Cefudyne

Cefuroxime axetil.

Each 5 mL (1 teaspoonful) of reconstituted suspension contains: Cefuroxime (as Axetil), USP 250 mg.
Cefuroxime Axetil (Cefudyne) 250 mg/5 mL Powder for Suspension when reconstituted gives an orange flavored suspension containing 250 mg Cefuroxime (as Axetil) per teaspoon (5 mL) of suspension.

Pharmacology: Pharmacodynamics: Cefuroxime is bactericidal and has 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 of Haemophilus influenzae and Neisseria gonorrhoeae.
Pharmacokinetics: Cefuroxime axetil is absorbed from the gastrointestinal tracts 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. 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 in neonates.
Cefuroxime is widely distributed in the body including pleural fluid, sputum, bone, synovial fluid and aqueous humour, but only achieves therapeutic concentrations in the CSF when the meninges are inflamed. It crosses the placenta and has been detected in breast milk.
Cefuroxime is excreted unchanged, by glomerular filtration and renal tubular secretion, and high concentrations are achieved in the urine. Probenecid competes for renal tubular secretion with cefuroxime resulting in higher and more prolonged plasma concentrations of cefuroxime. Small amounts of cefuroxime are excreted in bile. Plasma concentrations are reduced by dialysis.

For treatment of susceptible infections including those of bone and joint infections, bronchitis (and other lower respiratory tract infections), gonorrhea, meningitis, otitis media, peritonitis, pharyngitis, sinusitis, skin infections (including soft tissue infections) and urinary tract infections. Also can be used for surgical infection prophylaxis.

The usual duration of treatment is seven days (range: 5-10 days).
Administer oral suspension with food.
Dosage adjustment is required for patients with impaired renal function. (See Tables 1 and 2.)

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Overdosage of cephalosporins can cause cerebral irritation leading to convulsions. Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.

Cefuroxime should not be given to patients who are hypersensitive to it or to other cephalosporins. Care is also necessary in patients with history of allergy.

Cefuroxime should be given with caution to patients with renal impairment; a dosage reduction may be necessary. Renal hematological status should be monitored especially during prolonged and high-dose therapy.

There is no experimental evidence of embryonic or teratogenic effects attributable to cefuroxime axetil 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 axetil is administered to a nursing mother.

Gastrointestinal disturbances, including diarrhea, nausea, and vomiting, have occurred in some patients receiving cefuroxime. There have been rare reports of erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

Probenecid reduces the renal clearance of cefuroxime. Drugs which reduce gastric acidity may result in a lower bioavailability of Cefuroxime (as Axetil) compared with that of the fasting state and tend to cancel the effect of enhanced post-prandial absorption.

Directions for Reconstitution: Always shake the bottle vigorously in a diagonal direction for 1-2 minutes before use.
1. Shake the bottle to loosed powder completely. Remove the cap and the seal liner.
2. Add gradually the total amount of purified water stated in Table 3 and replace the cap. (See Table 3.)

Click on icon to see table/diagram/image

3. Invert the bottle and vigorously rock the bottle from side to side for at least 20 seconds.
4. Turn the bottle into an upright position and vigorously shake it in a diagonal direction for 1-2 minutes until powder is evenly suspended.
5. Store the reconstituted suspension either at room temperature (not exceeding 30°C) or in a refrigerator (2-8°C).
If the reconstituted suspension has been stored in refrigerator (2-8°C), let it stand at room temperature for 5 minutes then shake the bottle vigorously in a diagonal direction for 1-2 minutes before use.
AFTER RECONSTITUTION, SHAKE WELL BEFORE USING.
TO BE TAKEN AFTER MEALS.

Store at temperatures not exceeding 30°C. Protect from light.
The reconstituted suspension is stable for 7 days at temperatures not exceeding 30°C and 14 days under refrigeration (2-8°C).

Cephalosporins

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

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