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

Celecoxib

USE IF: OA/RA with GI risk, CKD (preferred vs NSAIDs), acute pain, dysmenorrhea, migraine (Elyxyb)

AVOID IF: Established IHD/CHF/PAD/stroke, pregnancy >=20 weeks, severe hepatic/renal impairment

Celecoxib

Selective COX-2 inhibitor (Coxib)

NSAIDGI-sparingCKD-preferred NSAIDCOX-2CV risk

Indication

OA/RA with GI risk, CKD preferred, acute pain, dysmenorrhea

At a glance

INDICATION -> NSAID of choice in GI risk or CKD (better GI/renal profile)

ADULT DOSE -> 100–200 mg BID

MAX DOSE -> 400 mg/day routine; 800 mg/day FAP only

CONTRA -> Established IHD/CHF/PAD/stroke; pregnancy >=20 weeks; severe hepatic/renal impairment

ANTIDOTE -> No specific; supportive care

Quick facts

Onset

30–60 min

Duration

8–12 h

Routes

PO only

Pregnancy

Avoid >=20 weeks; contraindicated >=30 weeks

Renal

Avoid severe impairment

Hepatic

Reduce dose (Child-Pugh B); avoid severe

Do not miss

Time to action: 30—60 min (capsule); ~1 h (Elyxyb)

Max dose

  • 400 mg/day routine; 800 mg/day only for FAP.

Black box risks

  • CV thrombotic events (black box).
  • GI bleed.
  • AKI risk.
  • Hepatic injury.

No specific antidote

  • No specific antidote; supportive care.

High-risk scenarios

  • Avoid in established CV disease (IHD, stroke, PAD).
  • If required: lowest dose, shortest duration.
  • Risk is dose-dependent (increases at higher doses).
  • Triple whammy: ACEi/ARB + diuretic + NSAID -> high AKI risk.
  • Avoid combination when possible or monitor closely.
  • CYP2C9 poor metabolizers (consider dose reduction).

Key interactions

  • Aspirin: does NOT interfere with aspirin antiplatelet effect.
  • Combination still increases GI risk -> COX-2 GI advantage reduced.
  • Key interactions: Warfarin (↑ INR, CYP2C9).
  • Fluconazole (↑ celecoxib levels -> reduce dose).
  • Lithium (↑ levels).
  • Methotrexate (↑ toxicity).
  • ACEi/ARB + diuretics (AKI risk).

Indications

Primary

  • OA
  • RA
  • AS
  • Acute pain
  • Dysmenorrhea

Secondary

  • JIA
  • Migraine (Elyxyb)
  • FAP

Other

  • Acute gout (off-label)
  • Perioperative analgesia

Dosing

Standard: 100—200 mg BID

Max daily dose

  • Routine: 400 mg/day.
  • FAP: up to 800 mg/day.

Adult - PO

  • Standard: 100–200 mg BID.
  • OA: 100 mg BID OR 200 mg/day.
  • RA: 100–200 mg BID.
  • Acute pain: 400 mg -> then 200 mg BID.
  • Dysmenorrhea: same as acute pain dosing.
  • Migraine (Elyxyb): 120 mg single dose.

Adult - IV

  • Not available

Pediatric

  • >=10–25 kg: 50 mg BID.
  • >25 kg: 100 mg BID.

Renal adjustment

  • Mild–moderate: caution.
  • Severe: avoid.

Hepatic adjustment

  • Mild–moderate impairment: reduce dose.
  • Severe impairment: avoid.

Warnings

Clinical warnings

  • Avoid in established CV disease (IHD, stroke, PAD).
  • CV thrombotic risk is dose-dependent (increases at higher doses).
  • GI bleeding (lower than NSAIDs but still present).
  • AKI risk, especially with volume depletion.
  • Hepatic toxicity.
  • Severe skin reactions (SJS/TEN).
  • Anaphylaxis in NSAID-sensitive patients.
  • BP elevation.

Adverse effects

  • Common: dyspepsia, nausea, edema, headache.
  • Serious: CV events, GI bleed, hepatic injury, SJS/TEN.

Contraindications / caution

Do not use

  • IHD, CHF, PAD, stroke.
  • Active GI bleed.
  • Severe hepatic impairment.
  • Severe renal impairment.
  • Pregnancy >=30 weeks.
  • CABG perioperative.

Use caution / avoid high doses

  • Moderate hepatic impairment.
  • CKD (30–60).
  • Elderly.
  • Anticoagulants.
  • Concurrent steroids.

Drug interactions

  • Warfarin -> ↑ INR (CYP2C9).
  • Fluconazole -> ↑ celecoxib levels (reduce dose).
  • Lithium -> ↑ levels.
  • Methotrexate -> ↑ toxicity.
  • ACEi/ARB + diuretics -> AKI risk.

Special populations

Pediatrics

Weight-based dosing; monitor renal/hepatic risks.

Pregnancy

Avoid >=20 weeks; contraindicated >=30 weeks.

Breastfeeding

Not preferred (limited data).

Elderly

Lower starting dose; monitor renal/BP.

Liver disease

Reduce dose in moderate; avoid severe.

Renal impairment

Prefer over NSAIDs in CKD 30–60; avoid severe.

Administration

  • PO only (capsule or oral solution).
  • With/without food (routine); with food for FAP.
  • Elyxyb: drink entire dose.

Monitoring

  • Renal function.
  • LFTs.
  • INR if on warfarin.
  • Lithium levels.
  • Blood pressure (NSAIDs may increase BP) within ~2 weeks.
  • GI symptoms.
  • CV symptoms.

Overdose / toxicity

IF SUSPECTED CELECOXIB OVERDOSE -> ASSESS ABC, labs

Recognition

  • Toxic dose: >5–10× therapeutic.
  • Features: GI symptoms, CNS depression, AKI.

Immediate actions

  • Activated charcoal (<=4 h).
  • IV fluids.
  • Supportive care.

Antidote

  • No specific antidote — supportive care.

Decontamination

  • Activated charcoal within <=4 h if appropriate.

Escalation

  • Dialysis for AKI only (not drug removal).

Clinical pearls

Common mistakes, resistance logic, and bedside traps

GI + renal balance

  • Best NSAID for GI + renal safety balance.

CV risk

  • CV risk still present -> avoid in established CV disease.

Aspirin replaced

  • Does NOT interfere with aspirin antiplatelet effect.
  • Combination still increases GI risk -> COX-2 GI advantage reduced.

Drug interactions

  • Fluconazole interaction is high-risk.
  • CYP2C9 poor metabolizers -> reduce dose.

FAP dosing

  • FAP dosing = highest (800 mg/day).

Migraine option

  • Elyxyb = fastest oral NSAID option for migraine.

Pharmacokinetics

  • Bioavailability increases with food (~10–20%).
  • Protein binding >97%.
  • Hepatic metabolism (CYP2C9).
  • Half-life ~11–12 h.
  • Fecal + renal elimination.

Mechanism of action

  • Selective COX-2 inhibition.
  • ↓ Prostaglandins -> ↓ inflammation/pain.
  • Spares COX-1 -> less GI toxicity.
  • No platelet inhibition.

Common brand names

Saudi Arabia

Celebrex · Arthrix · Movydia · Algoxib · Nexib

Global

Elyxyb · Onsenal · Consensi

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

  • Preferred NSAID in Gulf patients with diabetes/CKD due to better renal safety.
  • Widely used (Celebrex, Arthrix, Movydia, Algoxib).
  • CYP2C9 polymorphisms more relevant in Middle Eastern populations -> consider dose reduction.
  • GI protection still required if combined with aspirin.
  • Elyxyb not widely available regionally yet.

Saudi Arabia — confirm with local formulary.