Each tablet contains cefixime equivalent to anhydrous cefixime 400 mg.
Each 5 mL of reconstituted suspension contains cefixime equivalent to anhydrous cefixime 100 mg.
Pharmacology: Ixime is a broad-spectrum semisynthetic, cephalosporin antibiotic for oral administration.
Treatment of the following infections when caused by susceptible strains of the designated microorganisms: Uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis.
Otitis media caused by Haemophilus influenzae (β-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis (most of which are β-lactamase positive) and S. pyogenes*.
*Efficacy for this organism in this organ system was studied in fewer than 10 infections.
Pharyngitis and tonsillitis caused by S. pyogenes.
Note: Penicillin is the usual drug of choice in the treatment of S. pyogenes infections, including the prophylaxis of rheumatic fever. Cefixime is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of cefixime in the subsequent prevention of rheumatic fever are not available.
Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae (β-lactamase positive and negative strains).
Uncomplicated gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains).
Adults: Recommended dose: 400 mg once daily or every 12 hrs.
Uncomplicated Cervical/Urethral Gonococcal Infections: Single oral dose of 400 mg is recommended.
Children: Recommended dose: 8 mg/kg/day of the suspension. This may be administered as a single daily dose or may be given in 2 divided doses, as 4 mg/kg every 12 hrs. (See table.)
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Children weighing >50 kg or >12 years should be treated with the recommended adult dose.
Renal Impairment: Cefixime may be administered in the presence of impaired renal function as follows:
Creatinine Clearance ≥60 mL/min 400 mg daily,
21-60 mL/min 300 mg daily and
≤20 mL/min 200 mg daily.
Reconstitution Directions for Oral Suspension: Tap the bottle several times to loosen powder contents prior to reconstitution. Add boiled and cooled water. Swirl to dissolve the granules. Add more water up to the mark on the label. Shake the bottle to ensure uniformity.
After reconstitution, the suspension may be kept for 14 days either at room temperature or under refrigeration, without significant loss of potency. Keep tightly closed. Shake well before using. Discard unused portion after 14 days.
Gastric lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of cefixime did not differ from the profile seen in patients treated at the recommended doses.
Patients with known allergy to the cephalosporin group of antibiotics.
Before therapy with cefixime is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins or other drugs.
Prescribing cefixime in the absence of a proven or strongly suspected bacterial infection of a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
The possibility of the emergence of resistant organisms which might result in overgrowth should be kept in mind, particularly during prolonged treatment. In such use, careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
The dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (CAPD) and hemodialysis (HD). Patients on dialysis should be monitored carefully. Cefixime should be prescribed with caution in individuals with a history of gastrointestinal (GI) disease, particularly colitis.
Labor and Delivery: Cefixime has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.
Use in pregnancy: 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 harm to the fetus due to cefixime. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, cefixime should be used during pregnancy only if clearly needed.
Use in lactation: It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with cefixime.
Use in children: Safety and effectiveness of cefixime in children <6 months have not been established.
The incidence of GI adverse reactions, including diarrhea and loose stools, in the pediatric patients receiving the suspension, was comparable to the incidence seen in adult patients receiving tablets.
Use in pregnancy: 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 harm to the fetus due to cefixime. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, cefixime should be used during pregnancy only if clearly needed.
Use in lactation: It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with cefixime.
Ixime is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self-limiting in nature.
Gastrointestinal Disturbances: The most frequent side effects seen with Ixime are diarrhoea and stool changes; diarrhoea has been more commonly associated with higher doses. Some cases of moderate to severe diarrhoea have been reported; this has occasionally warranted cessation of therapy. Ixime should be discontinued if marked diarrhoea occurs. Other GI side effects seen less frequently are nausea, abdominal pain, dyspepsia, vomiting and flatulence. Pseudomembranous colitis has been reported.
Central Nervous System: Headache and dizziness.
Hypersensitivity Reactions: Allergies in the form of rash, pruritus, urticaria, drug fever and arthralgia have been observed. These reactions usually subsided upon discontinuation of therapy. Rarely, erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Haematological and Clinical Chemistry: Thrombocytopenia, leukopenia and eosinophilia have been reported. These reactions were infrequent and reversible.
Mild transient changes in liver and renal function tests have been observed.
Miscellaneous: Other possible reactions include genital pruritus and vaginitis.
Carbamazepine: Elevated carbamazepine levels have been reported in post-marketing experience when cefixime is administered concomitantly. Drug monitoring may be of assistance in detecting alterations in carbamazepine plasma concentrations.
Warfarin and Anticoagulants: Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly.
Tablet: Store at 20-25°C.
Suspension: Store the unreconstituted product between 20-25°C.
J01DD08 - cefixime ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.
Film-coated tab 400 mg x 6's. Susp 100 mg/5 mL x 50 mL.
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