Cefditoren pivoxil

Third-generation oral cephalosporin

ATC code: J01DD16

Brand names: Spectracef, Meiact

Updated 21 Jul 2026 · Methodology

Indications

Acute bacterial rhinosinusitis

Second line

Used in moderate acute bacterial sinusitis as an alternative to amoxicillin/clavulanate when penicillins are intolerable without prior anaphylaxis. Dose 400 mg twice daily for 5–7 days. 2012 and the Spanish SEORL 2023 consensus place cefditoren in the second-line group alongside levofloxacin and moxifloxacin. In patients without risk factors, antibiotics for acute sinusitis are often unnecessary – most cases are viral and resolve in 7–10 days.

Sources

AEMPS: Ficha técnica de Cefditoreno pivoxilo (2024)

ICD-10: J01.9 · ICD-11: CA01

Community-acquired pneumonia

Second line

Alternative for non-severe outpatient community-acquired pneumonia. Dose 400 mg twice daily for 5 days. SEPAR 2024 first-line is amoxicillin 1 g three times daily, with azithromycin added when atypical pathogens are suspected. Cefditoren is used in confirmed amoxicillin resistance or allergy. Patients with severe pneumonia and risk factors need admission and parenteral therapy.

Sources

ICD-10: J18.9 · ICD-11: CA40.Z

COPD exacerbation

Second line

Used in bacterial COPD exacerbations meeting two or more Anthonisen criteria (worsening dyspnea, increased sputum volume and purulence). Cefditoren is listed in Spanish GesEPOC 2021 as an alternative to amoxicillin/clavulanate. Dose 400 mg twice daily for 5–7 days. Not used in severe COPD with risk factors for Pseudomonas aeruginosa – ciprofloxacin or levofloxacin is preferred.

Sources

ICD-10: J44.1 · ICD-11: CA22.0

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

Common cold

Not recommended

Cefditoren pivoxil is prescribed for acute pharyngitis and upper respiratory infections without confirmed bacterial etiology. 2024 AWaRe places oral third-generation cephalosporins in the Watch category. NG191 2020 does not recommend antibiotics for acute bronchitis in immunocompetent adults. The AEMPS Ficha Técnica confines cefditoren to confirmed GAS tonsillopharyngitis, chronic bronchitis exacerbation, uncomplicated pneumonia and skin infections.

Sources

ICD-10: J00 · ICD-11: CA00

How to read tiers A–F

AStrong evidence – first or second line in international guidelines
BRecommended in selected cases
CStudy data contradict each other
DBenefit not proven, no documented harm
FDocumented harm, or risk without benefit

Mechanism of action

A bactericidal antibiotic that disrupts bacterial peptidoglycan synthesis by binding penicillin-binding proteins (PBPs). Active against Streptococcus pneumoniae (including penicillin-intermediate strains), Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes. Stable to most gram-negative beta-lactamases. Cefditoren pivoxil is a prodrug converted by intestinal esterases to active cefditoren. In Spain, it is widely prescribed for respiratory infections under brands Spectracef and Meiact.

Safety

Contraindications

Cephalosporin hypersensitivity
History of penicillin anaphylaxis
Primary carnitine deficiency (pivoxil ester depletes carnitine)

Serious adverse effects

Anaphylaxis
Pseudomembranous colitis (Clostridioides difficile)
Carnitine depletion with prolonged courses
Hepatotoxicity (rare)
Stevens–Johnson syndrome

Common adverse effects

Diarrhea (8–15%)
Nausea
Abdominal pain
Headache
Vaginal candidiasis

Pregnancy: can you take Cefditoren pivoxil?

AEMPS summary of product characteristics (section 4.6): animal studies show no direct or indirect harmful effects on pregnancy, embryonic or fetal development, delivery or postnatal development. There are not enough data on cefditoren use in pregnant women. If cefditoren is taken shortly before delivery, newborn screening may give a false-positive result for isovaleric acidaemia.

Breastfeeding: can you take Cefditoren pivoxil?

Milk concentrations are low. Lactation use is acceptable when indicated; transient infant diarrhea is possible.

RID, infant dose via milk: 0.05%

Calculate RID Full profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Take strictly with meals – food raises bioavailability by about 70%. On empty stomach plasma levels drop and efficacy suffers. Antacids and H2-blockers reduce absorption – separate by at least 2 hours. Adjust in renal impairment: 200 mg twice daily at eGFR 30–50; 200 mg once daily at eGFR under 30.

Label mentions7 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

antiácidosclass named in the label
«Antiácidos: La administración simultánea de antiácidos conteniendo hidróxido de magnesio y aluminio y»
AEMPS, section 4.5 · Open on CIMA
anticonceptivos hormonalesclass named in the label
«Anticonceptivos orales: La administración de cefditoreno pivoxilo no alteró las propiedades farmacocinéticas del anticonceptivo»
AEMPS, section 4.5 · Open on CIMA
Copper
«métodos de reducción de cobre, pero no con los métodos enzimáticos.»
AEMPS, section 4.5 · Open on CIMA
Estradiol
«etinil estradiol. Cefditoreno pivoxilo puede tomarse simultáneamente en combinación con»
AEMPS, section 4.5 · Open on CIMA
Famotidine
«Antagonistas de los receptores H 2: La administración simultánea de famotidina por vía intravenosa y cefditoreno pivoxilo oral produjo una»
AEMPS, section 4.5 · Open on CIMA
Magnesium hydroxide
«Antiácidos: La administración simultánea de antiácidos conteniendo hidróxido de magnesio y aluminio y»
AEMPS, section 4.5 · Open on CIMA

From other drugs’ labels

MajorValproic acid
«Medicamentos conjugados con pivalato: Se debe evitar la administración concomitante de valproato y medicamentos conjugados con pivalato (como cefditoreno pivoxilo, adefovir dipivoxil, pivmecilinam y…»
AEMPS, section 4.5 · Open on CIMA

Check interaction with another drug

Opens the checker prefilled with this drug. Pick the second one from your regimen.

Open checker

Summary of a multi-drug list →

Medicine list: everything you take in one place →

Frequently asked

What is Cefditoren pivoxil used for?

Cefditoren pivoxil is evaluated for the following indications with varying evidence strength: Community-acquired pneumonia (evidence tier B), Acute bacterial rhinosinusitis (evidence tier B), COPD exacerbation (evidence tier B). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Cefditoren pivoxil?

Common side effects of Cefditoren pivoxil (≥ 1 in 100): Diarrhea (8–15%), Nausea, Abdominal pain, Headache, Vaginal candidiasis. See the Safety section for uncommon and serious reactions.

Is Cefditoren pivoxil safe during pregnancy?

Is Cefditoren pivoxil compatible with breastfeeding?

Milk concentrations are low. Lactation use is acceptable when indicated; transient infant diarrhea is possible.

Who should not take Cefditoren pivoxil?

Cefditoren pivoxil is contraindicated in: Cephalosporin hypersensitivity; History of penicillin anaphylaxis; Primary carnitine deficiency (pivoxil ester depletes carnitine). Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

AEMPS / CIMALabel dated 04/17/2026

Other drugs in this group

Ceftriaxone, Cefuroxime axetil, Chloramphenicol, Ciprofloxacin, Clarithromycin, Erythromycin, Linezolid, Trimethoprim