Clinical beta

FMBM is currently in clinical beta. Content is for professional review/testing and must not replace local protocols, senior clinical judgment, or official prescribing references.

Drug Monograph

Cephalexin

Cephalexin

First-generation oral cephalosporin

MSSAStreptococcusUTISSTIPOβ-lactam

Indication

Uncomplicated SSTI • UTI • otitis media (susceptible organisms) • streptococcal pharyngitis (selected cases)

At a glance

INDICATIONS (CORE USE)

Susceptible MSSA / strep SSTI; uncomplicated UTI; some streptococcal pharyngitis alternatives — NOT MRSA reliable.

ADULT DOSE (STANDARD)

250–500 mg PO q6–12h (infection-dependent); UTI often 500 mg PO q12h

MAX DOSE

~4 g/day PO (adult) — follow local guideline

Route

PO

PEDIATRIC DOSE

25–50 mg/kg/day PO divided q6–12h (~max 2–4 g/day by indication/weight)

Do not miss

Must-not-miss safety points

Major warning

- **Misuse boundary:** NOT appropriate as sole therapy for **pyelonephritis**, **bacteremia**, or **unstable systemic infection** — escalate route/spectrum when indicated - **MRSA:** **no reliable MRSA coverage** — do not use as monotherapy when MRSA in differential - β-lactam → anaphylaxis risk; severe penicillin allergy → caution / alternative per protocol - Poor MRSA / enterococcus / anaerobe / many gram-neg coverage → treatment failure if wrong bug - Do not use for viral infections — drives resistance + C. diff risk - Renal impairment → reduce dose / extend interval

Indications

USE IF: Mild–moderate susceptible MSSA/strep SSTI; uncomplicated UTI; some respiratory/otitis when spectrum fits local susceptibility. AVOID IF: MRSA suspected; serious pseudomonal / ESBL / high-risk gram-negative infection; severe β-lactam allergy when cephalosporin contraindicated.

Primary

  • Uncomplicated SSTI due to susceptible MSSA / Streptococcus
  • Uncomplicated cystitis / selected UTI (susceptible E. coli / Klebsiella where appropriate)
  • Otitis media / sinusitis (only when local guidelines support and susceptibility expected)

Secondary

  • Streptococcal pharyngitis when penicillin not usable (guideline-dependent)
  • Dental prophylaxis in selected high-risk cardiac patients (regional protocol only)

Other

  • Step-down from IV therapy when bioavailability and susceptibility allow

Dosing

STANDARD (ADULT PO)

500 mg PO q12h (many mild–moderate infections)

ADULT DOSE

Uncomplicated UTI: often 500 mg PO q12h × ~7–14d (female cystitis often shorter course per guideline) SSTI mild–moderate: 500 mg PO q6–12h Pharyngitis alternative: per local guideline dosing

PEDIATRIC DOSE

25–50 mg/kg/day PO divided q6–12h (use suspension if needed).

MAX DOSE

Adult ~4 g/day PO ceiling in many references — reduce in CKD.

Practical Note

Take with food if GI upset. Verify culture/susceptibility for recurrent UTI.

Warnings

Clinical warnings

  • **β-lactam allergy — immediate** (anaphylaxis, angioedema, bronchospasm, hypotension) → **avoid** this agent; use non–β-lactam alternative
  • **β-lactam allergy — non-severe** (maculopapular rash without systemic anaphylaxis features) → **caution**; risk/benefit + allergy/ID pathway; graded challenge or test dose **only** per protocol — do not dismiss automatically
  • Oral β-lactams: **CNS toxicity uncommon** vs IV agents; still consider if massive overdose + severe CKD
  • C. difficile colitis risk with any antibiotic — suspect if diarrhea during/after therapy
  • Cross-sensitivity penicillin–cephalosporin is lower than penicillin–penicillin but not zero
  • False-positive Coombs; may interfere with some glucose tests (agent-specific)

Adverse effects

  • GI upset
  • rash
  • C. diff
  • rare hepatotoxicity
  • rare interstitial nephritis

Contraindications

  • Anaphylaxis to cephalexin / severe cephalosporin allergy when cephalosporin use unacceptable

Drug interactions

  • Probenecid → ↑ cephalexin levels
  • Warfarin → possible INR fluctuation (monitor)

Special populations

Pediatrics

25–50 mg/kg/day PO divided q6–12h (~max 2–4 g/day by indication/weight)

Pregnancy

Pregnancy: generally considered low risk (cephalosporin class) — use when clearly indicated.

Lactation

compatible with breastfeeding for most infants.

Renal impairment

CrCl <30–50 mL/min → extend interval and/or reduce total daily dose (pharmacy adjust). Dialysis: give after HD / per protocol. **CrCl scaffold (FMBM — titrate to FDA/SFDA label + institutional pharmacy nomogram):** - **CrCl ≥50** → usual PO regimen - **CrCl 10–50** → extend interval or ↓ total daily dose per label - **CrCl <10** → further reduction; align **HD** timing with absorption / redose per protocol

Hepatic impairment

No routine adjustment; monitor if combined hepato-renal illness.

Elderly

Higher bleeding risk if on anticoagulants; renal dosing; fall risk if delirium from intercurrent illness.

Administration

PO with or without food. Complete course for strep pharyngitis. Hydration for UTI.

Monitoring

  • Monitor: - CKD, frail elderly, or dehydration → estimate CrCl → adjust interval/dose per label - Institutional β-lactam allergy pathway → first-dose observation if protocol mandates - Renal function if CKD or dehydration; INR if on warfarin
  • Recheck: - Clinical response 48–72h; recurrent UTI → urology / resistance workup - No clinical improvement at 48–72h → reassess diagnosis, resistance, source control, and drug interactions - If targets not met after reassessment of dose, organ function, and interactions → escalate per protocol (DO NOT continue blindly)

Overdose / toxicity

Clinical Picture

**Life-threatening (first):** **anaphylaxis**; **CNS toxicity** (seizures, encephalopathy) — uncommon vs IV but consider **massive ingestion + severe CKD** or continued dosing in renal failure. **Secondary:** GI upset (nausea, vomiting, diarrhea).

Immediate Actions

Stop drug → ABCs; seizures → benzos; anaphylaxis → epinephrine + ACLS

Antidote

No specific antidote; treat complications (e.g. anaphylaxis → epinephrine per ACLS)

Decontamination

Large recent ingestion → charcoal if appropriate window, airway protected

Escalation

Refractory shock, angioedema, seizures, intractable vomiting → **ED/ICU**; **severe neurotoxicity or renal failure with suspected accumulation → consider hemodialysis** (agent-dependent) — nephrology + pharmacy

Clinical pearls

Common mistakes, resistance logic, and bedside traps

High-Yield Summary

Oral first-gen ceph for **susceptible** strep/MSSA + many uncomplicated UTIs. → Not your MRSA drug. → Renal adjust.

Clinical pearls

Stewardship: no antibiotics for viral URI. De-escalation: PO step-down when stable + susceptible. Resistance: rising ESBL in some regions — know your UTI antibiogram. *Stewardship (all antimicrobials):* Empiric choice → syndrome severity + **local antibiogram**; shortest effective course.

Stewardship & safety

  • C. diff vigilance
  • Renal dose in CKD
  • Allergy history documentation

Pharmacokinetics

PO well absorbed; renal elimination; T½ ~0.5–1 h (adults); penetrates many tissues modestly; CSF not reliable for meningitis.

Mechanism of action

Binds PBPs → inhibition of cell wall synthesis (bactericidal).

Common brand names

Saudi Arabia

Keflex, Ceporex

Global

(placeholder — verify local formulary)

Common trade names are curated examples only — formulations and availability vary. Verify the exact product name with your local pharmacy and national regulator before prescribing or dispensing.

Country practice notes

  • Empiric choice → tie to syndrome, severity, and local antibiogram — not habit.
  • IV → PO step-down when oral bioavailability and susceptibility allow.
  • Do not use antibiotics for uncomplicated viral illness — stewardship.

References

Saudi Arabia

  • SFDA (Saudi Food & Drug Authority)
  • Saudi National Formulary / MOH (where available)

International

  • WHO Model List of Essential Medicines (verify current edition)
  • US FDA or EU EMA product information (when national SmPC is unavailable)
  • Sanford Guide
  • IDSA / ESCMID (indication-specific)
  • Local antimicrobial stewardship / hospital formulary
  • FDA / SFDA / regional product labeling
  • Sanford Guide
  • IDSA / ESCMID (indication-specific)
  • Local antimicrobial stewardship / hospital formulary
  • FDA / SFDA / regional product labeling

Do not miss

  • Uncomplicated viral URI/bronchitis → antibiotics rarely indicated
  • Narrow or stop when susceptibilities + clinical stability allow
  • β-lactam anaphylaxis possible.
  • Treatment failure → think MRSA, resistant GNR, or non-bacterial mimic.
  • C. diff vigilance
  • Renal dose in CKD
  • Allergy history documentation