OXAZEPAM- oxazepam capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OXAZEPAM (UNII: 6GOW6DWN2A) (OXAZEPAM - UNII:6GOW6DWN2A)

Available from:

Sandoz Inc

INN (International Name):

OXAZEPAM

Composition:

OXAZEPAM 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Oxazepam Capsules, USP are available as: 10 mg: white capsules, imprinted GG 505 in black and pink ink bands and are supplied as: NDC 0781-2809-01 bottles of 100 capsules NDC 0781-2809-05 bottles of 500 capsules NDC 0781-2809-10 bottles of 1000 capsules 15 mg: white capsules, imprinted GG 506 in black and red ink bands and are supplied as: NDC 0781-2810-01 bottles of 100 capsules NDC 0781-2810-05 bottles of 500 capsules NDC 0781-2810-10 bottles of 1000 capsules 30 mg: white capsules, imprinted GG 507 in black and maroon ink bands and are supplied as: NDC 0781-2811-01 bottles of 100 capsules NDC 0781-2811-05 bottles of 500 capsules NDC 0781-2811-10 bottles of 1000 capsules Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Sandoz Inc
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MEDICATION GUIDE
Oxazepam (ox-AZE-e-pam) Capsules, C-IV
What is the most important information I should know about oxazepam?
•
Oxazepam is a benzodiazepine medicine. Taking benzodiazepines with
opioid medicines, alcohol,
or other central nervous system depressants (including street drugs)
can cause severe drowsiness,
breathing problems (respiratory depression), coma and death.
•
Oxazepam can make you sleepy or dizzy, and can slow your thinking and
motor skill.
o
Do not drive, operate heavy machinery, or do other dangerous
activities until you know how
oxazepam affects you.
o
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking oxazepam
without first talking to your healthcare provider. When taken with
alcohol or drugs that cause
sleepiness or dizziness, oxazepam may make your sleepiness or
dizziness much worse.
•
Do not take more oxazepam than prescribed.
What is oxazepam?
•
Oxazepam is a prescription medicine used:
o
to treat anxiety disorders
o
for the short-term relief of the symptoms of anxiety or anxiety that
can happen with depression
o
to treat anxiety, tension, agitation and irritability in elderly
people
o
to relieve the symptoms of alcohol withdrawal including agitation,
shakiness (tremor), anxiety
associated with acute alcohol withdrawal.
•
Oxazepam is a federal controlled substance (C-IV) because it can be
abused or lead to dependence.
Keep oxazepam in a safe place to prevent misuse and abuse. Selling or
giving away oxazepam may
harm others, and is against the law. Tell your healthcare provider if
you have abused or been
dependent on alcohol, prescription medicines or street drugs.
•
It is not known if oxazepam is safe and effective in children under 6
years of age.
•
It is known if oxazepam is safe and effective for use longer than 4
months.
Do not take oxazepam if you:
•
are allergic to oxazepam or any of the ingredients in oxazepam. See
the end of this Medication
Guide for a complete list of ingredients in oxazepam.
Before you

Summary of Product characteristics

OXAZEPAM- OXAZEPAM CAPSULE
SANDOZ INC
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OXAZEPAM CAPSULES, USP
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound
sedation, respiratory
depression, coma, and death (see Warnings, Drug Interactions).
•
•
•
DESCRIPTION
Oxazepam is the first of a chemical series of compounds, 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 is 7
chloro-1,3-dihydro-3-hydroxy-5-phenyl-2_H_-1,4-benzodiazepin-2-one and
has the
following structural formula:
Oxazepam is a white crystalline powder.
Each capsule for oral administration contains 10 mg, 15 mg or 30 mg of
oxazepam.
Inactive ingredients: hypromellose, lactose (monohydrate), magnesium
stearate and corn starch. The
capsule shells and imprinting inks contain: gelatin, titanium dioxide,
shellac, black iron oxide, propylene
Reserve concomitant prescribing of these drugs for use in patients for
whom alternative
treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and
sedation.
glycol and D&C Red #7 Calcium Lake E180. The 10 mg capsules also
contain: methylparaben,
butylparaben, propylparaben, benzyl alcohol, sodium propionate,
edetate calcium disodium and sodium
lauryl sulfate. The 15 mg ink also contains: D&C Yellow #10 Aluminum
Lake. The 30 mg ink also
contains: FD&C Red #40 Aluminum Lake #129 and FD&C Blue #2 Aluminum
Lake #132.
CLINICAL PHARMACOLOGY
Pharmacokinetic testing in 12 volunteers d