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Pronunciation:

(oks A ze pam)

U.S. Brand Names:

Serax®

Generic Available:

Yes: Capsule

Canadian Brand Names:

Apo-Oxazepam®; Novoxapram®; Oxpram®; PMS-Oxazepam

Use:

Treatment of anxiety; management of ethanol withdrawal

Use - Unlabeled/Investigational:

Anticonvulsant in management of simple partial seizures; hypnotic

Restrictions:

C-IV

Pregnancy Risk Factor:

Lactation:

Enters breast milk/not recommended

Contraindications:

Hypersensitivity to oxazepam or any component of the formulation (cross-sensitivity with other benzodiazepines may exist); narrow-angle glaucoma (not in product labeling, however, benzodiazepines are contraindicated); not indicated for use in the treatment of psychosis; pregnancy

Warnings/Precautions:

May cause hypotension (rare) - use with caution in patients with cardiovascular or cerebrovascular disease, or in patients who would not tolerate transient decreases in blood pressure. Serax® 15 mg tablet contains tartrazine; use is not recommended in pediatric patients <6 years of age; dose has not been established between 6-12 years of age.

Use with caution in elderly or debilitated patients, patients with hepatic disease (including alcoholics), or renal impairment. Use with caution in patients with respiratory disease or impaired gag reflex. Avoid use in patients with sleep apnea.

Causes CNS depression (dose-related) resulting in sedation, dizziness, confusion, or ataxia which may impair physical and mental capabilities. Patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Use with caution in patients receiving other CNS depressants or psychoactive agents. Effects with other sedative drugs or ethanol may be potentiated. Benzodiazepines have been associated with falls and traumatic injury and should be used with extreme caution in patients who are at risk of these events (especially the elderly).

Use caution in patients with depression, particularly if suicidal risk may be present. Use with caution in patients with a history of drug dependence. Benzodiazepines have been associated with dependence and acute withdrawal symptoms on discontinuation or reduction in dose. Acute withdrawal, including seizures, may be precipitated after administration of flumazenil to patients receiving long-term benzodiazepine therapy.

Benzodiazepines have been associated with anterograde amnesia. Paradoxical reactions, including hyperactive or aggressive behavior have been reported with benzodiazepines, particularly in adolescent/pediatric or psychiatric patients. Does not have analgesic, antidepressant, or antipsychotic properties.

Adverse Reactions:

Frequency not defined.

Cardiovascular: Syncope (rare), edema

Central nervous system: Drowsiness, ataxia, dizziness, vertigo, memory impairment, headache, paradoxical reactions (excitement, stimulation of effect), lethargy, amnesia, euphoria

Dermatologic: Rash

Endocrine & metabolic: Decreased libido, menstrual irregularities

Genitourinary: Incontinence

Hematologic: Leukopenia, blood dyscrasias

Hepatic: Jaundice

Neuromuscular & skeletal: Dysarthria, tremor, reflex slowing

Ocular: Blurred vision, diplopia

Miscellaneous: Drug dependence

Overdosage/Toxicology:

Symptoms of overdose include somnolence, confusion, coma, hypoactive reflexes, dyspnea, hypotension, slurred speech, and impaired coordination. Treatment for benzodiazepine overdose is supportive. Flumazenil has been shown to selectively block the binding of benzodiazepines to CNS receptors, resulting in a reversal of benzodiazepine-induced CNS depression, but not respiratory depression due to toxicity.

Drug Interactions:

Ethanol and other CNS depressants may increase the CNS effects of oxazepam

Levodopa: Therapeutic effects may be diminished in some patients following the addition of a benzodiazepine; limited/inconsistent data

Theophylline and other CNS stimulants may antagonize the sedative effects of oxazepam

Zidovudine: Increased incidence of headache with concurrent use.

Ethanol/Nutrition/Herb Interactions:

Ethanol: Avoid ethanol (may increase CNS depression).

Herb/Nutraceutical: Avoid valerian, St John's wort, kava kava, gotu kola (may increase CNS depression).

Mechanism of Action:

Binds to stereospecific benzodiazepine receptors on the postsynaptic GABA neuron at several sites within the central nervous system, including the limbic system, reticular formation. Enhancement of the inhibitory effect of GABA on neuronal excitability results by increased neuronal membrane permeability to chloride ions. This shift in chloride ions results in hyperpolarization (a less excitable state) and stabilization.

Pharmacodynamics/Kinetics:

Absorption: Almost complete

Protein binding: 86% to 99%

Metabolism: Hepatic to inactive compounds (primarily as glucuronides)

Half-life elimination: 2.8-5.7 hours

Time to peak, serum: 2-4 hours

Excretion: Urine (as unchanged drug (50%) and metabolites)

Dosage:

Oral:

Children: Anxiety: 1 mg/kg/day has been administered

Adults:

Anxiety: 10-30 mg 3-4 times/day

Ethanol withdrawal: 15-30 mg 3-4 times/day

Hypnotic: 15-30 mg

Elderly: Oral: Anxiety: 10 mg 2-3 times/day; increase gradually as needed to a total of 30-45 mg/day. Dose titration should be slow to evaluate sensitivity.

Hemodialysis: Not dialyzable (0% to 5%)

Administration:

Administer orally in divided doses

Monitoring Parameters:

Respiratory and cardiovascular status

Reference Range:

Therapeutic: 0.2-1.4 mcg/mL (SI: 0.7-4.9 mol/L)

Patient Education:

Take exactly as directed; do not increase dose or frequency. It may take 2-3 weeks to achieve desired results. Drug may cause physical and/or psychological dependence. Do not use alcohol or other prescription or OTC medications (especially pain medications, sedatives, antihistamines, or hypnotics) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. You may experience drowsiness, lightheadedness, impaired coordination, dizziness, or blurred vision (use caution when driving or engaging in tasks requiring alertness until response to drug is known); nausea, vomiting, or dry mouth (small, frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); constipation (increased exercise, fluids, fruit, or fiber may help); altered sexual drive or ability (reversible); or photosensitivity (use sunscreen, wear protective clothing and eyewear, and avoid direct sunlight). Report persistent CNS effects (eg, confusion, depression, increased sedation, excitation, headache, agitation, insomnia or nightmares, dizziness, fatigue, impaired coordination, changes in personality, or changes in cognition); changes in urinary pattern; muscle cramping, weakness, tremors, or rigidity; ringing in ears or visual disturbances; chest pain, palpitations, or rapid heartbeat; excessive perspiration, excessive GI symptoms (cramping, constipation, vomiting, anorexia); or worsening of condition. Pregnancy/breast-feeding precautions: Do not get pregnant while taking this medication; use appropriate barrier contraceptive measures. Breast-feeding is not recommended.

Nursing Implications:

Provide safety measures (ie, side rails, night light, and call button); remove smoking materials from area; supervise ambulation

Additional Information:

Not intended for management of anxieties and minor distresses associated with everyday life. Treatment longer than 4 months should be re-evaluated to determine the patient's need for the drug. Abrupt discontinuation after sustained use (generally >10 days) may cause withdrawal symptoms.

Anesthesia and Critical Care Concerns/Other Considerations:

Not intended for management of anxieties and minor distresses associated with everyday life; treatment >4 months should be re-evaluated to determine the patient's need for the drug. Chronic use of this agent may increase the perioperative benzodiazepine dose needed to achieve desired effect. Abrupt discontinuation after sustained use (generally >10 days) may cause withdrawal symptoms.

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Dosage Forms:

Capsule: 10 mg, 15 mg, 30 mg

Tablet: 15 mg

International Brand Names:

Adumbran® (AT, DE, ES, SI); Alepam® (AU); Alopam® (DK, NO); Anxiolit® (AT, CH); Apo-Oxazepam® (CA); Azutranquil® (DE); Benzotran® (NZ); durazepam® (DE); Enidrel® (AR); Limbial® (IT); Medopam® (ZA); Mirfudorm® (DE); Murelax® (AU); Nesontil® (AR); Noctazepam® (DE); Noripam® (ZA); Novoxapram® (CA); Nozepam® (RU); Oksazepam® (HR, PL, SI); Opamox® (FI); Oxa 1A Pharma® (DE); Oxabenz® (DK); Oxahexal® (AT); Oxamin® (FI); Oxapax® (DK); Oxaphar® (BE); Oxascand® (SE); oxa von ct® (DE); Oxazepam 1A Pharma® (DE); Oxazepam AL® (DE); Oxazepam Efeka® (BE, LU); Oxazepam EG® (BE); Oxazepam-Eurogenerics® (LU); Oxazepam Hexal® (DE); Oxazepam Leciva® (CZ); Oxazepam-neuraxpharm® (DE); Oxazepam® (PL, RO, RU); Oxazepam-ratiopharm® (DE, LU); Oxazepam SAD® (DK); Oxazepam Sandoz® (DE); Oxazepam Stada® (DE); Oxepam® (FI); Ox-Pam® (NZ); Oxpram® (CA); PMS-Oxazepam (CA); Praxiten® (AT, DE, HR, SI); Purata® (ZA); Serax® (HK); Serenal® (PT); Serepax® (AU, CL, DK, IN, NO, NZ, ZA); Seresta® (BE, CH); Séresta® (FR); Seresta® (LU, NL); Serpax® (IT); Sigacalm® (DE); Sobril® (NO, SE); Tranquo® (BE, LU); Uskan® (DE)

References

Hicks R, Dysken MW, Davis JM, et al, "The Pharmacokinetics of Psychotropic Medication in the Elderly: A Review,"J Clin Psychiatry, 1981, 42(10):374-85.

Mokhlesi B, Leikin JB, Murray P, et al, "Adult Toxicology in Critical Care: Part II: Specific Poisonings,"Chest, 2003, 123(3):897-922.

Moshkowitz M, Pines A, Finkelstein A, et al, "Skin Blisters as a Manifestation of Oxazepam Toxicity,"J Toxicol Clin Toxicol, 1990, 28(3):383-6.

Zileli MS, Teletar F, Deniz S, et al, "Oxazepam Intoxication Simulating Nonketo-Acidotic Diabetic Coma,"JAMA, 1971, 215(12):1986.

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