VA Class: CN302
Chemical Name: 7 chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one
Molecular Formula: C15H11ClN2O2
CAS Number: 604-75-1
Medically reviewed on December 11, 2017.
- Concomitant Use with Opiates
Concomitant use of benzodiazepines and opiates may result in profound sedation, respiratory depression, coma, and death.700 701 703 705 706 707
Reserve concomitant use for patients in whom alternative treatment options are inadequate; use lowest effective dosages and shortest possible duration of concomitant therapy and monitor closely for respiratory depression and sedation.700 703 (See Specific Drugs under Interactions.)
Benzodiazepine.a b c Anxiolytic, sedative.a b c
Uses for Oxazepam
Relief of agitation and tremor and prevention or symptomatic relief of delirium tremens and hallucinations associated with acute alcohol withdrawal.a b c
Management of anxiety disorders and short-term relief of anxiety or anxiety associated with depressive symptoms.a b c
One of several preferred benzodiazepines in geriatric patients and patients with liver disease (because of its short elimination half-life and lack of active metabolites).b
Oxazepam Dosage and Administration
Use the smallest effective dosage (especially in geriatric or debilitated patients and in those with low serum albumin) to avoid oversedation.a b
In patients who have received prolonged (e.g., for several months) therapy, avoid abrupt discontinuance, since manifestations of withdrawal can be precipitated; gradually taper dosage.a b c
Periodically reassess the usefulness of the drug.a b c Efficacy beyond 4 months not systematically evaluated.a b c Administer for the shortest possible period of time; frequent dosage adjustments may be required.b
Administer orally in divided doses, generally 3 or 4 times daily.a b c
Children 6–12 years of age: Dosage not clearly established.a c
15–30 mg 3 or 4 times daily.a c
Mild to moderate anxiety: 10–15 mg 3 or 4 times daily.a c
Severe anxiety: 15–30 mg 3 or 4 times daily.a c
No specific dosage recommendations.c
No specific dosage recommendations.c
Initially, 10 mg 3 times daily.a c Increase dosage to 15 mg 3 or 4 times daily if needed and tolerated.a c Use the smallest effective dosage to avoid oversedation.a b
Use the smallest effective dosage in debilitated patients and patients with low serum albumin concentrations to avoid oversedation.a b
Cautions for Oxazepam
Known hypersensitivity to oxazepam.c
Many manufacturers state that benzodiazepines are contraindicated in patients with acute angle-closure glaucoma but may be administered to patients with open-angle glaucoma who are receiving appropriate therapy; however, clinical rationale for this contraindication has been questioned.b
Concomitant Use with Opiates
Concomitant use of benzodiazepines, including oxazepam, and opiates may result in profound sedation, respiratory depression, coma, and death.700 701 703 705 706 707 Substantial proportion of fatal opiate overdoses involve concurrent benzodiazepine use.700 701 705 706 707 711
Reserve concomitant use of oxazepam and opiates for patients in whom alternative treatment options are inadequate.700 703 (See Specific Drugs under Interactions.)
Performance of activities requiring mental alertness and physical coordination may be impaired.b c
Concurrent use of other CNS depressants may cause additive or potentiated CNS depression.b c (See Concomitant Use with Opiates under Cautions and also see Specific Drugs under Interactions.)
Avoid use in patients with depressive neuroses or psychotic reactions in which anxiety is not prominent.b c
Possible tolerance, psychologic dependence, and physical dependence following prolonged use.b c
Patients with a history of drug or alcohol dependence or abuse are at risk of habituation or dependence; use only with careful surveillance in such patients.c
Abrupt discontinuance may result in symptoms of withdrawal (similar to barbiturates).a b c Symptoms may be relieved by tapering the dosage.a b c
Retrospective studies suggest increased risk of congenital malformations in infants of mothers who received anxiolytics (chlordiazepoxide, diazepam, meprobamate) during the first trimester of pregnancy. b c Since use of anxiolytics is rarely urgent, their use during the first trimester almost always should be avoided.b c
Hypotension reported rarely.c Administer with caution to patients in whom a drop in BP might lead to cardiac complications, particularly geriatric patients.c
Use with caution in depressed patients; potential for suicidal tendencies.b Prescribe and dispense drug in the smallest feasible quantity.b
Monitor blood counts and liver function tests periodically during prolonged therapy.b c Leukopenia and hepatic dysfunction (including jaundice) reported rarely.c
Category D.d (See Fetal/Neonatal Morbidity under Cautions.)
Many benzodiazepines are distributed into milk.b Not known whether oxazepam is distributed into milk.d Discontinue nursing or the drug.b
Safety and efficacy not established in children <6 years of age.a c
Dosage for children 6–12 years of age not clearly established.a c
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.c Possibility of greater sensitivity to the drug (e.g., sedation, hypotension, paradoxical excitation) in some geriatric individuals.c
Select initial dosage at the lower end of the usual range because of potential for greater sensitivity and age-related decreases in hepatic or renal function.c (See Geriatric Patients under Dosage and Administration.)
Use with caution.b
Use with caution.b
Common Adverse Effects
Drowsiness,b c dizziness,b c vertigo,b c headache.b c
Interactions for Oxazepam
CNS depressants (e.g., alcohol, anticonvulsants)
Additive CNS effectb c
Use with caution to avoid overdosage;b c dosage reduction or discontinuance of CNS depressant may be necessaryc
Avoid alcohol use700
Apparent increase in oxazepam metabolisme
Clinical importance not establishede
Opiate agonists and partial agonists
Risk of profound sedation, respiratory depression, coma, or death700 701 703 705 706 707
Whenever possible, avoid concomitant use708 709 710 711
Opiate analgesics: Use concomitantly only if alternative treatment options are inadequate; use lowest effective dosages and shortest possible duration of concomitant therapy; monitor closely for respiratory depression and sedation700 703
In patients receiving oxazepam, initiate opiate analgesic, if required, at reduced dosage and titrate based on clinical response700
In patients receiving an opiate analgesic, initiate oxazepam, if required, at lower dosage than indicated in the absence of opiate therapy and titrate based on clinical response700
Opiate antitussives: Avoid concomitant use700 704
Consider offering naloxone to patients receiving benzodiazepines and opiates concomitantly709 712
Readily absorbed from the GI tract,b with peak plasma concentration usually attained within about 3 hours.c
Benzodiazepines are widely distributed into body tissues and cross the blood-brain barrier.b
Oxazepam crosses the placenta.b d
Benzodiazepines generally are distributed into milk.b Not known whether oxazepam is distributed into milk.d
Plasma Protein Binding
Benzodiazepines are highly bound to plasma proteins.b
Conjugated with glucuronic acid in the liver to form a single, major inactive metabolite.b c
Excreted principally in urine.b c
8.2 hours (range: 3–21 hours).b c
Hepatic impairment: Pharmacokinetics not altered substantially in patients with cirrhosis.f
Geriatric patients >80 years of age: Half-life is prolonged.c Age <80 years does not appear to substantially alter pharmacokinetics.c
Benzodiazepines are not appreciably removed by hemodialysis.b
Tight, light-resistant container at 20–25°C; protect from moisture.c
Effects appear to be mediated through the inhibitory neurotransmitter GABA; the site and mechanism of action within the CNS appear to involve a macromolecular complex (GABAA-receptor-chloride ionophore complex) that includes GABAA receptors, high-affinity benzodiazepine receptors, and chloride channels.320 358 359 360 361 362 363 364 365 366 367 368 369 370
Advice to Patients
Risk of potentially fatal additive effects (e.g., profound sedation, respiratory depression, coma) if used concomitantly with opiates either therapeutically or illicitly.700 703 Avoid concomitant use of opiate antitussives;700 704 also avoid concomitant use of opiate analgesics unless use is supervised by clinician.700 703
Potential for drug to impair mental alertness or physical coordination; avoid driving or operating machinery until effects on individual are known.b c
Importance of informing clinicians of any behavioral or mental changes, memory impairment, tolerance, or dependence/withdrawal symptoms.b c
Importance of taking only as prescribed; do not increase dosage or duration of therapy or abruptly discontinue drug unless otherwise instructed by a clinician.b c
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and alcohol consumption.b c
Importance of informing clinicians about any concomitant illnesses, particularly depression.c
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a b c
Importance of informing patients of other important precautionary information.b c (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Subject to control under the Federal Controlled Substances Act of 1970 as a schedule IV (C-IV) drug.a
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Oxazepam Capsules ( C-IV)
Oxazepam Capsules ( C-IV)
Oxazepam Capsules ( C-IV)
AHFS DI Essentials. © Copyright 2018, Selected Revisions December 11, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
320. Rall TW. Hypnotics and sedatives; ethanol: benzodiazepines and management of insomnia. In: Gilman AG, Rall TW, Nies AS et al. Goodman and Gilman’s the pharmacological basis of therapeutics. 8th ed. New York: Pergamon Press; 1990:346-58,369-70.
358. Bloom FE. Neurohumoral transmission and the central nervous system: amino acids. In: Gilman AG, Rall TW, Nies AS et al, eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 8th ed. New York: Pergamon Press; 1990:256-8.
359. Haefely W. The GABA-benzodiazepine interaction fifteen years later. Neurochem Res. 1990; 15:169-74. [PubMed 2159122]
360. De Feudis FV. Overview—GABAa receptors. Ann NY Acad Sci. 1990; 585:231-40. [PubMed 2162643]
361. Mohler H, Malherbe P, Draguhn A et al. GABAa-receptors: structural requirements and sites of gene expression in mammalian brain. Neurochem Res. 1990; 15:199-207. [PubMed 2159125]
362. Farrant M, Gibbs TT, Farb DH. Molecular and cellular mechanisms of GABA/benzodiazepine-receptor regulation: electrophysiological and biochemical studies. Neurochem Res. 1990; 15:175-91. [PubMed 2159123]
363. Sieghart W. Benzodiazepine receptor subtypes and their possible clinical significance. Psychopharmacol Ser. 1989; 7:131-7. [PubMed 2574448]
364. Knapp RJ, Malatynska E, Yamamura HI. From binding studies to the molecular biology of GABA receptors. Neurochem Res. 1990; 15:105-12. [PubMed 2159117]
365. Williams M. Anxioselective anxiolytics. J Med Chem. 1983; 26:619-28. [PubMed 6132997]
366. Rogawski MA, Porter RJ. Antiepileptic drugs: pharmacological mechanisms and clinical efficacy with consideration of promising developmental stage compounds. Pharmacol Rev. 1990; 42:223-86. [PubMed 2217531]
367. Haefely WE. Pharmacology of the benzodiazepine receptor. Eur Arch Psychiatry Neurol Sci. 1989; 238:294-301. [PubMed 2569974]
368. Haefely WE. Benzodiazepines. Int Anesthesiol Clin. 1988; 26:262-72. [PubMed 2461909]
369. Schoch P, Richards JG, Haring P et al. Co-localization of GABA receptors and benzodiazepine receptors in the brain shown by monoclonal antibodies. Nature. 1985; 314:168-71. [PubMed 2983231]
370. Haefely W. Endogenous ligands of the benzodiazepine receptor. Pharmacopsychiatry. 1988; 21:43-6. [PubMed 2834760]
700. US Food and Drug Administration. Drug safety communication: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning. Silver Spring, MD; 2016 Aug 31. From FDA website.
701. Jones CM, Mack KA, Paulozzi LJ. Pharmaceutical overdose deaths, United States, 2010. JAMA. 2013; 309:657-9. [PubMed 23423407]
703. Hughes A. Letter to manufacturers of benzodiazepines: safety labeling change notification. Silver Spring, MD: US Food and Drug Administration. Accessed 2017 Mar 20.
704. Seymour S. Letter to manufacturers of opioid antitussives: safety labeling change notification. Silver Spring, MD: US Food and Drug Administration. Accessed 2017 Mar 20.
705. Park TW, Saitz R, Ganoczy D et al. Benzodiazepine prescribing patterns and deaths from drug overdose among US veterans receiving opioid analgesics: case-cohort study. BMJ. 2015; 350:h2698. [PubMed 26063215]
706. Jones CM, McAninch JK. Emergency Department Visits and Overdose Deaths From Combined Use of Opioids and Benzodiazepines. Am J Prev Med. 2015; 49:493-501. [PubMed 26143953]
707. Dasgupta N, Funk MJ, Proescholdbell S et al. Cohort Study of the Impact of High-Dose Opioid Analgesics on Overdose Mortality. Pain Med. 2016; 17:85-98. [PubMed 26333030]
708. Nuckols TK, Anderson L, Popescu I et al. Opioid prescribing: a systematic review and critical appraisal of guidelines for chronic pain. Ann Intern Med. 2014; 160:38-47. [PubMed 24217469]
709. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep. 2016; 65:1-49. [PubMed 26987082]
710. Manchikanti L, Abdi S, Atluri S et al. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2--guidance. Pain Physician. 2012; 15(3 Suppl):S67-116.
711. New York City Department of Health and Mental Hygiene. New York City emergency department discharge opioid prescribing guidelines. From NYC Health website. 2013 Jan.
712. Washington State Agency Medical Directors' Group (AMDG). Interagency guideline on prescribing opioids for pain, 3rd ed. From Washington State AMDG website. 2015 Jun.
a. AHFS drug information 2008. McEvoy GK, ed. Oxazepam. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2599-60.
b. AHFS drug information 2008. McEvoy GK, ed. Benzodiazepines general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2571-80.
c. Sandoz. Oxazepam capsules prescribing information. Princeton, NJ; 2007 Nov.
d. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Baltimore, MD: Williams & Wilkins; 2005:1220.
e. AHFS drug information 2008. McEvoy GK, ed. Estrogen-progestin combinations. Bethesda, MD: American Society of Health-System Pharmacists; 2008:3128-43.
f. Bailey L, Ward M, Musa MN. Clinical pharmacokinetics of benzodiazepines. J Clin Pharmacol. 1994; 34:804-11. [PubMed 7962667]
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