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Dry syrup
Cefixime is indicated for the oral treatment of bacterial infections such as Acute exacerbations of chronic bronchitis; enteric (typhpoid) fever; Community acquired pneumonia; ENT infections (e.g. otitis media, sinusitis, tonsillitis, pharyngitis, laryngitis); and urinary tract infections.
Posology
Children: The recommended dose is 8 mg/kg/day of the suspension. This may be administered as a single daily dose or may be given in two divided doses, as 4 mg/kg every 12 hourly or as directed by the Physician.
Adults: Once Suprax is constituted, the recommended dose of the suspension is 400 mg daily. For the treatment of uncomplicated cervical/urethral gonococcal infections, a single oral dose of 400 mg is recommended or as directed by the Physician.
Children weighing more than 50 kg or older than 12 years should be treated with the recommended adult dose.
The duration of treatment is dependent on the course of the infection. Generally, the duration of treatment with antibiotics is 7-10 days. It should be noted that streptococcal infections require a minimum therapy of 10 days in order to avoid secondary illnesses.
The safety and efficacy in children aged less than 6 months has not been established.
Patients with impaired renal function: Cefixime may be administered in the presence of impaired renal function. Normal dose and schedule may be given in patients with creatinine clearances of 20 ml/min or greater. There are insufficient data regarding use of cefixime in the pediatric and adolescent age group in the presence of renal insufficiency. Therefore, the use of cefixime in these patient-groups is not recommended.
Method of administration: For oral administration only.
After constitution keep in a refrigerator when not in use. Use constituted suspension within 7 days, without significant loss of potency. Keep tightly closed. Shake well before using. Discard unused portion after 7 days.
The absorption of cefixime is not significantly affected by the presence of food. Hence it can be administered with or without food.
Acute generalized exanthematous pustulosis (AGEP)
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 such as toxic epidermal necrolysis, Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS) have been reported in some patients on cefixime. When severe cutaneous adverse reactions occur, cefixime should be discontinued and appropriate therapy and/or measures should be taken.
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 crossallergenicity between the penicillins and cephalosporins.
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 should be administered with caution in patients with markedly impaired renal function.
Paediatric population
Safety of cefixime in premature or newborn infants has not been established.
Warfarin and Anticoagulants
In common with other cephalosporins, increases in prothrombin times have been noted in a few 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.
Nifedipine, a calcium channel blocker, may increase bioavailability of cefixime up to 70%.
Carbamazepine
Elevated carbamazepine levels have been reported in postmarketing experience when cefixime is administered concomitantly. Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations.
Pregnancy Category B. 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 should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.
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.
Fixed Drug Eruption (FDE) has been reported with cephalosporin class formulations Acute generalized exanthematous pustulosis (AGEP): 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.
Mouth ulceration: It is reported that Cefixime formulations may cause mouth ulceration.
General: Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self-limiting in nature. The following are the undesirable effects reported with Cefixime: Diarrhea, loose stools, abdominal pain, dyspepsia, nausea, and vomiting. Several cases of documented pseudomembranous colitis were identified during the studies. The onset of pseudomembranous colitis symptoms may occur during or after therapy.
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 2g Cefixime 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.
Pharmacotherapeutic group: Third generation cephalosporin.
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. Like all beta-lactam antibiotics, cefixime binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, causing the inhibition of the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cefixime interferes with an autolysin inhibitor.
Absorption
The absolute bioavailability of cefixime is in the range of 22-54%. Absorption is not significantly modified by the presence of food. Cefixime may therefore be given without regard for meals.
Distribution
Cefixime appears to be widely distributed, however, adequate tissue concentration data relating to tablet and suspension are not available. Serum protein binding is concentration independent with a bound fraction of approximately 65%.
Metabolism
There is no evidence of metabolism of cefixime in vivo. Metabolites of cefixime have not been isolated from human serum or urine.
Excretion
Cefixime is excreted by renal and biliary mechanisms. Cefixime is predominantly eliminated as unchanged drug in the urine. Glomerular filtration is considered the predominant mechanism. The elimination half-life is 2-4 hours and is not dependent on either the dose or the galenic formulation.
None stated.