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Bipolar Disorder Overview Bipolar Disorder Overview Drug Descriptionfont sizeAAA
XANAX® (CIV alprazolam) Tablets , USP DRUG 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-I 1,4 benzodiazepine.
The structural formula is represented to the right: Xanax (alprazolam ) Structural Formula Illustration
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:
| Xanax (alprazolam ) | XANAX Tablets, 2 mg, are |
| multi-scored and may be | divided as shown |
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.. Last updated on RxList: 8/1/2009
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. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES).
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.
DOSAGE AND ADMINISTRATION Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who require doses greater than 4 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.
Anxiety Disorders and Transient Symptoms of Anxiety Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment.
In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction. Panic Disorder
The successful treatment of many panic disorder patients has required the use of XANAX at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of XANAX in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received XANAX in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to achieve a successful response. Dose Titration
Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of XANAX. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule. Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (ie, a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.
Dose Maintenance For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of XANAX greater than 4 mg/day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit. Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided. (See WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE.)
The necessary duration of treatment for panic disorder patients responding to XANAX is unknown. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena. Dose Reduction
Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE). In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.
In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every 3 days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens. Dosing in Special Populations
In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered. 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 0.5 mg (peach, oval, scored, imprinted “XANAX 0.5”)
Bottles of 100 NDC 0009-0055-01 Reverse Numbered Unit Dose (100) NDC 0009-0055-46 Bottles of 500 NDC 0009-0055-03 Bottles of 1000 NDC 0009-0055-15
- mg (blue, oval, scored, imprinted “XANAX 1.0”)
Bottles of 100 NDC 0009-0090-01 Bottles of 500 NDC 0009-0090-04 Bottles of 1000 NDC 0009-0090-13
- mg (white, oblong, multi-scored, imprinted “XANAX ” on one side and “2” on the reverse side)
Bottles of 100 NDC 0009-0094-01 Bottles of 500 NDC 0009-0094-03 Store at controlled room temperature 20° to 25°C (68° to 77°F) see USP.
Rx only LAB-0004-3.0 Revised March 2006 FDA rev date: 4/2/2004
Last updated on RxList: 3/30/2007 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. Treatment-Emergent Adverse Events Reported in Placebo-Controlled Trials of Anxiety Disorders
ANXIETY DISORDERS Treatment-Emergent Symptom Incidence†
Incidence of Intervention Because of Symptom XANAX
PLACEBO XANAX
Number of Patients % of Patients Reporting: 565
505 565
Central Nervous System Drowsiness
41.0 21.6
15.1 Light-headedness
20.8 19.3
1.2 Depression
13.9 18.1
2.4 Headache
12.9 19.6
1.1 Confusion
9.9 10.0
0.9 Insomnia
8.9 18.4
1.3 Nervousness
4.1 10.3
1.1 Syncope
3.1 4.0
Dizziness
1.8 0.8
2.5 Akathisia
1.6 1.2
Tiredness/Sleepiness
1.8 Gastrointestinal
Dry Mouth 14.7
13.3 0.7
Constipation 10.4
11.4 0.9
Diarrhea 10.1
10.3 1.2
Nausea/Vomiting 9.6
12.8 1.7
Increased Salivation 4.2
2.4
Cardiovascular Tachycardia/Palpitations
7.7 15.6
0.4 Hypotension
4.7 2.2
Sensory
Blurred Vision 6.2
6.2 0.4
Musculoskeletal Rigidity
4.2 5.3
Tremor
4.0 8.8
0.4 Cutaneous
Dermatitis/Allergy 3.8
3.1 0.6
Other Nasal Congestion
7.3 9.3
Weight Gain
2.7 2.7
Weight Loss
2.3 3.0
None reported † Events reported by 1% or more of XANAX patients are included.
In addition to the relatively common (ie, greater than 1%) untoward events enumerated in the table above, the following adverse events have been reported in association with the use of benzodiazepines: dystonia, irritability, concentration difficulties, anorexia, transient amnesia or memory impairment, loss of coordination, fatigue, seizures, sedation, slurred speech, jaundice, musculoskeletal weakness, pruritus, diplopia, dysarthria, changes in libido, menstrual irregularities, incontinence and urinary retention. Treatment-Emergent Adverse Events Reported in Placebo-Controlled Trials of Panic Disorder
PANIC DISORDER Treatment-Emergent Symptom Incidence
XANAX PLACEBO
Number of Patients % of Patients Reporting: 1388
1231 Central Nervous System
Drowsiness 76.8
42.7 Fatigue and Tiredness
48.6 42.3
Impaired Coordination 40.1
17.9 Irritability
33.1 30.1
Memory Impairment 33.1
22.1 Light-headedness/Dizziness
29.8 36.9
Insomnia 29.4
41.8 Headache
29.2 35.6
Cognitive Disorder 28.8
20.5 Dysarthria
23.3 6.3
Anxiety 16.6
24.9 Abnormal Involuntary Movement
14.8 21.0
Decreased Libido 14.4
8.0 Depression
13.8 14.0
Confusional State 10.4
8.2 Muscular Twitching
7.9 11.8
Increased Libido 7.7
4.1 Change in Libido (Not Specified)
7.1 5.6
Weakness 7.1
8.4 Muscle Tone Disorders
6.3 7.5
Syncope 3.8
4.8 Akathisia
3.0 4.3
Agitation 2.9
2.6 Disinhibition
2.7 1.5
Paresthesia 2.4
3.2 Talkativeness
2.2 1.0
Vasomotor Disturbances 2.0
2.6 Derealization
1.9 1.2
Dream Abnormalities 1.8
1.5 Fear
1.4 1.0
Feeling Warm 1.3
0.5 Gastrointestinal
Decreased Salivation 32.8
34.2 Constipation
26.2 15.4
Nausea/Vomiting 22.0
31.8 Diarrhea
20.6 22.8
Abdominal Distress 18.3
21.5 Increased Salivation
5.6 4.4
Cardio-Respiratory Nasal Congestion
17.4 16.5
Tachycardia 15.4
26.8 Chest Pain
10.6 18.1
Hyperventilation 9.7
14.5 Upper Respiratory Infection
4.3 3.7
Sensory Blurred Vision
21.0 21.4
Tinnitus 6.6
10.4 Musculoskeletal
Muscular Cramps 2.4
2.4 Muscle Stiffness
2.2 3.3
Cutaneous Sweating
15.1 23.5
Rash 10.8
8.1 Other
Increased Appetite 32.7
22.8 Decreased Appetite
27.8 24.1
Weight Gain 27.2
17.9 Weight Loss
22.6 16.5
Micturition Difficulties 12.2
8.6 Menstrual Disorders
10.4 8.7
Sexual Dysfunction 7.4
3.7 Edema
4.9 5.6
Incontinence 1.5
0.6 Infection
1.3 1.7
Events reported by 1% or more of XANAX patients are included. In addition to the relatively common (ie, greater than 1%) untoward events enumerated in the table above, the following adverse events have been reported in association with the use of XANAX: seizures, hallucinations, depersonalization, taste alterations, diplopia, elevated bilirubin, elevated hepatic enzymes, and jaundice.
Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients (see PRECAUTIONS, General). Adverse Events Reported as Reasons for Discontinuation in Treatment of Panic Disorder in Placebo-Controlled Trials In a larger database comprised of both controlled and uncontrolled studies in which 641 patients received XANAX, discontinuation-emergent symptoms which occurred at a rate of over 5% in patients treated with XANAX and at a greater rate than the placebo treated group were as follows:
DISCONTINUATION-EMERGENT SYMPTOM INCIDENCE Percentage of 641 XANAX-Treated Panic Disorder Patients Reporting Events Body System/Event
Neurologic Gastrointestinal
Insomnia 29.5
Nausea/Vomiting 16.5
Light-headedness 19.3
Diarrhea 13.6
Abnormal involuntary movement 17.3
Decreased salivation 10.6
Headache 17.0
Metabolic-Nutritional Muscular twitching
6.9 Weight loss
13.3 Impaired coordination
6.6 Decreased appetite
12.8 Muscle tone disorders
5.9 Weakness
5.8 Dermatological
Psychiatric Sweating
14.4 Anxiety
19.2 Fatigue and Tiredness
18.4 Cardiovascular
Irritability 10.5
Tachycardia 12.2
Cognitive disorder 10.3
Memory impairment 5.5
Special Senses Depression
5.1 Blurred vision
10.0 Confusional state
5.0 From the studies cited, it has not been determined whether these symptoms are clearly related to the dose and duration of therapy with XANAX in patients with panic disorder. There have also been reports of withdrawal seizures upon rapid decrease or abrupt discontinuation of XANAX Tablets (see WARNINGS).
To discontinue treatment in patients taking XANAX, the dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of XANAX be decreased by no more than 0.5 mg every three days (see DOSAGE AND ADMINISTRATION). Some patients may benefit from an even slower dosage reduction. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. As with all benzodiazepines, paradoxical reactions such as stimulation, increased muscle spasticity, sleep disturbances, hallucinations and other adverse behavioral effects such as agitation, rage, irritability, and aggressive or hostile behavior have been reported rarely. In many of the spontaneous case reports of adverse behavioral effects, patients were receiving other CNS drugs concomitantly and/or were described as having underlying psychiatric conditions. Should any of the above events occur, alprazolam should be discontinued. Isolated published reports involving small numbers of patients have suggested that patients who have borderline personality disorder, a prior history of violent or aggressive behavior, or alcohol or substance abuse may be at risk for such events. Instances of irritability, hostility, and intrusive thoughts have been reported during discontinuation of alprazolam in patients with posttraumatic stress disorder.
Post Introduction Reports: Various adverse drug reactions have been reported in association with the use of XANAX since market introduction. The majority of these reactions were reported through the medical event voluntary reporting system. Because of the spontaneous nature of the reporting of medical events and the lack of controls, a causal relationship to the use of XANAX cannot be readily determined. Reported events include: liver enzyme elevations, hepatitis, hepatic failure, Stevens-Johnson syndrome, hyperprolactinemia, gynecomastia, and galactorrhea. Drug Abuse and Dependence
Physical and Psychological Dependence Withdrawal symptoms similar in character to those noted with sedative/hypnotics and alcohol have occurred following discontinuance of benzodiazepines, including XANAX. The symptoms can range from mild dysphoria and insomnia to a major syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors and convulsions. Distinguishing between withdrawal emergent signs and symptoms and the recurrence of illness is often difficult in patients undergoing dose reduction. The long term strategy for treatment of these phenomena will vary with their cause and the therapeutic goal. When necessary, immediate management of withdrawal symptoms requires re-institution of treatment at doses of XANAX sufficient to suppress symptoms. There have been reports of failure of other benzodiazepines to fully suppress these withdrawal symptoms. These failures have been attributed to incomplete cross-tolerance but may also reflect the use of an inadequate dosing regimen of the substituted benzodiazepine or the effects of concomitant medications.
While it is difficult to distinguish withdrawal and recurrence for certain patients, the time course and the nature of the symptoms may be helpful. A withdrawal syndrome typically includes the occurrence of new symptoms, tends to appear toward the end of taper or shortly after discontinuation, and will decrease with time. In recurring panic disorder, symptoms similar to those observed before treatment may recur either early or late, and they will persist. While the severity and incidence of withdrawal phenomena appear to be related to dose and duration of treatment, withdrawal symptoms, including seizures, have been reported after only brief therapy with XANAX at doses within the recommended range for the treatment of anxiety (eg, 0.75 to 4 mg/day). Signs and symptoms of withdrawal are often more prominent after rapid decrease of dosage or abrupt discontinuance. The risk of withdrawal seizures may be increased at doses above 4 mg/day (see WARNINGS).
too each its should each which been yours to should or hisPatients, especially individuals with a history of seizures or epilepsy, should not be abruptly discontinued from any CNS depressant agent, including XANAX. It is recommended that all patients on XANAX who require a dosage reduction be gradually tapered under close supervision (see WARNINGS and DOSAGE AND ADMINISTRATION). Psychological dependence is a risk with all benzodiazepines, including XANAX.
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