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Dosage and Administration

Swallowing alprazolam tablets is the safest route of use. Take XANAX (Alprazolam) exactly as your healthcare provider tells you to take it. Your healthcare provider will tell you how much XANAX (Alprazolam) to take and when to take it.

Initially, 0.25 mg to 0.5 mg PO 3 times per day. Use the lower dose for debilitated adults initially. If clinically indicated, increase the dose as tolerated at intervals of 3 to 4 days, up to a maximum of 4 mg/day in divided doses. If discontinuation becomes necessary, the manufacturer suggests that the daily dose be decreased by no more than 0.5 mg every 3 days. Some patients may require a more gradual and individualized taper.

Children† and Adolescents† 7 years and older

Definitive dosage not established. In a study of children 7 to 16 years old (n = 13), initial doses of 0.005 mg/kg/dose PO or 0.125 mg/dose PO were given 3 times per day for situational anxiety. Doses were increased in 0.125 mg to 0.25 mg increments. Max: 0.02 mg/kg/dose PO or 0.06 mg/kg/day PO. In another study of children with overanxious or avoidant disorder (n = 30), initial doses were 0.25 mg PO per day for children 40 kg or less and 0.5 mg PO per day for those more than 40 kg. Doses were titrated at 2-day intervals to a maximum of 0.04 mg/kg/day. Required doses ranged from 0.5 mg to 3.5 mg/day with a mean dose of 1.6 mg/day.

Dose for anxiety should be initiated with 0.25 to 0.5 mg given three times daily. It may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment.

Generally,all patients should reduce their dosage gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction.

Treatment of many panic disorder patients has required the use of XANAX(Alprazolam) at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of XANAX(Alprazolam) in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received XANAX(Alprazolam) in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to achieve a successful response.

Side Effects

Central Nervous System

Drowsiness

Light-headedness

Depression

Headache

Confusion

Insomnia

Nervousness

Syncope

Dizziness

Akathisia

Tiredness/Sleepiness

Gastrointestinal

Dry Mouth

Constipation

Diarrhea

Nausea/Vomiting

Increased Salivation

Cardiovascular

Tachycardia/Palpitations

Hypotension

Sensory

Blurred Vision

Musculoskeletal

Rigidity

Tremor

Cutaneous

Dermatitis/Allergy

Other

Nasal Congestion

Weight Gain

Weight Loss

WARNINGS

Dependence And Withdrawal Reactions, Including Seizures

Certain adverse clinical events, some life-threatening, are a direct consequence of physical dependence to XANAX. These include a spectrum of withdrawal symptoms; the most important is seizure (see Drug Abuse And Dependence). Even after relatively short term use at the doses recommended for the treatment of transient anxiety and anxiety disorder (ie, 0.75 to 4.0 mg per day), there is some risk of dependence. Spontaneous reporting system data suggest that the risk of dependence and its severity appear to be greater in patients treated with doses greater than 4 mg/day and for long periods (more than 12 weeks). However, in a controlled postmarketing discontinuation study of panic disorder patients, the duration of treatment (3 months compared to 6 months) had no effect on the ability of patients to taper to zero doses. In contrast, patients treated with doses of XANAX greater than 4 mg/day had more difficulty tapering to zero dose than those treated with less than 4 mg/day.

Relapse or return of illness was defined as a return of symptoms characteristic of panic disorder (primarily panic attacks) to levels approximately equal to those seen at baseline before active treatment was initiated. Rebound refers to a return of symptoms of panic disorder to a level substantially greater in frequency, or more severe in intensity than seen at baseline. Withdrawal symptoms were identified as those which were generally not characteristic of panic disorder and which occurred for the first time more frequently during discontinuation than at baseline.

In a controlled clinical trial in which 63 patients were randomized to XANAX and where withdrawal symptoms were specifically sought, the following were identified as symptoms of withdrawal: heightened sensory perception, impaired concentration, dysosmia, clouded sensorium, paresthesias, muscle cramps, muscle twitch, diarrhea, blurred vision, appetite decrease, and weight loss. Other symptoms, such as anxiety and insomnia, were frequently seen during discontinuation, but it could not be determined if they were due to return of illness, rebound, or withdrawal. More info