Generic Name: OXAZEPAM
Brand Name: Oxazepam
- Substance Name(s):
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 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.
USE IN PREGNANCY 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.
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.
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 flumazenil package insert including CONTRAINDICATIONS , WARNINGS , and PRECAUTIONS should be consulted prior to use.
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 capsules, USP contain 10 mg, 15 mg or 30 mg oxazepam, USP.
The following inactive ingredients are contained in these capsules: corn starch, croscarmellose sodium, FD&C Red #40, gelatin, hypromellose, lactose (monohydrate), magnesium stearate, methylparaben, propylparaben, sodium lauryl sulfate, titanium dioxide, and other inert ingredients.
The 10 mg capsule also contains D&C Red #28.
The 15 mg capsule also contains D&C Yellow #10.
The 30 mg capsule also contains D&C Red #28 and FD&C Blue #1.
Oxazepam, USP is 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-2 H- 1,4-benzodiazepin-2-one.
A white crystalline powder with a molecular weight of 286.72, its structural formula is as follows: Structural Formula
Oxazepam Capsules, USP are available as follows: 10 mg – Each pink opaque gelatin #4 capsule printed with and 067 in black ink on both cap and body contains 10 mg of Oxazepam, USP.
Capsules are supplied in unit dose packages of 100 (10 x 10) NDC 62584-812-01.
15 mg – Each red opaque gelatin #4 capsule printed with and 069 in black ink on both cap and body contains 15 mg of Oxazepam, USP.
Capsules are supplied in unit dose packages of 100 (10 x 10) NDC 62584-813-01.
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 unit dose packages of 100 (10 x 10) NDC 62584-814-01.
Store at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF).
FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Imprint on 10 mg Imprint on 15 mg Imprint on 30 mg
Geriatric Use: Clinical studies of oxazepam were not adequate to determine whether subjects aged 65 and over respond differently than younger subjects.
Age (less than 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 and 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 ].
INDICATIONS AND USAGE
INDICATIONS Oxazepam capsules are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.
Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
Anxiety associated with depression is also responsive to oxazepam therapy.
This product has been found particularly useful in the management of anxiety, tension, agitation, and irritability in older patients.
Alcoholics with acute tremulousness, inebriation, or with anxiety, associated with alcohol withdrawal are responsive to therapy.
The effectiveness of oxazepam 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.
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.
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 use in 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 oxazepam, 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 oxazepam and throughout treatment, assess each patient’s 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 withdrawal 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 ].
INFORMATION FOR PATIENTS
Information for Patients Advise the patient to read the FDA-approved patient labeling ( Medication Guide ).
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 or secondary to organic disease.
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 ].