Oxazepam
FDA Drug Information • Also known as: Oxazepam
- Brand Names
- Oxazepam
- Dosage Form
- CAPSULE, GELATIN COATED
- Product Type
- DRUG FOR FURTHER PROCESSING
⚠ Boxed Warning (Black Box)
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL REACTIONS
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
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 reactions, 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 ).
Side Effects (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 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.
Warnings and Precautions
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, prescribe 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 patient’s 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...
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.
Contraindications
CONTRAINDICATIONS History of previous hypersensitivity reaction to oxazepam. Oxazepam is not indicated in psychoses.
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 “ CONTRAINDICATIONS , ” “ WARNINGS , ” and “ PRECAUTIONS ” should be consulted prior to 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.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.