COMPOSITION
Cefotil
TM 125 mg tablet: Each film coated tablet contains Cefuroxime 125 mg, as
Cefuroxime axetil BP.
Cefotil
TM 250 mg tablet: Each film coated tablet contains Cefuroxime 250 mg, as
Cefuroxime axetil BP.
Cefotil
TM 500 mg tablet: Each film coated tablet contains Cefuroxime 500 mg, as
Cefuroxime axetil BP.
Cefotil
TM Powder for Suspension (70 ml): Each 5 ml reconstituted suspension contains
125 mg Cefuroxime, as Cefuroxime axetil BP.
Cefotil
TM 750 mg IM/IV injection: Each vial contains Cefuroxime 750 mg, as Cefuroxime
sodium BP.
Cefotil
TM 1.5 gm IV injection: Each vial contains Cefuroxime 1.5 gm, as Cefuroxime
sodium BP.
PHARMACOLOGY
Cefotil
TM (Cefuroxime) is a well-characterized and effective antibacterial agent, which has
broad-spectrum bactericidal activity against a wide range of common pathogens, including
b-lactamase producing strains. Cefuroxime has good stability to bacterial b-lactamase and
consequently, is active against many ampicillin-resistant and amoxycillin-resistant strains.
INDICATION
Cefotil
TM (Cefuroxime) is indicated in the treatment of:
1. Upper respiratory tract infections: for example, ear, nose and throat infections such as
otitis media, sinusitis, tonsillitis and pharyngitis.
2. Lower respiratory tract infections: for example, acute bronchitis, acute exacerbations of
chronic bronchitis and pneumonia.
3. Skin and soft tissue infections: such as furunculosis, pyoderma, and impetigo.
4. Genito-urinary tract infections: such as pyelonephritis, urethritis, and cystitis.
5. Gonorrhoea: acute uncomplicated gonococcal urethritis, and cervicitis.
6. Early Lyme disease & subsequent prevention of late Lyme disease.
DOSAGE & ADMINISTRATION
Adults: Most infections will respond to 250 mg b.i.d. In mild to moderate lower respiratory
tract infections e.g. bronchitis 250 mg b.i.d. should be given. For more severe lower
respiratory tract infections, or if pneumonia is suspected then 500 mg b.i.d. should be
given.
For urinary tract infections a dose of 125 mg b.i.d. is usually adequate; in pyelonephritis
the recommended dose is 250 mg b.i.d.
A single dose of one gram is recommended for the treatment of uncomplicated
gonorrhoea.
Lyme disease in adults and children over the age of 12 years: the recommended dose is
500 mg b.i.d. for 20 days.
Children: The usual dose is 125 mg b.i.d., or 10 mg/kg b.i.d. to a maximum of 250 mg
daily.
For otitis media, in children less than 2 years of age the usual dosage is 125 mg b.i.d., or
10 mg/kg b.i.d. to a maximum of 250 mg daily and in children over 2 years of age, 250 mg
b.i.d., or 15 mg/kg b.i.d. to a maximum of 500 mg daily.
There is no experience in children under three months of age. The usual course of therapy
is seven days. Cefuroxime should be taken after food for optimum absorption.
PARENTERAL DOSAGE
Adults: 750 mg to 1.5 g IM or IV every 8 hourly, usually 5 to 10 days.
Preoperative prophylaxis: For clean contaminated or potentially contaminated surgical
procedures, administer 1.5 g IV prior to surgery (1/2 to 1 hour before). Thereafter, give 750
mg IV or IM every 8 hours when the procedure is prolonged.
Infants and children (>3 months): 50 to 100 mg/kg/day in equally divided doses every 6
to 8 hours. Use 100 mg/kg/day (not to exceed the maximum adult dose) for more severe
or serious infections.
Bone & joint infections: 150 mg/kg/day (not to exceed the maximum adult dose) in
equally divided doses every 8 hours.
Bacterial meningitis: Initially 200 to 240 mg/kg/day IV in divided doses every 6 to 8
hours.
DIRECTION FOR RECONSTITUTION
For 750 mg Intramuscular Injection: Add 3 ml water for injection BP and shake gently for
dispersion.
For 750 mg Intravenous Injection: Add 6 ml water for injection BP and shake gently for
dispersion.
For 1.5 gm Intravenous Injection: Add 16 ml water for injection BP and shake gently for
dispersion.
For Suspension: Shake the bottle well before adding water. Then add 35 ml of boiled and
cooled water (with the help of the provided cup) to the bottle. Then continue shaking the
bottle until the powder is dissolved properly.
CONTRAINDICATION
Cefuroxime is contraindicated in patients with known allergy to Cephalosporins.
SIDE EFFECT
Cefuroxime has been associated with nausea and vomiting in a small number of patients.
ACUTE OVERDOSAGE
Excessively large doses of all Cephalosporins can cause cerebral irritation and may cause
convulsions. This complication is unlikely to occur in routine practice unless the patient is
in renal failure. Hemodialysis or peritoneal dialysis can remove Cefuroxime.
PRECAUTION
As with other antibiotics, prolonged use of Cefuroxime may result in the over growth of
non-susceptible organisms (e.g. Candida, Enterococci, Clostridium difficile), which may
require interruption of treatment.
USE IN PREGNANCY & LACTATION
While all antibiotics should be avoided in the first trimester if possible, Cefuroxime has
been safely used in later pregnancy to treat urinary and other infections. The placental
transfer of Cefuroxime into the fetus was studied in 20 women and therapeutically active
concentrations were found in the serum of infants for up to 6 hours after delivery.
Cefuroxime is excreted in human milk, and consequently caution should be exercised
when Cefuroxime is administered to a nursing mother.
DRUG INTERACTION
No potentially hazardous interactions have been reported.
STORAGE CONDITION
Tablet: Store below 300 C, protected from light and moisture.
Suspension: Store below 250 C, protected from light and moisture.
Injection: Store below 250 C, protected from light and moisture.Use reconstituted solution
immediately. The reconstituted solution is stable for 2 hours at room temperature and for
12 hours when refrigerated at 20 – 80 C.
HOW SUPPLIED
Cefotil
TM 125 mg tablet: Box containing 20 tablets in blister pack.
Cefotil
TM 250 mg tablet: Box containing 20 tablets in blister pack.
Cefotil
TM 500 mg tablet: Box containing 12 tablets in blister pack.
Cefotil
TM Powder for Suspension (70 ml): Bottle containing 70 ml suspension (after
reconstitution).
Cefotil
TM 750 mg IM/IV injection: Pack of 1 vial containing Cefuroxime 750 mg as
Cefuroxime sodium BP accompained by a solvent ampoule of 10 ml water for injection. It
also contains a complementary pouch comprised of disposable syringe (10 ml), butterfly
needle, alcohol pad and first aid bandage.
Cefotil
TM 1.5 gm IV injection: Pack of 1 vial containing Cefuroxime 1.5 gm as Cefuroxime
sodium BP accompained by two solvent ampoule of 10 ml water for injection in each. It
also contains a complementary pouch comprised of disposable syringe (20 ml), butterfly
needle, alcohol pad and first aid bandage.
Cefotil 500 mg 1pcs
৳ 45
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