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Cefixime Dispersible Tablets 100 mg is an orally active cephalosporin antibiotic which has marked in vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms.
It is indicated for the treatment of the following acute infections when caused by susceptible micro-organisms:
Upper Respiratory Tract Infections (URTI): e.g. otitis media; and other URTI where the causative organism is known or suspected to be resistant to other commonly used antibiotics, or where treatment failure may carry significant risk.
Lower Respiratory Tract Infection: e.g. bronchitis.
Urinary Tract Infections: e.g. cystitis, cystourethritis, uncomplicated pyelonephritis.
Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Kliebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Branhamella catarrhalis (beta-lactamase positive and negative) and Enterobacter species. CEFICONEX-100 is highly stable in the presence of beta-lactamase enzymes.
Most strains of enterococci (Streptococcus faecalis, group D Streptococci) and Staphylococci (including coagulase positive and negative strains and methicillin-resistant strains) are resistant to CEFICONEX-100. In addition, most strains of Pseudomonas, Bacteriodes fragalis, Listeria monocytogenes and Clostridia are resistant to Cefixime Dispersible Tablets 100 mg.
The usual course of treatment is 7 days. This may be continued for up to 14 days if required.
Eosinophilia, Hypeeosinophilia, Agranulocytosis, Leucopenia, Neutropenia, Granulocytopenia, Haemolytic anaemia, Thrombocytopenia, Thrombocytosis, Abdominal pain, ,Diarrhoea, Dyspepsia, Nausea, Vomiting, Flatulence, Jaundice, Pseudomembranous colitis, Vaginitis, Aspartate aminotransferase increased
Alanine aminotransferase increased, Blood bilirubin increased, Blood urea increased, Blood creatinine increased, Dizziness, Headache, Cases of convulsions have been reported with cephalosporins including cefixime (frequency not known)**
Beta-lactams, including cefixime, predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment (frequency not known)**
Dyspnoea
Acute renal failure with tubulointerstitial nephritis ,Anaphylactic reaction, Angio-oedema, Serum sickness-like reaction
Drug rash with eosinophilia and systemic symptoms (DRESS) Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis, Urticaria, Rash, Pruritus Acute generalised exanthematous pustulosis (AGEP) Drug Fever, Arthralgia, Pyrexia, Face oedema, Genital pruritus
Encephalopathy
Beta-lactams, including cefixime, predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment.
Severe cutaneous adverse reactions
Severe cutaneous adverse reactions (SCARS) including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS) drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in association with cefixime. Patients should be informed about the signs and symptoms of serious skin manifestations and monitored closely. Treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of skin hypersensitivity.
Ceficonex should be given with caution to patients who have shown hypersensitivity to other drugs.
Hypersensitivity to penicillins
As with other cephalosporins, cefixime should be given with caution to patients with a history of hypersensitivity to penicillin, as there is some evidence of partial cross-allergenicity between the penicillins and cephalosporins.
Patients have had severe reactions (including anaphylaxis) to both classes of drugs. If an allergic effect occurs with Ceficonex, the drug should be discontinued and the patient treated with appropriate agents if necessary.
Haemolytic anaemia
Drug-induced haemolytic anaemia, including severe cases with a fatal outcome, has been described for cephalosporins (as a class). The recurrence of haemolytic anaemia after re-administration of cephalosporins in a patient with a history of cephalosporin (including cefixime) –associated haemolytic anaemia has also been reported.
Acute renal failure
As with other cephalosporins, cefixime may cause acute renal failure including tubulointerstitial nephritis as an underlying pathological condition. When acute renal failure occurs, cefixime should be discontinued and appropriate therapy and/or measures should be taken.
Renal impairment
Cefixime Dispersible Tablets 100 mg should be administered with caution in patients with markedly impaired renal function.
Paediatric use
Safety of cefixime in premature or new-born infant has not been established.
Antibiotic-associated colitis
Treatment with broad spectrum antibiotics alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of antibiotic-associated diarrhoea. Pseudomembranous colitis is associated with the use of broad-spectrum antibiotics (including macrolides, semi-synthetic penicillins, lincosamides and cephalosporins); it is therefore important to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics. Symptoms of pseudomembranous colitis may occur during or after antibiotic treatment.
Management of pseudomembranous colitis should include sigmoidoscopy, appropriate bacteriologic studies, fluids, electrolytes and protein supplementation. If the colitis does not improve after the drug has been discontinued, or if the symptoms are severe, oral vancomycin is the drug of choice for antibiotic-associated pseudomembranous colitis produced by C. difficile. Other causes of colitis should be excluded.
Store below 30°C and protect from light and moisture.
Keep the medicine out of reach of children.
10 × 10 Alu/Alu Blister.
Cefixime Dispersible Tablets 100 mg are available in an Alu/Alu blister of 10 tablets. Such 10 blisters in a unit carton with pack insert.
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