Xanax (Alprazolam) Full Prescribing Information
Brand Name: Xanax
Outside U.S., Brand Names also known as: Alcelam; Algad; Alpaz; Alplax; Alpram; Alprax; Alprazolam Intensol; Alprox; Alzam; Alzolam; Anpress; Ansiopax; Azor; Cassadan; Constan; Frontal; Kalma; Panix; Pharnax; Prinox; Ralozam; Relaxol; Restyl; Solanax; Tafil; Tensivan; Trankimazin; Tranquinal; Tricalma; Valeans; Xanagis; Xanax; Xanor; Zacetin; Zanapam; Zenax; Zolarem; Zoldac; Zoldax; Zotran
Xanax patient information (in plain English)
Alprazolam (Xanax) is a benzodiazepine used to treat anxiety and panic disorder.
Benzodiazepines are used to relieve anxiety, nervousness, or tension. Benzodiazepines should not be used for anxiety, nervousness, or tension caused by the stress of everyday life. Alprazolam, lorazepam, and oxazepam are also used to help control anxiety that sometimes occurs with mental depression. Benzodiazepines may also be used for other conditions as determined by your doctor.
CNS agents of the 1,4 benzodiazepine class presumably exert their effects by binding at stereo specific 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.
Following oral administration, alprazolam is readily absorbed. Peak concentrations in the plasma occur in 1-2 hours following administration.
Because of its similarity to other benzodiazepines, it is assumed that alprazolam undergoes transplacental passage and that it is excreted in human milk.
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For the management of anxiety disorders or the short-term symptomatic relief of symptoms of excessive anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
Alprazolam is indicated for the treatment of Generalized Anxiety Disorder (GAD) and is also indicated for the management of panic disorder with or without agoraphobia.
Anxiety associated with depression is responsive to alprazolam.
Alprazolam Tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines. Alprazolam may be used in patients with open angle glaucoma who are receiving appropriate therapy, but is contraindicated in patients with acute narrow angle glaucoma. Alprazolam is also contraindicated in pregnancy, in infants and in patients with myasthenia gravis.
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. Even after relatively short-term use at the doses recommended for the treatment of transient anxiety and anxiety disorder (i.e., 0.75 to 4.0 mg per day), there is some risk of dependence. Postmarketing surveillance data suggest that the risk of dependence and its severity appear to be greater in patients treated with relatively high doses (above 4 mg per day) and for long periods (more than 8-12 weeks).
Alprazolam is not recommended for use in patients whose primary diagnosis is psychosis or depression.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that may make you drowsy or less alert). Check with your doctor before taking any such depressants while you are taking this medicine.
Benzodiazepines may cause some people to become drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert.
Usage in Pregnancy
Safety in pregnancy has not been established, therefore its use is not recommended. Studies have suggested an increased risk of congenital malformations associated with the use of the benzodiazepines, such as chlordiazepoxide, diazepam, and also meprobamate, during the first trimester of pregnancy. Since alprazolam is a benzodiazepine derivative, its administration is rarely justified in women of childbearing potential. If the drug is prescribed to a woman of child bearing potential she should be warned to consult her physician regarding the discontinuation of the drug if she intends to become or suspects that she is pregnant.
Studies in rats have indicated that alprazolam and its metabolites are secreted into the milk. Therefore, nursing should not be undertaken while a patient is receiving the drug.
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 (e.g., the patient forgets, the patient is admitted to a hospital, etc.). Therefore, the dosage of alprazolam should be reduced or discontinued gradually.
If alprazolam 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.
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.
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 alprazolam (alprazolam). A decreased systemic alprazolam elimination rate (e.g., increased plasma half-life) has been observed in both alcoholic liver disease patients and obese patients receiving alprazolam.
Episodes of hypomania and mania have been reported in association with the use of alprazolam in patients with depression.
For All Users Of Alprazolam
To assure safe and effective use of benzodiazepines, all patients prescribed alprazolam should be provided with the following guidance. In addition, panic disorder patients, for whom higher doses are typically prescribed, should be advised about the risks associated with the use of higher doses.
- 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.
Additional Advice For Panic Disorder Patients
The use of alprazolam at the high doses (above 4 mg per day), often necessary to treat panic disorder, is accompanied by risks that you need to carefully consider. When used at high doses for long intervals, which may or may not be required for your treatment, alprazolam has the potential to cause severe emotional and physical dependence in some patients and these patients may find it exceedingly difficult to terminate treatment. In two controlled trials of six to eight weeks duration where the ability of patients to discontinue medication was measured, 7 to 29% of alprazolam treated patients did not completely taper off therapy. The ability of patients to completely discontinue therapy with alprazolam after long-term therapy has not been reliably determined. In all cases, it is important that your physician help you discontinue this medication in a careful and safe manner to avoid overly extended use of alprazolam.
In addition, the extended use at high doses appears to increase the incidence and severity of withdrawal reactions when alprazolam is discontinued. These are generally minor but seizure can occur, especially if you reduce the dose too rapidly or discontinue the medication abruptly. Seizure can be life-threatening.
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.
BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. This includes clozapine, ketoconazole, nefazodone, valproic acid, and medicines used to treat HIV infection. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding.
Side effects of alprazolam 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, e.g. drowsiness or lightheadedness.
Less common or rare-- Behavior problems, including difficulty in concentrating and outbursts of anger; confusion or mental depression; convulsions (seizures); hallucinations; impaired memory; muscle weakness; skin rash or itching; sore throat, fever, and chills; ulcers or sores in mouth or throat (continuing); uncontrolled movements of body, including the eyes; unusual bleeding or bruising; unusual excitement, nervousness, or irritability; unusual tiredness or weakness; yellow eyes or skin.
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.
There have also been reports of withdrawal seizures upon rapid decrease or abrupt discontinuation of alprazolam tablets.
To discontinue treatment in patients taking alprazolam, the dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of alprazolam be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.
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. It should be remembered when treating an overdose that multiple agents may have been ingested. Fatalities with benzodiazepines rarely occur except when other drugs, alcohol or aggravating factors are involved. 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.
Vomiting may be induced if the patient is fully awake. Vital signs should be monitored and general supportive measures should be employed as indicated. Gastric lavage should be instituted as soon as possible. I.V. fluids may be administered and an adequate airway should be maintained.
Flumazenil (Mazicon), a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected.
HOW TO USE THIS MEDICINE:
DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit forming.
- Follow the directions for using this medicine provided by your doctor.
- Store this medicine at room temperature, away from heat and light.
- If you miss a dose of this medicine and you are using it regularly, take it as soon as possible. If you do not remember until later, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Additional Information: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.
Must be individualized and carefully titrated in order to avoid excessive sedation or mental and motor impairment. As with other anxiolytic-sedatives, short courses of treatment should be the rule for the symptomatic relief of excessive anxiety and the initial course of treatment should not last longer than 1 week without reassessment. If necessary, drug dosage can be adjusted after 1 week. Prescriptions should be limited to short courses of therapy.
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.
Elderly Patients: The initial dosage is 0.125 mg (125 mcg) 2 or 3 times daily. If necessary, this dosage may be increased gradually depending on patient tolerance and response.
Each alprazolam (Xanax) tablet, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam. With multiple doses, given 3 times daily, steady state is reached within 7 days.
Patient Information: Do not take any other sedating drugs or drink alcohol while taking this medication. Alprazolam may be habit forming. Withdrawal symptoms may occur after you stop taking it. Alprazolam may be taken with or without food.
The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse. Last updated 3/03.
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Xanax patient information (in plain English)
- Created: 03 January 2009
- Last Updated: 02 September 2014
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