Acute bacterial rhinosinusitis
Acute inflammation of the paranasal sinuses, usually secondary to viral URI. Bacterial etiology suspected with duration over 10 days or secondary worsening.
ICD-10 J01.94 drugs
Also known as: ABRS, Acute sinusitis
Drugs used for this condition
- AAmoxicillinFirst line · Penicillins with extended spectrumAmoxicillin is first-line for acute bacterial rhinosinusitis when an antibiotic is chosen: in adults per AAO-HNS 2015 (Amoxicillin with or without clavulanate), in children per AAP 2013 and the Spanish SEIP/AEPap consensus 2023. Guidelines differ: IDSA 2012 prefers Amoxicillin/clavulanate empirically, and NICE NG79 (2017) lists Phenoxymethylpenicillin first and does not mention Amoxicillin. An antibiotic is considered when symptoms last more than 10 days without improvement, worsen after initial improvement, or start severely (fever of 39 °C or higher with purulent discharge or facial pain for 3–4 consecutive days); before that no antibiotic is needed, and AAO-HNS and NICE allow watchful waiting or a delayed prescription. The benefit is modest: in the Cochrane 2014 review 91% were cured or improved on penicillin or Amoxicillin versus 86% on placebo, with more adverse events. The standard adult dose is 500 mg three times daily for 5–10 days per AAO-HNS 2015 (NICE: 5 days); an 875 mg strength is not marketed in Spain. Children: 45 mg/kg/day, 80–90 mg/kg/day with risk factors (AAP 2013), 10–14 days per IDSA. High-dose Amoxicillin/clavulanate is used where non-susceptible S. pneumoniae exceeds 10%, at age 65 or older, after recent hospitalisation or an antibiotic in the last month, and with immunosuppression. Eyelid swelling, visual change, severe headache or neck stiffness need urgent in-person assessment. Per the label, it is contraindicated in penicillin allergy and after anaphylaxis to another beta-lactam; AAO-HNS and NICE suggest Doxycycline for allergic patients. Avoid Amoxicillin if infectious mononucleosis is suspected (rash); antibiotic-associated colitis can occur. In pregnancy it is used when benefit outweighs risk; small amounts pass into breast milk. Interactions: Methotrexate (increased toxicity), oral anticoagulants (monitor prothrombin time), Allopurinol (more rash).
- AAmoxicillin + Clavulanic AcidFirst line · Fixed-dose combination: aminopenicillin plus beta-lactamase inhibitorAcute bacterial rhinosinusitis in adults and children when a bacterial cause is reasonably suspected (IDSA 2012, AAP 2013): symptoms lasting more than 10 days without improvement, worsening after initial improvement, or severe onset with fever ≥39 °C and purulent nasal discharge or facial pain for at least 3 consecutive days. IDSA 2012 recommends amoxicillin-clavulanate rather than amoxicillin as empirical first-line therapy in adults and children; AAP 2013 (children) and AAO-HNS 2015 (adults) name "amoxicillin with or without clavulanate" as first line and allow watchful waiting in uncomplicated cases. For children the Spanish framework differs: the pediatric SEIP/AEPap/SEPEAP/SEORL 2013 consensus and its 2023 update consider amoxicillin the drug of choice and keep the combination for selected cases (risk factors, amoxicillin failure). Per Cochrane 2018, the benefit of antibiotics in uncomplicated rhinosinusitis in adults is modest and adverse effects are more frequent. Adult dose: 875/125 mg every 12 h for 5–7 days (IDSA 2012; AAO-HNS 2015: 5–10 days); the Spanish SmPC gives 875/125 mg 2–3 times daily. IDSA 2012 reserves the high dose (2 g of amoxicillin twice daily; 90 mg/kg/day in children) for risk factors for resistance: age under 2 or over 65, daycare attendance, antibiotics or hospitalization in the past month, immunosuppression, severe illness. Children: 45 mg/kg/day of amoxicillin in two doses (IDSA 2012) for 10–14 days; in Spain the high dose is given with the 8:1 suspension (100/12.5 mg/ml). The 875/125 mg tablets are not recommended in severe kidney impairment (creatinine clearance below 30 ml/min). Contraindications (AEMPS SmPC, 4.3): penicillin allergy, anaphylaxis to other beta-lactams, and a history of jaundice or liver injury with amoxicillin-clavulanate. Possible cholestatic hepatitis, diarrhea up to C. difficile-associated colitis, and rash in infectious mononucleosis. Interactions: oral anticoagulants (higher INR), methotrexate, mycophenolate, allopurinol (more rash). Pregnancy (4.6): only if the doctor considers it essential; during breastfeeding the infant may develop diarrhea and candidiasis.
- BCefditoren pivoxilSecond line · Third-generation oral cephalosporinUsed 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. IDSA 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.
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.
How to read tiers A–F
Evidence tiers belong to the drug-indication pair, not to the drug as a whole: the same substance can be A for one condition and F for another.
- 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