Oxazepam

Oxazepam Recall

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FDA Labeling Changes

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Uses

INDICATIONS AND USAGE

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.

History

There is currently no drug history available for this drug.

Other Information

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-2H-1,4-benzodiazepin-2-one. A white crystalline powder with a molecular weight of 286.72, its structural formula is as follows:

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Oxazepam Recall

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Oxazepam Manufacturers

Stat Rx Usa Llc
No Recall
Oxazepam | Stat Rx Usa Llc
DOSAGE AND ADMINISTRATION
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
Mild-to-moderate anxiety, with associated tension, irritability, agitation, or related symptoms of functional origin or secondary to organic disease. 10 to 15 mg, 3 or 4 times daily Severe anxiety syndromes, agitation, or anxiety associated with depression. 15 to 30 mg, 3 or 4 times daily Older patients with anxiety, tension, irritability, and agitation. Initial dosage: 10 mg, 3 times daily. If necessary, increase cautiously to 15 mg, 3 or 4 times daily. Alcoholics with acute inebriation, tremulousness, or anxiety on withdrawal. 15 to 30 mg, 3 or 4 times daily
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.
Remedyrepack Inc.
No Recall
Oxazepam | Remedyrepack Inc.
Because of the flexibility of this product and the range of emotional disturbances responsive to it, dosage should be individualized for maximum beneficial effects.

OXAZEPAMUsual DoseMild-to-moderate anxiety, with associated tension, irritability, agitation or related symptoms of functional origin or secondary to organic disease10 to 15 mg, 3 or 4 times dailySevere anxiety syndromes, agitation, or anxiety associated with depression15 to 30 mg, 3 or 4 times dailyOlder patients with anxiety, tension, irritability and agitationInitial dosage: 10 mg, 3 times daily. If necessary, increase cautiously to 15 mg, 3 or 4 times dailyAlcoholics with acute inebriation, tremulousness, or anxiety on withdrawal15 to 30 mg, 3 or 4 times dailyThis 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.
Sandoz Inc
No Recall
Oxazepam | Sandoz Inc
Because of the flexibility of this product and the range of emotional disturbances responsive to it, dosage should be individualized for maximum beneficial effects.
OXAZEPAM Usual Dose
Mild-to-moderate anxiety, with associated

tension, irritability, agitation or related

symptoms of functional origin or secondary to
organic disease
10 to 15 mg, 3 or 4 times daily

Severe anxiety syndromes, agitation, or anxiety
associated with depression
15 to 30 mg, 3 or 4 times daily

Older patients with anxiety, tension, irritability

and agitation

Initial dosage: 10 mg, 3 times daily.

If necessary, increase cautiously to 15 mg,
3 or 4 times daily
Alcoholics with acute inebriation,
tremulousness, or anxiety on withdrawal
15 to 30 mg, 3 or 4 times daily

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.
Aphena Pharma Solutions – Tennessee, Inc.
No Recall
Oxazepam | Aphena Pharma Solutions - Tennessee, Inc.
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
Mild-to-moderate anxiety, with associated tension, irritability, agitation, or related symptoms of functional origin or secondary to organic disease. 10 to 15 mg, 3 or 4 times daily Severe anxiety syndromes, agitation, or anxiety associated with depression. 15 to 30 mg, 3 or 4 times daily Older patients with anxiety, tension, irritability, and agitation. Initial dosage: 10 mg, 3 times daily. If necessary, increase cautiously to 15 mg, 3 or 4 times daily. Alcoholics with acute inebriation, tremulousness, or anxiety on withdrawal. 15 to 30 mg, 3 or 4 times daily
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.
American Health Packaging
No Recall
Oxazepam | Alcon Laboratories, Inc.
Adults: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated in five to ten minutes if necessary. Complete recovery usually occurs in 24 hours. Complete recovery from mydriasis in some individuals may require several days. Children: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated five to ten minutes later by a second application of 0.5% or 1% solution if necessary. Small Infants: A single instillation of one drop of 0.5% in the eye. To minimize absorption, apply pressure over the nasolacrimal sac for two to three minutes. Observe infant closely for at least 30 minutes following instillation. Individuals with heavily pigmented irides may require higher strengths.
Actavis Elizabeth Llc
No Recall
Oxazepam | Actavis Elizabeth Llc
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
Mild-to-moderate anxiety, with associated tension, irritability, agitation, or related symptoms of functional origin or secondary to organic disease. 10 to 15 mg, 3 or 4 times daily Severe anxiety syndromes, agitation, or anxiety associated with depression. 15 to 30 mg, 3 or 4 times daily Older patients with anxiety, tension, irritability, and agitation. Initial dosage: 10 mg, 3 times daily. If necessary, increase cautiously to 15 mg, 3 or 4 times daily. Alcoholics with acute inebriation, tremulousness, or anxiety on withdrawal. 15 to 30 mg, 3 or 4 times daily
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.
Aphena Pharma Solutions – Tennessee, Llc
No Recall
Oxazepam | Aphena Pharma Solutions - Tennessee, Llc
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
Mild-to-moderate anxiety, with associated tension, irritability, agitation, or related symptoms of functional origin or secondary to organic disease. 10 to 15 mg, 3 or 4 times daily Severe anxiety syndromes, agitation, or anxiety associated with depression. 15 to 30 mg, 3 or 4 times daily Older patients with anxiety, tension, irritability, and agitation. Initial dosage: 10 mg, 3 times daily. If necessary, increase cautiously to 15 mg, 3 or 4 times daily. Alcoholics with acute inebriation, tremulousness, or anxiety on withdrawal. 15 to 30 mg, 3 or 4 times daily
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.
Bryant Ranch Prepack
No Recall
Oxazepam | Bryant Ranch Prepack
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 Mild-to-moderate anxiety, with associated tension, irritability, agitation, or related symptoms of functional origin or secondary to organic disease. 10 to 15 mg, 3 or 4 times daily Severe anxiety syndromes, agitation, or anxiety associated with depression. 15 to 30 mg, 3 or 4 times daily Older patients with anxiety, tension, irritability, and agitation. Initial dosage: 10 mg, 3 times daily. If necessary, increase cautiously to 15 mg, 3 or 4 times daily. Alcoholics with acute inebriation, tremulousness, or anxiety on withdrawal. 15 to 30 mg, 3 or 4 times daily
This product is not indicated in pediatric patients under 6 years of age. Absolute dosage for pediatric patients 6-12 years of age is not established.

Oxazepam

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