Axicef Tablet 500mg

Product Information

AXICEF

Axicef ®

(Cefuroxime Axetil )

Presentation

Axicef 250 tablet: White, capsule shaped, breakline on one side, film coated tablet; each tablet contains Cefuroxime Axetil BP

equivalent to Cefuroxime 250 mg

Axicef 500 tablet: White, capsule shaped, film coated tablet; each tablet contains Cefuroxime Axetil BP equivalent to Cefuroxime

500 mg

Axicef suspension: White, Tutti-frutti flavoured powder for Suspension; after reconstitution each 5 ml suspension contains

Cefuroxime Axetil BP equivalent to Cefuroxime 125 mg

Indication

Axicef (Cefuroxime Axetil) is Indicated for the treatment of Acute streptococcal tonsillitis and pharyngitis, Acute bacterial

sinusitis, Acute otitis media, Acute exacerbations of chronic bronchitis, Cystitis, Pyelonephritis, Uncomplicated skin and soft

tissue infections & early Lyme disease in adults and children (³3 months)

Dosage and Administration

The usual course of Axicef (Cefuroxime Axetil) is seven days (may range from five to ten days).

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There is no experience of using  Axicef (Cefuroxime Axetil) in children under the age of 3 months.

Renal impairment: The safety and efficacy of Axicef (Cefuroxime Axetil) in patients with renal failure have not been established.

Axicef (Cefuroxime Axetil) is primarily excreted by the kidneys. In patients with markedly impaired renal function it is

recommended that the dosage of Axicef (Cefuroxime Axetil) should be reduced to compensate for its slower excretion. Axicef

(Cefuroxime Axetil) is effectively removed by dialysis.

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Hepatic impairment: There are no data available for patients with hepatic impairment. Since Axicef (Cefuroxime Axetil)is primarily

eliminated by the kidney, the presence of hepatic dysfunction is expected to have no effect on the pharmacokinetics of Axicef

(Cefuroxime Axetil).

Method of administration: Oral use: Axicef (Cefuroxime Axetil) tablets should be taken after food for optimum absorption.

Contra-indication, warnings etc

Contra-indication: Patients with known hypersensitivity to cephalosporin antibiotics. History of severe hypersensitivity to any

other type of betalactam antibacterial agent (penicillins, monobactams and carbapenems).

Warnings and precautions: Hypersensitivity reactions: Special care is indicated in patients who have experienced an allergic

reaction to penicillins or other beta-lactam antibiotics because there is a risk of cross-sensitivity. As with all beta-lactam

antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported. In case of severe

hypersensitivity reactions, treatment with cefuroxime must be discontinued immediately and adequate emergency measures must be

initiated. Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity

reactions to cefuroxime, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if cefuroxime

is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents. Jarisch-Herxheimer reaction: The

Jarisch-Herxheimer reaction has been seen following cefuroxime axetil treatment of Lyme disease. It results directly from the

bactericidal activity of cefuroxime axetil on the causative bacteria of Lyme disease, the spirochaete Borrelia burgdorferi.

Patients should be reassured that this is a common and usually self-limiting consequence of antibiotic treatment of Lyme disease.

Overgrowth of non-susceptible microorganisms: As with other antibiotics, use of cefuroxime Axetil may result in the overgrowth of

Candida. Prolonged use may also result in the overgrowth of other non-susceptible microorganisms (e.g. enterococci and Clostridium

difficile), which may require interruption of treatment. Antibacterial agent-associated pseudomembranous colitis have been

reported with nearly all antibacterial agents, including cefuroxime and may range in severity from mild to life threatening. This

diagnosis should be considered in patients with diarrhoea during or subsequent to the administration of cefuroxime.

Discontinuation of therapy with cefuroxime and the administration of specific treatment for Clostridium difficile should be

considered. Medicinal products that inhibit peristalsis should not be given. Interference with diagnostic tests: The development

of a positive Coomb’s Test associated with the use of cefuroxime may interfere with cross matching of blood. 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 Axetil.

Drug Interactions: Drugs which reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with

that of the fasting state and tend to cancel the effect of enhanced absorption after food. Cefuroxime is excreted by glomerular

filtration and tubular secretion. Concomitant use of probenecid is not recommended. Concurrent administration of probenecid

significantly increases the peak concentration, area under the serum concentration time curve and elimination half-life of

Cefuroxime. Concomitant use with oral anticoagulants may give rise to increased INR.

Use in pregnancy and lactation: Pregnancy: Pregnancy category B. There are limited data from the use of cefuroxime in pregnant

women. Studies in animals have shown no harmful effects on pregnancy, embryonal or foetal development, parturition or postnatal

development. Cefuroxime Axetil should be prescribed to pregnant women only if the benefit outweighs the risk. Breastfeeding:

Cefuroxime is excreted in human milk in small quantities. Adverse effects at therapeutic doses are not expected, although a risk

of diarrhoea and fungus infection of the mucous membranes cannot be excluded. Breastfeeding might have to be discontinued due to

these effects. The possibility of sensitisation should be taken into account. Cefuroxime should only be used during breastfeeding

after benefit/risk assessment by the physician in charge. Fertility: There are no data on the effects of Cefuroxime Axetil on

fertility in humans. Reproductive studies in animals have shown no effects on fertility.

Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been

performed. However, as this medicine may cause dizziness, patients should be warned to be cautious when driving or operating

machinery.

Overdose: Overdose can lead to neurological sequelae including encephalopathy, convulsions and coma. Symptoms of overdose can

occur if the dose is not reduced appropriately in patients with renal impairment. Serum levels of cefuroxime can be reduced by

haemodialysis and peritoneal dialysis.

Direction for reconstitution of powder for suspension: Shake the bottle well so that powder does not clog. Add 45ml (9 x 5ml

spoonful) boiled and cooled water to the bottle. Shake well until all powder is dispersed. Reconstituted suspension should be

stored between 20 and 80 C in  a refrigerator. Discard unused portion after 10 days. Shake the bottle well before each use.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.

Packaging quantities

Axicef 250 tablet: Carton containing of 12 tablets in  alu-alu blisters.

Axicef 500 tablet: Carton containing of 8 tablets in blisters.

Axicef suspension: Carton containing powder to produce 70 ml suspension when reconstituted in glass bottle.

Manufactured by

UniMed & UniHealth Manufacturers Ltd.

B K Bari, Gazipur, Bangladesh

® Registered Trademark