Alprazolamdrug info
alprazolam 1 MG Disintegrating Oral Tablet
What it is used for
Alprazolam orally disintegrating tablets are a benzodiazepine indicated for: The treatment of generalized anxiety disorder. The efficacy of alprazolam was demonstrated in 5 short-term, placebo-controlled trials.. The treatment of panic disorder, with or without agoraphobia. The efficacy of alprazolam in the treatment of panic disorder was established in 2 short-term, placebo-controlled trials.
1.1 Generalized
Anxiety Disorder Alprazolam orally disintegrating tablets, USP are indicated for the treatment of generalized anxiety disorder. The efficacy of alprazolam in the treatment of generalized anxiety disorder was demonstrated in 5 short-term, placebo-controlled trials.
1.2 Panic Disorder
Alprazolam orally disintegrating tablets, USP are also indicated for the treatment of panic disorder, with or without agoraphobia. The efficacy of alprazolam in the treatment of panic disorder was established in 2 short-term, placebo-controlled trials. Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to 4 months in duration for generalized 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.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective December 1, 2022. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Alprazolam orally disintegrating tablets, USP contain alprazolam, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. Alprazolam orally disintegrating tablets, USP are an orally administered formulation of alprazolam, USP which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing. The chemical name of alprazolam, USP is 8-Chloro-1-methyl-6-phenyl-4H- s -triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C 17 H 13 CIN 4 and the molecular weight is 308.76.
The structural formula is: Alprazolam, USP is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. The structural formula of is alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C17H13CIN4 and the molecular weight is 308.76.
11.1 Alprazolam
Orally Disintegrating Tablets Each orally disintegrating tablet contains either 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam, USP and the following inactive ingredients: corn starch, crospovidone, magnesium stearate, mannitol, methacrylic acid copolymer (type C), microcrystalline cellulose, natural and artificial orange flavor, polysorbate 80, sodium lauryl sulfate, sucralose. In addition, the 1 mg and 2 mg tablets contain ferric oxide (yellow 10 synthetic yellow iron oxide). Product meets USP Dissolution Test 2. Product meets USP Disintegration Test 2.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective December 1, 2022. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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