Use in pregnancy and lactation Buspirone should be avoided during pregnancy and breast feeding.
COMPOSITION : Each tablet contains : Buspirone HCI USP 5 mg, 10 mg. DESCRIPTION : Busiral (Buspirone HCI) is an antianxiety agent with a selective effect since it does not have sedative, anticonvulsant and muscle relaxant actions. Buspirone has dopaminergic, noradrenergic, and serotonin modulating properties, however its anxiolytic effects appear to be related to its action on (5-HT1A). Buspirone is rapidly absorbed from
G.I.T but undergoes extensive first-pass metabolism. Peak plasma concentrations are reached within 40-90 minutes. Buspirone is about 95% bound to plasma proteins and the elimination half-life is usually about 2-3 hours but half-lives of up to 11 hours have been reported. Buspirone is excreted mainly as metabolites in the urine and also in the faeces. INDICATIONS : Busiral is indicated in the management of anxiety disorders or short term relief of symptoms of anxiety. DOSAGE & ADMINISTRATION: The usual starting dose is 5 mg 2-3 times daily. This may be increased by 5mg increments every 2-3 days, depending upon the therapeutic response, to the maximum daily dose of 60 mg / daily.
• The dose should be adjusted in patients with moderate hepatic or
• safety and effectiveness of Buspirone have not been determined in
children below 18 years of age. RESTRICTIONS ON USE : Contraindications - Hypersensitivity to Buspirone HCI. - Patients with severe renal or hepatic diseases. - Patients with a history of seizure disorders or epilepsy. Precautions - Use with caution in patients with moderate hepatic or renal diseases. - Benzodiazepines should be gradually withdrawn before initiating
therapy with Buspirone. Effect on the capacity to drive vehicles and operate machinery Buspirone has a low incidence of sedation, so patients should be cautioned about driving or operating machine.
DRUG INTERACTIONS: - Using of Buspirone with MAOIs increased blood pressure of patients. - Sedative effects of Buspirone are enhanced by the simultaneous
administration of alcohol or other CNS depressants. - The plasma concentration of Buspirone increased when Co
administred with nefazodone, erythromycin, itraconazole and consumption large amounts of grapefruit juice. - The toxicity effects of Buspirone will be increased if administred with
diltiazem or verapamil. - The plasma concentration of Buspirone decreased when
coadministred with rifampicin. - Caution should be excercised if Buspirone is concomitantly used with diazepam, prazepam, chlorodiazepoxid, chlorozepate and haloperidol. SIDE EFFECTS: Adverse effects are usually appear at the beginning of therapy & subsequently subsides. - The most common adverse effects include: dizziness, nausea,
headache, nervousness, lightheadedness, sleep disturbances and
syndrome of restlessness. - The less common adverse effects include: dryness of mouth, tinnitus, drowsiness, fatigue, sweating, palpitation, tachycardia and confusion.
STORAGE INSTRUCTIONS : Store between 15-25°C in a dry place. Protect from light. PRESENTATIONS : Busiral 5mg, 10mg tablets : Pack of 20 tablets and hospital packs of
INSTRUCTIONS TO THE PATIENT - Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you. - Follow strictly the doctor's prescription, the method of use and the instructions of the pharmacist who sold the medicament. - The doctor and the pharmacist are experts in medicine, its benefits and risks. - Do not by yourself interrupt the period of treatment prescribed for you. - Do not repeat the same prescription without consulting your doctor.
Keep medicament out of reach of children
Council of Arab Health Ministers
Union of Arab Pharmacists
Mfd. By Shiba Pharma P.O.Box: 4265 Sana'a /Yemen.