ANKSILON

What it is

ANKSILON is buspirone hydrochloride , supplied as tablets containing either 5 mg or 10 mg of buspirone hydrochloride . It is an antianxiety agent that is not chemically or pharmacodynamically related to benzodiazepines and belongs to the class of pharmacologic agents with selective anxiolytic psychotropic activity known as the azapirones . Buspirone has a high affinity for serotonin (5-HT1A) receptors and has no significant affinity for benzodiazepine receptors .

Approved indications

— Short-term treatment of anxiety .

Dosing overview

The recommended initial dose for adults is 15 mg daily (5 mg three times a day). The dosage may be increased 5 mg per day every 2 to 3 days as needed, and the maximum daily dosage should not exceed 60 mg per day . In most patients, an optimal therapeutic response is obtained by titration to a total daily dose of 20–30 mg given in 2 to 3 divided doses . The maximum daily dose in elderly patients should not exceed 30 mg per day . ANKSILON should be taken at the same time each day and consistently with or without food .

Key safety warnings

The administration of ANKSILON to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard, as there have been reports of elevated blood pressure when buspirone has been added to a regimen including a MAOI. It is recommended that ANKSILON should not be used concomitantly with a MAOI . Seizures have been reported rarely in patients taking buspirone and selective serotonin reuptake inhibitors (SSRIs). Buspirone should be used with caution in combination with serotonergic drugs as there are isolated reports of serotonin syndrome occurring in patients on concomitant SSRI therapy. If this condition is suspected, treatment with buspirone should be immediately discontinued and supportive symptomatic treatment should be initiated . Grapefruit juice increases the plasma concentrations of buspirone. Patients taking ANKSILON should avoid consuming grapefruit juice . If buspirone is given with a potent inhibitor of CYP3A4 such as itraconazole or nefazodone, the initial dose of buspirone should be reduced and titrated based on clinical assessment . The most common adverse reactions encountered with buspirone hydrochloride are dizziness, headache, drowsiness and nausea .

Contraindications

ANKSILON should not be administered to patients with hypersensitivity to buspirone hydrochloride or other ingredients listed in the excipients . Severe hepatic impairment (biopsy proven cirrhosis) is a contraindication. ANKSILON should not be given to patients with severe renal insufficiency (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73m²), acute angle-closure glaucoma, myasthenia gravis, epilepsy, or acute intoxication with alcohol, hypnotics, analgesics or antipsychotic drugs .

Regulatory history

ANKSILON buspirone hydrochloride 5 mg and 10 mg tablets were first listed on the ARTG on 16 January 2025 .