Recofast 250 Recofast 500 Recofast 70 ml Recofast 750 mg IV/IM Recofast Group
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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-1-azabicyclo [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 first- and second-generation cephalosporins. Anaerobic microorganisms: Gram-positive and gram-negative 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.