Cefdinir

J01D - Other beta-lactam antibacterials ATC J01DD15 Small molecule approved 1997 Oral Natural product

🧬 Cross-allergy: Cephalosporins

JFDA label: Omnicef 125 Suspension

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

Approved

Acute bacterial otitis media
Acute exacerbations of chronic bronchitis
Acute maxillary sinusitis
Community-acquired pneumonia
Pharyngitis/Tonsillitis
Skin and skin structure infections, uncomplicated

Off-label

Cystitis, acute uncomplicated

Antimicrobial Spectrum

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

Bacteria

Organism	Activity	MIC
Citrobacter koseri	Active	—
Escherichia coli	Active	—
Haemophilus influenzae	Active	—
Haemophilus parainfluenzae	Active	—
Klebsiella pneumoniae	Active	—
Moraxella catarrhalis	Active	—
Proteus mirabilis	Active	—
Staphylococcus aureus	Active	—
Staphylococcus epidermidis	Active	—
Streptococcus agalactiae	Active	—
Streptococcus pneumoniae	Active	—
Streptococcus pyogenes	Active	—

Class profile

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

Contraindications

Source: Lexicomp

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

Adverse Reactions

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

Nervous system disorders (1)

Common Headache

Hepatobiliary disorders (2)

Common Increased serum alkaline phosphatase · increased serum ALT

Renal and urinary disorders (7)

Common Increased urine specific gravity · occult blood in urine · proteinuria · urine abnormality · urine alkalinization · vaginitis · Vulvovaginal candidiasis

Blood and lymphatic system disorders (6)

Common abnormal neutrophils · change in WBC count · eosinophilia · lymphocytopenia · Lymphocytosis · thrombocythemia

Metabolism and nutrition disorders (6)

Common Decreased serum bicarbonate · glycosuria · hyperglycemia · hyperphosphatemia · increased gamma-glutamyl transferase · increased lactate dehydrogenase

Gastrointestinal disorders (3)

Common abdominal pain · Nausea · vomiting

Skin and subcutaneous tissue disorders (1)

Common Skin rash

Other (1)

Very Common Gastrointestinal: Diarrhea

Dosing

Source: Lexicomp

Acute exacerbations of chronic bronchitis, pharyngitis/tonsillitis: Oral: 300 mg twice daily for 5 to 10 days or 600 mg once daily for 10 days Acute maxillary sinusitis: Oral: 300 mg twice daily or 600 mg once daily for 10 days. Note: According to the IDSA guidelines for acute bacterial rhinosinusitis, cefdinir is no longer recommended as monotherapy for initial empiric treatment (Chow 2012). Community-acquired pneumonia, skin and skin structure infections (uncomplicated): Oral: 300 mg twice daily for 10 days Cystitis, acute uncomplicated (alternative agent) (off-label use): Oral: 300 mg twice daily for 5 to 7 days (Hooton 2018)

(For additional information see "Cefdinir: Pediatric drug information") Infants ≥6 months and Children: Acute bacterial otitis media, pharyngitis/tonsillitis: Oral: 7 mg/kg/dose twice daily for 5 to 10 days or 14 mg/kg/dose once daily for 10 days (maximum: 600 mg/day) Acute maxillary sinusitis: Oral: 7 mg/kg/dose twice daily or 14 mg/kg/dose once daily for 10 days (maximum: 600 mg/day). Note: According to the IDSA guidelines for acute bacterial rhinosinusitis, cefdinir is no longer recommended as monotherapy for initial empiric treatment (Chow, 2012). Uncomplicated skin and skin structure infections: Oral: 7 mg/kg/dose twice daily for 10 days (maximum: 600 mg/day) Adolescents: Refer to adult dosing.

Refer to adult dosing.

CrCl ≥30 mL/minute: No dosage adjustment necessary. CrCl Adolescents and Adults: 300 mg once daily Infants ≥6 months and Children: 7 mg/kg once daily (maximum: 300 mg/day) ESRD requiring intermittent hemodialysis (IHD): Dialyzable: (63%): Initial dose: 300 mg (or 7 mg/kg/dose) every other day. Postdialysis, 300 mg (or 7 mg/kg/dose) should be given. Subsequent doses (300 mg or 7 mg/kg/dose) should be administered every other day.

No dosage adjustment necessary.

Warnings & Precautions

Source: Lexicomp

Penicillin allergy

Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).

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:

Colitis

Use with caution in patients with a history of colitis.

Renal impairment

Use with caution in patients with renal impairment (CrCl Concurrent drug therapy issues:

Drug-drug interactions

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Iron-containing products

Cases of reddish stools have been reported with concomitant use of cefdinir and iron-containing products due to the formation of a nonabsorbable complex in the GI tract.

Pregnancy & Lactation

Pregnancy

FDA category B Teratogenic

Teratogenic events have not been observed in animal reproduction studies. An increase in most types of birth defects was not found following first trimester exposure to cephalosporins.

Lactation

Cefdinir was not detectable in breast milk following a single cefdinir 600 mg dose. In general, if antibiotics are present in breast milk, nondose-related modification of bowel flora may occur. Monitor infants for GI disturbances, such as thrush and diarrhea (WHO 2002).

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	C14H13N5O5S2
Molecular weight	395.42 g/mol
IUPAC name	(6R,7R)-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-hydroxyiminoacetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
CAS	91832-40-5
PubChem CID	6915944
InChIKey	`RTXOFQZKPXMALH-GHXIOONMSA-N`
logP	-0.17 (XLogP 0.0)
Polar surface area	158.21 Å²
H-bond acceptors / donors	9 / 4
Drug-likeness (QED)	0.23
Lipinski violations	0

SMILES

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

Biology & Pharmacokinetics

Pharmacokinetics

BBB penetrant	No

Transporters

BCRP (Inhibitor)BSEP (Inhibitor)BSEP (Inhibitor)MRP1 (Inhibitor)MRP2 (Inhibitor)MRP3 (Inhibitor)MRP4 (Inhibitor)OAT1 (Inhibitor)OAT3 (Inhibitor)OATP1B1 (Inhibitor)OATP1B3 (Inhibitor)OCTN2 (Inhibitor)P-gp (Inhibitor)PEPT1 (Inhibitor)PEPT2 (Inhibitor)OAT1 (Substrate)OAT2 (Substrate)OAT3 (Substrate)P-gp (Substrate)PEPT1 (Substrate)

Drug–drug interactions (16, DDInter)

Interacting drug	Severity	Management
Aluminum hydroxide	moderate
Balsalazide	moderate
Chloramphenicol	moderate
Dicoumarol	moderate
Ethinylestradiol	moderate
Ferrous fumarate	moderate
Ferrous gluconate	moderate
Iron	moderate
Magaldrate	moderate
Magnesium carbonate	moderate
Magnesium hydroxide	moderate
Magnesium oxide	moderate
Mycophenolic acid	moderate
Pemetrexed	moderate
Tetraferric tricitrate decahydrate	moderate
Warfarin	moderate

Registered Products (26)

Brand	Form / strength	Pack	Agent	Citizen (JOD)
Omnicef 125 Suspension	Suspension 125 mg/5 ml	30 ml pack varies	Hikma Pharmaceuticals Co.Ltd/Jordan	7.430
Dinixir (125mg/5ml) Dry Suspension	Suspension 125 mg/5 ml	40 ml pack varies	UNITED PHARM.MFG.CO.LTD(UPM)/JORDAN	7.980
Azord Susp	Suspension 125 mg/5 ml	40 ml pack varies	Dar Al Dawa Development and Investment Co Ltd/Jordan	8.400
Iconir 125	Solution 125 mg/5 ml	40 MILLILITER pack varies	RETAJ PHARMACEUTICALS INDUSTRIES /JORDAN	8.400
Sefarin	Suspension 125 mg/5 ml	50 ml pack varies	Pharma International Company/ Jordan	8.510
Omnicef 125 Suspension	Suspension 125 mg/5 ml	40 ml pack varies	Hikma Pharmaceuticals Co.Ltd/Jordan	10.500
Iconir 125	Solution 125 mg/5 ml	60 MILLILITER pack varies	RETAJ PHARMACEUTICALS INDUSTRIES /JORDAN	11.330
Safe 125mg powder for suspension	Suspension 125 mg/5 ml	60 ml pack varies	RAM Pharmaceutical Industries Co. Ltd.	11.330
Minocet	Capsule Cefdinir 309.60 mg	10 cap	Sukhtian Group	12.800
Omnicef 125 Suspension	Suspension 125 mg/5 ml	60 ml pack varies	Hikma Pharmaceuticals Co.Ltd/Jordan	14.160
Azord Susp	Suspension 125 mg/5 ml	80 ml pack varies	Dar Al Dawa Development and Investment Co Ltd/Jordan	15.200
Dinixir (125mg/5ml) Dry Suspension	Suspension 125 mg/5 ml	80 ml pack varies	UNITED PHARM.MFG.CO.LTD(UPM)/JORDAN	15.200
Iconir 125	Solution 125 mg/5 ml	80 MILLILITER pack varies	RETAJ PHARMACEUTICALS INDUSTRIES /JORDAN	15.200
Azord Cap	Capsule 300 mg	10 cap	Dar Al Dawa Development and Investment Co Ltd/Jordan	16.450
Dinixir	Capsule 300 mg	10 cap	UNITED PHARM.MFG.CO.LTD(UPM)/JORDAN	16.450
Iconir	Capsule 300 mg	10 cap	RETAJ PHARMACEUTICALS INDUSTRIES /JORDAN	16.450
Sefarin	Capsule 300 mg	10 cap pack varies	Pharma International Company/ Jordan	16.450
Safe 125mg powder for suspension	Suspension 125 mg/5 ml	100 ml pack varies	RAM Pharmaceutical Industries Co. Ltd.	16.830
Sefarin	Suspension 125 mg/5 ml	100 ml pack varies	Pharma International Company/ Jordan	17.010
Sefarin	Solution Cefdinir 250 mg/5 ml	60 ml	/ Pharma International Company/Jordan / General	17.360
Omnicef 300 Capsules	Capsule 300 mg	10 cap	Hikma Pharmaceuticals Co.Ltd/Jordan	18.280
Omnicef 125 Suspension	Suspension 125 mg/5 ml	80 ml pack varies	Hikma Pharmaceuticals Co.Ltd/Jordan	20.000
Omnicef DS 250mg/5ml Powder for Oral Suspension	Suspension 250 mg/5 ml	60 ml	Hikma Pharmaceuticals Co.Ltd/Jordan	23.220
Sefarin	Tablet Cefdinir 600 mg	10 tab	/ Pharma International Company/Jordan / General	23.840
Omnicef	Tablet 600 mg	10 tab	Hikma Pharmaceuticals Co.Ltd/Jordan	29.800
Sefarin	Capsule 300 mg	20 cap pack varies	Pharma International Company/ Jordan	31.260