Cefixime Trihydrate

100mg / 5mL

POWDER FOR ORAL SUSPENSION

Formulation

Each 5mL (reconstituted suspension) contains: Cefixime Trihydrate USP

Mechanism of Action

The batericidal action of Cefixime results from inhibition of cell-wall synthesis. Cefixime is highly beta-lactamase stable and as a resultmany organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases may be susceptible to Cefixime. Clinical efficacy has been demonstrated in infections caused by commonly occuring pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive and negaive), Branhamella catarrhalis (beta-lactamase positive negative), Branhamella catarrhalis (beta-lactamase positive and negative) and Enterobac species. Most strains of Streptococcus faecalis, group D Staphylococci (including coagulase positive and negative strains and methicillinresistant strains) are resistant to Cefixime. In addition, most strains of Pseudomonas, Bacteroides, fragilis, Listeria monocytogenes and clostridia are resistant to Cefixime

Pharmacokinetics

Cefixime, given orally, is about 40% to 50% absorbed wether administered with or without food; however, time to maximal absorption is increased approximately 0.8 hours when admnistered with food. A single 200mg capsule of cefixime produces an average peak serum concentration of approximately 2mcg/mL. Peak serum concentration following oral administration of the absorbed dose is excreted unchanged in the urine in 24hours. In animal studies, it was noted that Cefixime is also excreted in bile in excess of 10% of the administered dose . Serum protein binding is concentration independent with a bound fraction of approximately 65%. The serum half-life of Cefixime in healthy subjects is independent of dosage form and average 3 to 4 hours. In subjects with moderate impairment of renal function. (20 to 40 mL/minute creatinine clearance), the average serum half-life of Cefixime is prolonged to 6.4 hours. In severe renal impairment (5 to 20 mL/minute creatinine clearnce), the average serum half-life of Cefixime is prolonged to 11.5 hours. There is no evidence of metabolism of Cefixime in vivo. 60mL

Indications

For the treatment of susceptible infections icluding gonorrhea, otitis media, pharyngitis, lower-respiratory tract infections such as bronchitis, and urinary tract infections.

Dosage and Administration

Absorption of Cefixime is not significatly modified by the presence of food. The usual course of treatment is 7-14 days.

Adults and Children over 12 years: The recommended adult dosage is 400 mg either as a single dose or in two divided doses.

Children: The recommended dosage for children is 8 mg/kg/day administered as a single dose or in two divided doses. The safety and efficacy of Cefixime have not been established in children aged less than 6 months. Dosagen in renal impairment: Cefixime may be administered be given in patients with creatinine clearances of 60mL/min or greater. Patients whose clearance is between 21 and 60mL/min patients who are on renal hemodialysis may be given 75% of the standard dosage at the standard dosing interval. Patients whose clearance is < 20 mL/min., ior patients who are o continous ambulatory peritoneal dialysis may be given half the standard dosage at the standard dosing interval. Or as prescribed by the physician.

Directions for Reconstitution

Slowly add previously boiled & cooled water up to the mark on bottle. Shake vigorously. The reconstituted suspension is stable for 7 days at temperatures not exceeding 30°C and 14 days when refrigerated (2-8° C).

Contraindications

Cefixime is contraindicated in patients with known hypersensitivity to cephalosporin antibiotics.

Warnings

Cefixime should be given with caution to patients who have shown hypersensitivity to penicillins, cephalosporins or other drugs. Cephalosporins should be given with caution to penicillin sensitive patients, as there is some evidence of patial cross-allergenicity between the penicillins and the cephalosporins. Patients have had severe reactions (including anaphylaxis) to both classes of drugs. If an allergic effect occurs with Cefixime, the drug should be discontinued and the patient treated with appropriate agents if necessary.

Treatment with broad spectrum antibiotics, including Cefixime alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicated that a toxin produced by Clostridium difficile is a primary cause of severe antibiotic-associated diarrhea including pseudomembranous colitis.

Precautions

Cefixime should be administered with caution in patients with markedly impaired renal function. Cefixime should be prescribed with caution in patients with history of gastrointestinal disease, particularly colitis. A false-positive reaction for ketones in the urine may occur with tests using nitroprusside but not with Those using nitroferricyanide. A false-positive reaction to glucose in the urine may occur with Benedict's or Fehling's solution or with copper sulfate test capsules, 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.

USE IN PREGNANCY, LACTATION & CHILDREN

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. The safety and efficacy of Cefixime has not been established in children aged less than 6 months.

Drug interactions

Care should be exercised in patients receiving anticoagulants and cefixime due to the possibility may increase prothrombin times.

Adverse Effects

Cefixime 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 with Cefixime are diarrhea and stool changes. Some cases of moderate to severe diarrhea have been reported; this has occasionally warranted cessation of therapy. Cefixime should be discontinued if marked diarrhea occurs. Other gastrointestinal side effects seen less frequently are neausea, 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, urticarial, drug fever and arthralgia have been observed. These reactions usually subsided upon discontinuation of therapy

Haemotological and clinical chemistry: Thrombocytopenia, leucopenia and eosinophilia have been reported. These reactions where ifrequent and reversible. Mild transient changes in liver and renal function tests have been observed. Miscellaneous: Other possible reactions include genital pruritus and vaginitis.

Overdosage

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 2g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

Storage

Store at temperatures not exceeding 30°C.
Keep out of reach of children.

Caution

Food, Drugs Devices and Cosmetics Act Prohibits Dispensing without prescription.

Availability

60mL HDPE bottle in a box