Clinical medicine profile
Cefadroxil
Beta-lactam antibiotic — cephalosporin
- Route
- ORAL / PARENTERAL (generation-dependent)
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- Serious hypersensitivity to cephalosporins.
- Use extreme caution or avoid if prior anaphylaxis to penicillins (cross-reactivity lower than historically feared but not zero, especially similar side chains).
Precautions
- BEFORE THERAPY WITH CEFADROXIL IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFADROXIL, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS.
- IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-SENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY.
- IF AN ALLERGIC REACTION TO CEFADROXIL OCCURS, DISCONTINUE THE DRUG.
- SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.
- Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefadroxil, and may range in severity from mild diarrhea to fatal colitis.
- Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
- C. difficile produces toxins A and B which contribute to the development of CDAD.
- Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
- CDAD must be considered in all patients who present with diarrhea following antibiotic use.
- Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
- If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
- Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
Cefadroxil is acid-stable and may be administered orally without regard to meals. Administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy. Adults Urinary Tract Infections: For uncomplicated lower urinary tract infections (i.e., cystitis) the usual dosage is 1 or 2 g per day in a single (q.d.) or divided doses (b.i.d.). For all other urinary tract infections the usual dosage is 2 g per day in divided doses (b.i.d.). Skin and Skin Structure Infections: For skin and skin structure infections the usual dosage is 1 g per day in single (q.d.) or divided doses (b.i.d.). Pharyngitis and Tonsillitis: Treatment of group A beta-hemolytic streptococcal pharyngitis and tonsillitis—1 g per day in single (q.d.) or divided doses (b.i.d.) for 10 days. Children For urinary tract infections, the recommended daily dosage for children is 30 mg/kg/day in divided doses every 12 hours. For pharyngitis, tonsillitis, and impetigo, the recommended daily dosage for children is 30 mg/kg/day in a single dose or in equally divided doses every 12 hours. For other skin and skin structure infections, the recommended daily dosage is 30 mg/kg/day in equally divided doses every 12 hours. In the treatment of beta-hemolytic streptococcal infections, a therapeutic dosage of cefadroxil should be administered for at least 10 days. Renal Impairment In patients with renal impairment, the dosage of cefadroxil should be adjusted according to creatinine clearance rates to prevent drug accumulation. The following schedule is suggested. In adults, the initial dose is 1000 mg of cefadroxil and the maintenance dose (based on the creatinine clearance rate [mL/min/1.73 m2]) is 500 mg at the time intervals listed below. Creatinine Clearances Dosage Interval 0 to 10 mL/min 36 hours 10 to 25 mL/min 24 hours 25 to 50 mL/min 12 hours Patients with creatinine clearance rates over 50 mL/min may be treated as if they were patients having normal renal function.
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Most require dose adjustment in renal impairment (exceptions/nuances per agent — check SmPC).
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Usually low; transient LFT elevations possible.
Use, effects & interactions
Indications
- Cefadroxil is indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caused by E. coli, P. mirabilis, and Klebsiella species.
- Skin and skin structure infections caused by staphylococci and/or streptococci.
- Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci).
- Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever.
- Cefadroxil is generally effective in the eradication of streptococci from the oropharynx.
- However, data establishing the efficacy of cefadroxil for the prophylaxis of subsequent rheumatic fever are not available.
- Note: Culture and susceptibility tests should be initiated prior to and during therapy.
- Renal function studies should be performed when indicated.
- To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefadroxil and other antibacterial drugs, cefadroxil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
- When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
- In the absence of such data, local epidemology and susceptibility patterns may contribute to the empiric selection of therapy.
Adverse effects
- Gastrointestinal Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS).
- Dyspepsia, nausea and vomiting have been reported rarely.
- Diarrhea has also occurred.
- Hypersensitivity Allergies (in the form of rash, urticaria, angioedema, and pruritus) have been observed.
- These reactions usually subsided upon discontinuation of the drug.
- Anaphylaxis has also been reported.
- Other Other reactions have included hepatic dysfunction including cholestasis and elevations in serum transaminase, genital pruritus, genital moniliasis, vaginitis, moderate transient neutropenia, fever.
- Agranulocytosis, thrombocytopenia, idiosyncratic hepatic failure, erythema multiforme, Stevens-Johnson syndrome, serum sickness, and arthralgia have been rarely reported.
- In addition to the adverse reactions listed above which have been observed in patients treated with cefadroxil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: Toxic epidermal necrolysis, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, prolonged prothrombin time, positive Coombs’ test, increased BUN, increased creatinine, elevated alkaline phosphatase, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated bilirubin, elevated LDH, eosinophilia, pancytopenia, neutropenia.
- Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced (see DOSAGE AND ADMINISTRATION and OVERDOSAGE).
- If seizures associated with drug therapy occur, the drug should be discontinued.
- Anticonvulsant therapy can be given if clinically indicated.
- Gastrointestinal Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS).
- Dyspepsia, nausea and vomiting have been reported rarely.
Drug interactions
Open multi-drug checker ↗- Choose generation by indication and resistance patterns.
- Prefer narrowest effective spectrum.
- IV-to-oral switch when clinically stable.
- Align duration with guidelines (often shorter than historical practice for many infections).
Mechanism & disposition
Inhibits synthesis of bacterial cell wall, causing cell death, hence bactericidal.
Read complete mechanism
Inhibits synthesis of bacterial cell wall, causing cell death, hence bactericidal. Cephalosporins inhibit bacterial cell-wall synthesis by binding PBPs and blocking peptidoglycan cross-linking, producing bactericidal activity against susceptible organisms. Spectrum broadens from 1st to later generations; stability to beta-lactamases varies.
Rapid (IV); 1–2 h oral
6–24 hours (agent-dependent; ceftriaxone long)
ORAL / PARENTERAL (generation-dependent)
Pregnancy, lactation & diet
Generally considered acceptable in pregnancy when indicated; prefer agents with established safety data.
Usually compatible; monitor infant for GI effects.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| ACTIDROX | DAIMA BIASHARA / Wholesale Import | 1000MG 10*S | KES 1,032.54daima_biashara_price_list |
| ACTIDROX-500 | KRISHNA CHEMISTS LTD | Capsule, Hard | Unavailable |
| ACTIDROX-1000 | KRISHNA CHEMISTS LTD | Film-Coated Tablet | Unavailable |
| DROX | Not recorded | 500MG*10`S | KES 150.50Daima Chemist price-list reference ↗ Source date not recorded · verify current price |
| DURAXYL POWDER FOR ORAL SUSPENSION (125MG/5ML) | LABORATORY & ALLIED LTD | Powder For Oral Suspension 125MG | Unavailable |
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.