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Recofast®
Rx only
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
Recofast® (Cefuroxime Axetil) and other antibacterial drugs, Recofast® should be used only to
treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
Description
Recofast® tablets and Recofast® granules for suspension contain Cefuroxime as Cefuroxime
Axetil. Cefuroxime Axetil is a semisynthetic, broad-spectrum, cephalosporin antibiotic for oral
administration. Chemically, Cefuroxime Axetil, the 1-(acetyloxy) ethyl ester of Cefuroxime, is
(RS)-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl) glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1azabicyclo [4.2.0]-oct-2-ene-2-carboxylate, 72-(Z)-(O-methyl-oxime),1- acetate 3-carbamate. Its
molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48. Cefuroxime
Axetil is in the amorphous form and has the following structural formula:
Composition
Recofast® 125 Tablet: Each film-coated tablet contains Cefuroxime Axetil USP equivalent to
Cefuroxime 125 mg.
Recofast® 250 Tablet: Each film-coated tablet contains Cefuroxime Axetil USP equivalent to
Cefuroxime 250 mg.
Recofast® 500 Tablet: Each film-coated tablet contains Cefuroxime Axetil USP equivalent to
Cefuroxime 500 mg.
Recofast® Granules for Suspension: When reconstituted each 5 ml of suspension contains
Cefuroxime Axetil USP equivalent to Cefuroxime 125 mg.
Microbiology
Cefuroxime has an activity against a wide range of gram-positive and gram-negative organisms,
and it is highly stable in the presence of beta-lactamases of certain gram-negative bacteria. The
bactericidal action of Cefuroxime results from inhibition of cell-wall synthesis. Cefuroxime is
usually active against the following organisms, both in vitro and in clinical infections. Aerobic
gram-positive microorganisms: Staphylococcus aureus (including penicillinase-producing
strains), Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes and
other Streptococci. Note: Most strains of enterococci, e.g., Enterococcus faecalis (formerly
Streptococcus faecalis), are resistant to Cefuroxime. Methicillin-resistant staphylococci and
Listeria monocytogenes are resistant to Cefuroxime. Aerobic gram-negative microorganisms:
Citrobacter spp., Enterobacter spp., Escherichia coli, Haemophilus influenzae (including
ampicillin-resistant and beta-lactamase producing strains), Haemophilus parainfluenzae,
Klebsiella spp. (including klebsiella pneumoniae), Moraxella (Branhamella) catarrhalis
(including ampicillin- and cephalothin-resistant strains), Morganella morganii (formerly Proteus
morganii), Neisseria gonorrhoeae (including penicillinase- and non penicillinase-producing
strains), Neisseria meningitidis, Proteus mirabilis, Providencia rettgeri (formerly Proteus
rettgeri), Salmonella spp., and Shigella spp. Note: Some strains of Morganella morganii,
Enterobacter cloacae, and Citrobacter spp. have been shown by in vitro tests to be resistant to
Cefuroxime and other cephalosporins. Pseudomonas and Campylobacter spp., Acinetobacter
calcoaceticus, and most strains of Serratia spp. and Proteus vulgaris are resistant to most firstand second-generation cephalosporins. Anaerobic microorganisms: Gram-positive and gramnegative cocci (including Peptococcus and Peptostreptococcus spp.), gram-positive bacilli
(including Clostridium spp.), and gram-negative bacilli (including Bacteroides and
Fusobacterium spp.). Note: Clostridium difficile and most strains of Bacteroides fragilis are
resistant to Cefuroxime.
Pharmacokinetic
Absorption: After oral administration, Cefuroxime Axetil is absorbed from the gastrointestinal
tract and rapidly hydrolyzed in the intestinal mucosa and blood to release Cefuroxime into the
circulation. Optimal absorption occurs when it is administered after a meal. Peak serum
Cefuroxime levels occur approximately two to three hours after oral dosing. The serum half-life
is about 1.2 hours. Distribution: Approximately 50% of serum Cefuroxime is bound to protein.
The volume of distribution after a 1 g dose is 11.1 - 13.71 per 1.73 m2. Metabolism: Cefuroxime
is not metabolized. Elimination: Cefuroxime is excreted by glomerular filtration and tubular
secretion. Approximately 50% of the administered dose is recovered in the urine within 12 hours.
Indication and Use
Tablet: Recofast tablets are indicated for the treatment of patients with mild to moderate
infections caused by susceptible strains of the designated microorganisms in the conditions listed
below: Pharyngitis / Tonsillitis, Acute Bacterial Otitis Media, Acute Bacterial Maxillary
Sinusitis, Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial
Infections of Acute Bronchitis, Uncomplicated Skin and Skin-Structure Infections,
Uncomplicated Urinary Tract Infections, Uncomplicated Gonorrhea and Early Lyme Disease
(erythema migrans). Suspension: Recofast Suspension is indicated for the treatment of paediatric
patients 3 months to 12 years of age with mild to moderate infections caused by susceptible
strains of the designated microorganisms in the conditions listed below: Pharyngitis / Tonsillitis,
Acute Bacterial Otitis Media and Impetigo.
Dosage and Administration
Tablet: May be administered without regard to meals.
Suspension: Must be administered with food. Shake well each time before using.
Impaired renal function: The safety and efficacy of Cefuroxime Axetil in patients with renal
failure have not been established. Since Cefuroxime is renally eliminated, its half-life will be
prolonged in patients with renal failure.
Direction for use
Granules for Suspension: Shake the bottle well before adding water. Then add 35 ml of boiled
and cool water (with the help of the provided measuring cup) to the bottle. Then continue
shaking the bottle gently until the granules are mixed properly. Shake the bottle well before each
use.
Contraindication
Cefuroxime is contraindicated in patients with known allergy to the cephalosporin class of
antibiotics.
Use in Pregnancy and Lactation
Pregnancy: The safety of Cefuroxime in the treatment of infections during pregnancy has not
been established. Cefuroxime should only be used during pregnancy if the likely benefit
outweighs the potential risk to the fetus and/or the mother. Lactation: Cefuroxime is excreted in
breast milk, caution should be exercised when Cefuroxime is administered to a nursing mother.
Side Effect
Cefuroxime is generally well tolerated. General: Anaphylaxis, angioedema, pruritus, rash, serum
sickness like reaction, and urticaria. Gastrointestinal: Pseudomembranous colitis. Hematological:
Haemolytic anaemia, leukopenia, pancytopenia, thrombocytopenia and increased prothrombin
time. Hepatic: Hepatic impairment including hepatitis and cholestasis, jaundice. Neurological:
Seizure. Skin: Erythema multiforme, and toxic epidermal necrolysis. Urological: Renal
dysfunction. Cephalosporin-class adverse reactions: Toxic nephropathy, aplastic anaemia,
haemorrhage, increased creatinine, false-positive test for urinary glucose, increased alkaline
phosphatase, neutropenia, elevated bilirubin, and agranulocytosis.
Precaution
As with other antibiotics, prolonged use of Cefuroxime may result in overgrowth of
nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs
during therapy, appropriate measures should be taken. Cefuroxime, as with other broad-spectrum
antibiotics, should be prescribed with caution in individuals with a history of colitis. The safety
and effectiveness of Cefuroxime have not been established in patients with gastrointestinal
malabsorption. Cephalosporins, including Cefuroxime, should be given with caution to patients
receiving concurrent treatment with potent diuretics because these diuretics are suspected of
adversely affecting renal function. Prothrombin time should be monitored in patients at risk.
Warning
Before therapy with Cefuroxime is instituted, careful inquiry should be made to determine
whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins and
other drugs. This product should be given cautiously to penicillin hypersensitive patients. Serious
acute hypersensitivity reactions may require the use of subcutaneous epinephrine and other
emergency measures. Pseudomembranous colitis has been reported with nearly all antibacterial
agents, including Cefuroxime and may range in severity from mild to life-threatening. Therefore,
it is important to consider this diagnosis in patients who develop diarrhoea subsequent to the
administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora
of the colon and may permit overgrowth of Clostridia. Studies indicate that a toxin produced by
Clostridium difficile is one primary cause of antibiotic-associated colitis.
Drug Interaction
Probenecid increases Cefuroxime blood levels; drugs lowering gastric acidity may decrease
Cefuroxime bioavailability.
Overdosage
Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels
of Cefuroxime can be reduced by hemodialysis and peritoneal dialysis.
Stability and Storage Recommendation
Tablet: Store between 15°-30°C. Suspension: Store granules below 30°C. After reconstitution,
suspension should be stored below 25°C preferably in a refrigerator (2° - 8°C) and used within
10 days of preparation.
Packaging Quantity
Recofast® 125 Tablet: Box containing 2 x 4 tablets in alu-alu pack.
Recofast® 250 Tablet: Box containing 3 x 4 tablets in alu-alu pack.
Recofast® 500 Tablet: Box containing 2 x 4 tablets in alu-alu pack.
Recofast® Granules for Suspension: Bottle containing granules to produce 70 ml of suspension
when reconstituted.