Cefixime

J01D - Other beta-lactam antibacterials ATC J01DD08 Small molecule approved 1989 Oral Natural product

🧬 Cross-allergy: Cephalosporins

JFDA label: Magnacef-400mg capsules

Mechanism of Action

Inhibitor of Bacterial penicillin-binding protein — Bacterial penicillin-binding protein inhibitor

Target	Action	Gene / class
Bacterial penicillin-binding protein efficacy	INHIBITOR

Indications

Off-label

Acute bacterial rhinosinusitis
Gonococcal infection, expedited partner therapy
Gonococcal, uncomplicated infection of the rectum
Typhoid fever

Antimicrobial Spectrum

Expected / intrinsic spectrum (EUCAST breakpoints & labels) — not local resistance. Source: EUCAST v16 · curated · openfda-label.

Bacteria

Organism	Activity	MIC
Bacteroides fragilis	Active	—
Citrobacter amalonaticus	Active	—
Citrobacter diversus	Active	—
Enterobacterales	Susceptible	1.0 mg/L
Escherichia coli	Susceptible	1.0 mg/L
Haemophilus influenzae	Susceptible	1.0 mg/L
Haemophilus influenzae	Susceptible	0.125 mg/L
Haemophilus parainfluenzae	Active	—
Klebsiella oxytoca	Active	—
Klebsiella pneumoniae	Active	—
Listeria monocytogenes	Active	—
Moraxella catarrhalis	Susceptible	0.5 mg/L
Neisseria gonorrhoeae	Susceptible	0.125 mg/L
Neisseria gonorrhoeae	Susceptible	0.125 mg/L
Pasteurella multocida	Active	—
Proteus mirabilis	Active	—
Proteus vulgaris	Active	—
Salmonella spp.	Susceptible	1.0 mg/L
Serratia marcescens	Active	—
Streptococcus agalactiae	Active	—
Streptococcus pneumoniae	Active	—
Streptococcus pyogenes	Active	—
Neisseria gonorrhoeae	Resistant	0.25 mg/L

Class profile

gramStatus	Gram-
spectrumBreadth	Broad
atypicalCoverage	No
isBactericidal	1
moaCategory	Cell wall synthesis inhibitor (beta-lactam, 3rd generation cephalosporin, oral)
pdIndex	Time-dependent
postAntibioticEffect	None
mrsaCoverage	0
resistanceMechanisms	ESBL production,AmpC beta-lactamase

Contraindications

Source: Lexicomp

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

Adverse Reactions

Very Common >10%Common 1–10%Uncommon 0.1–1% Rare 0.01–0.1%Very Rare <0.01%Not Known

Gastrointestinal disorders (3)

Common Abdominal pain · Diarrhoea · Nausea

Skin and subcutaneous tissue disorders (1)

Uncommon Rash

Infections and infestations (1)

Uncommon Clostridioides difficile colitis

Other (6)

Very Common Gastrointestinal: Diarrhea

Common dyspepsia · flatulence · Gastrointestinal: Abdominal pain · loose stools · nausea

Dosing

Source: Lexicomp

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. 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)

(For additional information see "Cefixime: Pediatric drug information") 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 to 10.1 to 12.6 to 20.6 to 28.1 to 33.1 to 40.1 to ≤45 kg: 350 mg daily Children >45 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 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)

Refer to adult dosing.

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 CrCl

No dosage adjustment provided in manufacturer’s labeling.

Warnings & Precautions

Source: Lexicomp

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.

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 cephalosporin-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; avoid use or use with caution in patients with phenylketonuria (PKU).

Pregnancy & Lactation

Pregnancy

FDA category B Teratogenic

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

Lactation

It is not known if cefixime is excreted in breast milk. The manufacturer recommends that consideration be given to discontinuing nursing temporarily during treatment. If present in breast milk, nondose-related effects could include modification of bowel flora.

Monitoring

Efficacy	Culture and susceptibility testing; clinical resolution (temperature, WBC, CRP, procalcitonin)
Toxicity	Renal function (dose adjustment in renal impairment); hepatic function for hepatically cleared agents; signs of C. difficile infection (diarrhoea)
Clinical pearl	Culture results guide de-escalation to narrower-spectrum therapy. Review antibiotic appropriateness at 48–72 h (antimicrobial stewardship).
Counseling	Complete the full course. Report persistent diarrhoea, rash, or lack of improvement after 48–72 h.

Chemistry & Properties

Formula	C16H15N5O7S2
Molecular weight	453.46 g/mol
IUPAC name	(6R,7R)-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(carboxymethoxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
CAS	79350-37-1
PubChem CID	5362065
InChIKey	`OKBVVJOGVLARMR-QSWIMTSFSA-N`
logP	-0.54 (XLogP -0.7)
Polar surface area	184.51 Å²
H-bond acceptors / donors	10 / 4
Drug-likeness (QED)	0.23
Lipinski violations	0

SMILES

C=CC1=C(C(=O)O)N2C(=O)[C@@H](NC(=O)/C(=N\OCC(=O)O)c3csc(N)n3)[C@H]2SC1

Biology & Pharmacokinetics

Pharmacokinetics

BBB penetrant	No

Enzyme interactions

Enzyme	Role	Detail
CYP2C9	Substrate	—

Transporters

BCRP (Inhibitor)BSEP (Inhibitor)BSEP (Inhibitor)MRP1 (Inhibitor)MRP2 (Inhibitor)MRP4 (Inhibitor)OAT1 (Inhibitor)OAT3 (Inhibitor)OATP1B1 (Inhibitor)OATP1B3 (Inhibitor)OCT(unspecified) (Inhibitor)OCTN2 (Inhibitor)P-gp (Inhibitor)PEPT1 (Inhibitor)PEPT2 (Inhibitor)OAT1 (Substrate)OAT3 (Substrate)P-gp (Substrate)PEPT1 (Substrate)Transporter(unspecified) (Substrate)

Drug–drug interactions (13, DDInter)

Interacting drug	Severity	Management
Amikacin	moderate
Amikacin (liposome)	moderate
Chloramphenicol	moderate
Dicoumarol	moderate
Ethinylestradiol	moderate
Gentamicin	moderate
Kanamycin	moderate
Mycophenolic acid	moderate
Neomycin	moderate
Pemetrexed	moderate
Picosulfuric acid	moderate
Streptomycin	moderate
Warfarin	moderate

Registered Products (55)

Brand	Form / strength	Pack	Agent	Citizen (JOD)
Apex-100mg/5ml	Suspension 100 mg/5 ml	30 ml pack varies	RETAJ PHARMACEUTICALS INDUSTRIES /JORDAN	4.400
Betixim Dry Suspension	Suspension 100 mg/5 ml	30 ml pack varies	MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN	4.400
Cefix SUS	Suspension 100 mg/5 ml	30 ml pack varies	Pharma International Company/ Jordan	4.400
Magnacef-100 suspension	Suspension 100 mg/5 ml	30 ml pack varies	AL-RAM PHARMA.INDUS.CO.LTD/JORDAN	4.400
Mixif Susp	Suspension 100 mg/5 ml	30 ml pack varies	Dar Al Dawa Development and Investment Co Ltd/Jordan	4.400
Suprax 100 Suspension	Suspension 100 mg/5 ml	30 ml pack varies	Hikma Pharmaceuticals Co.Ltd/Jordan	5.500
Mixif Susp	Suspension 100 mg/5 ml	40 ml pack varies	Dar Al Dawa Development and Investment Co Ltd/Jordan	5.870
Pancef	Tablet 400 mg	5 tab pack varies	Orient Montreal Drug Store	6.430
PANCEF	Solution Cefixime Trihydrate 100 g/5 ml	60 ml pack varies	Orient Montreal Drug Store	6.790
Winex	Suspension (as Trihydrate) 100 mg/5 ml	60 ml	Sukhtian Group	7.320
Suprax 200 Capsules	Capsule 200 mg	5 cap pack varies	Hikma Pharmaceuticals Co.Ltd/Jordan	7.500
Apex-100mg/5ml	Suspension 100 mg/5 ml	60 ml pack varies	RETAJ PHARMACEUTICALS INDUSTRIES /JORDAN	8.360
Betixim Dry Suspension	Suspension 100 mg/5 ml	60 ml pack varies	MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN	8.360
Cefix SUS	Suspension 100 mg/5 ml	60 ml pack varies	Pharma International Company/ Jordan	8.360
Mixif Susp	Suspension 100 mg/5 ml	60 ml pack varies	Dar Al Dawa Development and Investment Co Ltd/Jordan	8.360
Magnacef-100 suspension	Suspension 100 mg/5 ml	60 ml pack varies	AL-RAM PHARMA.INDUS.CO.LTD/JORDAN	8.400
Suprax 200 Capsules	Capsule 200 mg	6 cap pack varies	Hikma Pharmaceuticals Co.Ltd/Jordan	9.000
Magnacef Capsules	Capsule 200 mg	8 cap pack varies	AL-RAM PHARMA.INDUS.CO.LTD/JORDAN	9.220
Suraxim	Tablet 200 mg	8 tab	UNITED PHARM.MFG.CO.LTD(UPM)/JORDAN	9.520
Macrocef	Capsule 200 mg	8 cap	Abu Sheikha Drug Store	9.550
Betixim Capsules	Capsule 200 mg	8 cap	MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN	9.600
Cefix cap	Capsule 200 mg	8 cap pack varies	Pharma International Company/ Jordan	9.600
Mixif Caps	Capsule 200 mg	8 cap	Dar Al Dawa Development and Investment Co Ltd/Jordan	9.600
Cefim 400 Caps	Capsule 400 mg	6 cap	Noor Drug Store	9.810
PANCEF	Solution Cefixime Trihydrate 100 g/5 ml	100 ml pack varies	Orient Montreal Drug Store	10.210
Suprax 100 Suspension	Suspension 100 mg/5 ml	60 ml pack varies	Hikma Pharmaceuticals Co.Ltd/Jordan	10.450
Magnacef-400mg capsules	Capsule 400 mg	5 cap pack varies	AL-RAM PHARMA.INDUS.CO.LTD/JORDAN	10.670
Macrocef	Capsule 400 mg	6 cap	Abu Sheikha Drug Store	11.430
Suraxim	Tablet 400 mg	5 tab pack varies	UNITED PHARM.MFG.CO.LTD(UPM)/JORDAN	11.910
Apex	Tablet (as trihydrate ) 400 mg	5 tab pack varies	RETAJ PHARMACEUTICALS INDUSTRIES /JORDAN	12.000
Betixim Hard Gelatin Capsules	Capsule 400 mg	5 cap pack varies	MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN	12.000
Cefix cap	Capsule 400 mg	5 cap pack varies	Pharma International Company/ Jordan	12.000
Cefix cap	Capsule 400 mg	8 cap pack varies	Pharma International Company/ Jordan	12.000
Mixif	Tablet 400 mg	5 tab	Dar Al Dawa Development and Investment Co Ltd/Jordan	12.000
Suprax 200 Capsules	Capsule 200 mg	8 cap pack varies	Hikma Pharmaceuticals Co.Ltd/Jordan	12.000
Suprax 400 Capsules	Capsule 400 mg	4 cap pack varies	Hikma Pharmaceuticals Co.Ltd/Jordan	12.000
Pancef	Tablet 400 mg	10 tab pack varies	Orient Montreal Drug Store	12.220
Winex	Capsule 400 mg	6 cap	Sukhtian Group	12.600
Magnacef-400mg capsules	Capsule 400 mg	6 cap pack varies	AL-RAM PHARMA.INDUS.CO.LTD/JORDAN	12.800
Suprax DS	Suspension (Micronized) 200 mg/5 ml	50 ml	Hikma Pharmaceuticals Co.Ltd/Jordan	14.280
Suraxim	Tablet 400 mg	6 tab pack varies	UNITED PHARM.MFG.CO.LTD(UPM)/JORDAN	14.290
Apex	Tablet (as trihydrate ) 400 mg	6 tab pack varies	RETAJ PHARMACEUTICALS INDUSTRIES /JORDAN	14.400
Cefix cap	Capsule 400 mg	6 cap pack varies	Pharma International Company/ Jordan	14.400
Suprax 400 capsules	Capsule 400 mg	5 cap pack varies	Hikma Pharmaceuticals Co.Ltd/Jordan	15.000
Suprax D	Tablet (As Trihydarte)400 mg	5 tab	Hikma Pharmaceuticals Co.Ltd/Jordan	15.000
Suprax 200 Capsules	Capsule 200 mg	12 cap pack varies	Hikma Pharmaceuticals Co.Ltd/Jordan	17.100
Suprax 400 Capsules	Capsule 400 mg	6 cap pack varies	Hikma Pharmaceuticals Co.Ltd/Jordan	18.000
Suprax D	Tablet 400 mg	6 tab	Hikma Pharmaceuticals Co.Ltd/Jordan	18.000
Suprax 200 Capsules	Capsule 200 mg	64 cap pack varies	Hikma Pharmaceuticals Co.Ltd/Jordan	85.440
Suprax 400 Capsules	Capsule 400 mg	48 cap pack varies	Hikma Pharmaceuticals Co.Ltd/Jordan	128.160
Magnacef Capsules	Capsule 200 mg	400 cap pack varies	AL-RAM PHARMA.INDUS.CO.LTD/JORDAN	391.850
Betixim Hard Gelatin Capsules	Capsule 400 mg	250 cap pack varies	MIDDLE EAST PHARMA&CHEMICAL IND/JORDAN	404.600
Cefix cap	Capsule 200 mg	400 cap pack varies	Pharma International Company/ Jordan	408.000
Cefix cap	Capsule 400 mg	250 cap pack varies	Pharma International Company/ Jordan	509.800
Magnacef Capsules	Capsule 400 mg	600 cap pack varies	AL-RAM PHARMA.INDUS.CO.LTD/JORDAN	1088.000