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NIRAVAM
Anxiety/OCD
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Drug Name:

NIRAVAM CIV

Generic Name and Formulations:
Alprazolam 0.25mg, 0.5mg. 1mg, 2mg; orally-disintegrating scored tabs; orange flavor.

Company:
Jazz Pharmaceuticals plc

Therapeutic Use:

Indications for NIRAVAM:

Anxiety disorder. Short-term treatment of anxiety symptoms. Panic disorder (with or without agoraphobia).

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.

Contraindications:

Acute narrow-angle glaucoma. Concomitant itraconazole, ketoconazole.

Warnings/Precautions:

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:

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.

Pharmacological Class:

Benzodiazepine.

Adverse Reactions:

CNS depression, fatigue, impaired coordination, memory impairment, dysarthria, changes in libido or appetite, constipation, paradoxical excitation, withdrawal reactions/seizures.

How Supplied:

Tabs—100

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