Buspirone is a medicine sold in the U.S. under 2 brand and generic names, for anxiety disorders, depressive disorder and intellectual disability. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Buspar (application NDA018731). Other buspirone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 (see CONTRAINDICATIONS and DRUG INTERACTIONS ). Use of Buspirone 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…
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. Approximately 10% of the 2,200 anxious patients who participated in the buspirone hydrochloride tablets premarketing clinical efficacy trials in anxiety disorders lasting 3 to 4 weeks discontinued treatment due to an adverse event. The more common events causing discontinuation included: central nervous system disturbances (3.4%), primarily dizziness, insomnia, nervousness, drowsiness, and lightheaded feeling; gastrointestinal disturbances (1.2%), primarily nausea; and miscellaneous disturbances (1.1%), primarily headache and fatigue. In addition, 3.4% of patients had multiple complaints, none of which could be characterized as primary. Incidence in Controlled Clinical Trials The table that follows enumerates adverse events that occurred at a frequency of 1% or more among buspirone hydrochloride patients who participated in 4-week,…
Grapefruit & grapefruit juice
Avoid grapefruit and grapefruit juice with this medicine unless your pharmacist or the label says it's fine — check, because not every drug in a class is affected the same way.
Grapefruit Juice and Some Drugs Don't Mix — U.S. FDA ↗Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Tablet | Generic | $1 | View → | |
| 2 | 72/100 | Prescription | Capsule | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| E78 | 2.5 mg | white | round | — |
| E135 | 12.5 mg | white | round | — |
| UpArrowhead;90 | 7.5 mg | white | oval | — |
| U;244 | 5 mg | white | round | — |
| U;245 | 10 mg | white | round | — |
| 5;5;5;ZE;38 | 15 mg |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
The elimination half-life of buspirone is about 2 to 3 hours. This is the parent drug's elimination half-life; buspirone has an active metabolite (1-PP) with roughly one-quarter of its activity, but the label documents no longer metabolite half-life, so effective duration is not materially extended. Buspirone shows nonlinear pharmacokinetics, and blood levels rise sharply in liver impairment (steady-state AUC ~13-fold higher) and kidney impairment (~4-fold higher).
BUSPAR (buspirone hydrochloride) tablet — DailyMed ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
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. 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 DRUG INTERACTIONS ).
| $1 |
| View → |
| white |
| capsule |
| — |
| U;246 | 15 mg | white | rectangle | — |
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