Cefixime

Contraindications

Documented hypersensitivity

Cautions

Limited activity against anaerobes

Dosage must be adjusted in severe renal insufficiency (high doses may cause CNS toxicity); superinfections and promotion of nonsusceptible organisms may occur with prolonged use or repeated therapy

Use with caution in patients with history of penicillin allergy

Bacterial or fungal overgrowth of nonsusceptible organisms may occur with prolonged or repeated therapy

Phenylalanine can be harmful to patients with phenylketonuria (PKU); chewable tablets contain aspartame, a source of phenylalanine; before prescribing, consider combined daily amount of phenylalanine from all sources, including chewable tablets

Cefixime is used to treat certain infections caused by bacteria such as bronchitis (infection of the airway tubes leading to the lungs); gonorrhea (a sexually transmitted disease); and infections of the ears, throat, tonsils, and urinary tract. Cefixime is in a class of medications called cephalosporin antibiotics. It works by killing bacteria.

Antibiotics such as cefixime will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Cefixime is a cephalosporin (SEF a low spor in) antibiotic. It works by fighting bacteria in your body.

Cefixime is used to treat many different types of infections caused by bacteria.

Cefixime may also be used for purposes not listed in this medication guide.

You should not take this medicine if you are allergic to cefixime, or to similar antibiotics, such as Ceftin, Cefzil, Keflex, Omnicef, and others. Tell your doctor if you are allergic to penicillins.

You should not take this medicine if you are allergic to cefixime or to other cephalosporin antibiotics, such as:

• cefaclor (Raniclor);
• cefadroxil (Duricef);
• cefazolin (Ancef);
• cefdinir (Omnicef);
• cefditoren (Spectracef);
• cefpodoxime (Vantin);
• cefprozil (Cefzil);
• ceftibuten (Cedax);
• cefuroxime (Ceftin);
• cephalexin (Keflex);
• cephradine (Velosef); and others.

To make sure cefixime is safe for you, tell your doctor if you are allergic to any drugs, especially penicillins.

FDA pregnancy category B. Cefixime is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether cefixime passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

The cefixime suspension (liquid) contains sucrose. Talk to your doctor before using this form of cefixime if you have diabetes.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• diarrhea that is watery or bloody;
• jaundice (yellowing of the skin or eyes);
• swelling, rapid weight gain, little or no urinating;
• seizure (convulsions);
• fever, swollen gums, painful mouth sores, easy bruising, unusual bleeding;
• pale or yellowed skin, dark colored urine, confusion or weakness; or
• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• stomach pain, nausea, upset stomach, gas;
• mild itching or rash;
• headache; or
• vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

GENERIC AVAILABLE: Yes

Mechanism Of Action

Cefixime is a semisynthetic cephalosporin antibacterial drug [see Microbiology].

Pharmacokinetics

SUPRAX chewable tablets are bioequivalent to oral suspension.

SUPRAX 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 [see DOSAGE AND ADMINISTRATION]. 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.

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.

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

Geriatrics: 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:

Pharmacokinetic Parameters (mean ± SD) for Cefixime in Both Young & Elderly Subjects

However, these increases were not clinically significant [see DOSAGE AND ADMINISTRATION].

Renal Impairment: 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.

Microbiology

As with other cephalosporins, the bactericidal action of cefixime results from inhibition of cell wall synthesis. Cefixime is stable in the presence of certain beta-lactamase enzymes. As a result, certain organisms resistant to penicillins and some cephalosporins due to the presence of betalactamases may be susceptible to cefixime.

Resistance to cefixime in isolates of Haemophilus influenzae and Neisseria gonorrhoeae is most often associated with alterations in penicillin-binding proteins (PBPs). Cefixime may have limited activity against Enterobacteriaceae producing extended spectrum beta-lactamases (ESBLs). Pseudomonas species, Enterococcus species, strains of Group D streptococci, Listeria monocytogenes, most strains of staphylococci (including methicillin-resistant strains), most strains of Enterobacter species, most strains of Bacteroides fragilis, and most strains of Clostridium species are resistant to cefixime.

Cefixime has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections [see INDICATIONS AND USAGE].

Streptococcus pneumoniae
Streptococcus pyogenes

Escherichia coli
Haemophilus influenzae
Moraxella catarrhalis
Neisseria gonorrhoeae
Proteus mirabilis

The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for cefixime against isolates of similar genus or organism group. However, the efficacy of cefixime in treating clinical infections caused by these bacteria has not been established in adequate and well-controlled clinical trials.

Streptococcus agalactiae

Citrobacter amalonaticus
Citrobacter diversus
Haemophilus parainfluenzae
Klebsiella oxytoca
Klebsiella pneumoniae
Pasteurella multocida
Proteus vulgaris
Providencia species
Salmonella species
Serratia marcescens
Shigella species

Susceptibility Test Methods

When available, the clinical microbiology laboratory should provide cumulative reports of in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug for treatment.

Dilution Techniques

Quantitative methods are used to determine antimicrobial MICs. These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test method1,2 (broth and/or agar). The MIC values should be interpreted according to criteria provided in Table 3.

Diffusion Techniques

Quantitative methods that require measurement of zone diameters can also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized test method.2.3 This procedure uses paper disks impregnated with 5 mcg cefixime to test the susceptibility of bacteria to cefixime. The disk diffusion breakpoints are provided in Table 3.

Table 3: Susceptibility Interpretive Criteria for Cefixime

A report of Susceptible (S) indicates that the antimicrobial drug is likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentration usually achievable at the site of infection. A report of Intermediate (I) indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where a high dosage of the drug can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant (R) indicates that the antimicrobial drug is not likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentration usually achievable at the infection site; other therapy should be selected.

Quality Control

Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individuals performing the test.1,2,3 Standard cefixime powder should provide the following range of MIC values noted in Table 4. For the diffusion technique using the 5 mcg disk, the criteria in Table 4 should be achieved.

Table 4: Acceptable Quality Control Ranges for Cefixime

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 antibacterial drug) 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.

Bacteriological Outcome of Otitis Media at Two to Four Weeks Post-Therapy Based on Repeat Middle Ear Fluid Culture or Extrapolation from Clinical Outcome

REFERENCES

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard -Tenth Edition. CLSI document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-sixth Informational Supplement, CLSI document M100-S26, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2016.

3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard -Twelfth Edition. CLSI document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

Cefixime is a prescription medication used to treat bacterial infections of the lungs, urinary tract, ears, throat, and infections that cause gonorrhea. Cefixime belongs to a group of drugs called cephalosporin antibiotics, which work to stop the growth of bacteria in the body.

This medication is available in tablet, chewable tablet, capsule, and oral (by mouth) suspension forms and is taken once or twice daily, with or without food.

Common side effects of cefixime include rash, diarrhea, nausea, loose stools, and upset stomach.

Take the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

Avoid using antacids within 1 hour before or after taking cefixime. Antacids can make it harder for your body to absorb cefixime.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Antibacterial; β-lactam antibiotic; third generation cephalosporin.1 2 3 4 6 7 13 23 57 60 75 83

Acute Otitis Media (AOM)

Treatment of AOM1 2 3 5 23 43 56 61 62 63 75 138 164 165 caused by Haemophilus influenzae,1 2 23 61 62 63 Moraxella catarrhalis,1 2 23 61 62 63 or Streptococcus pyogenes (group A β-hemolytic streptococci).1 2 23 62 63

When anti-infectives indicated, AAP recommends high-dose amoxicillin or amoxicillin and clavulanate as drugs of choice for initial treatment of AOM; certain cephalosporins (cefdinir, cefpodoxime, cefuroxime, ceftriaxone) recommended as alternatives for initial treatment in penicillin-allergic patients without a history of severe and/or recent penicillin-allergic reactions.184

Pharyngitis and Tonsillitis

Treatment of pharyngitis and tonsillitis caused by susceptible S. pyogenes (group A β-hemolytic streptococci).1 2 3 5 23 44 56 64 75 Generally effective in eradicating S. pyogenes from nasopharynx; efficacy in prevention of subsequent rheumatic fever not established to date.1

AAP, IDSA, AHA, and others recommend a penicillin regimen (10 days of oral penicillin V or oral amoxicillin or single dose of IM penicillin G benzathine) as treatment of choice for S. pyogenes pharyngitis and tonsillitis;82 86 104 152 other anti-infectives (oral cephalosporins, oral macrolides, oral clindamycin) recommended as alternatives in penicillin-allergic patients.82 86 104 152

If an oral cephalosporin used, 10-day regimen of first generation cephalosporin (cefadroxil, cephalexin) preferred instead of other cephalosporins with broader spectrums of activity (e.g., cefaclor, cefdinir, cefixime, cefpodoxime, cefuroxime).82 86 152

Respiratory Tract Infections

Treatment of acute exacerbations of chronic bronchitis caused by S. pneumoniae,1 2 23 44 70 72 103 H. influenzae,1 2 23 44 70 72 103 or M. catarrhalis†.2 44 70 72 103

Treatment of mild to moderate community-acquired pneumonia† (CAP) caused by S. pneumoniae,2 23 44 70 72 103 H. influenzae,1 2 23 44 70 72 103 M. catarrhalis,2 44 70 72 103 137 166 Escherichia coli, H. parahaemolyticus, or H. parainfluenzae.2 3 44 64 75

Treatment of mild to moderate sinusitis† caused by S. pneumoniae,2 23 44 70 72 103 H. influenzae,1 2 23 44 70 72 103 M. catarrhalis,2 44 70 72 103 137 166 E. coli, H. parahaemolyticus, or H. parainfluenzae.2 3 44 75 Because of variable activity against S. pneumoniae and H. influenzae, IDSA no longer recommends second or third generation oral cephalosporins for empiric monotherapy of acute bacterial sinusitis.192 Oral amoxicillin or amoxicillin and clavulanate usually recommended for empiric treatment.192 193 If an oral cephalosporin used as an alternative in children (e.g., in penicillin-allergic individuals), combination regimen that includes a third generation cephalosporin (cefixime or cefpodoxime) and clindamycin (or linezolid) recommended.192 193

Urinary Tract Infections (UTIs)

Treatment of uncomplicated UTIs1 2 5 40 51 64 74 75 182 caused by susceptible E. coli1 2 40 51 64 74 75 182 or Proteus mirabilis;1 2 40 51 74 75 182 also has been used for treatment of uncomplicated UTIs caused by susceptible Citrobacter spp.†,2 51 64 74 C. diversus†,2 74 C. freundii†,2 74 Enterobacter spp.†,2 40 51 E. aerogenes†,2 40 74 E. agglomerans†,2 64 Klebsiella spp.†,2 40 51 182 K. pneumoniae†,2 64 74 Morganella morganii†,2 Proteus spp.†,2 51 64 or Serratia†.2 51 74

Has been used for treatment of uncomplicated UTIs1 2 5 40 51 64 74 75 182 caused by susceptible gram-positive bacteria, including Staphylococcus epidermidis†,2 Staphylococcus spp.†,2 51 Streptococcus agalactiae†,2 40 nonhemolytic streptococci†,2 40 51 or Enterococcus faecalis†.2 40 Consider that treatment failures have been reported and gram-positive bacteria (e.g., staphylococci, S. agalactiae, enterococci) have been isolated in urine during or after cefixime treatment and usually are resistant to cefixime.2 51 74

Treatment of pyelonephritis† and other complicated UTIs†2 23 40 75 caused by susceptible Enterobacteriaceae, including E. coli.2 23

Gonorrhea and Associated Infections

Treatment of uncomplicated urethral, endocervical, or rectal infections† caused by susceptible Neisseria gonorrhoeae.1 2 23 48 71 106 108 109 110 111 130 197

Because of concerns related to recent reports of N. gonorrhoeae with reduced susceptibility to cephalosporins, CDC states that oral cephalosporins no longer recommended as first-line treatment for uncomplicated gonorrhea.197 For treatment of uncomplicated urogenital, anorectal, or pharyngeal gonorrhea, CDC recommends a combination regimen that includes a single dose of IM ceftriaxone and either a single dose of oral azithromycin or 7-day regimen of oral doxycycline.197

Cefixime recommended by CDC as an alternative in patients with urogenital or rectal† gonorrhea when ceftriaxone cannot be used or not available;197 used in conjunction with single dose of oral azithromycin or 7-day regimen of oral doxycycline.197

Consider that N. gonorrhoeae with reduced susceptibility to cefixime, including some treatment failures, reported in US and other countries.194 195 196 197 198 Perform test-of-cure follow-up (culture or nucleic acid amplification test [NAAT]) 1 week after cefixime treatment.197

If infection persists (treatment failure), culture relevant clinical specimens and perform in vitro susceptibility tests.197 Also consult infectious disease specialist, STD/HIV Prevention Training Center (), or CDC (404-639-8659) for treatment advice and report the case to CDC through local or state health departments within 24 hours of diagnosis.197

For all gonorrhea patients, ensure that their sex partners from preceding 60 days are evaluated promptly with culture and treated with a recommended regimen if indicated.197

Lyme Disease

Has been used for treatment of disseminated Lyme disease†.181 Other cephalosporins (cefotaxime, ceftriaxone, cefuroxime axetil) usually recommended by IDSA and others when a cephalosporin is used in the treatment of Lyme disease.104 185

Salmonella and Shigella Infections

Has been used for treatment of typhoid fever (enteric fever) or septicemia caused by multidrug-resistant Salmonella typhi†.141 142 189 190 191

Has been used for treatment of shigellosis† caused by susceptible Shigella.139 148

Storage

Oral

20–25°C.1

20–25°C.1 After reconstitution, store suspension in tight container at room temperature or in the refrigerator; discard after 14 days.1

• Advise patients that antibacterials (including cefixime) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).1

• Importance of completing full course of therapy, even if feeling better after a few days.1

• Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with cefixime or other antibacterials in the future.1

• Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.1 Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.1

• Importance of discontinuing cefixime and informing clinician if an allergic reaction occurs.1

• Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)

To reduce the development of drug resistant bacteria and maintain the effectiveness of Cefixime for oral suspension and other antibacterial drugs, Cefixime for oral suspension should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antimicrobial therapy. In the absence of such data,local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Cefixime for oral suspension is a cephalosporin antibacterial drug indicated in the treatment of adults and pediatric patients six months of age or older with the following infections when caused by susceptible isolates of the designated bacteria:

Uncomplicated Urinary Tract Infections

Uncomplicated Urinary Tract Infections caused by Escherichia coli and Proteus mirabilis

Otitis Media

Otitis media caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes. (Efficacy for Streptococcus pyogenes in this organ system was studied in fewer than 10 infections.)
Note: For patients with otitis media caused by Streptococcus pneumoniae, overall response was approximately 10% lower for Cefixime than for the comparator. [see CLINICAL STUDIES (14)].

Pharyngitis and Tonsillitis

Pharyngitis and Tonsillitis caused by Streptococcus pyogenes. (Note: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes infections. Cefixime for oral suspension is generally effective in the eradication of Streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of Cefixime for oral suspension in the subsequent prevention of rheumatic fever is not available.)

Acute Exacerbations of Chronic Bronchitis

Acute Exacerbations of Chronic Bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae.

Uncomplicated Gonorrhea (cervical/urethral)

Uncomplicated Gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae (penicillinase –and non- penicillinase-producing isolates).

Hypersensitivity to cefixime, any component of the formulation, or other cephalosporins or penicillins

Adults:

CrCl ≥60 mL/minute: No dosage adjustment necessary.

CrCl 21 to 59 mL/minute:

Chewable tablet, tablet: Not recommended

100 mg/5 mL, 200 mg/5 mL, or 500 mg/5 mL suspension: 260 mg once daily

CrCl ≤20 mL/minute:

Chewable tablet, tablet: 200 mg once daily

100 mg/5 mL suspension: 172 mg once daily

200 mg/5 mL suspension: 176 mg once daily

500 mg/5 mL suspension: 180 mg once daily

Intermittent hemodialysis (not significantly removed by hemodialysis):

Chewable tablet, tablet: Not recommended

Suspension: 260 mg once daily

CAPD (not significantly removed by peritoneal dialysis):

Chewable tablet, tablet: 200 mg once daily

100 mg/5 mL suspension: 172 mg once daily

200 mg/5 mL suspension: 176 mg once daily

500 mg/5 mL suspension: 180 mg once daily

Canadian labeling:

CrCl ≥40 mL/minute: No dosage adjustment necessary

CrCl 20 to <40 mL/minute: Administer 75% of normal daily dose

CrCl <20 mL/minute: Administer 50% of normal daily dose

No dosage adjustment provided in manufacturer’s labeling.

Powder for suspension: Refer to manufacturer’s product labeling for reconstitution instructions.

>10%: Gastrointestinal: Diarrhea (16%)

2% to 10%: Gastrointestinal: Abdominal pain, nausea, dyspepsia, flatulence, loose stools

<2% (Limited to important or life-threatening): Acute renal failure, anaphylactoid reaction, anaphylaxis, angioedema, candidiasis, dizziness, drug fever, eosinophilia, erythema multiforme, facial edema, fever, headache, hepatitis, hyperbilirubinemia, increased blood urea nitrogen, increased serum creatinine, increased serum transaminases, jaundice, leukopenia, neutropenia, prolonged prothrombin time, pruritus, pseudomembranous colitis, seizure, serum sickness-like reaction, skin rash, Stevens-Johnson syndrome, thrombocytopenia, toxic epidermal necrolysis, urticaria, vaginitis, vomiting

(Not approved by FDA)

CDC recommendations: 400 mg orally twice a day

Comments:
-Initial therapy for disseminated gonococcal infections requires parenteral therapy which should be continued for 24 to 48 hours after clinical improvement is observed. Oral therapy may then be administered to complete a total course of at least 1 week.
-Doxycycline therapy for 7 days (if not pregnant) or single-dose azithromycin is also recommended to treat possible concurrent chlamydial infection.
-The patient's sexual partner(s) should also be evaluated/treated.

(Not approved by FDA)

CDC recommendations for sexual assault victims: 400 mg orally as a single dose plus metronidazole plus (azithromycin or doxycycline)

Data not available

Administration advice:
-Children weighing more than 45 kg or older than 12 years should be treated with the usual adult dose.
-In the treatment of infections due to Streptococcus pyogenes, a therapeutic dose should be administered for at least 10 days.
-Tablets or capsules should not be substituted for the oral suspension or chewable tablets in the treatment of otitis media.
-Tablets and capsules may be given without regard to food. Chewable tablets must be chewed or crushed before swallowing.
-Oral suspension should be shaken well before each dose.

Storage requirements:
-Tablets, capsules, chewable tablets: Store at controlled room temperature.
-Oral suspension: Store at controlled room temperature prior to reconstitution; store at room temperature or under refrigeration for 14 days after reconstitution (discard after 14 days).

Reconstitution/preparation techniques:
-The manufacturer's product information should be consulted.

General:
-Chewable tablets contain 3.3 mg, 5 mg, and 6.7 mg of phenylalanine per 100 mg, 150 mg, and 200 mg strength, respectively.

Monitoring:
-Cardiovascular: Prothrombin time in patients at risk.

Patient advice:
-Patients should avoid missing doses and complete the entire course of therapy.

Substance Name

Cefixime

CAS Registry Number

79350-37-1

Drug Class

Antiinfective Agents

Antibacterial Agents

Cephalosporins