Buspirone Hydrochloride 15mg
Usage and indications:
Exupar is indicated for the treatment of short-term management of anxiety disorders and the relief of symptoms of anxiety with or without accompanying symptoms of depression.
Dosage and administration:
The dosage should be individualized for each patient.
Adults (including the elderly):
Common: nervousness, insomnia, disturbance in attention, depression, confusional state, sleep disorder, anger.
Very rare: psychotic disorder, hallucination, depersonalization, affect lability.
Nervous System Disorders:
Very common: dizziness*, headache, somnolence.
Common: paraesthesia, vision blurred, coordination abnormal, tremor, tinnitus.
Very rare: serotonin syndrome, convulsion, tunnel vision, extrapyramidal disorder, cogwheel rigidity, dyskinesia, dystonia, syncope, amnesia, ataxias, Parkinsonism, akathisia, restless leg syndrome, restlessness.
* Dizziness includes lightheadedness.
Common: tachycardia, chest pain.
Respiratory, Thoracic and Mediastinal Disorders:
Common: nasal congestion, pharyngolaryngeal pain.
Common: nausea, abdominal pain, dry mouth, diarrhoea, constipation, vomiting.
Skin and Subcutaneous Tissue Disorders:
Common: cold sweat, rash.
Rare: angioneurotic edema, ecchymosis, urticaria.
Musculoskeletal and Connective Tissue Disorders:
Common: musculoskeletal pain.
Renal and Urinary Disorders:
Very rare: urinary retention.
Reproductive System and Breast Disorders:
Very rare: galactorrhoea.
General Disorders and Administration Site Conditions:
Warnings and precautions:
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 care in the following situations:
• Acute narrow-angle glaucoma.
• Myasthenia gravis.
• Drug dependence.
• Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose – galactose mal-absorption should not take this medicine.
• Patients with a history of renal or hepatic 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 20mg.
Buspirone should not be used alone to treat depression, and may potentially mask the clinical signs of depression.
The long-term safety and effectiveness of buspirone have not been determined in individuals below 18 years of age. Buspirone is not recommended in children and adolescents.
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.
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.
Because its mechanism of action is not fully elucidated, long-term toxicity in the CNS or other organ systems cannot be predicted.
Pack: Carton box containing a plastic bottle of 20 tablets.