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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.
Each XANAX Tablet, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam.

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Indications

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 III-R] 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. At least 6 of the following 18 symptoms are often present
in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension,
aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness
of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or
cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other
abdominal distress; flushes or chills; frequent urination; trouble swallowing or ‘lump in throat’);
Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty
concentrating or ‘mind going blank’ because of anxiety; trouble falling or staying asleep; irritability).
These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor.
Anxiety associated with depression is responsive to XANAX

Panic Disorder XANAX
is also indicated for the treatment of panic disorder, with or
without agoraphobia. Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, ie, a discrete period
of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within
10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4)
sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or
abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or
depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias
(numbness or tingling sensations); (13) chills or hot flushes.
Demonstrations of the effectiveness of XANAX by systematic clinical study are limited to 4 months duration for anxiety
disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open
basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of
the drug for the individual patient.

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Contraindications

XANAX Tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines. XANAX may be
used in patients with open angle glaucoma who are receiving appropriate therapy, but is contraindicated in patients with
acute narrow angle glaucoma.
XANAX is contraindicated with ketoconazole and itraconazole, since these medications significantly impair the oxidative
metabolism mediated by cytochrome P450 3A (CYP3A)

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Side Effects

Side effects to XANAX Tablets, if they occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. In the usual patient, the most frequent side effects are likely to be an extension of the pharmacological activity of alprazolam, eg, drowsiness or light-headedness.
The data cited in the two tables below are estimates of untoward clinical event incidence among patients who participated under the following clinical conditions: relatively short duration (ie, four weeks) placebo-controlled clinical studies with dosages up to 4 mg/day of XANAX (for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety) and short-term (up to ten weeks) placebo-controlled clinical studies with dosages up to 10 mg/day of XANAX in patients with panic disorder, with or without agoraphobia.
These data cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics, and other factors often differ from those in clinical trials. These figures cannot be compared with those obtained from other clinical studies involving related drug products and placebo as each group of drug trials are conducted under a different set of conditions.
Comparison of the cited figures, however, can provide the prescriber with some basis for estimating the relative contributions of drug and non-drug factors to the untoward event incidence in the population studied. Even this use must be approached cautiously, as a drug may relieve a symptom in one patient but induce it in others. (For example, an anxiolytic drug may relieve dry mouth [a symptom of anxiety] in some subjects but induce it [an untoward event] in others.)

Additionally, for anxiety disorders the cited figures can provide the prescriber with an indication as to the frequency with which physician intervention (eg, increased surveillance, decreased dosage or discontinuation of drug therapy) may be necessary because of the untoward clinical event.

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Pregnancy and Lactation

Pregnancy Teratogenic Effects:

Pregnancy Category D: (See WARNINGS section). Nonteratogenic Effects: It should be considered that the child born of a mother who is receiving benzodiazepines may be at some risk for withdrawal symptoms from the drug during the postnatal period. Also, neonatal flaccidity and respiratory problems have been reported in children born of mothers who have been receiving benzodiazepines.

Labor and Delivery XANAX
has no established use in labor or delivery

Nursing Mothers Benzodiazepines are known to be excreted in human milk. It should be assumed that alprazolam is as well. Chronic administration of diazepam to nursing mothers has been reported to cause their infants to become lethargic and to lose weight. As a general rule, nursing should not be undertaken by mothers who must use XANAX.
Pediatric Use Safety and effectiveness of XANAX in individuals below 18 years of age have not been established.
Geriatric Use The elderly may be more sensitive to the effects of benzodiazepines. They exhibit higher plasma alprazolam concentrations due to reduced clearance of the drug as compared with a younger population receiving the same doses. The smallest effective dose of XANAX should be used in the elderly to preclude the development of ataxia and oversedation.

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Interactions

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.
Drugs that inhibit alprazolam metabolism via cytochrome P450 3A The initial step in alprazolam metabolism is hydroxylation catalyzed by cytochrome P450 3A (CYP3A). Drugs which inhibit this metabolic pathway may have a profound effect on the clearance of alprazolam (see CONTRAINDICATIONS and WARNINGS for additional drugs of this type).
Drugs demonstrated to be CYP3A inhibitors of possible clinical significance on the basis of
clinical studies involving alprazolam (caution is recommended during coadministration with
alprazolam)
Fluoxetine—Coadministration of fluoxetine with alprazolam increased the maximum plasma
concentration of alprazolam by 46%, decreased clearance by 21%, increased half-life by 17%,
and decreased measured psychomotor performance.

Propoxyphene—Coadministration of propoxyphene decreased the maximum plasma concentration of alprazolam by 6%, decreased clearance by 38%, and increased half-life by 58%.
Oral Contraceptives—Coadministration of oral contraceptives increased the maximum plasma concentration of alprazolam by 18%, decreased clearance by 22%, and increased half-life by 29%.
Drugs and other substances demonstrated to be CYP 3A inhibitors on the basis of clinical studies involving benzodiazepines metabolized similarly to alprazolam or on the basis of in vitro studies with alprazolam or other benzodiazepines (caution is recommended during coadministration with alprazolam) Available data from clinical studies of benzodiazepines other than alprazolam suggest a possible drug interaction with alprazolam for the following: diltiazem, isoniazid, macrolide antibiotics such as erythromycin and clarithromycin, and grapefruit juice. Data from in vitro studies of alprazolam suggest a possible drug interaction with alprazolam for the following: sertraline and paroxetine. However, data from an in vivo drug interaction study involving a single dose of alprazolam 1 mg and steady state dose of sertraline (50 to 150 mg/day) did not reveal any clinically significant changes in the pharmacokinetics of alprazolam. Data from in vitro studies of benzodiazepines other than alprazolam suggest a possible drug interaction for the following: ergotamine, cyclosporine, amiodarone, nicardipine, and nifedipine. Caution is recommended during the coadministration of any of these with alprazolam.

Overdose

Clinical Experience Manifestations of alprazolam overdosage include somnolence, confusion, impaired coordination, diminished reflexes and coma. Death has been reported in association with overdoses of alprazolam by itself, as it has with other benzodiazepines. In addition, fatalities have been reported in patients who have overdosed with a combination of a single benzodiazepine, including alprazolam, and alcohol; alcohol levels seen in some of these patients have been lower than those usually associated with alcohol-induced fatality.
The acute oral LD50 in rats is 331-2171 mg/kg. Other experiments in animals have indicated that cardiopulmonary collapse can occur following massive intravenous doses of alprazolam (over 195 mg/kg; 975 times the maximum recommended daily human dose of 10 mg/day). Animals could be resuscitated with positive mechanical ventilation and the intravenous infusion of norepinephrine bitartrate. Buy Xanax Online NOW!
Animal experiments have suggested that forced diuresis or hemodialysis are probably of little value in treating overdosage.

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