$200.00 – $900.00
Product name: Xanax
Generic Name: Alprazolam
Drug Class: Benzodiazepines
Steroid cycle: Antidepressants
Pregnancy Category: D – Positive evidence of risk
CSA Schedule: 4 – Some potential for abuse
Labeler / Supplier: Pfizer U.S. Pharmaceuticals Group
Strength: 0.25, 0.5, 1 mg, 2 mg
Quantity: 100 – 750 Tablets
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Xanax is used in the treatment of anxiety; depression; panic disorder and belongs to the drug class benzodiazepines. There is positive evidence of human fetal risk during pregnancy. Xanax is classified as a Schedule 4 controlled substance under the Controlled Substance Act (CSA). It is supplied by Pfizer U.S. Pharmaceuticals Group.
Xanax (alprazolam) is a benzodiazepine. Alprazolam affects chemicals in the brain that may be unbalanced in people with anxiety.
Xanax is used to treat anxiety disorders, panic disorders, and anxiety caused by depression.
Xanax may also be used for purposes not listed in this medication guide.
XANAX Tablets (alprazolam) are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-IIIR] 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.
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.
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:
- palpitations, pounding heart, or accelerated heart rate;
- trembling or shaking;
- sensations of shortness of breath or smothering;
- feeling of choking;
- chest pain or discomfort;
- nausea or abdominal distress;
- feeling dizzy, unsteady, lightheaded, or faint;
- derealization (feelings of unreality) or depersonalization (being detached from oneself);
- fear of losing control;
- fear of dying;
- paresthesias (numbness or tingling sensations);
- 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.
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:
if you are also taking itraconazole or ketoconazole; or
if you are allergic to alprazolam or to other benzodiazepines, such as chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or oxazepam (Serax).
- To make sure Xanax is safe for you, tell your doctor if you have:
- seizures or epilepsy;
- kidney or liver disease (especially alcoholic liver disease);
- asthma or other breathing disorder;
- open-angle glaucoma;
- a history of depression or suicidal thoughts or behavior;
- a history of drug or alcohol addiction; or
- if you also use a narcotic (opioid) medication.
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.
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. 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.
Avoid drinking alcohol. Dangerous side effects could occur.
Grapefruit and grapefruit juice may interact with alprazolam and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.
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. If side effects occur at the recommended starting dose, the dose may be lowered.
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:
- depressed mood, thoughts of suicide or hurting yourself;
- racing thoughts, increased energy, unusual risk-taking behavior;
- confusion, agitation, hostility, hallucinations;
- uncontrolled muscle movements, tremor, seizure (convulsions); or
- pounding heartbeats or fluttering in your chest.
Common Xanax side effects may include:
- drowsiness, feeling tired;
- slurred speech, lack of balance or coordination;
- memory problems; or
- feeling anxious early in the morning.
Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient.
Vigor Health Pharmaceuticals does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.
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