CURAM 457MG SYRUP 70 ML; amoxicillin, clavulanic acid, antibacterials .
CURAM 457MG SYRUP 70 ML
ACTIVE-INGREDIENT OF CURAM 457MG SYRUP
each 5 ml reconstituted contains : amoxicillin trihydrate 459 mg corresponding to 400 mg amoxicillin . Potassium clavulanate 76 mg corresponding to 57 mg clavulanic acid .
INDICATION OF CURAM 457MG SYRUP
treatment of bacterial infections indused by gram-negative and gram-positive amoxicillin resistant microorganisms whose resistance is caused by B-lactamase which how ever are sensitive to the combination of amoxcillin and clavulanic acid . Curam is suitable for treatment of the following indications when known or likely to be due to suspceptible organisms – infections of the upper respiratory tract ( including ear-nose-throat ) , in particular sinusitis , otitis media , recurrent tonsillitis ,. – infections of the lower respiratory tract , in particular acute exacerbations of chronic bronchitis and bronchopneumonia . – genital and urinary tract infections . – infections of the skin and skin and soft tissues including dental infections . – bone and joint infections, in particular osteomyelitis .
DOSAGE OF CURAM 457MG SYRUP
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 dosage of curam depends on the age , weight and renal function of the particular patient, on the severity and the site of the infection and the site of infection and on the suspected or demonstrated causative agents . The single doses should be taken at regular intervals . usual recommended daily dosage for children body weight < 40 kg 25/3.6 mg /kg / day to 45/6.4 mg /kg / day given as two divided doses every 12 hours .up to 70 mg/ 10 mg / kg /day given as two divided doses may be considered in some infections such as otitis media ,sinusitis , lower respiratory tract infections and urinary tract infections. no clinical data are available on doses of curam 7:1 formulations higher than 45 /6.4 mg/ kg / day in children under 2 years . there is no clinical information on patients under 2 months of age .there fore dose recommendations cannot be given to this patients group . – dosage recommendations according to body weight : 80 mg/ ml oral suspension ( 1 ml oral suspension = 80 mg amoxicillin ) .usual recommended daily dosage for adults and children >̷ 40 kg : standard dose : 875/125 mg two times a day . – dosage in renal functional impairment : the dose should be redused in patients with renal functional impairment depending on the severity of the impairment and the patient’s weight . curam presentations with an amoxicillin to clavulanic acid ratio of 7:1 should only be used in patients with a GFR > 30 ML/MIN . dosage in hepatic functional impairment : administer with caution . the liver function should be monitored at regular intervals . the experience in the use of the product in hepatic insufficiency is not adequate in order to given dose recommendations .
OVER-DOSAGE OF CURAM 457MG SYRUP
gastrointestinal symptoms and disturbance of the fluid and electrolytle balance may be evident . Amoxicillin crystalluria, in some cases leading to renal failure , has been observed convulsions may occur in patients with impaired renal function or in those receiving high doses . amoxicillin has been reported to precipitate in bladder catheters , predominantly after intervenous administration of large doses . a regular check of potency should be maintained
CONTRA-INDICATION OF CURAM 457MG SYRUP
hypersensitivity to the active substances , to any of the pencillins or to any of the excipients – history of a severe immediate hypersensitivity reactions ( eg . Anaphylaxis ) to an other betalactam agent ( e.g . A cephalosporin, carbapenem , or monobactam) . – history of jaundice/ hepatic impairment due to amoxicillin / clavulanic acid .
STORAGE OF CURAM 457MG SYRUP
store at temperature not exceed 25 C . The reconstituted suspension should be store in a refrigerator (2-8 C) and used within 7 days . Shake the bottle well before each use .
PACK OF CURAM 457MG SYRUP 70 ML
carton box contain 70 ml glass bottle WITH POWDER INSIDE FOR oral suspension preparation , plastic measuring spoon and an insert leaflet .
CURAM 457MG SYRUP 70 ML MANUFACTURED BY
sandozGmbH , KUNDL- AUSTRIA .