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Cefixime

Pronunciation

Pronunciation

(sef IKS eem)

Index Terms

  • Cefixime Trihydrate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Suprax: 400 mg

Suspension Reconstituted, Oral:

Suprax: 100 mg/5 mL (50 mL) [strawberry flavor]

Suprax: 200 mg/5 mL (50 mL, 75 mL); 500 mg/5 mL (10 mL, 20 mL) [contains sodium benzoate; strawberry flavor]

Generic: 100 mg/5 mL (50 mL); 200 mg/5 mL (50 mL, 75 mL)

Tablet, Oral:

Suprax: 400 mg [DSC] [scored]

Tablet Chewable, Oral:

Suprax: 100 mg, 200 mg [contains aspartame, fd&c red #40 aluminum lake; tutti-frutti flavor]

Brand Names: U.S.

  • Suprax

Pharmacologic Category

  • Antibiotic, Cephalosporin (Third Generation)

Pharmacology

Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs); which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.

Absorption

40% to 50%; Note: Capsule AUC reduced by ~15% and Cmax by ~25% when taken with food.

Distribution

Widely throughout the body and reaches therapeutic concentration in most tissues and body fluids, including synovial, pericardial, pleural, peritoneal; bile, sputum, and urine; bone, myocardium, gallbladder, and skin and soft tissue

Excretion

Urine (50% of absorbed dose as active drug); feces (10%)

Time to Peak

Serum: Tablet, suspension: 2 to 6 hours; Capsule: 3 to 8 hours; Delayed with food

Half-Life Elimination

Normal renal function: 3 to 4 hours; Moderate impairment (CrCl 20 to 40 mL/minute): 6.4 hours; Renal failure: Up to 11.5 hours

Protein Binding

65%

Special Populations: Elderly

Average AUCs at steady state in elderly patients are ~40% higher than average AUCs in healthy adults.

Use: Labeled Indications

Treatment of uncomplicated urinary tract infections (due to Escherichia coli and Proteus mirabilis), otitis media (due to Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes), pharyngitis and tonsillitis (due to Streptococcus pyogenes), acute exacerbations of chronic bronchitis (due to Streptococcus pneumoniae and Haemophilus influenzae); uncomplicated cervical/urethral gonorrhea (due to N. gonorrhoeae [penicillinase- and nonpenicillinase-producing])

Canadian labeling (not in US labeling): Treatment of uncomplicated urinary tract infections also due to Klebsiella spp., otitis media, acute exacerbations of chronic bronchitis, pharyngitis and tonsillitis or sinusitis also due to Moroxella catarrhalis (beta-lactamase positive and negative strains), or sinusitis caused by S. pneumoniae, H influenzae (beta-lactamase positive and negative strains) and S. pyogenes.

Note: Due to concerns of resistance, the CDC no longer recommends use of cefixime as a first-line regimen in the treatment of uncomplicated gonorrhea in the US; ceftriaxone is the preferred cephalosporin in combination with azithromycin (CDC 2012; CDC [Workowski 2015]).

Use: Unlabeled

Acute bacterial rhinosinusitis (ABRS) (pediatric) in combination with clindamycin; typhoid fever; uncomplicated rectal gonorrhea (due to N. gonorrhoeae [penicillinase- and nonpenicillinase-producing])

Contraindications

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

Dosing: Adult

Note: Suprax 400 mg tablets have been discontinued in the US for more than 1 year.

Susceptible infections: Oral: 400 mg daily divided every 12 to 24 hours. Note: Canadian labeling recommends once daily dosing for urinary tract infection treatment.

Gonococcal infection, uncomplicated infections of the cervix, urethra or rectum (rectum off-label use): Oral: 400 mg as a single dose in combination with oral azithromycin as a single dose (CDC [Workowski 2015]). Note: CDC no longer recommends cefixime as a first-line agent (ceftriaxone is the preferred cephalosporin in combination with azithromycin); cefixime should only be used if ceftriaxone is unavailable. In addition, cefixime is not an option for the treatment of uncomplicated gonorrhea of the pharynx due to limited efficacy; if it must be used instead of ceftriaxone, a test-of-cure follow up should be performed 14 days after treatment (CDC [Workowski 2015]). In Canada, due to increased antimicrobial resistance, the Public Health Agency of Canada recommends 800 mg as a single dose (off-label dose) for treatment of uncomplicated gonococcal infections.

Gonococcal infection, expedited partner therapy (off-label use): Oral: 400 mg as a single dose in combination with oral azithromycin (CDC [Workowski 2015]). Note: To be used only for heterosexual partners with gonorrhea if health department partner-management strategies are impractical/unavailable and there is concern by the provider for the prompt evaluation and treatment of the partner; medication may be delivered to partner by patient, collaborating pharmacy, or disease investigation specialist as permitted by law; written materials to educate partners about their exposure to gonorrhea, importance of therapy, and when to seek clinical evaluation for adverse reactions/complications must also be provided with the medication (CDC [Workowski 2015]).

S. pyogenes infections: Oral: 400 mg daily divided every 12 to 24 hours for ≥10 days

Typhoid fever (off-label use): Oral: 15 to 20 mg/kg/day in 2 divided doses for 7 to 14 days (Parry 2002; WHO 2003)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Suprax 400 mg tablets have been discontinued in the US for more than 1 year.

Susceptible infections: Oral: Note: Otitis media should be treated using the chewable tablets or suspension only. Chewable tablets and suspension achieve higher peak blood levels compared to an equivalent dose using the tablet or capsule.

Children ≥6 months and ≤45 kg: 8 mg/kg/day divided every 12 to 24 hours (maximum: 400 mg daily)

Dosing recommendations based on body weight (doses are rounded for use of oral suspension or chewable tablet):

5 to <7.6 kg: 50 mg daily

7.6 to <10.1 kg: 80 mg daily

10.1 to <12.6 kg: 100 mg daily

12.6 to <20.6 kg: 150 mg daily

20.6 to <28.1 kg: 200 mg daily

28.1 to <33.1 kg: 250 mg daily

33.1 to <40.1 kg: 300 mg daily

40.1 to ≤45 kg: 350 mg daily

Children >45 kg or >12 years and Adolescents: Refer to adult dosing.

Canadian labeling:

Children ≥6 months and ≤50 kg: Oral: 8 mg/kg/day divided every 12 to 24 hours (maximum: 400 mg daily). Note: Otitis media should be treated using the suspension only.

Dosing recommendations based on body weight:

6 kg: 48 mg daily

12.5 kg: 100 mg daily

19 kg: 152 mg daily

25 kg: 200 mg daily

35 kg: 280 mg daily

Children >50 kg or >12 years and Adolescents: Refer to adult dosing

Acute bacterial rhinosinusitis (off-label use): Oral: 8 mg/kg/day divided every 12 hours with concomitant clindamycin for 10 to 14 days. Note: Recommended in patients with non-type I penicillin allergy, after failure of initial therapy or in patients at risk for antibiotic resistance (eg, daycare attendance, age <2 years, recent hospitalization, antibiotic use within the past month) (Chow 2012).

Gonococcal infection, uncomplicated infections of the cervix, urethra or rectum (rectum off-label use): Adolescents: Refer to adult dosing.

Gonococcal infection, expedited partner therapy (off-label use): Adolescents: Refer to adult dosing.

S. pyogenes infections: Oral:

Children ≥6 months and ≤45 kg: 8 mg/kg/day divided every 12 to 24 hours for ≥10 days (maximum: 400 mg daily)

Children >45 kg or >12 years and Adolescents: 400 mg daily divided every 12 to 24 hours for ≥10 days

Typhoid fever (off-label use): Oral: 15 to 20 mg/kg/day divided every 12 hours for 7 to 14 days; maximum 400 mg daily (Girgis 1995; Stephens 2002)

Dosing: Renal Impairment

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

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling.

Reconstitution

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

Administration

May be administered with or without food. Shake oral suspension well before use. Chewable tablets must be chewed or crushed before swallowing.

Dietary Considerations

Chewable tablets contain phenylalanine.

Storage

Capsule, chewable tablet, tablet: Store at 20°C to 25°C (68°F to 77°F).

Powder for suspension: Prior to reconstitution, store at 20°C to 25°C (68°F to 77°F). After reconstitution, suspension may be stored for 14 days at room temperature or under refrigeration.

Drug Interactions

Aminoglycosides: Cephalosporins (3rd Generation) may enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Avoid combination

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Monitor therapy

Probenecid: May increase the serum concentration of Cephalosporins. Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy

Test Interactions

Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest®, Fehling's solution), may cause false-positive serum or urine creatinine with the alkaline picrate-based Jaffé reaction for measuring creatinine; false-positive urine ketones using tests with nitroprusside (but not those using nitroferricyanide).

Adverse Reactions

>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

Warnings/Precautions

Concerns related to adverse effects:

• Dermatologic reactions: Severe cutaneous reactions (eg, toxic epidermal necrolysis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms [DRESS]) have been reported. If a reaction occurs, discontinue and institute supportive therapy.

• Hemolytic anemia: Immune-mediated hemolytic anemia (including fatalities) have been reported. Monitor patient (including hematologic parameters and drug-induced antibody testing when clinically appropriate) during and for 2 to 3 weeks after therapy. If hemolytic anemia occurs during therapy, discontinue use.

• Hypersensitivity: Hypersensitivity and anaphylaxis have been reported in patients receiving beta-lactam drugs. Use caution in patients with a history of hypersensitivity to cephalosporins, penicillins, or other beta-lactams. If administered to penicillin-sensitive patients, use with caution and discontinue use if allergic reaction occurs.

• Renal failure: May cause acute renal failure including tubulointerstitial nephritis. If renal failure occurs, discontinue and initiate appropriate supportive therapy.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Renal impairment: Use with caution in patients with renal impairment; may increase the risk of seizures if dosage not reduced; modify dosage. Canadian labeling recommends dose modification if CrCl <40 mL/minute.

• Gastrointestinal disease: Use with caution in patients with a history of gastrointestinal disease.

• Hemolytic anemia: Should not be administered to patients with a history of cephaolosporin-associated hemolytic anemia; recurrence of hemolysis is more severe.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Phenylalanine: Chewable tablets contain phenylalanine.

Monitoring Parameters

Renal function; with prolonged therapy, monitor renal and hepatic function periodically. Observe for signs and symptoms of anaphylaxis during first dose. When used as part of alternative treatment for gonococcal infection, test-of-cure 7 days after dose (CDC 2012). Monitor hematologic parameters and drug-induced antibody testing (when clinically appropriate) during and for 2 to 3 weeks after therapy.

Pregnancy Risk Factor

B

Pregnancy Considerations

Teratogenic effects were not observed in animal reproduction studies. Cefixime crosses the placenta and can be detected in the amniotic fluid (Ozyüncü 2010).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea. Have patient report immediately to prescriber severe nausea, severe vomiting, bruising, bleeding, vaginitis, severe loss of strength and energy, urinary retention, change in amount of urine passed, seizures, or signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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