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BUSPIRONE HYDROCHLORIDE is a brand name for Buspirone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Buspirone hydrochloride tablets are indicated for short-term treatment of general anxiety disorders and to relieve the symptoms of anxiety with or without accompanying symptoms of depression.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The dosage should be individualised for each patient. Food increases the bioavailability of buspirone. 5). Grapefruit juice increases the plasma concentrations of buspirone. 5).
Adults (including the elderly):
Initially, a dose of 5 mg two to three times daily is given. After several weeks, to allow for a lag period, this may be increased in increments of 5 mg at 2 to 3 day intervals according to the therapeutic response. After dosage titration, the usual daily dose is 15 to 30 mg per day in divided doses.
The maximum recommended dose should not exceed 60 mg per day.
Older people:
Current data do not support a change in dosage regimen based on age or sex of the patient.
Paediatric population:
The therapeutic use of buspirone in children has not been established. 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.
2).
Renal impairment:
After a single administration to patients with mild to moderate renal insufficiency (creatinin clearance 20-49 ml/min/1,72m2) a slight increase in the buspirone blood levels was seen, without increase of the half-life time. In these patients buspirone hydrochloride Tablets 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 Hydrochloride Tablets 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.
Undesirable effects most frequently reported include dizziness, headache, light- headedness, nausea, nervousness, excitement, sweating and clamminess. Side effects, if they occur, are generally observed at the beginning of treatment and usually subside or disappear as treatment progresses and/or with dose lowering.
10) in the buspirone group than in the placebo group. The list of undesirable effects shown below is presented by system organ class, MedDRA preferred term, and frequency using the following frequency categories: very common (≥1/10), common (≥1/100 to <1/10), rare (≥ 1/10,000 to < 1/1,000) and very rare (<1/10,000).
ADVERSE DRUG EVENTS REPORTED DURING CLINICAL EXPERIENCE System Organ Class Frequency MedDRA Terms common nervousness, insomnia, disturbance in attention, depression, confusional state, sleep disorder, anger, excitement. Psychiatric disorders very rare psychotic disorder, hallucination, depersonalization, affect lability.
very common dizziness*, headache, somnolence, drowsiness, common Paraesthesia/numbness, coordination abnormal, coordination disturbances, tremor. Eye disorders very rare tunnel vision. Ear and labyrinth disorders common tinnitus. Cardiac disorders common tachycardia, chest pain, palpitations Respiratory, thoracic and mediastinal disorders common nasal congestion, nasal stuffiness, throat pain, pharyngolaryngeal pain Gastrointestinal disorders common nausea, abdominal pain, dry mouth, diarrhoea, constipation, vomiting common cold sweat, rashSkin and Subcutaneous Tissue Disorders rare angioneurotic oedema, ecchymosis, urticaria, pruritus, alopecia Musculoskeletal and connective tissue disorders common musculoskeletal pain Renal and urinary disorders very rare urinary retention Reproductive system and breast disorders very rare galactorrhoea ADVERSE DRUG EVENTS REPORTED DURING CLINICAL EXPERIENCE System Organ Class Frequency MedDRA Terms General disorders and administration site conditions common fatigue/weakness * Dizziness includes lightheadedness.
The administration of buspirone 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 has been added to a regimen including a MAOI.
Therefore, it is recommended that buspirone not be used concomitantly with a MAOI. Buspirone should be used with caution in patients with: • Acute narrow-angle glaucoma. • Myasthenia gravis. • Drug dependence. • History of hepatic or renal impairment.
• Alcohol use should be avoided, although buspirone has not been reported to potentiate the psychomotor impairment produced by alcohol. No data are available on concomitant use of alcohol and single doses of buspirone greater than 20 mg.
Buspirone should not be used alone to treat depression, and may potentially mask the clinical signs of depression. Paediatric population The long-term safety and effectiveness of buspirone have not been determined in individuals below 18 years of age.
2). Potential for withdrawal reactions in sedative/hypnotic/anxiolytic drug-dependent patients Because buspirone does not exhibit cross-tolerance with benzodiazepines and other common sedative/hypnotic drugs, it will not block the withdrawal syndrome often seen with cessation of therapy with these drugs.
Therefore, before starting therapy with buspirone, it is advisable to withdraw these drugs gradually, especially in patients who have been using a CNS-depressant drug chronically. Drug abuse and dependence Buspirone is not a controlled substance.
Buspirone has shown no potential for drug abuse and dependence based on human and animal studies. Cases of insomnia, anxiety, agitation, depersonalisation and paraesthesias are seen in a few patients on discontinuation of the therapy.
Long-term toxicity Because its mechanism of action is not fully elucidated, long-term toxicity in the CNS or other organ systems cannot be predicted. Excipients This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
1. 72 m2 or a plasma creatinine above 200 micromoles/litre) or severe hepatic insufficiency. • Acute intoxication with alcohol, hypnotics, analgesics or antipsychotic drugs. • Patients with epilepsy.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Buspirone in United Kingdom.
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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.
Method of administration For oral use. Buspirone should be taken at the same time each day and consistently with or without food. Tablets should be taken with some fluid and should not be chewed.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard).
This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.