BUSPIRONE Tablet Ref.[6716] Active ingredients: Buspirone

Posology

The dosage should be individualised for each patient.

Adults (including the elderly): the usual starting dosage is 5mg given two to three times per day. The dosage may be increased every 2-3 days. The usual therapeutic dosage is 15 to 30mg daily in divided doses. The maximum recommended dose should not exceed 60mg per day.

Food increases the bioavailability of buspirone. Buspirone should be taken at the same time each day and consistently with or without food. If buspirone is administered with a potent CYP3A4 inhibitor, the initial dose should be lowered and only increased gradually after medical evaluation (see section 4.5).

Grapefruit juice increases the plasma concentrations of buspirone. Patients taking buspirone should avoid consuming large quantities of grapefruit juice.

Renal impairment

After a single administration to patients with mild to moderate renal insufficiency (creatinin clearance 20-49 ml/min/1.72 m²) a slight increase in the buspirone blood levels was seen, without increase of the half-life time. In these patients buspirone should be administered with caution and a low dosage, two-times daily, is advised. The response and the symptoms of the patients should be evaluated carefully, before an eventual increase of the dosage is made. A single administration to anuretic patients causes an increase in the blood levels of the metabolite 1-pyrimidine/piperazine (1-PP), in which dialysis did not prove to have any influence on the buspirone levels, neither on the 1-PP levels. Buspirone should not be administered to patients with a creatinin clearance <20 ml/min/1.72 m²), especially not to anuretic patients, because of the fact that increased and untreated levels of buspirone and its metabolites may occur.

Hepatic impairment

As may be expected agents as buspirone used in patients with a reduced liver function show a reduced “first pass effect”. After a single administration to patients with liver cirrhosis, higher maximum concentrations of unchanged buspirone are seen, with an increase in the half life time. In these patients buspirone should be used with caution and individual dosages should be titrated with care to reduce the chance of central undesirable effects, which may occur because of high maximum concentrations of buspirone. Increased dosages should be considered carefully and only after 4-5 days experience with the prior dosage.

Elderly Patients

Current data do not support a change in dosage regimen based on age or sex of the patient.

Paediatric population

Placebo-controlled trials, in which 334 patients were treated with buspirone for up to six weeks, have not shown buspirone at doses recommended for adults to be an effective treatment for generalised anxiety disorder in patients less than 18 years.

Plasma concentrations of buspirone and its active metabolite were higher in paediatric patients, compared to adults given equivalent doses. (see 5.2, Pharmacokinetic Properties.)

Method of Administration

For oral administration.

Features

In normal volunteers, the maximum tolerated dose of buspirone was 375 mg/day. As the maximum dose levels were approached, the most commonly observed symptoms include nausea, vomiting, headache, dizziness, drowsiness, tinnitus, restlessness, miosis, and gastric distress. Mild bradycardia and hypotension have been reported. Extrapyramidal symptoms have been reported after therapeutic doses. Rarely convulsions may occur.

There is no specific antidote to buspirone. Buspirone is not removed by haemodialysis. The stomach should be emptied as quickly as possible. Treatment should be symptomatic and supportive. The ingestion of multiple agents should be suspected.

Management

Treatment should by symptomatic and supportive. The benefit of gastric decontamination is uncertain. Consider activated charcoal if the patient presents within 1 hour of ingestion of more than 5mg/kg provided they are not too drowsy.

Three years.

Do not store above 25°C.

Store in the original container.

250µm white opaque PVC/20µm aluminium foil blister packs.

Blister pack sizes: 20, 21, 28, 30, 56, 60, 84, 90, 100, 112, 126

There are no special instructions for use/handling.