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OXAZEPAM

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Overview

What is OXAZEPAM?

DESCRIPTION

Oxazepam is the first of a chemical series of compounds known as the 3-hydroxybenzodiazepinones. A therapeutic agent providing versatility and flexibility in control of common emotional disturbances, this product exerts prompt action in a wide variety of disorders associated with anxiety, tension, agitation, and irritability, and anxiety associated with depression. In tolerance and toxicity studies on several animal species, this product reveals significantly greater safety factors than related compounds (chlordiazepoxide and diazepam) and manifests a wide separation of effective doses and doses inducing side effects.

Oxazepam capsules contain 10 mg, 15 mg or 30 mg oxazepam. The following inactive ingredients are contained in these capsules: corn starch, croscarmellose sodium, FDANDC Red #40, gelatin, hypromellose, lactose (monohydrate), magnesium stearate, methylparaben, propylparaben, sodium lauryl sulfate, titanium dioxide, and other inert ingredients. The 10 mg capsule also contains DANDC Red #28. The 15 mg capsule also contains DANDC Yellow #10. The 30 mg capsule also contains DANDC Red #28 and FDANDC Blue #1.

Oxazepam is 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-21,4-benzodiazepin-2-one. A white crystalline powder with a molecular weight of 28672, its structural formula is as follows:



What does OXAZEPAM look like?



What are the available doses of OXAZEPAM?

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What should I talk to my health care provider before I take OXAZEPAM?

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How should I use OXAZEPAM?

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.

Because of the flexibility of this product and the range of emotional disturbances responsive to it, dosage should be individualized for maximum beneficial effects.

USUAL DOSE

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.


What interacts with OXAZEPAM?

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What are the warnings of OXAZEPAM?

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What are the precautions of OXAZEPAM?

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What are the side effects of OXAZEPAM?

Sorry No records found


What should I look out for while using OXAZEPAM?

History of previous hypersensitivity reaction to oxazepam. Oxazepam is not indicated in psychoses


What might happen if I take too much OXAZEPAM?

In the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.

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.

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 complete flumazenil package insert including , , and should be consulted prior to use.


How should I store and handle OXAZEPAM?

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CIII Narcotic.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CIII Narcotic.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CIII Narcotic.HOW SUPPLIEDOxazepam capsules are available as follows:10 mg — Each pink opaque gelatin #4 capsule printed with Image from Drug Label Content and 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 with Image from Drug Label Content and 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 Image from Drug Label Content 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).Keep tightly closed.Dispense in a tight, light-resistant container as defined in the USP.Store at controlled room temperature 15°-30°C (59°-86°F).Rx onlyHOW SUPPLIEDOxazepam capsules are available as follows:10 mg — Each pink opaque gelatin #4 capsule printed with Image from Drug Label Content and 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 with Image from Drug Label Content and 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 Image from Drug Label Content 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).Keep tightly closed.Dispense in a tight, light-resistant container as defined in the USP.Store at controlled room temperature 15°-30°C (59°-86°F).Rx onlyHOW SUPPLIEDOxazepam capsules are available as follows:10 mg — Each pink opaque gelatin #4 capsule printed with Image from Drug Label Content and 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 with Image from Drug Label Content and 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 Image from Drug Label Content 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).Keep tightly closed.Dispense in a tight, light-resistant container as defined in the USP.Store at controlled room temperature 15°-30°C (59°-86°F).Rx onlyHOW SUPPLIEDOxazepam capsules are available as follows:10 mg — Each pink opaque gelatin #4 capsule printed with Image from Drug Label Content and 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 with Image from Drug Label Content and 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 Image from Drug Label Content 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).Keep tightly closed.Dispense in a tight, light-resistant container as defined in the USP.Store at controlled room temperature 15°-30°C (59°-86°F).Rx onlyHOW SUPPLIEDOxazepam capsules are available as follows:10 mg — Each pink opaque gelatin #4 capsule printed with Image from Drug Label Content and 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 with Image from Drug Label Content and 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 Image from Drug Label Content 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).Keep tightly closed.Dispense in a tight, light-resistant container as defined in the USP.Store at controlled room temperature 15°-30°C (59°-86°F).Rx onlyHOW SUPPLIEDOxazepam capsules are available as follows:10 mg — Each pink opaque gelatin #4 capsule printed with Image from Drug Label Content and 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 with Image from Drug Label Content and 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 Image from Drug Label Content 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).Keep tightly closed.Dispense in a tight, light-resistant container as defined in the USP.Store at controlled room temperature 15°-30°C (59°-86°F).Rx onlyHOW SUPPLIEDOxazepam capsules are available as follows:10 mg — Each pink opaque gelatin #4 capsule printed with Image from Drug Label Content and 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 with Image from Drug Label Content and 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 Image from Drug Label Content 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).Keep tightly closed.Dispense in a tight, light-resistant container as defined in the USP.Store at controlled room temperature 15°-30°C (59°-86°F).Rx onlyHOW SUPPLIEDOxazepam capsules are available as follows:10 mg — Each pink opaque gelatin #4 capsule printed with Image from Drug Label Content and 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 with Image from Drug Label Content and 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 Image from Drug Label Content 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).Keep tightly closed.Dispense in a tight, light-resistant container as defined in the USP.Store at controlled room temperature 15°-30°C (59°-86°F).Rx onlyHOW SUPPLIEDOxazepam capsules are available as follows:10 mg — Each pink opaque gelatin #4 capsule printed with Image from Drug Label Content and 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 with Image from Drug Label Content and 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 Image from Drug Label Content 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).Keep tightly closed.Dispense in a tight, light-resistant container as defined in the USP.Store at controlled room temperature 15°-30°C (59°-86°F).Rx only


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Pharmacokinetic testing in healthy adult subjects has demonstrated that a single 30 mg dose of a capsule or tablet will result in equivalent extent of absorption. Peak plasma levels were observed to occur about 3 hours after dosing. The mean elimination half-life for oxazepam was approximately 82 hours (range 57 to 109 hours).

This product has a single, major inactive metabolite in man, a glucuronide excreted in the urine.

Age (less than 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 (greater than 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 of oxazepam in the very elderly. (see ).

Non-Clinical Toxicology
History of previous hypersensitivity reaction to oxazepam. Oxazepam is not indicated in psychoses

Few systemic data have been collected on the metabolism of bupropion following concomitant administration with other drugs or, alternatively, the effect of concomitant administration of bupropion on the metabolism of other drugs.

Because bupropion is extensively metabolized, the coadministration of other drugs may affect its clinical activity. studies indicate that bupropion is primarily metabolized to hydroxybupropion by the CYP2B6 isoenzyme. Therefore, the potential exists for a drug interaction between bupropion hydrochloride tablets and drugs that are substrates or inhibitors of the CYP2B6 isoenzyme (e.g., orphenadrine, thiotepa, and cyclophosphamide). In addition, studies suggest that paroxetine, sertraline, norfluoxetine, and fluvoxamine as well as nelfinavir, ritonavir, and efavirenz inhibit the hydroxylation of bupropion. No clinical studies have been performed to evaluate this finding. The threohydrobupropion metabolite of bupropion does not appear to be produced by the cytochrome P450 isoenzymes. The effects of concomitant administration of cimetidine on the pharmacokinetics of bupropion and its active metabolites were studied in 24 healthy young male volunteers. Following oral administration of two 150 mg sustained-release tablets with and without 800 mg of cimetidine, the pharmacokinetics of bupropion and hydroxybupropion were unaffected. However, there were 16% and 32% increases in the AUC and C, respectively, of the combined moieties of threohydrobupropion and erythrohydrobupropion.

While not systematically studied, certain drugs may induce the metabolism of bupropion (e.g., carbamazepine, phenobarbital, phenytoin).

Multiple oral doses of bupropion had no statistically significant effects on the single dose pharmacokinetics of lamotrigine in 12 healthy volunteers.

Animal data indicated that bupropion may be an inducer of drug-metabolizing enzymes in humans. In one study, following chronic administration of bupropion, 100 mg 3 times daily to 8 healthy male volunteers for 14 days, there was no evidence of induction of its own metabolism. Nevertheless, there may be the potential for clinically important alterations of blood levels of coadministered drugs.

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 section).

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.

Although hypotension has occurred only rarely, oxazepam should be administered with caution to patients in whom a drop in blood pressure might lead to cardiac complications. This is particularly true in the elderly patient.

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.

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.

Clinical studies of oxazepam were not adequate to determine whether subjects aged 65 and over respond differently than younger subjects. Age (less than 80 years old) does not appear to have a clinically significant effect on oxazepam kinetics (see ).

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 (see ; see ). In general, dose selection for oxazepam for elderly patients should be cautious, usually starting at the lower end of the dosing range (see ).

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

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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