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What is Xanax (Alprazolam) and how is it used?

Xanax (Alprazolam) is a prescription medicine used to treat the symptoms of anxiety, panic disorder, and anxiety associated with depression. Xanax may be used alone or with other medications.

Xanax belongs to a class of drugs called Antiaxiety Agents, Anxiolytics, Benzodiazepines.

It is not known if Xanax is safe and effective in children younger than 18 years of age.

What are the possible side effects of Xanax?

Xanax may cause serious side effects including:

  • depressed mood,
  • thoughts of suicide or hurting yourself,
  • racing thoughts,
  • increased energy,
  • unusual risk-taking behavior,
  • confusion,
  • agitation,
  • hostility,
  • hallucinations,
  • uncontrolled muscle movements,
  • tremor,
  • convulsions (seizure), and
  • pounding heartbeats or fluttering in your chest

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Xanax include:

  • drowsiness,
  • feeling tired,
  • slurred speech,
  • lack of balance or coordination,
  • memory problems, and
  • feeling anxious early in the morning

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Xanax. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

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-α] [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® tablets - Structural Formula Illustration 2

 

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.

Indications & Dosage

INDICATIONS

XANAX is indicated for the:

  • acute treatment of generalized anxiety disorder (GAD) in adults.
  • treatment of panic disorder (PD), with or without agoraphobia in adults.

DOSAGE AND ADMINISTRATION

Dosage In Generalized Anxiety Disorder

The recommended starting oral dosage of XANAX for the acute treatment of patients with GAD is 0.25 mg to 0.5 mg administered three times daily. Depending upon the response, the dosage may be adjusted at intervals of every 3 to 4 days. The maximum recommended dosage is 4 mg daily (in divided doses).

Use the lowest possible effective dose and frequently assess the need for continued treatment [see WARNINGS AND PRECAUTIONS].

Dosage In Panic Disorder

The recommended starting oral dosage of XANAX for the treatment of PD is 0.5 mg three times daily. Depending on the response, the dosage may be increased at intervals of every 3 to 4 days in increments of no more than 1 mg per day.

Controlled trials of XANAX in the treatment of panic disorder included dosages in the range of 1 mg to 10 mg daily. The mean dosage was approximately 5 mg to 6 mg daily. Occasional patients required as much as 10 mg per day.

For patients receiving doses greater than 4 mg per 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 per day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit.

The necessary duration of treatment for PD in patients responding to XANAX is unknown. After a period of extended freedom from panic 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 [see DOSAGE AND ADMINISTRATION].

Discontinuation Or Dosage Reduction Of XANAX

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue XANAX or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly [see WARNINGS AND PRECAUTIONSDrug Abuse And Dependence].

Reduced the dosage by no more than 0.5 mg every 3 days. Some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.

In a controlled postmarketing discontinuation study of panic disorder patients which compared the 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.

Dosage Recommendations In Geriatric Patients

In geriatric patients, the recommended starting oral dosage of XANAX is 0.25 mg, given 2 or 3 times daily. This may be gradually increased if needed and tolerated. Geriatric patients may be especially sensitive to the effects of benzodiazepines. If adverse reactions occur at the recommended starting dosage, the dosage may be reduced [see Use In Specific PopulationsCLINICAL PHARMACOLOGY].

Dosage Recommendations In Patients With Hepatic Impairment

In patients with hepatic impairment, the recommended starting oral dosage of XANAX is 0.25 mg, given 2 or 3 times daily. This may be gradually increased if needed and tolerated. If adverse reactions occur at the recommended starting dose, the dosage may be reduced [see Use In Specific PopulationsCLINICAL PHARMACOLOGY].

Dosage Modifications For Drug Interactions

XANAX should be reduced to half of the recommended dosage when a patient is started on ritonavir and XANAX together, or when ritonavir administered to a patient treated with XANAX. Increase the XANAX dosage to the target dose after 10 to 14 days of dosing ritonavir and XANAX together. It is not necessary to reduce XANAX dose in patients who have been taking ritonavir for more than 10 to 14 days.

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