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

Nitrofurantoin

Nitrofurantoin

Nitrofuran (PO)

UTIUncomplicatedPulmonary fibrosis

Indication

Acute cystitis β€’ UTI prophylaxis β€’ NOT pyelonephritis

At a glance

INDICATIONS (CORE USE)

**Uncomplicated cystitis** first-line many guidelines β€” **avoid CrCl <30** (ineffective + toxicity); **pulmonary/hepatic** toxicity long-term suppressive.

ADULT DOSE (STANDARD)

Macrocrystal 100 mg PO BID Γ— 5–7d cystitis; prophylaxis 50–100 mg HS

MAX DOSE

400 mg/day total

Route

PO

PEDIATRIC DOSE

5–7 mg/kg/day divided (max 400 mg/day) β€” verify formulation

Do not miss

Must-not-miss safety points

Major warning

- **Misuse boundary:** NOT appropriate as sole therapy for **pyelonephritis**, **bacteremia**, or **unstable systemic infection** β€” escalate route/spectrum when indicated - **MRSA:** **no reliable MRSA coverage** β€” do not use as monotherapy when MRSA in differential - **CrCl <30** β†’ avoid (ineffective urine levels + toxicity) - **Pulmonary fibrosis** acute/chronic β€” stop if new dyspnea - **Hepatotoxicity** β€” LFTs if prolonged - Peripheral neuropathy renal impairment

Indications

USE IF: Uncomplicated lower UTI, prophylaxis when indicated. AVOID IF: Pyelonephritis, men, indwelling catheter stones (often inadequate), CrCl <30.

Primary

  • Acute uncomplicated cystitis in women (resistance-dependent)
  • Urinary tract infection prophylaxis selected indications

Secondary

  • UTI in pregnancy second/third trimester when susceptible and guideline supports

Other

  • NOT reliable for febrile UTI / pyelonephritis

Dosing

STANDARD (ADULT PO)

100 mg BID Γ— 5–7 days cystitis

ADULT DOSE

Macro 100 mg BID; Monohydrate/macrocrystal BID schedules differ slightly by product

PEDIATRIC DOSE

Weight-based divided.

MAX DOSE

400 mg/day

Practical Note

Take with food; complete short course.

Warnings

Clinical warnings

  • Pulmonary reaction early or late
  • Peripheral neuropathy

Adverse effects

  • nausea
  • dark harmless urine
  • headache

Contraindications

  • Anuria/oliguria
  • CrCl <30 (product-specific)
  • Acute porphyria
  • Infants <1 month

Drug interactions

  • Magnesium trisilicate antacid ↓ absorption
  • Probenecid ↓ efficacy

Special populations

Pediatrics

5–7 mg/kg/day divided (max 400 mg/day) β€” verify formulation

Pregnancy

Avoid near term (hemolysis newborn G6PD); earlier pregnancy per guideline

Lactation

compatible generally.

Renal impairment

CrCl <30 β†’ **avoid**; 30–50 use caution short course only per some labels. **CrCl scaffold (FMBM β€” titrate to FDA/SFDA label + institutional pharmacy nomogram):** - **CrCl β‰₯50** β†’ short cystitis courses per indication - **CrCl 10–50** β†’ caution β€” many labels **avoid if CrCl <30** (urine penetration + toxicity); verify SFDA/FDA - **CrCl <10** β†’ **avoid** (ineffective urine + toxicity risk)

Hepatic impairment

Acute hepatitis on nitro β€” never rechallenge.

Elderly

Renal function estimate β€” Cockcroft-Gault matters here.

Administration

PO with food; plenty of water.

Monitoring

  • Monitor: - Before start (especially elderly) β†’ **CrCl** β†’ **<30** β†’ **avoid** (urine + toxicity) - New cough / dyspnea / fever on drug β†’ **stop** β†’ **CXR** (pulmonary toxicity) - CrCl before starting in elderly - CXR if new cough/fever on therapy
  • Recheck: - No clinical improvement at 48–72h β†’ reassess diagnosis, resistance, source control, and drug interactions - If targets not met after reassessment of dose, organ function, and interactions β†’ escalate per protocol (DO NOT continue blindly)

Overdose / toxicity

Clinical Picture

**Life-threatening (first):** **hypoxemic pulmonary** reaction; **acute liver failure**. **Secondary:** neuropathy with renal impairment.

Immediate Actions

Stop β†’ CXR if respiratory symptoms; LFTs if hepatitis

Antidote

No specific antidote; treat complications (e.g. anaphylaxis β†’ epinephrine per ACLS)

Decontamination

Supportive PO

Escalation

Hypoxemic respiratory failure, ALF β†’ **ICU** / transplant referral; **severe renal failure + toxicity β†’ consider HD** (limited role) β€” supportive

Clinical pearls

Common mistakes, resistance logic, and bedside traps

High-Yield Summary

**Cystitis champion** β€” **pyelonephritis pretender**. **CrCl <30 = stop**. **Lungs** can fry on long suppressive.

Clinical pearls

Stewardship: first-line cystitis where resistance low. Do not use for bacteremia source. Pregnancy: avoid term; OK mid-pregnancy many guidelines. *Stewardship (all antimicrobials):* Empiric choice β†’ syndrome severity + **local antibiogram**; shortest effective course.

Stewardship & safety

  • CrCl screen
  • Not pyelo
  • Dyspnea = stop

Pharmacokinetics

Low serum, high urine concentration; short half-life β€” only lower UTI.

Mechanism of action

Reduced by bacterial flavoproteins β†’ reactive intermediates damage DNA/ribosomes.

Common brand names

Global data (no country-specific data available)

Saudi Arabia

(placeholder β€” verify local formulary)

Common trade names are curated examples only β€” 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 β†’ tie to syndrome, severity, and local antibiogram β€” not habit.
  • IV β†’ PO step-down when oral bioavailability and susceptibility allow.
  • Do not use antibiotics for uncomplicated viral illness β€” 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 β†’ antibiotics rarely indicated
  • Narrow or stop when susceptibilities + clinical stability allow
  • Prescribing nitro for febrile UTI with back pain β†’ undertreatment.
  • Acute pulmonary nitro weeks into therapy β€” stop + steroids sometimes.
  • CrCl screen
  • Not pyelo
  • Dyspnea = stop