What is Xanax?
Alprazolam available under the trade name Xanax among others, is a short-acting anxiolytic of the benzodiazepine class. Alprazolam affects chemicals in the brain that may be unbalanced in people with anxiety. It is commonly used for the treatment of panic disorder, and anxiety disorders, such as generalized anxiety disorder (GAD) or social anxiety disorder (SAD).It was the 12th most prescribed medicine in 2010. Alprazolam, like other benzodiazepines, binds to specific sites on the GABAA receptor. It possesses anxiolytic, sedative, hypnotic, skeletal muscle relaxant, anticonvulsant, and amnestic properties.Alprazolam is available for oral administration in compressed tablet (CT) and extended-release capsule (XR) formulations.
Xanax may also be used for purposes not listed in this medication guide.
Alprazolam has a fast onset of action and symptomatic relief. Ninety percent of peak effects are achieved within the first hour of using either the CT formulation or the XR formulation in preparation for panic disorder, and full peak effects are achieved in 1.5 and 1.6 hours respectively.Peak benefits achieved for generalized anxiety disorder (GAD) may take up to a week. Tolerance to the anxiolytic/antipanic effects is controversial with some authoritative sources reporting the development of tolerance, and others reporting no development of tolerance; tolerance will, however, develop to the sedative-hypnotic effects within a couple of days. Withdrawal symptoms or rebound symptoms may occur after ceasing treatment abruptly following a few weeks or longer of steady dosing, and may necessitate a gradual dose reduction.
Alprazolam was first released by Upjohn (now a part of Pfizer). It is covered under U.S. Patent 3,987,052, which was filed on 29 October 1969, granted on 19 October 1976, and expired in September 1993. Alprazolam was released in 1981.The first approved indication was panic disorder and within two years of its original marketing Upjohn's Xanax became a blockbuster drug in the US. Presently, alprazolam is the most prescribedand the most misused benzodiazepine on the U.S. retail market. The potential for misuse among those taking it for medical reasons is controversial with some expert reviews stating that the risk is low and similar to that of other benzodiazepine drugsand others stating that there is a substantial risk of misuse and dependence in both patients and non-medical users of alprazolam and that the pharmacological properties of alprazolam, high affinity binding, high potency, having a short elimination half-life as well as a rapid onset of action may increase the misuse potential of alprazolam. Compared to the large number of prescriptions, relatively few individuals increase their dose on their own initiative or engage in drug-seeking behavior.Alprazolam is classified as a schedule IV controlled substance by the U.S. Drug Enforcement Administration (DEA).
Alprazolam is mostly used to treat anxiety disorders, panic disorders, and nausea due to chemotherapy. The FDA label advises that the physician should periodically reassess the usefulness of the drug.Alprazolam may also be indicated for the treatment of generalized anxiety disorder, as well as for the treatment of anxiety conditions with co-morbid depression.Alprazolam is also often prescribed with instances of hypersomnia and co-morbid sleep deficits.
Alprazolam is effective in the relief of moderate to severe anxiety and panic attacks.However, it is not a first line treatment since the development of selective serotonin reuptake inhibitors, and alprazolam is no longer recommended in Australia for the treatment of panic disorder due to concerns regarding tolerance, dependence and abuse.Evidence supporting the effectiveness of alprazolam in treating panic disorder has been limited to 4 to 10 weeks. However, people with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit.
In the United States, alprazolam is FDA-approved for the treatment of panic disorder with or without agoraphobia. Alprazolam is recommended by the World Federation of Societies of Biological Psychiatry (WFSBP) for treatment-resistant cases of panic disorder where there is no history of tolerance or dependence.
Anxiety associated with depression is responsive to alprazolam. Demonstrations of the effectiveness by systematic clinical study are limited to 4 months duration for anxiety disorder. However, the research into antidepressant properties of alprazolam is of poor quality and only assessed the short-term effects of alprazolam against depression. In one study, some long term, high-dosage users of alprazolam developed reversible depression.In the US, alprazolam is FDA-approved for the management of anxiety disorders (a condition corresponding most closely to the APA Diagnostic and Statistical Manual DSM-IV-TR diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. In the UK, alprazolam is recommended for the short-term treatment (2–4 weeks) of severe acute anxiety.
Nausea due to chemotherapy
Alprazolam may be used in combination with other medications for chemotherapy-induced nausea and vomiting.
You should not use Xanax if you have narrow-angle glaucoma, if you also take itraconazole or ketoconazole, or if you are allergic to Xanax or similar medicines (Valium, Ativan, Tranxene, and others).
Do not use Xanax if you are pregnant. This medicine can cause birth defects or life-threatening withdrawal symptoms in a newborn.
Alprazolam may be habit-forming. Misuse of habit-forming medicine can cause addiction, overdose, or death.
Do not drink alcohol while taking Xanax. This medication can increase the effects of alcohol. Alprazolam may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.
Before taking this medicine
It is dangerous to purchase Xanax on the Internet or from vendors outside the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. The sale and distribution of Xanax outside the U.S. does not comply with the regulations of the Food and Drug Administration (FDA) for the safe use of this medication.
You should not take Xanax if you have:
To make sure Xanax is safe for you, tell your doctor if you have:
Do not use Xanax if you are pregnant. This medicine can cause birth defects. Your baby could also become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant. Use effective birth control to prevent pregnancy while you are taking Xanax.
Alprazolam can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Xanax.
The sedative effects of Xanax may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking Xanax.
Xanax is not approved for use by anyone younger than 18 years old.
How should I take Xanax?
Take Xanax exactly as prescribed by your doctor. Follow all directions on your prescription label. Never use alprazolam in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in treating your symptoms.
Alprazolam may be habit-forming. Never share Xanax with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.
Misuse of habit-forming medicine can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.
Do not crush, chew, or break a Xanax extended-release tablet. Swallow the tablet whole.
Call your doctor if this medicine seems to stop working as well in treating your panic or anxiety symptoms.
Do not stop using Xanax suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.
If you use this medicine long-term, you may need frequent medical tests.
Store Xanax at room temperature away from moisture and heat.
Keep track of the amount of medicine used from each new bottle. Xanax is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
See also: Dosage Information (in more detail)
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of alprazolam can be fatal. Overdose symptoms may include extreme drowsiness, confusion, muscle weakness, loss of balance or coordination, feeling light-headed, and fainting.
What should I avoid while taking Xanax?
Xanax may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Drinking alcohol with this medicine can cause side effects.
Grapefruit and grapefruit juice may interact with alprazolam and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.
Xanax side effects
Get emergency medical help if you have signs of an allergic reaction to Xanax: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
Common Xanax side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Xanax dosing information
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.
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.
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.
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.
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.
Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided.
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, hence alprazolam at daily doses greater than 2 mg is potentially inappropriate for use in older adults. Smaller doses may be effective as well as safer. If side effects occur at the recommended starting dose, the dose may be lowered.
What other drugs will affect Xanax?
Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking Xanax with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.
Tell your doctor about all your current medicines and any you start or stop using, especially:
This list is not complete. Other drugs may interact with alprazolam, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
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