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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.
