Alprazolam Orally Disintegrating Tablets Generic Name & Formulations
Legal Class
CIV
General Description
Alprazolam 0.25mg, 0.5mg. 1mg, 2mg; scored tabs; orange flavor.
Pharmacological Class
Benzodiazepine.
How Supplied
Contact supplier.
Manufacturer
Alprazolam Orally Disintegrating Tablets Indications
Indications
Anxiety disorder. Short-term treatment of anxiety symptoms. Panic disorder (with or without agoraphobia).
Alprazolam Orally Disintegrating Tablets Dosage and Administration
Adult
≥18yrs: Anxiety: Initially 0.25–0.5mg three times daily. May increase at 3–4 day intervals to 4mg/day in divided doses. Panic: Initially 0.5mg three times daily; may increase at intervals of 3–4 days in increments of up to 1mg/day; usual max 10mg/day. Advanced liver disease, elderly, or debilitated: initially 0.25mg 2–3 times daily. For all: individualize; reevaluate periodically; withdraw gradually.
Children
<18yrs: not recommended.
Alprazolam Orally Disintegrating Tablets Contraindications
Contraindications
Acute narrow-angle glaucoma. Concomitant itraconazole, ketoconazole.
Alprazolam Orally Disintegrating Tablets Boxed Warnings
Boxed Warning
Risks from concomitant use with opioids.
Alprazolam Orally Disintegrating Tablets Warnings/Precautions
Warnings/Precautions
Risks from concomitant use with opioids; see Interactions. Not for use in untreated open-angle glaucoma. Discard unused portions of scored tabs (drug stability not ensured). Suicidal ideation. Depression. Psychosis. Mania. Renal, cardiovascular, hepatic, or pulmonary impairment; monitor. Obesity. Reevaluate periodically. Change dose gradually. Withdrawal symptoms on abrupt cessation or dose reduction. Monitor periodic CBCs, urinalysis, blood chemistry. Drug or alcohol abuse. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.D), nursing mothers: not recommended.
Alprazolam Orally Disintegrating Tablets Pharmacokinetics
See Literature
Alprazolam Orally Disintegrating Tablets Interactions
Interactions
See Contraindications; other azole antifungals: not recommended. Increased sedation, respiratory depression, coma, and death with concomitant opioids; reserve use in those for whom alternative treatment options are inadequate; if needed, limit dosages/durations to minimum and monitor. Additive CNS depressant effects with alcohol or other CNS depressants (eg, other benzodiazepines, psychotropics, anticonvulsants, antihistamines); consider dose reductions. Potentiated by CYP3A inhibitors (eg, cimetidine, nefazodone, fluvoxamine); reduce alprazolam dose; caution with weaker CYP3A inhibitors (eg, fluoxetine, propoxyphene, oral contraceptives). Caution with diltiazem, isoniazid, erythromycin, clarithromycin, grapefruit juice, sertraline, paroxetine, ergotamine, cyclosporine, amiodarone, nicardipine, nifedipine, others metabolized by CYP3A. Antagonized by CYP3A inducers (eg, carbamazepine). May increase levels of imipramine, desipramine. Absorption may be affected by drugs or conditions that affect salivation or gastric pH.
Alprazolam Orally Disintegrating Tablets Adverse Reactions
Adverse Reactions
CNS depression (eg, sedation, somnolence, memory impairment, dysarthria, coordination abnormal, ataxia), fatigue, lethargy, dyspnea, dry mouth, constipation, withdrawal seizures, tremors, decreased libido, sexual dysfunction, paradoxical excitement.
Alprazolam Orally Disintegrating Tablets Clinical Trials
See Literature
Alprazolam Orally Disintegrating Tablets Note
Not Applicable
Alprazolam Orally Disintegrating Tablets Patient Counseling
See Literature