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Bucapsol

BUSPIRONE HYDROCHLORIDE

Standard Dose

DOSAGE AND ADMINISTRATION The recommended initial dose is 15 mg daily (7.5 mg two times per day). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed. The maximum daily dosage should not exceed 60 mg per day. In clinical trials allowing dose titration, divided doses of 20 to 30 mg per day were commonly employed. The bioavailability of buspirone is increased when given with food as compared to the fasted state (see CLINICAL PHARMACOLOGY ). Consequently, patients should take buspirone in a consistent manner with regard to the timing of dosing; either always with or always without food. For patients who have difficulty swallowing capsules, Bucapsol TM capsules can be opened and the contents sprinkled on a small amount (about 1-2 tablespoons) of applesauce. The drug-applesauce mixture should be swallowed immediately. When buspirone is to be given with a potent inhibitor of CYP3A4, the dosage recommendations described in the PRECAUTIONS: Drug Interactions section should be followed. Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Antidepressant At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with Bucapsol TM capsules. Conversely, at least 14 days should be allowed after stopping Bucapsol TM capsules before starting an MAOI antidepressant (see CONTRAINDICATIONS and DRUG INTERACTIONS ). Use of Bucapsol TM Capsules with (Reversible) MAOIs, Such as Linezolid or Methylene Blue Do not start Bucapsol TM capsules in a patient who is being treated with a reversible MAOI such as linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, including hospitalization, should be considered (see CONTRAINDICATIONS and DRUG INTERACTIONS ). In some cases, a patient already receiving therapy with Bucapsol TM capsules may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Bucapsol TM capsules should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Bucapsol TM capsules may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS ). The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg per kg with Bucapsol TM capsules are unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see CONTRAINDICATIONS , WARNINGS and DRUG INTERACTIONS ).

Max Dose

See official label

Primary Use

INDICATIONS AND USAGE Bucapsol TM capsules are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety.

Summary

Indications and usage INDICATIONS AND USAGE Bucapsol TM capsules are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety.

Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

Structured Monograph

Clinical summary

Indications and usage INDICATIONS AND USAGE Bucapsol TM capsules are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III 1 as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge", irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride for extended periods should periodically reassess the usefulness of the drug for the individual patient. Dosage and administration DOSAGE AND ADMINISTRATION The recommended initial dose is 15 mg daily (7.5 mg two times per day). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed. The maximum daily dosage should not exceed 60 mg per day. In clinical trials allowing dose titration, divided doses of 20 to 30 mg per day were commonly employed. The bioavailability of buspirone is increased when given with food as compared to the fasted state (see CLINICAL PHARMACOLOGY ). Consequently, patients should take buspirone in a consistent manner with regard to the timing of dosing; either always with or always without food. For patients who have difficulty swallowing capsules, Bucapsol TM capsules can be opened and the contents sprinkled on a small amount (about 1-2 tablespoons) of applesauce. The drug-applesauce mixture should be swallowed immediately. When buspirone is to be given with a potent inhibitor of CYP3A4, the dosage recommendations described in the PRECAUTIONS: Drug Interactions section should be followed. Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Antidepressant At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with Bucapsol TM capsules. Conversely, at least 14 days should be allowed after stopping Bucapsol TM capsules before starting an MAOI antidepressant (see CONTRAINDICATIONS and DRUG INTERACTIONS ). Use of Bucapsol TM Capsules with (Reversible) MAOIs, Such as Linezolid or Methylene Blue Do not start Bucapsol TM capsules in a patient who is being treated with a reversible MAOI such as linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, including hospitalization, should be considered (see CONTRAINDICATIONS and DRUG INTERACTIONS ). In some cases, a patient already receiving therapy with Bucapsol TM capsules may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to ou

Monitoring

• WARNINGS The administration of Bucapsol TM capsules to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard.
• There have been reports of the occurrence of elevated blood pressure when buspirone hydrochloride has been added to a regimen including an MAOI.
• Therefore, it is recommended that Bucapsol TM capsules not be used concomitantly with an MAOI.
• Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs, SSRIs, and other serotonergic drugs, including buspirone, alone but particularly with concomitant use of other serotonergic drugs (including triptans), with drugs that impair metabolism of serotonin (in particular, MAOIs, including reversible MAOIs such as linezolid and intravenous methylene blue), or with antipsychotics or other dopamine antagonists.

Interaction Notes

• Drug Interactions Psychotropic Agents MAO inhibitors: The use of monoamine oxidase inhibitors (MAOIs) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure.
• The use of buspirone within 14 days of stopping an MAOI intended to treat depression is also contraindicated.
• Starting buspirone in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.
• (see WARNINGS , DOSAGE AND ADMINISTRATION and CONCOMITANT DRUG ) Amitriptyline: After addition of buspirone to the amitriptyline dose regimen, no statistically significant differences in the steady-state pharmacokinetic parameters (C max , AUC, and C min ) of amitriptyline or its metabolite nortriptyline were observed.