Cefixime

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# Overview
Cefixime is a 3rd generation cephalosporin that is FDA approved for the treatment of uncomplicated urinary tract infections, otitis media, pharyngitis and tonsillitis, acute exacerbations of chronic bronchitis and uncomplicated gonorrhea..   Common adverse reactions include diarrhea, nausea, abdominal pain, dyspepsia and vomiting..

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- The recommended dose of cefixime is 400 mg daily.
- May be given as a 400 mg tablet or capsule daily or
- 400 mg tablet may be split and given as one half tablet every 12 hours

### Uncomplicated Urinary Tract Infections
- Caused by Escherichia coli and Proteus mirabilis.

### Otitis Media
- Caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes.

### Pharyngitis and Tonsillitis
- Caused by Streptococcus pyogenes.
- Dosage: A therapeutic dosage of cefixime for at least 10 days

### Acute Exacerbations of Chronic Bronchitis
- Caused by Streptococcus pneumoniae and Haemophilus influenzae.

### Uncomplicated Gonorrhea (cervical/urethral)
- Caused by Neisseria gonorrhoeae.
- Dosage: a single oral dose of 400 mg

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cefixime in adult patients.

### NonGuideline-Supported Use
- Salmonella infection
- Prophylaxis of sexually transmitted infectious disease for victim of sexual aggression
- Cefixime 400 mg orally in a single dose PLUS metronidazole or azithromycin 
- Sinusitis

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
- Pediatric patients six months of age or older
- 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 hours.
- Children weighing more than 45 kg or older than 12 years should be treated with the recommended adult dose. cefixime chewable tablets must be chewed or crushed before swallowing.

### Uncomplicated Urinary Tract Infections
- Caused by Escherichia coli and Proteus mirabilis.

### Otitis Media
- Caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes

### Pharyngitis and Tonsillitis
- Caused by Streptococcus pyogenes.
- A therapeutic dosage of cefixime for at least 10 days

### Acute Exacerbations of Chronic Bronchitis
- Caused by Streptococcus pneumoniae and Haemophilus influenzae.

### Uncomplicated Gonorrhea (cervical/urethral)
- Caused by Neisseria gonorrhoeae.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cefixime in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Cefixime in pediatric patients.

# Contraindications
Cefixime is contraindicated in patients with known allergy to cefixime or other cephalosporins.

# Warnings

### Hypersensitivity Reactions
- Anaphylactic/anaphylactoid reactions (including shock and fatalities) have been reported with the use of cefixime.
- Before therapy with Suprax is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs. If this product is to be given to penicillin-sensitive patients, caution should be exercised because cross hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Suprax occurs, discontinue the drug.

### Clostridium difficile-Associated Diarrhea
- Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Suprax, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
- C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
- If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

### Dose Adjustment in Renal Impairment
- 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

### Coagulation Effects
- Cephalosporins may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated.

### Development of Drug-Resistant Bacteria
- Prescribing cefixime in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

# Adverse Reactions

## Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most commonly seen adverse reactions in U.S. trials of the tablet formulation were gastrointestinal events, which were reported in 30% of adult patients on either the twice daily or the once daily regimen. Five percent (5%) of patients in the U.S. clinical trials discontinued therapy because of drug-related adverse reactions. Individual adverse reactions included diarrhea 16%, loose or frequent stools 6%, abdominal pain 3%, nausea 7%, dyspepsia 3%, and flatulence 4%. The incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in pediatric patients receiving the suspension was comparable to the incidence seen in adult patients receiving tablets.

## Postmarketing Experience
The following adverse reactions have been reported following the use of cefixime. Incidence rates were less than 1 in 50 (less than 2%).

### Gastrointestinal
- Several cases of documented pseudomembranous colitis were identified in clinical trials. The onset of pseudomembranous colitis symptoms may occur during or after therapy.

### Hypersensitivity Reactions
- Anaphylactic/anaphylactoid reactions (including shock and fatalities), skin rashes, urticaria, drug fever, pruritus, angioedema, and facial edema. Erythema multiforme, Stevens-Johnson syndrome, and serum sickness-like reactions have been reported.

### Hepatic
- Transient elevations in SGPT, SGOT, alkaline phosphatase, hepatitis, jaundice.

### Renal
- Transient elevations in BUN or creatinine, acute renal failure.

### Central Nervous System
- Headaches, dizziness, seizures.

### Hemic and Lymphatic System
- Transient thrombocytopenia, leukopenia, neutropenia, prolongation in prothrombin time, elevated LDH, pancytopenia, agranulocytosis, and eosinophilia.

### Abnormal Laboratory Tests
- Hyperbilirubinemia

### Other Adverse Reactions
- Genital pruritus, vaginitis, candidiasis, toxic epidermal necrolysis.

### Adverse Reactions Reported for Cephalosporin-class Drugs
- Allergic reactions, superinfection, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, and colitis.
- Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

# Drug Interactions

### 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.

### Warfarin and Anticoagulants
- Increased prothrombin time, with or without clinical bleeding, has been reported when cefixime is administered concomitantly.

### Drug/Laboratory Test 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 cefixime 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 or TesTape) be used. A false-positive direct Coombs test has been reported during treatment with other cephalosporins; therefore, it should be recognized that a positive Coombs test may be due to the drug.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): B
Reproduction studies have been performed in mice and rats at doses up to 40 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, this drug should be used during pregnancy only if clearly needed.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cefixime in women who are pregnant.

### Labor and Delivery
Cefixime has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.

### Nursing Mothers
It is not known whether cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.

### Pediatric Use
Safety and effectiveness of cefixime in children aged less than six months old have not been established. The incidence of gastrointestinal 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.

### Geriatic Use
Clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. A pharmacokinetic study in the elderly detected differences in pharmacokinetic parameters. These differences were small and do not indicate a need for dosage adjustment of the drug in the elderly.

### Gender
There is no FDA guidance on the use of Cefixime with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Cefixime with respect to specific racial populations.

### Renal Impairment
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 may be administered in the presence of impaired renal function. Normal dose and schedule may be employed in patients with creatinine clearances of 60 mL/min or greater. Refer to Table 2 for dose adjustments for adults with renal impairment. Neither hemodialysis nor peritoneal dialysis removes significant amounts of drug from the body.

### Hepatic Impairment
There is no FDA guidance on the use of Cefixime in patients with hepatic impairment.

### Females of Reproductive Potential and Males
In rats, fertility and reproductive performance were not affected by cefixime at doses up to 25 times the adult therapeutic dose.

### Immunocompromised Patients
There is no FDA guidance one the use of Cefixime in patients who are immunocompromised.

# Administration and Monitoring

### Administration
Oral

### Monitoring
Patients on dialysis should be monitored carefully.

# IV Compatibility
There is limited information regarding the compatibility of Cefixime and IV administrations.

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

# Pharmacology

## Mechanism of Action
Cefixime is a semisynthetic cephalosporin antibacterial drug

## Structure
Chemically, it is (6R,7R)-7--8-oxo-3-vinyl-5-thia-1-azabicyclo  oct-2-ene-2-carboxylic acid, 72-(Z)- trihydrate.
Molecular weight = 507.50 as the trihydrate. Chemical Formula is C16H15N5O7S2.3H2O
The structural formula for cefixime is:

## Pharmacodynamics
There is limited information regarding Cefixime Pharmacodynamics in the drug label.

## Pharmacokinetics
Cefixime chewable tablets are bioequivalent to oral suspension.
Cefixime tablets and suspension, given orally, are about 40% to 50% absorbed whether administered with or without food; however, time to maximal absorption is increased approximately 0.8 hours when administered with food. A single 200 mg tablet of cefixime produces an average peak serum concentration of approximately 2 mcg/mL (range 1 to 4 mcg/mL); a single 400 mg tablet produces an average peak concentration of approximately 3.7 mcg/mL (range 1.3 to 7.7 mcg/mL). The oral suspension produces average peak concentrations approximately 25% to 50% higher than the tablets, when tested in normal adult volunteers. Two hundred and 400 mg doses of oral suspension produce average peak concentrations of 3 mcg/mL (range 1 to 4.5 mcg/mL) and 4.6 mcg/mL (range 1.9 to 7.7 mcg/mL), respectively, when tested in normal adult volunteers. The area under the time versus concentration curve (AUC) is greater by approximately 10% to 25% with the oral suspension than with the tablet after doses of 100 to 400 mg, when tested in normal adult volunteers. 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 in the treatment of otitis media. Cross-over studies of tablet versus suspension have not been performed in children.
The 400 mg capsule is bioequivalent to the 400 mg tablet under fasting conditions. However, food reduces the absorption following administration of the capsule by approximately 15% based on AUC and 25% based on Cmax.
Peak serum concentrations occur between 2 and 6 hours following oral administration of a single 200 mg tablet, a single 400 mg tablet or 400 mg of cefixime suspension. Peak serum concentrations occur between 2 and 5 hours following a single administration of 200 mg of suspension. Peak serum concentrations occur between 3 and 8 hours following oral administration of a single 400 mg capsule.

### Distribution
Serum protein binding is concentration independent with a bound fraction of approximately 65%. In a multiple dose study conducted with a research formulation which is less bioavailable than the tablet or suspension, there was little accumulation of drug in serum or urine after dosing for 14 days. Adequate data on CSF levels of cefixime are not available.

### Metabolism and Excretion
There is no evidence of metabolism of cefixime in vivo. Approximately 50% of the absorbed dose is excreted unchanged in the urine in 24 hours. In animal studies, it was noted that cefixime is also excreted in the bile in excess of 10% of the administered dose. The serum half-life of cefixime in healthy subjects is independent of dosage form and averages 3 to 4 hours but may range up to 9 hours in some normal volunteers.

### Special Populations
Average AUCs at steady state in elderly patients are approximately 40% higher than average AUCs in other healthy adults. Differences in the pharmacokinetic parameters between 12 young and 12 elderly subjects who received 400 mg of cefixime once daily for 5 days are summarized as follows:
However, these increases were not clinically significant.
In subjects with moderate impairment of renal function (20 to 40 mL/min creatinine clearance), the average serum half-life of cefixime is prolonged to 6.4 hours. In severe renal impairment (5 to 20 mL/min creatinine clearance), the half-life increased to an average of 11.5 hours. The drug is not cleared significantly from the blood by hemodialysis or peritoneal dialysis. However, a study indicated that with doses of 400 mg, patients undergoing hemodialysis have similar blood profiles as subjects with creatinine clearances of 21 to 60 mL/min.

## Nonclinical Toxicology
Lifetime studies in animals to evaluate carcinogenic potential have not been conducted. Cefixime did not cause point mutations in bacteria or mammalian cells, DNA damage, or chromosome damage in vitro and did not exhibit clastogenic potential in vivo in the mouse micronucleus test.

# Clinical Studies
Comparative clinical trials of otitis media were conducted in nearly 400 children between the ages of 6 months to 10 years. Streptococcus pneumoniae was isolated from 47% of the patients, Haemophilus influenzae from 34%, Moraxella catarrhalis from 15% and S. pyogenes from 4%.
The overall response rate of Streptococcus pneumoniae to cefixime was approximately 10% lower and that of Haemophilus influenzae or Moraxella catarrhalis approximately 7% higher (12% when beta-lactamase positive isolates of H. influenzae are included) than the response rates of these organisms to the active control drugs.
In these studies, patients were randomized and treated with either cefixime at dose regimens of 4 mg/kg twice a day or 8 mg/kg once a day, or with a comparator. Sixty-nine to 70% of the patients in each group had resolution of signs and symptoms of otitis media when evaluated 2 to 4 weeks post-treatment, but persistent effusion was found in 15% of the patients. When evaluated at the completion of therapy, 17% of patients receiving cefixime and 14% of patients receiving effective comparative drugs (18% including those patients who had Haemophilus influenzae resistant to the control drug and who received the control antibiotic) were considered to be treatment failures. By the 2 to 4 week follow-up, a total of 30%-31% of patients had evidence of either treatment failure or recurrent disease.

# How Supplied
- Cefixime Tablets 400 mg
- Bottle of 50 tablets, 27437-201-08
- Bottle of 100 tablets, 27437-201-01
- Cefixime Capsules 400 mg
- Bottle of 50 capsules, 27437-208-08
- 1 blister of 10 capsules, 27437-208-11
- Bottles of 10 tablets, 27437-203-10
- Cefixime Capsules 100 mg
- Bottle of 50 tablets, 27437-203-08
- 1 blister of 10 tablets, 27437-203-11
- Bottles of 10 tablets, 27437-204-10
- Cefixime Chewable Tablets 150 mg
- Bottle of 50 tablets, 27437-204-08
- 1 blister of 10 tablets, 27437-204-11
- Bottles of 10 tablets, 27437-205-10
- Cefixime Chewable Tablets 200 mg
- Bottle of 50 tablets, 27437-205-08
- 1 blister of 10 tablets, 27437-205-11
- Cefixime Chewable Tablets 100 mg/5 mL
- Bottle of 75 mL, 68180-202-02
- Bottle of 100 mL, 68180-202-01
- Bottle of 25 mL, 27437-206-05
- Bottle of 37.5 mL, 27437-206-06
- Cefixime for Oral Suspension 200 mg/5 mL
- Bottle of 50 mL, 27437-206-03
- Bottle of 75 mL, 27437-206-02
- Bottle of 100 mL, 27437-206-01
- Cefixime for Oral Suspension 500 mg/5 mL
- Bottle of 10 mL, 27437-207-02
- Bottle of 20 mL, 27437-207-03

## Storage
Store at 20 to 25C (68 to 77F)

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
Patients should be counseled that antibacterial drugs, including cefixime, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefixime is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may:
- decrease the effectiveness of the immediate treatment
- increase the likelihood that bacteria will develop resistance and will not be treatable by cefixime for oral suspension or cefixime chewable tablets or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

# Precautions with Alcohol
Alcohol-Cefixime interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- Suprax 

# Look-Alike Drug Names
There is limited information regarding Cefixime Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price