Buspirone

Buspirone hydrochloride tablets 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 tablets 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 tablets relieved anxiety in the presence of these coexisting depressive symptoms. …

• The recommended initial dose is 15 mg daily (7.5 mg b.i.d.)
• 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 mg 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
• 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 buspirone hydrochloride tablets
• Conversely, at least 14 days should be allowed after stopping buspirone hydrochloride tablets before starting an MAOI antidepressant CONTRAINDICATIONS and DRUG INTERACTIONS )
• Use of buspirone hydrochloride tablets with (Reversible) MAOIs, Such as Linezolid or Methylene Blue Do not start buspirone hydrochloride tablets 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. …

• The safety and effectiveness of buspirone were evaluated in two placebo-controlled 6 week trials involving a total of 559
• Pediatric patients (ranging from 6 to 17 years of age) with GAD
• Doses studied were 7.5 mg to 30 mg b.i.d. (15 to 60 mg/day)
• There were no significant differences between buspirone and placebo with regard to the symptoms of GAD following doses recommended
• For the treatment of GAD
• In adults
• Pharmacokinetic studies have shown that, for identical doses, plasma exposure to buspirone and its active metabolite, 1-PP, are equal to or higher
• In pediatric patients than adults. …

In one study of 6632 patients who received buspirone for the treatment of anxiety, 605 patients were ≥ 65 years old and 41 were ≥ 75 years old; the safety and efficacy profiles for these 605 elderly patients (mean age = 70.8 years) were similar to those in the younger population (mean age = 43.3 years). …

• To assure safe and effective use of buspirone hydrochloride tablets, the following information and instructions should be given to patients: Do not take a monoamine oxidase inhibitor (MAOI)
• Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid
• Do not take an MAOI within 2 weeks of stopping buspirone unless directed to do so by your physician
• Do not start buspirone if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician. …

• Buspirone hydrochloride tablets are contraindicated in patients hypersensitive to buspirone hydrochloride
• 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. …

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 ). …

The administration of buspirone hydrochloride tablets 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 buspirone hydrochloride tablets not be used concomitantly with an MAOI. …

(See also PRECAUTIONS .) Commonly Observed The more commonly observed untoward events associated with the use of buspirone hydrochloride tablets not seen at an equivalent incidence among placebo-treated patients include dizziness, nausea, headache, nervousness, lightheadedness, and excitement. Associated with Discontinuation of Treatment One guide to the relative clinical importance of adverse events associated with buspirone hydrochloride tablets is provided by the frequency with which they caused drug discontinuation during clinical testing. …

Pregnancy Teratogenic Effects Pregnancy Category B No fertility impairment or fetal damage was observed in reproduction studies performed in rats and rabbits at buspirone doses of approximately 30 times the maximum recommended human dose. In humans, however, adequate and well-controlled studies during pregnancy have not been performed. …

Signs and Symptoms In clinical pharmacology trials, doses as high as 375 mg/day were administered to healthy male volunteers. As this dose was approached, the following symptoms were observed: nausea, vomiting, dizziness, drowsiness, miosis, and gastric distress. A few cases of overdosage have been reported, with complete recovery as the usual outcome. No deaths have been reported following overdosage with buspirone hydrochloride tablets alone. …

Controlled Substance Class Buspirone hydrochloride is not a controlled substance. Physical and Psychological Dependence In human and animal studies, buspirone has shown no potential for abuse or diversion and there is no evidence that it causes tolerance, or either physical or psychological dependence. Human volunteers with a history of recreational drug or alcohol usage were studied in two double-blind clinical investigations. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.