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Product Description

Tab. CEFKART

 

Cefixime tablets, 200 & 400 mg

Cefixime for oral suspension, Mfr. Std., 100 mg/5 mL

THERAPEUTIC CLASSIFICATION

Antibiotic

ACTION AND CLINICAL PHARMACOLOGY

CEFKART (cefixime) exerts its bactericidal effect by attaching to penicillin-binding proteins (PBP) and inhibiting peptidoglycan synthesis, thus causing damage to the bacterial cell wall. Following oral dosing, CEFKART attains peak serum levels in approximately 4 hours. The half-life is about 3 to 4 hours and is not dose dependent. Cefixime is excreted by renal and biliary mechanisms. About 50% of the absorbed dose is excreted unchanged in the urine within 24 hours. There is no evidence of metabolism of cefixime in vivo.

INDICATIONS AND USAGE

CEFKART (cefixime) is indicated in the treatment of the following infections caused by

susceptible strains of the designated microorganisms:

Upper Respiratory Tract:

Pharyngitis and tonsillitis caused by S. pyogenes.

Middle Ear:

Otitis media caused by S. pneumoniae, H. influenzae (beta-lactamase positive and negative strains), M. catarrhalis (former B. catarrhalis) (beta-lactamase positive and negative strains) and

  1. pyogenes.

Paranasal sinuses:

Sinusitis caused by S. pneumoniae, H. influenzae (beta-lactamase positive and negative strains), and M. catarrhalis (former B. catarrhalis) (beta-lactamase positive and negative strains).

Lower Respiratory Tract:

Acute bronchitis caused by S. pneumoniae, M. catarrhalis (former B. catarrhalis) (beta-lactamase positive and negative strains) and H. influenzae (beta-lactamase positive and negative strains).

Urinary Tract:

Acute uncomplicated cystitis and urethritis caused by E. coli, P. mirabilis, and Klebsiella species.

Uncomplicated Gonorrhea:

Uncomplicated gonorrhea (cervical/urethral and rectal) caused by Neisseria gonorrhoeae, including penicillinase (beta-lactamase-positive) and nonpenicillinase (beta-lactamase-negative) producing strains. Appropriate cultures should be taken for susceptibility testing before initiating treatment with CEFKART. If warranted, therapy may be instituted before susceptibility results are known; however, once these are obtained, therapy may need to be adjusted.

CONTRAINDICATIONS

Cefixime is contraindicated in patients with known allergies to the cephalosporin or penicillin antibiotics or to any ingredients in the formulation or component of the container. 

WARNINGS

Hypersensitivity:

IN PENICILLIN-SENSITIVE PATIENTS, CEFKART (CEFIXIME) SHOULD BE ADMINISTERED CAUTIOUSLY. PATIENTS MAY BE SENSITIVE TO PENICILLINS AND NOT TO CEPHALOSPORINS SUCH AS CEFKART OR BE SENSITIVE TO BOTH. MEDICAL LITERATURE INDICATES THAT PATIENTS SENSITIVE TO CEPHALOSPORINS ARE VERY LIKELY TO BE PENICILLIN SENSITIVE.

Antibiotics, including CEFKART, should be administered cautiously to any patient who has demonstrated some form of allergy, particularly to drugs.

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. 

Clostridium Difficile-Associated Disease:

Clostridium difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including CEFKART. CDAD may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea, or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of colon subsequent to the administration of any antibacterial agent. CDAD has been reported to occur over 2 months after the administration of antibacterial agents. Treatment with antibacterial agents may alter the normal flora of the colon and may permit overgrowth of Clostridium difficile. C. difficile produces toxins A and B, which contribute to the development of CDAD. CDAD may cause significant morbidity and mortality. CDAD can be refractory to antimicrobial therapy.

If the diagnosis of CDAD is suspected or confirmed, appropriate therapeutic measures should be initiated. Mild cases of CDAD usually respond to discontinuation of antibacterial agents not directed against Clostridium difficile. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial agent clinically effective against Clostridium difficile. Surgical evaluation should be instituted as clinically indicated, as surgical intervention may be required in certain severe cases.

Hemolytic Anemia:

CEFKART SHOULD NOT BE USED IN PATIENTS WITH A HISTORY OF CEPHALOSPORIN-ASSOCIATED HEMOLYTIC ANEMIA SINCE THE RECURRENCE OF HEMOLYSIS IS MUCH MORE SEVERE. 

An immune mediated hemolytic anemia has been observed in patients receiving cephalosporin class antibacterials, including CEFKART. Severe cases of hemolytic anemia, including fatalities, have been reported with cephalosporins in both adults and children. If a patient develops anemia anytime during, or within 2-3 weeks subsequent to the administration of CEFKART, the diagnosis of a cephalosporin-associated anemia should be considered and the drug discontinued until the etiology is determined.

Patients may benefit from periodic monitoring for signs and symptoms of hemolytic anemia, including measurement of hematological parameters or drug-induced antibody testing, where appropriate (see ADVERSE REACTIONS).

Acute Renal Failure:

As with other cephalosporins, CEFKART may cause acute renal failure including tubulointerstitial nephritis. When acute renal failure occurs, CEFKART should be discontinued and appropriate therapy and/or measures should be taken. 

PRECAUTIONS

General:

If an allergic reaction to CEFKART (cefixime) occurs, the drug should be discontinued, and, if necessary, the patient should be treated with appropriate agents, e.g., pressor amines, antihistamines, or corticosteroids. 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. Broad-spectrum antibiotics such as CEFKART should be prescribed with caution in individuals with a history of gastrointestinal disease.  Once daily dosing only must be used for urinary tract infections, since twice daily dosing was shown to be not as effective in clinical studies.

Do not use CEFKART to treat Staphylococcus aureus as this strain of staphylococcus is resistant to cefixime.

Renal Impairment:

CEFKART should be used with particular care in the presence of severely impaired renal function. Dose modification is recommended for patients with moderate or severe renal impairment (i.e., creatinine clearance of < 40 mL/min) (see PHARMACOLOGY and DOSAGE AND ADMINISTRATION).

Bioavailability Differences Between Tablet and Suspension:

The area under the time versus concentration curve is greater by approximately 26.4% and the Cmax is greater by approximately 20.7% with the oral suspension when compared to the tablet after doses of 400 mg. This increased absorption should be taken into consideration if the oral suspension is to be substituted for the tablet. Because of the lack of bioequivalence, tablets should not be substituted for oral suspension particularly in the treatment of otitis media where clinical trial experience with the suspension only is available (see DOSAGE AND ADMINISTRATION).

Drug/Drug Interactions:

CEFKART should be administered with caution to patients receiving coumarin-type anticoagulants such as warfarin potassium. Since CEFKART may enhance effects of the anticoagulants, prolonged prothrombin time with or without bleeding may occur (see ADVERSE REACTIONS and PHARMACOLOGY).

Drug/Laboratory Interactions:

A false-positive reaction for ketones in the urine may occur with tests using nitroprusside but not with those using nitroferricyanide. The administration of beta-lactams may result in a false-positive reaction for glucose in the urine using Clinitest*, Benedict’s solution, or Fehling’s solution. It is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix*) be used. 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.

Usage in Pregnancy:

The safety of CEFKART in the treatment of infection in pregnant women has not been established. 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 fetus due to cefixime. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the likely benefits of using CEFKART outweigh the potential risk to the fetus and/or the mother.

Labour and Delivery:

CEFKART has not been studied for use during labour and delivery.

Nursing Mothers:

It is not known whether CEFKART is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CEFKART is administered to a nursing woman.

Usage in Children:

Safety and effectiveness of CEFKART in children less than six months old have not been established.

 

DOSAGE AND ADMINISTRATION

Adults:

The recommended dose of CEFKART (cefixime) is 400 mg once daily. When necessary, a dose of 200 mg (one-half of a 400 mg tablet) given twice daily may be considered except for urinary tract infections where once daily dosing must be used. For treatment of uncomplicated gonococcal infections, a single oral dose of 400 mg is recommended.

Children (≥ 6 months):

The recommended dose of CEFKART is 8 mg/kg/day once daily. When necessary, a dose of 4 mg/kg given twice daily may be considered except for urinary tract infections where once daily dosing must be used.

Children weighing more than 50 kg or older than 12 years should be treated with the recommended adult dose. Safety and effectiveness in infants aged less than six months have not been established.

Otitis media should be treated with the suspension. Clinical studies of otitis media were conducted with the suspension only and the suspension results in higher peak blood levels than the tablet when administered at the same dose. Therefore, the tablet should not be substituted for the suspension in the treatment of otitis media (see PRECAUTIONS).

 

Duration of Therapy:

Duration of dosage in clinical trials was 10 to 14 days. The duration of treatment should be guided by the patient’s clinical and bacteriological response. In the treatment of infections due to Streptococcus pyogenes, a therapeutic dose of CEFKART should be administered for at least 10 days.

Renal Impairment:

CEFKART may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 40 mL/min or greater. Patients whose clearance is between 20 and 40 mL/min should be given 75% of the standard daily dosage. Patients whose creatinine clearance is less than 20 mL/min should be given 50% of the standard daily dosage.

Experience in children with renal impairment is very limited.

NOTE: Neither hemodialysis, nor peritoneal dialysis remove significant amounts of CEFKART from the body.