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Xanax
Overview
What is Xanax?
XANAX XR 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-4--triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is CHClN which corresponds to a molecular weight of 308.76.
The structural formula is represented below:
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 XR extended-release tablet, for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam. The inactive ingredients are lactose, magnesium stearate, colloidal silicon dioxide, and hypromellose. In addition, the 1 mg and 3 mg tablets contain D & C yellow No. 10 and the 2 mg and 3 mg tablets contain FD&C blue No. 2.
What does Xanax look like?
What are the available doses of Xanax?
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What should I talk to my health care provider before I take Xanax?
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How should I use Xanax?
XANAX XR Tablets are indicated for the treatment of panic disorder, with or without agoraphobia.
This claim is supported on the basis of two positive studies with XANAX XR conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see ).
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.
The longer-term efficacy of XANAX XR has not been systematically evaluated. Thus, the physician who elects to use this drug for periods longer than 8 weeks should periodically reassess the usefulness of the drug for the individual patient.
XANAX XR Tablets may be administered once daily, preferably in the morning. The tablets should be taken intact; they should not be chewed, crushed, or broken.
The suggested total daily dose ranges between 3 to 6 mg/day. Dosage should be individualized for maximum beneficial effect. While the suggested total daily dosages given will meet the needs of most patients, there will be some patients who require doses greater than 6 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.
What interacts with Xanax?
XANAX XR Tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines.
XANAX XR is contraindicated with ketoconazole and itraconazole, since these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP3A) (see , and ).
What are the warnings of Xanax?
Risks from Concomitant Use with Opioids
Concomitant use of benzodiazepines, including XANAX XR, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe XANAX XR concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. In patients already receiving an opioid analgesic, prescribe a lower initial dose of XANAX XR than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking XANAX XR, prescribe a lower initial dose of the opioid and titrate based upon clinical response.
Advise both patients and caregivers about the risks of respiratory depression and sedation when XANAX XR is used with opioids. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see ).
Dependence and Withdrawal Reactions, Including Seizures
Certain adverse clinical events, some life-threatening, are a direct consequence of physical dependence to alprazolam. These include a spectrum of withdrawal symptoms; the most important is seizure (see ). Even after relatively short-term use at doses of ≤ 4 mg/day, there is some risk of dependence. Spontaneous reporting system data suggest that the risk of dependence and its severity appear to be greater in patients treated with doses greater than 4 mg/day and for long periods (more than 12 weeks). However, in a controlled postmarketing discontinuation study of panic disorder patients who received XANAX Tablets, the duration of treatment (3 months compared to 6 months) had no effect on the ability of patients to taper to zero dose. In contrast, patients treated with doses of XANAX Tablets greater than 4 mg/day had more difficulty tapering to zero dose than those treated with less than 4 mg/day.
Relapse or return of illness was defined as a return of symptoms characteristic of panic disorder (primarily panic attacks) to levels approximately equal to those seen at baseline before active treatment was initiated. Rebound refers to a return of symptoms of panic disorder to a level substantially greater in frequency, or more severe in intensity than seen at baseline. Withdrawal symptoms were identified as those which were generally not characteristic of panic disorder and which occurred for the first time more frequently during discontinuation than at baseline.
The rate of relapse, rebound, and withdrawal in patients with panic disorder who received XANAX XR Tablets has not been systematically studied. Experience in randomized placebo-controlled discontinuation studies of patients with panic disorder who received XANAX Tablets showed a high rate of rebound and withdrawal symptoms compared to placebo treated patients.
In a controlled clinical trial in which 63 patients were randomized to XANAX Tablets and where withdrawal symptoms were specifically sought, the following were identified as symptoms of withdrawal: heightened sensory perception, impaired concentration, dysosmia, clouded sensorium, paresthesias, muscle cramps, muscle twitch, diarrhea, blurred vision, appetite decrease, and weight loss. Other symptoms, such as anxiety and insomnia, were frequently seen during discontinuation, but it could not be determined if they were due to return of illness, rebound, or withdrawal.
In two controlled trials of 6 to 8 weeks duration where the ability of patients to discontinue medication was measured, 71%–93% of patients treated with XANAX Tablets tapered completely off therapy compared to 89%–96% of placebo treated patients. In a controlled postmarketing discontinuation study of panic disorder patients treated with XANAX Tablets, the duration of treatment (3 months compared to 6 months) had no effect on the ability of patients to taper to zero dose.
Seizures were reported for three patients in panic disorder clinical trials with XANAX XR. In two cases, the patients had completed 6 weeks of treatment with XANAX XR 6 mg/day before experiencing a single seizure. In one case, the patient abruptly discontinued XANAX XR, and in both cases, alcohol intake was implicated.The third case involved multiple seizures after the patient completed treatment with XANAX XR 4 mg/day and missed taking the medication on the first day of taper. All three patients recovered without sequelae.
Seizures have also been observed in association with dose reduction or discontinuation of XANAX Tablets, the immediate release form of alprazolam. Seizures attributable to XANAX were seen after drug discontinuance or dose reduction in 8 of 1980 patients with panic disorder or in patients participating in clinical trials where doses of XANAX greater than 4 mg/day for over 3 months were permitted. Five of these cases clearly occurred during abrupt dose reduction, or discontinuation from daily doses of 2 to 10 mg. Three cases occurred in situations where there was not a clear relationship to abrupt dose reduction or discontinuation. In one instance, seizure occurred after discontinuation from a single dose of 1 mg after tapering at a rate of 1 mg every three days from 6 mg daily. In two other instances, the relationship to taper is indeterminate; in both of these cases the patients had been receiving doses of 3 mg daily prior to seizure. The duration of use in the above 8 cases ranged from 4 to 22 weeks. There have been occasional voluntary reports of patients developing seizures while apparently tapering gradually from XANAX. The risk of seizure seems to be greatest 24–72 hours after discontinuation (see for recommended tapering and discontinuation schedule).
Status Epilepticus
The medical event voluntary reporting system shows that withdrawal seizures have been reported in association with the discontinuation of XANAX Tablets. In most cases, only a single seizure was reported; however, multiple seizures and status epilepticus were reported as well.
Interdose Symptoms
Early morning anxiety and emergence of anxiety symptoms between doses of XANAX Tablets have been reported in patients with panic disorder taking prescribed maintenance doses. These symptoms may reflect the development of tolerance or a time interval between doses which is longer than the duration of clinical action of the administered dose. In either case, it is presumed that the prescribed dose is not sufficient to maintain plasma levels above those needed to prevent relapse, rebound, or withdrawal symptoms over the entire course of the interdosing interval.
Risk of Dose Reduction
Withdrawal reactions may occur when dosage reduction occurs for any reason. This includes purposeful tapering, but also inadvertent reduction of dose (eg, the patient forgets, the patient is admitted to a hospital). Therefore, the dosage of XANAX XR should be reduced or discontinued gradually (see ).
CNS Depression and Impaired Performance
Because of its CNS depressant effects, patients receiving XANAX XR should be cautioned against engaging in hazardous occupations or activities requiring complete mental alertness such as operating machinery or driving a motor vehicle. For the same reason, patients should be cautioned about the simultaneous ingestion of alcohol and other CNS depressant drugs during treatment with XANAX XR.
Risk of Fetal Harm
Benzodiazepines can potentially cause fetal harm when administered to pregnant women. If alprazolam is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Because of experience with other members of the benzodiazepine class, alprazolam is assumed to be capable of causing an increased risk of congenital abnormalities when administered to a pregnant woman during the first trimester. Because use of these drugs is rarely a matter of urgency, their use during the first trimester should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug.
Alprazolam Interaction With Drugs That Inhibit Metabolism Via Cytochrome P450 3A
The initial step in alprazolam metabolism is hydroxylation catalyzed by cytochrome P450 3A (CYP3A). Drugs that inhibit this metabolic pathway may have a profound effect on the clearance of alprazolam. Consequently, alprazolam should be avoided in patients receiving very potent inhibitors of CYP3A. With drugs inhibiting CYP3A to a lesser but still significant degree, alprazolam should be used only with caution and consideration of appropriate dosage reduction. For some drugs, an interaction with alprazolam has been quantified with clinical data; for other drugs, interactions are predicted from in vitro data and/or experience with similar drugs in the same pharmacologic class.
The following are examples of drugs known to inhibit the metabolism of alprazolam and/or related benzodiazepines, presumably through inhibition of CYP3A.
Potent CYP3A Inhibitors
Other Drugs Possibly Affecting Alprazolam Metabolism
Other drugs possibly affecting alprazolam metabolism by inhibition of CYP3A are discussed in the PRECAUTIONS section (see ).
What are the precautions of Xanax?
General
Suicide
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 Tablets 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 alprazolam.
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 (see ). 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 Tablets. 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 Tablets (see ).
Information for Patients
- Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when XANAX XR is used with opioids and not to use such drugs concomitantly unless supervised by a health care provider.
- Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined (see ).
- Inform your physician about any alcohol consumption and medicine you are taking now, including medication you may buy without a prescription. Alcohol should generally not be used during treatment with benzodiazepines.
- Not recommended for use in pregnancy. Therefore, inform your physician if you are pregnant, if you are planning to have a child, or if you become pregnant while you are taking this medication.
- Inform your physician if you are nursing.
- Until you experience how this medication affects you, do not drive a car or operate potentially dangerous machinery, etc.
- Do not increase the dose even if you think the medication "does not work anymore" without consulting your physician. Benzodiazepines, even when used as recommended, may produce emotional and/or physical dependence.
- Do not stop taking this medication abruptly or decrease the dose without consulting your physician, since withdrawal symptoms can occur.
- Some patients may find it very difficult to discontinue treatment with XANAX XR due to severe emotional and physical dependence. Discontinuation symptoms, including possible seizures, may occur following discontinuation from any dose, but the risk may be increased with extended use at doses greater than 4 mg/day, especially if discontinuation is too abrupt. It is important that you seek advice from your physician to discontinue treatment in a careful and safe manner. Proper discontinuation will help to decrease the possibility of withdrawal reactions that can range from mild reactions to severe reactions such as seizure.
To assure safe and effective use of XANAX XR, the physician should provide the patient with the following guidance.
Laboratory Tests
Laboratory tests are not ordinarily required in otherwise healthy patients. However, when treatment is protracted, periodic blood counts, urinalysis, and blood chemistry analyses are advisable in keeping with good medical practice.
Drug Interactions
Use with Opioids
The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and monitor patients closely for respiratory depression and sedation.
Use with Other CNS Depressants
If XANAX XR 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 coadministered with other psychotropic medications, anticonvulsants, antihistaminics, ethanol and other drugs which themselves produce CNS depression.
Use with Digoxin
Increased digoxin concentrations have been reported when alprazolam was given, especially in elderly (>65 years of age). Patients who receive alprazolam and digoxin should therefore be monitored for signs and symptoms related to digoxin toxicity.
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 and 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)
Drugs and other substances demonstrated to be CYP3A 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 doses 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 (see ).
Drugs demonstrated to be inducers of CYP3A
Carbamazepine can increase alprazolam metabolism and therefore can decrease plasma levels of alprazolam.
Drug/Laboratory Test Interactions
Although interactions between benzodiazepines and commonly employed clinical laboratory tests have occasionally been reported, there is no consistent pattern for a specific drug or specific test.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No evidence of carcinogenic potential was observed during 2-year bioassay studies of alprazolam in rats at doses up to 30 mg/kg/day (150 times the maximum recommended daily human dose of 10 mg/day) and in mice at doses up to 10 mg/kg/day (50 times the maximum recommended daily human dose).
Alprazolam was not mutagenic in the rat micronucleus test at doses up to 100 mg/kg, which is 500 times the maximum recommended daily human dose of 10 mg/day. Alprazolam also was not mutagenic in vitro in the DNA Damage/Alkaline Elution Assay or the Ames Assay.
Alprazolam produced no impairment of fertility in rats at doses up to 5 mg/kg/day, which is 25 times the maximum recommended daily human dose of 10 mg/day.
Pregnancy
Teratogenic Effects
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
Alprazolam 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 alprazolam.
Pediatric Use
Safety and effectiveness of alprazolam 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 alprazolam should be used in the elderly to preclude the development of ataxia and oversedation (see and ).
What are the side effects of Xanax?
The information included in the subsection on Adverse Events Observed in Short-Term, Placebo-Controlled Trials with XANAX XR Tablets is based on pooled data of five 6- and 8-week placebo-controlled clinical studies in panic disorder.
Adverse event reports were elicited either by general inquiry or by checklist, and were recorded by clinical investigators using terminology of their own choosing. The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened during therapy following baseline evaluation. In the tables and tabulations that follow, standard MedDRA terminology (version 4.0) was used to classify reported adverse events.
Adverse Events Observed in Short-Term, Placebo-Controlled Trials of XANAX XR
Adverse Events Reported as Reasons for Discontinuation of Treatment in Placebo-Controlled Trials
Approximately 17% of the 531 patients who received XANAX XR in placebo-controlled clinical trials for panic disorder had at least one adverse event that led to discontinuation compared to 8% of 349 placebo-treated patients. The most common events leading to discontinuation and considered to be drug-related (ie, leading to discontinuation in at least 1% of the patients treated with XANAX XR at a rate at least twice that of placebo) are shown in the following table.
| System Organ Class/Adverse Event | Percentage of Patients Discontinuing Due to Adverse Events | |
|---|---|---|
| XANAX XR(n=531) | Placebo(n=349) | |
| Nervous system disorders | ||
| Sedation | 7.5 | 0.6 |
| Somnolence | 3.2 | 0.3 |
| Dysarthria | 2.1 | 0 |
| Coordination abnormal | 1.9 | 0.3 |
| Memory impairment | 1.5 | 0.3 |
| General disorders/administration site conditions | ||
| Fatigue | 1.7 | 0.6 |
| Psychiatric disorders | ||
| Depression | 2.5 | 1.2 |
Adverse Events Occurring at an Incidence of 1% or More Among Patients Treated with XANAX XR
| System Organ Class/Adverse Event | Percentage of Patients Reporting Adverse Event | |
|---|---|---|
| XANAX XR(n=531) | Placebo(n=349) | |
| Nervous system disorders | ||
| Sedation | 45.2 | 22.6 |
| Somnolence | 23.0 | 6.0 |
| Memory impairment | 15.4 | 6.9 |
| Dysarthria | 10.9 | 2.6 |
| Coordination abnormal | 9.4 | 0.9 |
| Mental impairment | 7.2 | 5.7 |
| Ataxia | 7.2 | 3.2 |
| Disturbance in attention | 3.2 | 0.6 |
| Balance impaired | 3.2 | 0.6 |
| Paresthesia | 2.4 | 1.7 |
| Dyskinesia | 1.7 | 1.4 |
| Hypoesthesia | 1.3 | 0.3 |
| Hypersomnia | 1.3 | 0 |
| General disorders/administration site conditions | ||
| Fatigue | 13.9 | 9.2 |
| Lethargy | 1.7 | 0.6 |
| Infections and infestations | ||
| Influenza | 2.4 | 2.3 |
| Upper respiratory tract infections | 1.9 | 1.7 |
| Psychiatric disorders | ||
| Depression | 12.1 | 9.2 |
| Libido decreased | 6.0 | 2.3 |
| Disorientation | 1.5 | 0 |
| Confusion | 1.5 | 0.9 |
| Depressed mood | 1.3 | 0.3 |
| Anxiety | 1.1 | 0.6 |
| Metabolism and nutrition disorders | ||
| Appetite decreased | 7.3 | 7.2 |
| Appetite increased | 7.0 | 6.0 |
| Anorexia | 1.5 | 0 |
| Gastrointestinal disorders | ||
| Dry mouth | 10.2 | 9.7 |
| Constipation | 8.1 | 4.3 |
| Nausea | 6.0 | 3.2 |
| Pharyngolaryngeal pain | 3.2 | 2.6 |
| Investigations | ||
| Weight increased | 5.1 | 4.3 |
| Weight decreased | 4.3 | 3.7 |
| Injury, poisoning, and procedural complications | ||
| Road traffic accident | 1.5 | 0 |
| Reproductive system and breast disorders | ||
| Dysmenorrhea | 3.6 | 2.9 |
| Sexual dysfunction | 2.4 | 1.1 |
| Premenstrual syndrome | 1.7 | 0.6 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 2.4 | 0.6 |
| Myalgia | 1.5 | 1.1 |
| Pain in limb | 1.1 | 0.3 |
| Vascular disorders | ||
| Hot flushes | 1.5 | 1.4 |
| Respiratory, thoracic, and mediastinal disorders | ||
| Dyspnea | 1.5 | 0.3 |
| Rhinitis allergic | 1.1 | 0.6 |
| Skin and subcutaneous tissue disorders | ||
| Pruritis | 1.1 | 0.9 |
Other Adverse Events Observed During the Premarketing Evaluation of XANAX XR Tablets
Discontinuation-Emergent Adverse Events Occurring at an Incidence of 5% or More Among Patients Treated with XANAX XR
| System Organ Class/AdverseEvent | Percentage of Patients Reporting Adverse Event | |
|---|---|---|
| XANAX XR(n=422) | Placebo(n=261) | |
| Nervous system disorders | ||
| Tremor | 28.2 | 10.7 |
| Headache | 26.5 | 12.6 |
| Hypoesthesia | 7.8 | 2.3 |
| Paraesthesia | 7.1 | 2.7 |
| Psychiatric disorders | ||
| Insomnia | 24.2 | 9.6 |
| Nervousness | 21.8 | 8.8 |
| Depression | 10.9 | 5.0 |
| Derealization | 8.0 | 3.8 |
| Anxiety | 7.8 | 2.7 |
| Depersonalization | 5.7 | 1.9 |
| Gastrointestinal disorders | ||
| Diarrhea | 12.1 | 3.1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Hyperventilation | 8.5 | 2.7 |
| Metabolism and nutrition disorders | ||
| Appetite decreased | 9.5 | 3.8 |
| Musculosketal and connective tissue disorders | ||
| Muscle twitching | 7.4 | 2.7 |
| Vascular disorders | ||
| Hot flushes | 5.9 | 2.7 |
Post Introduction Reports
Various adverse drug reactions have been reported in association with the use of XANAX Tablets 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 Tablets cannot be readily determined. Reported events include: gastrointestinal disorder, hypomania, mania, liver enzyme elevations, hepatitis, jaundice, hepatic failure, Stevens-Johnson syndrome, photosensitivity reaction, angioedema, peripheral edema, menstruation irregular, hyperprolactinemia, gynecomastia, and galactorrhea (see ).
What should I look out for while using Xanax?
XANAX XR Tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines.
XANAX XR is contraindicated with ketoconazole and itraconazole, since these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP3A) (see , and ).
What might happen if I take too much Xanax?
How should I store and handle Xanax?
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.XANAX XR (extended-release) Tablets are available as follows:0.5 mg1 mg2 mg3 mgXANAX XR (extended-release) Tablets are available as follows:0.5 mg1 mg2 mg3 mgXANAX XR (extended-release) Tablets are available as follows:0.5 mg1 mg2 mg3 mgXANAX XR (extended-release) Tablets are available as follows:0.5 mg1 mg2 mg3 mgXANAX XR (extended-release) Tablets are available as follows:0.5 mg1 mg2 mg3 mg
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
CNS agents of the 1,4 benzodiazepine class presumably exert their effects by binding at stereospecific receptors at several sites within the central nervous system. Their exact mechanism of action is unknown. Clinically, all benzodiazepines cause a dose-related central nervous system depressant activity varying from mild impairment of task performance to hypnosis.
Non-Clinical Toxicology
XANAX XR Tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines.XANAX XR is contraindicated with ketoconazole and itraconazole, since these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP3A) (see , and ).
The information included in the subsection on Adverse Events Observed in Short-Term, Placebo-Controlled Trials with XANAX XR Tablets is based on pooled data of five 6- and 8-week placebo-controlled clinical studies in panic disorder.
Adverse event reports were elicited either by general inquiry or by checklist, and were recorded by clinical investigators using terminology of their own choosing. The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened during therapy following baseline evaluation. In the tables and tabulations that follow, standard MedDRA terminology (version 4.0) was used to classify reported adverse events.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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