BUSPAR 10MG TAB; buspirone, antidepressants .
ACTIVE-INGREDIENT OF BUSPAR 10MG TAB
each tablet contains buspirone hydrochloride 10 mg .
INDICATION OF BUSPAR 10MG TAB
buspirone hydrochloride is indicated for : the short term management of anxiety disorders . The relief of symptoms of anxiety with or without accompanying symptoms of depression .
DOSAGE OF BUSPAR 10MG TAB
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
the maximum daily dosage should not exceed 60 mg per day . 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 . – route of administration : for oral use . adults : dosage should be adjusted according to response for optimal efficacy and safety . the recommended initial dose is 5 mg two to three times daily and this may be increased every two or three days . the usual therapeutic dose is 15 to 30 mg daily in divided doses with amaximum recommended dose of 45 mg daily in divided doses . 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 generalised anxiety disorder in patients less than 18 years . plasma concentrations of buspirone and its active metabolite were higher in paediatric patients , compared to adults given equivalent doses . elderly : current data do not support a change in dosage regimen based on age or sex of the patients . 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 divided . the response and the syptoms 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 should not be administered to patients with a creatinine clearance OVER-DOSAGE OF BUSPAR 10MG TAB
symptoms and signs : in the normal volunteers , the maximum tolerated dose of buspirone was 375 mg/day . As the maximum dose levels were approached , the most commonly observed symptoms were nausea , vomiting , headache , dizziness , drowniness , tinnitus , restlessness, miosis , and gastric distress . mild bradycardia and hypotension have been reported . extrapyramidal symptoms have been reported after therapeutic doses . rarely convulsions may occur . treatment : there is no specific antidote to buspirone . buspirone is not removed by haemodialysis . treatment should be symptomatic and supportive as clinically indicated or as recommended by the national poisons centre , where available . the ingestion of multiple agents should be suspected .
CONTRA-INDICATION OF BUSPAR 10MG TAB
buspirone hydrochloride is contraindicated in : patients hypersensitive to buspirone hydrochloride or any of the excipients . Severe renal ( creatinine clearance STORAGE OF BUSPAR 10MG TAB
store at temperature not exceeding 30 °C, in dry place away from light .
PACK OF BUSPAR 10MG TAB
carton box containing 2 (AL foil /transparent pvc ) strips each of 10 tablets + insert leaflet .
BUSPAR 10MG TAB MANUFACTURED BY
SMITHKLONE BEECHAM – EL HARM – GIZA – EGYPT .