Alprazolam - Xr (Xanax)

Trade Name : Xanax

Pharmacia and Upjohn Company LLC

TABLET, EXTENDED RELEASE

Strength 0.5 mg/1

Storage and handling for Xanax

ALPRAZOLAM Benzodiazepine [EPC],Benzodiazepines [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Alprazolam - Xr (Xanax) which is also known as Xanax and Manufactured by Pharmacia and Upjohn Company LLC. It is available in strength of 0.5 mg/1 per ml. Read more

Alprazolam - Xr (Xanax) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

About GNH

No data

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death see .

XANAX XR 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-4--triazolo [4,3-u03b1] [1,4] benzodiazepine. The molecular formula is CHClN which corresponds to a molecular weight of 308.76.
The structural formula is represented below:
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 XR extended-release tablet, for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam. The inactive ingredients are lactose, magnesium stearate, colloidal silicon dioxide, and hypromellose. In addition, the 1 mg and 3 mg tablets contain D & C yellow No. 10 and the 2 mg and 3 mg tablets contain FD&C blue No. 2.

No data

The efficacy of XANAX XR Tablets in the treatment of panic disorder was established in two 6-week, placebo-controlled studies of XANAX XR in patients with panic disorder.
In two 6-week, flexible-dose, placebo-controlled studies in patients meeting DSM-III criteria for panic disorder, patients were treated with XANAX XR in a dose range of 1 to 10 mg/day, on a once-a-day basis. The effectiveness of XANAX XR was assessed on the basis of changes in various measures of panic attack frequency, on various measures of the Clinical Global Impression, and on the Overall Phobia Scale. In all, there were seven primary efficacy measures in these studies, and XANAX XR was superior to placebo on all seven outcomes in both studies. The mean dose of XANAX XR at the last treatment visit was 4.2 mg/day in the first study and 4.6 mg/day in the second.
In addition, there were two 8-week, fixed-dose, placebo-controlled studies of XANAX XR in patients with panic disorder, involving fixed XANAX XR doses of 4 and 6 mg/day, on a once-a-day basis, that did not show a benefit for either dose of XANAX XR.
The longer-term efficacy of XANAX XR in panic disorder has not been systematically evaluated.
Analyses of the relationship between treatment outcome and gender did not suggest any differential responsiveness on the basis of gender.

XANAX XR Tablets are indicated for the treatment of panic disorder, with or without agoraphobia.
This claim is supported on the basis of two positive studies with XANAX XR conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see ).
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: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.
The longer-term efficacy of XANAX XR has not been systematically evaluated. Thus, the physician who elects to use this drug for periods longer than 8 weeks should periodically reassess the usefulness of the drug for the individual patient.

XANAX XR Tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines.
XANAX XR is contraindicated with ketoconazole and itraconazole, since these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP3A) (see , and ).

No data

No data

The information included in the subsection on Adverse Events Observed in Short-Term, Placebo-Controlled Trials with XANAX XR Tablets is based on pooled data of five 6- and 8-week placebo-controlled clinical studies in panic disorder.
Adverse event reports were elicited either by general inquiry or by checklist, and were recorded by clinical investigators using terminology of their own choosing. The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened during therapy following baseline evaluation. In the tables and tabulations that follow, standard MedDRA terminology (version 4.0) was used to classify reported adverse events.

No data

No data

XANAX XR Tablets may be administered once daily, preferably in the morning. The tablets should be taken intact; they should not be chewed, crushed, or broken.
The suggested total daily dose ranges between 3 to 6 mg/day. Dosage should be individualized for maximum beneficial effect. While the suggested total daily dosages given will meet the needs of most patients, there will be some patients who require doses greater than 6 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.

XANAX XR (extended-release) Tablets are available as follows:
0.5 mg
1 mg
2 mg
3 mg
Store at 25u00b0C (77u00b0F); excursions permitted to 15u201330u00b0C (59u201386u00b0F) [see USP Controlled Room Temperature].

When rats were treated with alprazolam at 3, 10, and 30 mg/kg/day (15 to 150 times the maximum recommended human dose) orally for 2 years, a tendency for a dose related increase in the number of cataracts was observed in females and a tendency for a dose related increase in corneal vascularization was observed in males. These lesions did not appear until after 11 months of treatment.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
LAB-0006-8.0December 2016

This Medication Guide has been approved by the U.S. Food and Drug Administration.
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com
LAB-0824-1.0December 2016

ALWAYS DISPENSE WITH MEDICATION GUIDEn- Pfizer
Xanax XRn CIV
alprazolamextended-release tablets
0.5 mg
60 Tabletsn n

ALWAYS DISPENSE WITH MEDICATION GUIDEn- Pfizer
Xanax XRn CIV
alprazolamextended-release tablets
1 mg
60 Tabletsn n

ALWAYS DISPENSE WITH MEDICATION GUIDEn- Pfizer
Xanax XRn CIV
alprazolamextended-release tablets
2 mg
60 Tabletsn n

ALWAYS DISPENSE WITH MEDICATION GUIDEn- Pfizer
Xanax XRn CIV
alprazolamextended-release tablets
3 mg
60 Tabletsn n

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