Rucef

Cefuroxime axetil.

FC tab: Rucef 500 mg is a white to off-white film-coated capsule shaped tablet plain on one side and bisected on the other side.
Each film-coated tablet contains: Cefuroxime, USP 500 mg.
Oral Suspension: Prepared by adding water to the granules to give a strawberry flavoured and coloured suspension containing 250 mg and 125 mg Cefuroxime in each 5 mL.
Each 5 mL (1 teaspoonful) of reconstituted suspension contains: Cefuroxime (as axetil), USP 250 mg and 125 mg.

Pharmacology: Pharmacokinetics: Cefuroxime axetil is absorbed from the gastrointestinal tract and is rapidly hydrolyzed in the intestinal mucosa and blood to cefuroxime. Absorption is enhanced in the presence of food. Peak plasma concentrations are reported about 2 to 3 hours after an oral dose. The sodium salt is given by intramuscular or intravenous injection. Peak plasma concentrations of about 24 μg per mL have been achieved 45 minutes after an intramuscular dose of 750 mg with measurable amounts present 8 hours after a dose. Up to 50% of cefuroxime in the circulation is bound to plasma proteins. The plasma half-life is about 70 minutes and is prolonged in patients with renal impairment and neonates.
Microbiology: Antimicrobial Action: Cefuroxime is bactericidal and has a similar spectrum of antimicrobial action and pattern of resistance to those of cefamandole. It is more resistant to hydrolysis by beta-lactamases than cefamandole, and therefore may be more active against beta-lactamase-producing strains, Haemophilus influenzae and Neisseria gonorrhea. However treatment failures have occurred in patients with H. influenzae meningitis given with cefuroxime and might be associated with a relatively high minimum bactericidal concentration when compared with the minimum inhibitory concentrations or with a significant inoculums effect. Reduced affinity of penicillin-binding proteins for cefuroxime has also been reported to be responsible for resistance in a beta-lactamase-strain of H. influenza.

FC tab: Use in the treatment of susceptible infections including bone and joint infections, bronchitis, gonorrhea, otitis media, peritonitis, pharyngitis, sinusitis, skin and soft tissue infections, and urinary tract infections.
Oral Suspension: Used in the treatment of susceptible infections. These have included bone and joint infections, bronchitis, gonorrhea, meningitis (although treatment failures have been reported in H. influenzae meningitis), otitis media, peritonitis, pharyngitis, sinusitis, skin infections (including soft-tissue infections), and urinary tract infections. It is also used for surgical infection prophylaxis.

FC tablet: Usual oral dose for adults: 250 mg to 500 mg twice daily for respiratory tract infections or 250 mg daily for uncomplicated urinary tract infections or as prescribed by the physician.
Oral Suspension: Children more than 3 months of age: 125 mg twice daily or 10 mg per kg body weight twice daily to a maximum of 250 mg daily. Children over 2 years of age with otitis media may be given 250 mg twice daily or 15 mg per kg body weight twice daily to a maximum of 500 mg daily or as prescribed by the physician.

Signs and symptoms: Overdosage of cephalosporins can cause cerebral irritation leading to convulsions.
Treatment: Serum levels of Cefuroxime can be reduced by hemodialysis and peritoneal dialysis.

Patients with known hypersensitivity to cephalosporin antibiotics.

Cefuroxime should not be given to patients who are hypersensitive to it or to other cephalosporins. About 20% of penicillin-sensitive patients may also be allergic to cephalosporins although the true incidence is uncertain; great care should be taken if cefuroxime is to be given to such patients. Care is also necessary in patients with a history of allergy.
Effects on Ability to Drive and Use Machines: As this medicine may cause dizziness, patients should be warned to be cautious when driving or operating machinery.

There is no experimental evidence of embryopathic or teratogenic effects attributable to Cefuroxime but as with all drugs, it should be administered with caution during the early months of pregnancy. Cefuroxime is excreted in human milk, and consequently caution should be exercised when Cefuroxime is administered to a nursing mother.

The most common are hypersensitivity reactions, including skin rashes, urticarial, eosinophilia, fever, reactions resembling serum sickness, and anaphylaxis. There may be a positive response to the Coombs' test although haemolytic anaemia rarely occurs. Neutropenia and thrombocytopenia have occasionally been reported. Agranulocytosis has been associated rarely with some cephalosporins.
ADR Reporting Statement: Seek medical attention immediately at the first sign of any adverse drug reaction.
FC tablet: Bleeding complications related to hypoprothrombinaemia and/or platelet dysfunctions have occurred especially with cephalosporins and cephamycins having a N-methylthiotetrazole side-chain, including cefamandole, and latamoxef. The presence of a methylthiadiazolethiol side-chain, as in cefazolin, or a N-methylthiotriazine ring, as ceftriaxone, might also be associated with such bleeding disorders.
Oral Suspension: Bleeding complications related to hypoprothrombinaemia and/or platelet dysfunctions have occurred especially with cephalosporins and cephamycins having a N-methylthiotetrazole side chain, including cefamandole, cefbuperazone, cefmenoxime, cefmerazole, cefonicid, cefoperazone, cefotetan, cefpiramide, and latamoxef. The presence of a methylthiadiazolethiol side chain, as in cefazolin, or a N-methylthiotriazine ring, in ceftriaxone, might also be associated with such bleeding disorders.

Probenecid reduces the renal clearance of cefuroxime.
FC tablet: Drugs which reduce gastric acidity may result in a lower bioavailability of Cefuroxime compared with that of the fasting state and tend to cancel the effect of enhanced post-prandial absorption. In common with other antibiotics, Cefuroxime may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral contraceptives. As a false negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving Cefuroxime. This antibiotic does not interfere in the alkaline picrate assay for creatinine.

Oral Suspension: Direction for Reconstitution: To make 50 mL reconstituted suspension, add approximately 25 ml of water. Shake well until the granules are evenly suspended. The suspension is stable for one week at temperatures not exceeding 30°C and two weeks under refrigeration (2-8°C).

Store at temperatures not exceeding 30°C.

Cephalosporins

J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.

Rx