Buspirone Hydrochloride 5mg, 10mg, 15mg and 30mg tablets Prescribing Information |
Presentation: Each buspirone hydrochloride tablet contains 5mg, 10mg, 15mg or 30mg buspirone hydrochloride and 41.03mg, 82.06mg, 123.09mg or 246.18mg of lactose (anhydrous) respectively. Indications: Short-term management of anxiety disorders and relief of symptoms of anxiety with or without accompanying symptoms of depression. Dosage and administration: Dosage should be individualised for each patient. Adults (including elderly): starting dosage is 5mg given two to three times per day. Dosage may be increased every 2-3 days. Usual dosage is 15 to 30mg daily in divided doses. Maximum recommended dose should not exceed 60mg per day. If administered with a potent CYP3A4 inhibitor, lower initial dose and only increase after medical evaluation. Method of Administration: Oral. Food increases the bioavailability of buspirone therefore instruct patients to take at the same time each day and consistently with or without food and to avoid consuming large quantities of grapefruit juice. Special Populations: Paediatric Population: not recommended in patients aged under 18 years. Renal impairment: administer with caution. A low dosage, two-times daily is advised. Carefully monitor patients response and symptoms before eventual increase of dosage. Do not administer to patients with a creatinine clearance < 20 ml/min/1.72 m2. Hepatic impairment: use with caution. Titrate individual dosages with care. Consider increased dosages carefully and only after 4-5 days experience with the prior dosage. Fertility, pregnancy and lactation: Pregnancy: there are no or limited amount of data. Avoid use during pregnancy. Breastfeeding: it is unknown whether buspirone is excreted in human milk. Decide to discontinue breastfeeding or buspirone therapy based on benefit of breast feeding for the child versus benefit of buspirone therapy for the woman. Fertility: animal studies do not indicate harmful effects with respect to reproductive toxicity. Contraindications: patients who have: known hypersensitivity to the active substance or to any of the excipients, severe renal or severe hepatic insufficiency, epilepsy, acute intoxication with alcohol, hypnotics, analgesics, or antipsychotic drugs. Special warnings and precautions: Do not use concomitantly with a monoamine oxidase inhibitor (MAOI). Use with caution in patients with acute narrow-angle glaucoma, myasthenia gravis, drug dependence and a history of renal or hepatic impairment. Alcohol useshould be avoided. Do not use alone to treat depression as may potentially mask the clinical signs of depression. Drug abuse and dependence: no potential for drug abuse and dependence based on human and animal studies. Potential for withdrawal reactions in sedative/hypnotic/anxiolytic drug-dependent patients: gradually withdraw benzodiazepines and other common sedative/hypnotic agents before initiating treatment. Long-term toxicity: in the CNS or other organ systems cannot be predicted. Lactose: should not be taken by patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. |
Drug Interactions: CNS-active drugs, MAOI, erythromycin, itraconazole, diltiazem, verapamil, rifampicin, antidepressants, baclofen, lofexidine, nabilone, antihistamines, SSRI, serotonergic drugs, less firmly protein bound drugs like digoxin, nefazodone, grapefruit juice, potent inhibitors and potent inducers of CYP3A4, fluvoxamine, trazodone, cimetidine, diazepam, haloperidol, warfarin. Effects on ability to drive/use machines: Moderate influence. This is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. Inform patient that this can impair cognitive function and can affect their ability to drive safely. Undesirable effects: Nervousness, insomnia, disturbance in attention, depression, confusional state, sleep disorder, anger, excitement, psychotic disorder, hallucination, depersonalization, affect lability, dizziness, headache, somnolence, paraesthesia, coordination abnormal, tremor, serotonin syndrome, convulsion, extrapyramidal disorder, cogwheel rigidity, dyskinesia, dystonia, syncope, amnesia, ataxias, parkinsonism, akathisia, restless leg syndrome, restlessness, vision blurred, tunnel vision, tinnitus, tachycardia, chest pain, nasal congestion, pharyngolaryngeal pain, nausea, abdominal pain, dry mouth, diarrhoea, constipation, vomiting, cold sweat, rash, angioneurotic oedema, ecchymosis, urticaria, musculoskeletal pain, urinary retention, galactorrhoea , fatigue. Pack size and UK list price: Buspirone Hydrochloride 5mg (PL42289/0017) pack size: 30 £12.50; Buspirone Hydrochloride 10mg (PL 42289/0018) pack size: 30 £28.50; Buspirone Hydrochloride 15mg (PL 42289/0019) pack size:30 £23.33; Buspirone Hydrocholoride 30mg (PL42289/0020) pack size: 30 £30.38 Legal category: POM Marketing Authorisation Holder: Wave Pharma Limited, 4th Floor, Cavendish House, 369 Burnt Oak, Broadway, Edgware, HA8 5AW, United Kingdom Distributor: Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom Date of Preparation: 30-May-2024 Ref: 000664641 |