FIXET 200 (Cefixime Tablets USP 200 mg)

Pharmacotherapeutic group: third generation cephalosporin. ATC code: J01DD08

Cefixime is an oral third generation cephalosporin which has marked in vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms.

Clinical efficacy has been demonstrated in infections caused by commonly occurring pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Branhamella catarrhalis (beta- lactamase positive and negative) and Enterobacter species. It 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 cefixime. In addition, most strains of Pseudomonas, Bacteroides fragilis, Listeria monocytogenes and Clostridia are resistant to cefixime.

Therapeutic indications

Uncomplicated Urinary Tract Infections: Cefixime Tablets is an orally active cephalosporin antibiotic which has marked in vitrobactericidal 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. cefixime Tablets 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 Cefixime Tablets. In addition, most strains of Pseudomonas, Bacteriodes fragalis, Listeria monocytogenes and Clostridia are resistant to Cefixime Tablets.

Posology and method of administration

The usual course of treatment is 7 days. This may be continued for up to 14 days if required.

Adults and Children over 10 Years or weighing more than 50 kg: The recommended adult dosage is 200-400 mg daily according to the severity of infection,given either as a single dose or in two divided doses

Elderly: Elderly patients may be given the same dose as recommended for adults. Renal functionshould be assessed and dosage should be adjusted in severe renal impairment.

Children under 10 Years: Cefixime Tablets 200 mg are not recommended for use in children under 10 years old.The safety and efficacy of cefixime has not been established in children less than 6 months.

Renal Impairment: Cefixime Tablets may be administered in the presence of impaired renal function. Normaldose and schedule may be given in patients with creatinine clearances of 20 ml/min or greater.

In patients whose creatinine clearance is less than 20 ml/min, it is recommended that a dose of 200 mg once daily should not be exceeded. The dose and regimen for patients who are maintained on chronic ambulatory peritoneal dialysis or haemodialysis should follow the same recommendation as that for patients with creatinine clearances of less than 20 ml/min.

Method for administration

For oral administration.

Absorption of cefixime Tablets is not significantly modified by the presence of food.

Contraindications

Hypersensitivity to cephalosporin antibiotics or to any of the excipients.

Special warnings and precautions for use

Encephalopathy: Beta-lactams, including cefixime, predispose the patient to encephalopathy risk (which mayinclude convulsions, confusion, impairment of consciousness, movement disorders),particularly in case of overdose or renal impairment.

Severe cutaneous adverse reactions: Severe cutaneous adverse reactions such as toxic epidermal necrolysis, Stevens- Johnsonsyndrome and drug rash with eosinophilia and systemic symptoms (DRESS) have beenreported in some patients on cefixime. When severe cutaneous adverse reactions occur,cefixime should be discontinued and appropriate therapy and/or measures should be taken.Cefixime Tablets should be given with caution to patients who have shown hypersensitivity toother drugs

Hypersensitivity to penicillins: As with other cephalosporins, cefixime should be given with caution to patients with a historyof hypersensitivity to penicillin, as there is some evidence of partial cross-allergenicity betweenthe penicillins and cephalosporins.

Patients have had severe reactions (including anaphylaxis) to both classes of drugs. If an allergic effect occurs with Cefixime Tablets, 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 beendescribed for cephalosporins (as a class). The recurrence of haemolytic anaemia after readministrationof cephalosporins in a patient with a history of cephalosporin (includingcefixime) –associated haemolytic anaemia has also been reported.

Acute renal failure: As with other cephalosporins, cefixime may cause acute renal failure includingtubulointerstitial nephritis as an underlying pathological condition. When acute renal failureoccurs, cefixime should be discontinued and appropriate therapy and/or measures should betaken.

Renal impairment: Cefixime Tablets should be administered with caution in patients with markedly impairedrenal function.

Paediatric use: Safety of cefixime in premature or newborn infant has not been established.

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.

Interaction with other medicinal products and other forms of interaction

Anticoagulants: In common with other cephalosporins, increases in prothrombin times have been noted in afew patients. Care should therefore be taken in patients receiving anticoagulation therapy.

Cefixime should be administered with caution to patients receiving coumarin-type anticoagulants, e.g. warfarin potassium. Since cefixime may enhance effects of the anticoagulants, prolonged prothrombin time with or without bleeding may occur.

Other forms of interaction

A false positive reaction for glucose in the urine may occur with Benedict’s or Fehling’s solutions or with copper sulphate test tablets, but not with tests based on enzymatic glucose oxidase reactions.

A false positive direct Coombs test has been reported during treatment with cephalosporin antibiotics, therefore it should be recognized that a positive Coombs test may be due to the drug.

Fertility, pregnancy and lactation

Reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and have revealed no evidence of impaired fertility or harm to the foetus due to cefixime. In the rabbit, at doses up to 4 times the human dose, there was no evidence of a teratogenic effect; there was a high incidence of abortion and maternal death which is an expected consequence of the known sensitivity of rabbits to antibiotic-induced changes in the population of the microflora of the intestine. There are no adequate and well-controlled studies in pregnant women. Cefixime Tablets should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.

Effects on ability to drive and use machines

In the case of side effects such as encephalopathy (which may include convulsion, confusion, impairment of consciousness, movement disorders), the patient should not operate machines or drive a vehicle.

Overdose

There is a risk of encephalopathy in cases of administration of beta-lactam antibiotics, including cefixime, particularly in case of overdose or renal impairment.

Adverse reactions seen at dose levels up to 2 g cefixime Tablets in normal subjects did not differ from the profile seen in patients treated at the recommended doses.

Cefixime is not removed from the circulation in significant quantities by dialysis. No specific antidote exists. General supportive measures are recommended.

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FIXET 200 (Cefixime Tablets USP 200 mg)

FIXET 200 (Cefixime Tablets USP 200 mg)