Oxazepam Tablets

Oxazepam capsules are available as follows:

• 10 mg — Each pink opaque gelatin #4 capsule printed with logo 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 logo 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 logo 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

Distributed by: American Health Packaging, Columbus, OH 43217.. Revised: Apr 2014.

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 is 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.

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.

Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines (see Drug Abuse And Dependence).

Use In Pregnancy

An increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam, and meprobamate) during the first trimes ter 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.

To assure the safe and effective use of oxazepam, patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.

Oxazepam is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Oxazepam affects chemicals in the brain that may become unbalanced and cause anxiety.

Oxazepam is used to treat anxiety disorders or alcohol withdrawal symptoms.

Oxazepam may also be used for other purposes not listed in this medication guide.

Do not use this medication if you are allergic to oxazepam or to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), or lorazepam (Ativan).

Before taking oxazepam, tell your doctor if you are allergic to any drugs, or if you have:

• glaucoma;
• asthma, emphysema, bronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems;
• kidney or liver disease;
• a history of depression or suicidal thoughts or behavior; or
• a history of drug or alcohol addiction.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

Oxazepam can cause birth defects in an unborn baby. Do not use oxazepam without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication.

Oxazepam may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The sedative effects of oxazepam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking oxazepam.

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 nausea, lethargy, edema, slurred speech, tremor, altered libido, and minor diffuse skin rashes-morbilliform, urticarial, and maculopapular. 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.

Read the entire FDA prescribing information for Serax (Oxazepam Tablets)