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
flumazenil package insert including CONTRAINDICATIONS,
WARNINGS, and PRECAUTIONS
should be consulted prior to use.
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DRUG ABUSE AND DEPENDENCE
Oxazepam Capsules are classified by the Drug Enforcement
Administration as a schedule IV controlled substance.
Withdrawal symptoms, similar in character to those noted with barbiturates
and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting, and
sweating), have occurred following abrupt discontinuance of oxazepam. The more
severe withdrawal symptoms have usually been limited to those patients who
received excessive doses over an extended period of time. Generally milder
withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following
abrupt discontinuance of benzodiazepines taken continuously at therapeutic
levels for several months. 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.
REFERENCES
1. FOX, K.A, LAHCEN, R.B.: Liver-cell Adenomas and Peliosis
Hepatis in Mice Associated with Oxazepam. Res. Commun. Chem. Pathol. Pharmacol.
8:481-488, 1974.
Manufactured by:
Actavis Elizabeth LLC
200 Elmora Avenue, Elizabeth, NJ 07207 USA
40-9021
Revised — March 2006
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