Monograph Details
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Central Nervous System
> Anxiety/OCD
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NIRAVAM |
| Manufacturer |
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Schwarz Pharma, Inc. |
| Legal Classification |
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CIV |
| Pharmacological Class |
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Benzodiazepine. |
| Generic Name |
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Alprazolam 0.25mg, 0.5mg. 1mg, 2mg; orally-disintegrating scored tabs; orange flavor. |
| Indications |
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Anxiety disorder. Short-term treatment of anxiety symptoms. Panic disorder (with or without agoraphobia). |
| Children |
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<18yrs: not recommended. |
| Adults |
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≥18 yrs: 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. |
| Contraindications |
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Acute narrow-angle glaucoma. Concomitant itraconazole, ketoconazole. |
| Precautions |
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Not for use in untreated open-angle glaucoma. Discard unused portions of scored tabs (drug stability not ensured). Suicidal ideation. Avoid abrupt cessation. Psychosis. Mania. Renal, hepatic, cardiovascular, pulmonary dysfunction (monitor). Obesity. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.D), nursing mothers: not recommended. |
| Interactions |
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See Contraindications; other azole antifungals: not recommended. Potentiates CNS depression with alcohol, psychotropics, anticonvulsants, antihistamines, other CNS depressants. Potentiated by CYP3A inhibitors: reduce alprazolam dose; caution with cimetidine, nefazodone, fluvoxamine; caution with weaker CYP3A inhibitors (eg, fluoxetine, propoxyphene, oral contraceptives, ergots, cyclosporine, amiodarone, paroxetine, nicardipine, nifedipine). 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. |
| Adverse Reactions |
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CNS depression, fatigue, impaired coordination, memory impairment, dysarthria, changes in libido or appetite, constipation, paradoxical excitation, withdrawal reactions/seizures. |
| How Supplied |
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Tabs—100 |
| Additional Resources |
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• Related Prescribing Note |
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