XANAX, alprazolam tablets, USP
CIV 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]
The structural formula is represented to the right:
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:
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.
Alprazolam and its metabolites are excreted primarily in the urine.
- Race — Maximal concentrations and half-life of alprazolam are approximately 15% and 25%
higher in Asians compared to Caucasians.
- Pediatrics — The pharmacokinetics of alprazolam in pediatric patients have not been studied.
- Gender — Gender has no effect on the pharmacokinetics of alprazolam.
- Cigarette Smoking — Alprazolam concentrations may be reduced by up to 50% in smokers
compared to non-smokers.
XANAX Tablets were compared to placebo in double blind clinical studies (doses up to 4
mg/day) in patients with a diagnosis of anxiety or anxiety with associated depressive
symptomatology. XANAX was significantly better than placebo at each of the evaluation 4
periods of these 4-week studies as judged by the following psychometric instruments:
Physician’s Global Impressions, Hamilton Anxiety Rating Scale, Target Symptoms, Patient’s
Global Impressions and Self-Rating Symptom Scale.
Support for the effectiveness of XANAX in the treatment of panic disorder came from three
short-term, placebo-controlled studies (up to 10 weeks) in patients with diagnoses closely
corresponding to DSM-III-R criteria for panic disorder.
The average dose of XANAX was 5-6 mg/day in two of the studies, and the doses of XANAX
were fixed at 2 and 6 mg/day in the third study. In all three studies, XANAX was superior to
placebo on a variable defined as "the number of patients with zero panic attacks" (range, 37-
83% met this criterion), as well as on a global improvement score. In two of the three studies,
XANAX was superior to placebo on a variable defined as "change from baseline on the
number of panic attacks per week" (range, 3.3-5.2), and also on a phobia rating scale. A
subgroup of patients who were improved on XANAX during short-term treatment in one of
these trials was continued on an open basis up to 8 months, without apparent loss of benefit.
XANAX Tablets are contraindicated in patients with known sensitivity to this drug or other
benzodiazepines. XANAX may be used in patients with open angle glaucoma who are
receiving appropriate therapy, but is contraindicated in patients with acute narrow angle
XANAX is contraindicated with ketoconazole and itraconazole, since these medications
significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP3A)
(see WARNINGS and PRECAUTIONS–Drug Interactions).
For all users of XANAX:
To assure safe and effective use of benzodiazepines, all patients prescribed XANAX should be
provided with the following guidance.
1. 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.
2. 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
3. Inform your physician if you are nursing.
4. Until you experience how this medication affects you, do not drive a car or operate
potentially dangerous machinery, etc.
5. 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.
6. Do not stop taking this medication abruptly or decrease the dose without consulting your
physician, since withdrawal symptoms can occur.
XANAX Tablets are available as follows:
0.25 mg (white, oval, scored, imprinted “XANAX 0.25”)
Bottles of 100 NDC 0009-0029-01
Unit dose (100) NDC 0009-0029-46
Bottles of 500 NDC 0009-0029-02
Bottles of 1000 NDC 0009-0029-14
0.5 mg (peach, oval, scored, imprinted “XANAX 0.5”)
Bottles of 100 NDC 0009-0055-01
Unit Dose (100) NDC 0009-0055-46
Bottles of 500 NDC 0009-0055-0322
Bottles of 1000 NDC 0009-0055-15
1 mg (blue, oval, scored, imprinted “XANAX 1.0”)
Bottles of 100 NDC 0009-0090-01
Bottles of 500 NDC 0009-0090-04
Bottles of 1000 NDC 0009-0090-13
2 mg (white, oblong, multi-scored, imprinted “XANAX ” on one side and “2” on the reverse
Bottles of 100 NDC 0009-0094-01
Bottles of 500 NDC 0009-0094-03
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].