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Oxazepam

Pronunciation

Pronunciation: ox-AZE-uh-pam
Class: Benzodiazepine

For Professionals Side Effects Interactions More...

Trade Names

Oxazepam
- Capsules 10 mg
- Capsules 15 mg
- Capsules 30 mg

Apo-Oxazepam (Canada)

Pharmacology

Potentiates action of GABA, an inhibitory neurotransmitter, resulting in increased neuronal inhibition and CNS depression, especially in limbic system and reticular formation.

Pharmacokinetics

Absorption

Readily absorbed orally. T _max is 2 to 4 h; C _max is approximately 450 mg/mL.

Distribution

Protein bound approximately 87%.

Metabolism

In liver to inactive compounds (glucuronide conjugates).

Elimination

Excreted in the urine. The t _½ is 8.2 h.

Onset

Slow.

Indications and Usage

Control of anxiety, anxiety associated with depression; control of anxiety, tension, agitation, and irritability in elderly; treatment of alcoholic patients with acute tremulousness, inebriation, or anxiety associated with alcohol withdrawal.

Contraindications

Hypersensitivity to benzodiazepines; psychoses.

Dosage and Administration

Mild to Moderate Anxiety with Associated Tension, Irritability, and Agitation
Adults

PO 10 to 15 mg 3 to 4 times daily.

Severe Anxiety Syndromes, Agitation or Anxiety Associated with Depression, Alcoholics with Acute Inebriation and Tremulousness, or Anxiety on Withdrawal
Adults

PO 15 to 30 mg 3 to 4 times daily.

Elderly

PO 10 mg 3 times daily; increase cautiously up to 15 3 to 4 times daily.

Storage/Stability

Store capsules at controlled room temperature (59° to 86°F).

Drug Interactions

Alcohol, CNS depressants

Additive CNS depressant effects.

Digoxin

Increased serum digoxin concentrations.

Theophyllines

May antagonize sedative effects of oxazepam.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Changes in ECG pattern; hypotension; syncope.

CNS

Drowsiness; dizziness; lethargy; vertigo; tremor; fatigue; memory impairment; disorientation; anterograde amnesia; ataxia; hallucinations; restlessness; headache; slurred speech; stupor; euphoria; paradoxical reactions (eg, anger, hostility, mania, insomnia).

Dermatologic

Rashes (morbilliform, urticaria, maculopapular).

EENT

Blurred vision; diplopia.

GI

Nausea.

Hematologic

Blood dyscrasias including agranulocytosis; leukopenia.

Hepatic

Hepatic function impairment and jaundice.

Miscellaneous

Dependence/withdrawal syndrome (eg, confusion, abnormal perception of movement, depersonalization, muscle twitching, psychosis, paranoid delusions, seizures); edema; altered libido; incontinence; fever; menstrual irregularities.

Precautions

Pregnancy

Category D .

Lactation

Undetermined.

Children

Dosage and efficacy not established in children younger than 6 yr of age; absolute dosage not established for patients 6 to 12 yr of age.

Elderly

For elderly and debilitated patients, initial dose should be small; increase gradually.

Dependence

Prolonged use may lead to dependence. Withdrawal syndrome has occurred within 4 to 6 wk of treatment with therapeutic doses, especially if abruptly discontinued. Use caution and taper dosage.

Long-term use (more than 4 mo)

Effectiveness has not been assessed.

Psychiatric disorders

Not intended for use in patients with primary depressive disorder, psychoses, or disorders in which anxiety is not prominent.

Suicide

Use drug with caution in patients with suicidal tendencies; do not allow access to large quantities of drug.

Overdosage

Symptoms

Drowsiness, mental confusion, lethargy, ataxia, hypotonia, hypotension, hypnotic state, coma, death.

Patient Information

Advise patient or caregiver to read the patient information leaflet before starting therapy and with each refill.
Advise patient that medication is usually started at a low dose and then gradually increased until max benefit is obtained.
Caution patient that medication may be habit forming, to take as prescribed, and not to stop taking or change the dose unless advised by health care provider.
Advise patient to take each dose without regard to meals but to take with food if stomach upset occurs.
Advise patient that if a dose is missed to skip that dose and take the next dose at the regularly scheduled time. Caution patient to never take 2 doses at the same time.
Advise patient that if medication needs to be discontinued it will be slowly withdrawn unless safety concerns (eg, rash) require a more rapid withdrawal.
Instruct patient to avoid alcoholic beverages and other depressants while taking this medication.
Advise patient with anxiety to take as needed and to seek alternative methods for controlling or preventing anxiety (eg, stress reduction, counseling).
Instruct patient to contact health care provider if symptoms do not appear to be getting better, are getting worse, or if bothersome adverse reactions (eg, drowsiness, memory impairment) occur.
Advise patient that drug may cause drowsiness or impair judgment, thinking, or reflexes and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.