Exupar      Tablets

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):

  • 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 is 45mg daily in divided doses.
  • 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.
  • Grapefruit juice increases the plasma concentrations of buspirone. Patients taking buspirone should avoid consuming large quantities of grapefruit juice.

Children:

  • 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 generalized anxiety disorder in patients less than 18 years.  Plasma concentrations of buspirone and its active metabolite were higher in pediatric patients, compared to adults given equivalent doses.

Renal impairment:

  • After a single administration to patients with mild to moderate renal insufficiency (creatinine 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-pyrimidinylpiperazine (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 creatinine 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.

Undesirable effects:

Psychiatric Disorders:

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.

Cardiac Disorders:

Common: tachycardia, chest pain.

Respiratory, Thoracic and Mediastinal Disorders:

Common: nasal congestion, pharyngolaryngeal pain.

Gastrointestinal Disorders:

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:

Common: fatigue.

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.

Pediatric use

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.

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.

Pack: Carton box containing a plastic bottle of 20 tablets.

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