XANAX: HOW SUPPLIED
XANAX Tablets are available as follows:
0.25 mg (white, oval, scored, imprinted “XANAX 0.25”)
Bottles of 100 NDC 0009-0029-01
Reverse Numbered
Unit dose (100) NDC 0009-0029-46
Bottles of 500 NDC 0009-0029-02
Bottles of 1000 NDC 0009-0029-14
XANAX: Drug Interactions
Use with Other CNS Depressants
If XANAX Tablets are to be combined with other psychotropic agents or
anticonvulsant drugs, careful consideration should be given to the
pharmacology of the agents to be employed, particularly with compounds
which might potentiate the action of benzodiazepines.
The benzodiazepines, including alprazolam, produce additive CNS
depressant effects when co-administered with other psychotropic
medications, anticonvulsants, antihistaminics, ethanol and other drugs
which themselves produce CNS depression.
Use with Imipramine and Desipramine
The steady state plasma concentrations of imipramine and desipramine
have been reported to be increased an average of 31% and 20%,
respectively, by the concomitant administration of XANAX Tablets in
doses up to 4 mg/day. The clinical significance of these changes is
unknown.
XANAX: PRECAUTIONS
As
with other psychotropic medications, the usual precautions with respect
to administration of the drug and size of the prescription are
indicated for severely depressed patients or those in whom there is
reason to expect concealed suicidal ideation or plans. Panic disorder
has been associated with primary and secondary major depressive
disorders and increased reports of suicide among untreated patients.
Mania
Episodes of hypomania and mania have been reported in association with the use of XANAX in patients with depression.
Uricosuric Effect
Alprazolam
has a weak uricosuric effect. Although other medications with weak
uricosuric effect have been reported to cause acute renal failure,
there have been no reported instances of acute renal failure
attributable to therapy with XANAX.
Use in Patients with Concomitant Illness
It
is recommended that the dosage be limited to the smallest effective
dose to preclude the development of ataxia or oversedation which may be
a particular problem in elderly or debilitated patients. The usual precautions in treating patients with
impaired renal, hepatic or pulmonary function should be observed. There
have been rare reports of death in patients with severe pulmonary
disease shortly after the initiation of treatment with XANAX. A
decreased systemic alprazolam elimination rate (eg, increased plasma
half-life) has been observed in both alcoholic liver disease patients
and obese patients receiving XANAX.
XANAX: INDICATIONS AND USAGE
Anxiety Disorders
XANAX Tablets (alprazolam) are indicated for the management of
anxiety disorder (a condition corresponding most closely to the APA
Diagnostic and Statistical Manual [DSM-IIIR] diagnosis of generalized
anxiety disorder) or the short-term relief of symptoms of anxiety.
Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
Generalized
anxiety disorder is characterized by unrealistic or excessive anxiety
and worry (apprehensive expectation) about two or more life
circumstances, for a period of 6 months or longer, during which the
person has been bothered more days than not by these concerns.
Xanax: CLINICAL STUDIES
Anxiety Disorders
XANAX Tablets were compared to placebo in double blind clinical studies (doses up to 4 mg/day) in patients with a diagnosis of anxiety or anxiety with associated depressive symptomatology. XANAX was significantly better than placebo at each of the evaluation periods of these 4-week studies as judged by the following psychometric instruments: Physician’s Global Impressions, Hamilton Anxiety Rating Scale, Target Symptoms, Patient’s Global Impressions and Self-Rating Symptom Scale.
Panic Disorder
Support for the effectiveness of XANAX in the treatment of panic disorder came from three short-term, placebo-controlled studies (up to 10 weeks) in patients with diagnoses closely corresponding to DSM-III-R criteria for panic disorder.
The average dose of XANAX was 5-6 mg/day in two of the studies, and the doses of XANAX were fixed at 2 and 6 mg/day in the third study. In all three studies, XANAX was superior to placebo on a variable defined as "the number of patients with zero panic attacks" (range, 37- 83% met this criterion), as well as on a global improvement score. In two of the three studies, XANAX was superior to placebo on a variable defined as "change from baseline on the number of panic attacks per week" (range, 3.3-5.2), and also on a phobia rating scale. A subgroup of patients who were improved on XANAX during short-term treatment in one of these trials was continued on an open basis up to 8 months, without apparent loss of benefit.
XANAX®
alprazolam tablets, USP
DESCRIPTION
XANAX Tablets contain alprazolam which
is a triazolo analog of the 1,4 benzodiazepine class of central nervous
system-active compounds.
The chemical name of alprazolam is
8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine.
The structural formula is represented to
the right:
Alprazolam is a white crystalline
powder, which is soluble in methanol or ethanol but which has no appreciable
solubility in water at physiological pH. Each XANAX Tablet, for oral
administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam.
XANAX Tablets, 2 mg, are multi-scored
and may be divided as shown below:
Inactive ingredients: Cellulose, corn
starch, docusate sodium, lactose, magnesium stearate, silicon dioxide and
sodium benzoate. In addition, the 0.5 mg tablet contains FD&C Yellow No. 6
and the 1 mg tablet contains FD&C Blue No. 2.
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