Data from in vitro studies of alprazolam suggest a possible drug interaction between alprazolam and the following: sertraline and paroxetine. However, data from an in vivo drug interaction study involving a single dose of alprazolam 1 mg and steady state doses of sertraline 50 mg to mg per day did not reveal any clinically significant changes in the pharmacokinetics of alprazolam.
Data from in vitro studies of benzodiazepines other than alprazolam suggest a possible drug interaction between benzodiazepines and the following: ergotamine, cyclosporine, amiodarone, nicardipine, and nifedipine. The efficacy of alprazolam in the treatment of generalized anxiety disorder was demonstrated in 5 short-term, placebo-controlled trials. 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. The studies included patients with a diagnosis of anxiety or anxiety with associated depressive symptomatology.
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Alprazolam doses ranged from 0. The mean daily doses ranged from 1. The average dose of alprazolam was 5 mg to 6 mg per day in two of the studies, and the doses of alprazolam were fixed at 2 mg and 6 mg per day in the third study. In two of the three studies, alprazolam was superior to placebo on a variable defined as "change from baseline on the number of panic attacks per week" range, 3. A subgroup of patients who were improved on alprazolam during short-term treatment in one of these trials was continued on an open basis up to 8 months, without apparent loss of benefit.
Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Avoid abrupt discontinuation. Reduce or discontinue the dose gradually. Caution patients about the use of alcohol and other CNS depressant drugs during treatment with alprazolam. Consider dividing the daily dose into more frequent administrations.
There have been rare reports of death in patients with severe pulmonary disease shortly after the initiation of treatment with alprazolam. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe alprazolam concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation.
In patients already receiving an opioid analgesic, prescribe a lower initial dose of alprazolam than indicated in the absence of an opioid and titrate based on clinical response. If an opioid is initiated in a patient already taking alprazolam, prescribe a lower initial dose of the opioid and titrate based upon clinical response. Advise both patients and caregivers about the risks of respiratory depression and sedation when alprazolam is used with opioids.
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Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see Drug Interactions 7. Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients. In most cases, only a single seizure was reported; however, multiple seizures and status epilepticus were reported as well.
The use of benzodiazepines, including alprazolam, may lead to physical and psychological dependence. Even after relatively short-term use at the recommended doses, there is some risk of dependence and withdrawal symptoms [see Dependence 9. Certain adverse clinical events, some life-threatening, are a direct consequence of physical dependence to alprazolam.
These include a spectrum of withdrawal symptoms; the most important is seizure [see Drug Abuse and Dependence 9.
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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 per 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 dose. In contrast, patients treated with doses of alprazolam greater than 4 mg per day had more difficulty tapering to zero dose than those treated with less than 4 mg per day.
The importance of dose and the risks of alprazolam as a treatment for panic disorder Because the management of panic disorder often requires the use of average daily doses of alprazolam above 4 mg, the risk of dependence among panic disorder patients may be higher than that among those treated for less severe anxiety. Experience in randomized placebo-controlled discontinuation studies of patients with panic disorder showed a high rate of rebound and withdrawal symptoms in patients treated with alprazolam compared to placebo-treated patients. 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 alprazolam 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.
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 dose. Five of these cases clearly occurred during abrupt dose reduction, or discontinuation from daily doses of 2 mg to 10 mg. Three cases occurred in situations where there was not a clear relationship to abrupt dose reduction or discontinuation.
In one instance, seizure occurred after discontinuation from a single dose of 1 mg after tapering at a rate of 1 mg every 3 days from 6 mg daily. In two other instances, the relationship to taper is indeterminate; in both of these cases the patients had been receiving doses of 3 mg daily prior to seizure.
The duration of use in the above 8 cases ranged from 4 to 22 weeks.
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There have been occasional voluntary reports of patients developing seizures while apparently tapering gradually from alprazolam. To discontinue treatment in patients taking alprazolam, the dosage should be reduced gradually. Decrease the daily dosage of alprazolam by no more than 0. Some patients may benefit from an even slower dosage reduction. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome.
Because use of these drugs is rarely a matter of urgency, their use during the first trimester should almost always be avoided. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug. Caution patients about the simultaneous ingestion of alcohol and other CNS depressant drugs during treatment with alprazolam.
Drugs that inhibit this metabolic pathway may have a profound effect on the clearance of alprazolam. Consequently, alprazolam should be avoided in patients receiving potent inhibitors of CYP3A. With drugs inhibiting CYP3A to a lesser but still significant degree, alprazolam should be used only with caution and consideration of appropriate dosage reduction. The coadministration of alprazolam with these agents is not recommended.
Other drugs possibly affecting alprazolam metabolism Other drugs possibly affect alprazolam metabolism by inhibition of CYP3A [see Drug Interactions 7. These symptoms may reflect the development of tolerance or a time interval between doses which is longer than the duration of clinical action of the administered dose. In either case, it is presumed that the prescribed dose is not sufficient to maintain plasma levels above those needed to prevent relapse, rebound or withdrawal symptoms over the entire course of the interdosing interval.
This includes purposeful tapering, but also inadvertent reduction of dose e. Although other medications with weak uricosuric effect have been reported to cause acute renal failure, there have been no reported instances of acute renal failure attributable to therapy with alprazolam. The usual precautions in treating patients with impaired renal, hepatic or pulmonary function should be observed.
A decreased systemic alprazolam elimination rate e. Add Drug. Maximum: Doses up to 10 mg per day may be required to achieve a successful response Pregnancy 8. Death has been reported in association with overdoses of alprazolam by itself, as it has with other benzodiazepines.
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In addition, fatalities have been reported in patients who have overdosed with a combination of a single benzodiazepine, including alprazolam, and alcohol; alcohol levels seen in some of these patients have been lower than those usually associated with alcohol-induced fatality. In case of an overdose, provide supportive care, including close medical supervision and monitoring.
Treatment should consist of those general measures employed in the management of overdosage with any drug. Consider the possibility of multiple drug overdose. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs. Use supportive and symptomatic measures.
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Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. Xanax is an anti-anxiety medication used to reduce the symptoms associated with anxiety disorders and panic disorders.
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