30mg, 3 to 4 times daily
* Symptoms related to alcohol withdrawal - 15 to 30mg, 3 to 4 times daily
==Availability==
In the United Kingdom, oxazepam is available generically in the form of 10mg, 15mg and 30mg tablets.
==Side effects==
The side effects of oxazepam are similar in nature to those of other benzodiazepines.
Side effects from oxazepam are common and include:
drowsiness,
dizziness,
tiredness,
weakness,
dry mouth,
diarrhea,
upset stomach,
changes in appetite,
heart palpitations,
anxiety,
trouble breathing,
shortness of breath,
angry outbursts,
trouble sleeping,
tremors
{{sect-stub}}
Internal tremors have been alleviated by using 15mg of oxazepam as required, usually approximately four hourly.
==Interactions==
As oxazepam is an active metabolite of [[diazepam]], there is likely an overlap in possible interactions with other drugs or food, with exception of the pharmacokinetic CY[[P450]] interactions (e.g. with [[cimetidine]]). Take precautions, and follow closely the prescription of your doctor, when taking oxazepam (or other benozodiazepines) in combinations with potent [[Analgesic|painkillers]] (opioids, e.g. [[morphine]], [[oxycodone]] or [[methadone]]). Avoid drinking alcoholic beverages when taking oxazepam; alcohol and oxazepam (as well as other [[benzodiazepine]]s) are interacting in a way, that is difficult to pre-estimate, concomitant use of oxazepam and alcohol can lead to increased [[sedation]], severe problems with [[coordination]] ([[ataxia]]e), decreased muscle tone and in severe cases or in predisposed patients even to life-threatening [[intoxication]]s with [[coma]] and [[collapse]].
Concomitant use of alcohol and oxazepam (as well as other benzodiazepines) also increases the risk of an [[addiction]].
Benzodiazepines including oxazepam may inhibit the [[glucuronidation]] of [[morphine]] leading to increased levels of and prolongation of the effects of morphine.<ref>{{cite journal | author = Pacifici GM | coauthors = Gustafsson LL, Säwe J, Rane A. | year = 1986 | month = Apr | title = Metabolic interaction between morphine and various benzodiazepines. | journal = Acta Pharmacol Toxicol (Copenh). | volume = 58 | issue = 4 | pages = 249-52 | pmid = 2872767 }}</ref>
==Special precautions==
Benzodiazepines including oxazepam are lipophilic drugs and rapidly penetrate membranes and therefore rapidly cross over into the placenta with significant uptake of the drug. Use of benzodiazepines in late pregnancy especially high doses may result in [[floppy infant syndrome]].<ref>{{cite journal | author = Kanto JH. | coauthors = | year = 1982 | month = May | title = Use of benzodiazepines during pregnancy, labour and lactation, with particular reference to pharmacokinetic considerations. | journal = Drugs. | volume = 23 | issue = 5 | pages = 354-80 | pmid = 6124415 }}</ref>
===Pregnancy===
There is inconclusive evidence that benzodiazepines including oxazepam if taken early in pregnancy may result in reduced IQ, neurodevelopmental problems, physical malformations in cardiac or facial structure as well as other malformations in some new borns. Oxazepam when taken during late in pregnancy, the [[third trimester]], causes a definite risk to the [[neonate]] including a severe [[benzodiazepine withdrawal syndrome]] in the neonate with symptoms including [[hypotonia]], and reluctance to suck, to [[apnoeic]] spells, [[cyanosis]], and impaired [[metabolic]] responses to cold stress. Floppy infant syndrome and sedation in the new born may also occur. Symptoms of floppy infant syndrome and the neonatal benzodiazepine withdrawal syndrome have been reported to persist from hours to months after birth.<ref>{{cite journal | author = McElhatton PR. | coauthors = | year = 1994 | month = Nov-Dec | title = The effects of benzodiazepine use during pregnancy and lactation. | journal = Reprod Toxicol. | volume = 8 | issue = 6 | pages = 461-75 | pmid = 7881198 }}</ref>
===Carcinogenicity===
Oxazepam is listed a possible [[carcinogen]] ([[List_of_IARC_Group_2B_carcinogens|Group 2b]]) by the [[International_Agency_for_Research_on_Cancer|IARC]].
==Contraindications==
{{sect-stub}}
==Overdose==
Oxazepam is a drug which is very frequently involved in drug intoxication, including overdose.<ref>{{cite journal | author = Zevzikovas A | coauthors = Kiliuviene G, Ivanauskas L, Dirse V. | year = 2002 | month = | date = | title = [Analysis of benzodiazepine derivative mixture by gas-liquid chromatography] | journal = Medicina (Kaunas). | volume = 38 | issue = 3 | pages = 316-20 | pmid = 12474705 }}</ref> Oxazepam overdose has been involved in fatal overdoses in an Australian study of drug related deaths. Benzodiazepines were found to be the sole cause of death in one third of cases.<ref>{{cite journal | author = Drummer OH | coauthors = Ranson DL. | year = 1996 | month = Dec | title = Sudden death and benzodiazepines. | journal = Am J Forensic Med Pathol. | volume = 17 | issue = 4 | pages = 336-42 | pmid = 8947361 }}</ref>
Symptoms of overdose include:
* [[Somnolence]]
* Confusion
* Impaired motor function
* Coma
* [[Hypoventilation]] (respiratory depression)
* [[Hypotension]]
==Abuse==
Benzodiazepines, including [[diazepam]], oxazepam, [[nitrazepam]], [[temazepam]], and [[flunitrazepam]] account for the largest volume of forged drug prescriptions in Sweden, a total of 52% of drug forgeries being for benzodiazepines, suggesting benzodiazepines are a major prescription drug class of abuse.<ref>{{cite journal | author = Bergman U | coauthors = Dahl-Puustinen ML. | year = 1989 | month = | title = Use of prescription forgeries in a drug abuse surveillance network. | volume = 36 | issue = 6 | pages = 621-3 | pmid = 2776820 | journal = Eur J Clin Pharmacol.}}</ref>
==Legal Status==
Oxazepam is a [[Schedule IV]] drug under the [[Convention on Psychotropic Substances]] [http://www.incb.org/pdf/e/list/green.pdf].
==Usage==
Oxazepam along with diazepam, nitrazepam and temazepam represent 82% of the benzodiazepine market in Australia.<ref>{{cite journal | author = Mant A | coauthors = Whicker SD, McManus P, Birkett DJ, Edmonds D, Dumbrell D. | title =Benzodiazepine utilisation in Australia: report from a new pharmacoepidemiological database. | journal = Aust J Public Health. | volume =17 | issue =4 | pages =345-9 | month =Dec | year=1993 | pages=345-9 | pmid = 7911332 }}</ref>
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Overview
Oxazepam is a Benzodiazepine that is FDA approved for the treatment of anxiety disorders and anxiety with alcohol withdrawal syndrome. Common adverse reactions include drowsiness, Dizziness, Headache, Somnolence, Vertigo.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Anxiety
Because of the flexibility of this product and the range of emotional disturbances responsive to it, dosage should be individualized for maximum beneficial effects.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Oxazepam in adult patients.
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.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Oxazepam in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Oxazepam in pediatric patients.
Contraindications
History of previous hypersensitivity reaction to oxazepam.
Oxazepam is not indicated in psychoses.
Warnings
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.
Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage-tapering schedule followed.
Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving oxazepam or other psychotropic agents because of the predisposition of such patients to habituation and dependence.
Adverse Reactions
Clinical Trials Experience
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 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.
Postmarketing Experience
There is limited information regarding Oxazepam Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Oxazepam Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
An increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam, and meprobamate) during the first trimester of pregnancy has been suggested in several studies. Oxazepam, a benzodiazepine derivative, has not been studied adequately to determine whether it, too, may be associated with an increased risk of fetal abnormality. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physician about the desirability of discontinuing the drug.
Pregnancy Category (AUS): C
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Oxazepam in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Oxazepam during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Oxazepam in women who are nursing.
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.
Geriatic 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.
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.
In general, dose selection for oxazepam for elderly patients should be cautious, usually starting at the lower end of the dosing range.
Gender
There is no FDA guidance on the use of Oxazepam with respect to specific gender populations.
Race
There is no FDA guidance on the use of Oxazepam with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Oxazepam in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Oxazepam in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Oxazepam in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Oxazepam in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Monitoring
Although rare, leukopenia and hepatic dysfunction including jaundice have been reported during therapy. Periodic blood counts and liver-function tests are advisable.
IV Compatibility
There is limited information regarding the compatibility of Oxazepam and IV administrations.
Overdosage
In the management of overdosage with any drug, it should be born in mind that multiple agents may have been taken.
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 benzodiazepineantagonistflumazenil 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 should be consulted prior to use.
There is limited information regarding mechanism of action of oxazepam in the drug label.
Structure
Oxazepam is the first of a chemical series of compounds, the 3-hydroxybenzodiazepinones.
Oxazepam is 7 chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one, and has the following structural formula:
Oxazepam is a white crystalline powder.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of oxazepam in the drug label.
Pharmacokinetics
Pharmacokinetic testing in 12 volunteers demonstrated that a single 30 mg dose of a capsule, tablet or suspension will result in an 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 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 ofoxazepam in the very elderly.
Nonclinical Toxicology
There is limited information regarding nonclinical toxicology of oxazepam in the drug label.
Clinical Studies
There is limited information regarding Oxazepam Clinical Studies in the drug label.
How Supplied
Oxazepam capsules are available as follows:
10 mg — Each pink opaque gelatin #4 capsule printed withand 067 in black ink on both cap and body contains 10 mg of Oxazepam, USP. Capsules are supplied in bottles of 100 (NDC 0228-2067-10) and 500 (NDC 0228-2067-50).
15 mg — Each red opaque gelatin #4 capsule printed withand 069 in black ink on both cap and body contains 15 mg of Oxazepam, USP. Capsules are supplied in bottles of 100 (NDC 0228-2069-10) and 500 (NDC 0228-2069-50).
30 mg — Each maroon opaque gelatin #4 capsule printed with and 073 in blue ink on both cap and body contains 30 mg of Oxazepam, USP. Capsules are supplied in bottles of 100 (NDC 0228-2073-10).
Storage
Store at 25(C (77(F); excursions permitted to 15( to 30(C (59( to 86(F).
Keep tightly closed.
Dispense in a tight, light-resistant container as defined in the USP.
Images
Drug Images
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There is limited information regarding Oxazepam Patient Counseling Information in the drug label.
Precautions with Alcohol
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.
