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

Naproxen

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USE IF: Acute pain, gout, dysmenorrhea, arthritis, patients needing NSAID with lower CV risk

AVOID IF: eGFR <30, active GI bleed, pregnancy >=20 weeks, AERD, concurrent high bleeding risk

Naproxen

Non-selective NSAID (propionic acid derivative)

NSAIDAnti-inflammatoryGoutDysmenorrheaCV-safer NSAID

Indication

Acute pain, gout, dysmenorrhea, arthritis (lower CV-risk NSAID)

At a glance

INDICATION -> Acute pain, gout, dysmenorrhea, arthritis (lower CV-risk NSAID when appropriate)

ADULT DOSE -> 250–500 mg BID (Rx); 220 mg q8–12h OTC

MAX DOSE -> 1,500 mg/day Rx; 660 mg/day OTC

CONTRA -> eGFR <30, active GI bleed, AERD, pregnancy >=20 wk, concurrent high bleeding risk

ANTIDOTE -> No specific; supportive care

Quick facts

Onset

30–60 min (IR)

Duration

Peak 2–4 h; up to 12 h effect; t1/2 ~12–17 h (enables BID).

Routes

PO only

Pregnancy

Avoid >=20 weeks; contraindicated >=28 weeks

Renal

Avoid if eGFR <30

Hepatic

Avoid severe impairment

Do not miss

Time to action: 30—60 min (IR); EC delayed 4—6 h

Max dose

  • Max 1,500 mg/day (Rx).

Black box risks

  • GI bleed/ulcer
  • AKI risk
  • CV events risk
  • Pregnancy toxicity

Aspirin interaction

  • No specific antidote — supportive care.
  • Aspirin cardioprotection may be affected (timing/washout may be required when clinically indicated).

Hidden NSAIDs / combos

  • High-risk scenarios: elderly, CKD, HF, anticoagulants, pregnancy >=20 wk.
  • PPI co-prescription is standard in elderly or dual therapy when appropriate.
  • TRIPLE WHAMMY: NSAID + ACEi/ARB + diuretic → high AKI risk.
  • Avoid combination or monitor closely.

Warfarin

  • Warfarin/NOACs -> increased bleeding.
  • Aspirin -> reduced cardioprotection (washout effect).
  • Methotrexate -> increased toxicity.
  • Lithium -> increased levels.
  • SSRIs -> increased GI bleeding.

Indications

Primary

  • Acute pain
  • Gout
  • Dysmenorrhea
  • Arthritis (RA/OA)

Secondary

  • JIA
  • Migraine
  • Pericarditis

Other

  • Heterotopic ossification (off-label)
  • Fibroids (off-label)

Dosing

Standard: 250—500 mg BID

Max daily dose

  • Rx: 1,500 mg/day.
  • OTC: 660 mg/day.

Adult - PO

  • PAIN / OA: 250–500 mg BID.
  • ACUTE PAIN: 500 mg loading → then 250 mg q6–8h.
  • GOUT: 750 mg loading → then 250 mg q8h until resolved.
  • DYSMENORRHEA: 500 mg loading → then 250 mg q6–8h.
  • NOTE: Always use lowest effective dose for shortest duration.

Adult - IV

  • Not available

Pediatric

  • JIA: 5 mg/kg BID (max 1,000 mg/day).

Renal adjustment

  • eGFR >=30: reduce dose.
  • eGFR <30: avoid.

Hepatic adjustment

  • Mild: caution.
  • Severe: avoid.

Warnings

Clinical warnings

  • GI bleeding and ulcer risk
  • CV risk (lowest among NSAIDs but still present)
  • AKI risk (especially with dehydration, CKD, ACEi/ARB + diuretics)
  • Fluid retention and HF exacerbation
  • Hepatotoxicity (rare)
  • Aseptic meningitis (rare)
  • Pseudoporphyria in children with JIA

Adverse effects

  • Common: dyspepsia, nausea, edema.
  • Serious: GI bleed/ulcer, renal impairment, CV events, aseptic meningitis.

Contraindications / caution

Do not use

  • eGFR <30
  • Active GI bleed
  • NSAID hypersensitivity / AERD
  • Pregnancy >=20 weeks (especially >=28 weeks)
  • CABG perioperative

Use caution / avoid high doses

  • Elderly
  • CKD (30–60)
  • Anticoagulants
  • Peptic ulcer history
  • HF, cirrhosis

Drug interactions

  • Warfarin/NOACs -> increased bleeding
  • Aspirin -> reduced cardioprotection (washout effect)
  • Methotrexate -> increased toxicity
  • Lithium -> increased levels
  • SSRIs -> increased GI bleeding

Special populations

Pediatrics

JIA dosing (5 mg/kg BID, max 1,000 mg/day); monitor for pseudoporphyria.

Pregnancy

Avoid >=20 weeks; contraindicated >=28 weeks.

Breastfeeding

Not preferred (ibuprofen often preferred).

Elderly

Start low (250 mg BID); high GI/renal risk.

Liver disease

Avoid severe liver disease.

Renal impairment

Avoid if eGFR <30.

Administration

  • PO only; take with food.
  • Use IR for acute pain; avoid EC for acute conditions.

Monitoring

  • Renal function
  • LFTs
  • INR if on warfarin
  • Lithium levels (if relevant)
  • BP
  • GI bleeding
  • Edema/weight
  • Pain response

Overdose / toxicity

IF SUSPECTED NAPROXEN OVERDOSE: • Assess ABC, check renal function, electrolytes • Consider activated charcoal within 1–2 hours if protected airway

Recognition

  • <100 mg/kg -> usually mild
  • 100–400 mg/kg -> moderate toxicity (GI, CNS)
  • >400 mg/kg -> severe toxicity risk (seizures, acidosis)

Immediate actions

  • Assess ABC; check renal function and electrolytes.
  • Activated charcoal within 1–2 hours if protected airway.
  • IV fluids.
  • Treat acidosis (bicarbonate) if present.
  • Supportive care; monitor vitals and labs.

Antidote

  • No specific antidote — supportive care.

Decontamination

  • Activated charcoal within 1–2 hours if protected airway.

Escalation

  • Persistent CNS depression.
  • Severe metabolic acidosis.
  • Renal failure.
  • NOTE: Dialysis NOT effective (high protein binding).

Clinical pearls

Common mistakes, resistance logic, and bedside traps

CV risk

  • Naproxen has relatively lower CV risk vs other NSAIDs
  • BUT still increases CV risk vs no NSAID
  • Use lowest dose, shortest duration

Practical dosing

  • BID dosing improves compliance.
  • Use loading dose in gout for faster control.

Formulation

  • Use IR for acute pain.
  • Avoid EC for acute conditions (delayed).

Aspirin interference

  • Interferes with aspirin cardioprotection (washout/timing may be needed).

Peri-op stop

  • Long half-life -> stop 5–7 days pre-op when clinically indicated.

Elderly

  • Higher GI bleed risk -> consider PPI co-prescription.

Pharmacy Tool

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Naproxen 25 mg/mL oral suspension

suspension · oral

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Pharmacokinetics

  • Bioavailability ~95%
  • Highly protein bound (>99%)
  • Hepatic metabolism (CYP2C9)
  • Renal excretion
  • Long half-life supports BID dosing

Mechanism of action

  • Reversible COX-1 and COX-2 inhibition
  • Reduced prostaglandins -> decreased pain/inflammation
  • Partial reversible platelet inhibition

Common brand names

Saudi Arabia

Naprotex · Proxen · Axen · Nopain · Naproxen

Global

Naprosyn · Aleve · Naprelan · Anaprox · Vimovo

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

  • Commonly used in Gulf for musculoskeletal pain and gout.
  • Preferred NSAID in patients with CV risk vs diclofenac/ibuprofen.
  • PPI co-prescription standard in elderly or dual therapy (aspirin/SSRI) when appropriate.
  • Avoid in CKD patients common in Gulf (diabetes prevalence).
  • Widely available: Proxen, Naprotex, Nopain, Axen.

Saudi Arabia — confirm with local formulary.