CELEBREX 200/MG CAP 20/CAP

Indications

Approved Uses

Osteoarthritis, Rheumatoid arthritis, Acute pain in adults, Primary dysmenorrhea, Ankylosing spondylitis, Juvenile rheumatoid arthritis (in patients ≥2 years)

Dosage & Administration

Dosing by Condition

Osteoarthritis: 200 mg once daily or 100 mg twice daily. Rheumatoid arthritis: 100-200 mg twice daily. Ankylosing spondylitis: 200 mg daily (once daily or 100 mg twice daily); if no response after ~6 weeks, may increase to 400 mg/day. Acute pain/primary dysmenorrhea: 400 mg initial dose, then 200 mg if needed on day 1; then 200 mg twice daily as needed on subsequent days. Juvenile idiopathic arthritis (≥2 years): 10-25 kg: 50 mg twice daily; >25 kg: 100 mg twice daily.

Initial Dose

Osteoarthritis: 200 mg once daily or 100 mg twice daily; Rheumatoid arthritis: 100 to 200 mg twice daily; Acute pain or primary dysmenorrhea: initial 400 mg followed by 200 mg if needed on first day.

Maintenance Dose

100-200mg twice daily for rheumatoid arthritis; 200mg once daily for osteoarthritis.

Maximum Dose

OA: 200 mg daily; RA: 400 mg daily; Acute pain: 400 mg daily after day 1; JRA: 400 mg daily max.

Children's Dosage

Juvenile rheumatoid arthritis (≥2 years): 10-25kg: 50mg twice daily; >25kg: 100mg twice daily. Not approved for children under 2 years

Dose Adjustment Notes

Hepatic impairment: reduce dose by ~50% in moderate impairment (Child-Pugh B); avoid in severe impairment (Child-Pugh C). Renal impairment: avoid use in advanced renal disease unless benefits outweigh risks and monitor renal function. CYP2C9 poor metabolizers or strong CYP2C9 inhibitors (e.g., fluconazole): start at the lowest dose/consider ~50% dose reduction and monitor.

How to Take

Swallow capsule whole with water; may be taken with or without food (take with food/milk if GI upset occurs). For patients unable to swallow, the capsule may be opened and the contents sprinkled onto a teaspoon of cool/room-temperature applesauce, swallowed immediately without chewing, then followed with water; do not store the mixture for later use.

Side Effects

Common Side Effects

Dyspepsia/indigestion, abdominal pain, diarrhea, nausea, flatulence; headache and dizziness; peripheral edema; upper respiratory tract infection/sinusitis/pharyngitis.

Side Effect Frequency

Common (≥1% to <10%): dyspepsia, diarrhea, abdominal pain, nausea, flatulence, peripheral edema, dizziness, headache, hypertension; URTI/sinusitis are also reported among common events in trials; serious CV thrombotic events, GI bleeding/perforation, severe skin reactions, hepatotoxicity, renal impairment, and anaphylaxis are rare but clinically important warnings.

Safety & Warnings

Contraindications

Contraindications: hypersensitivity to celecoxib or any component; history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; use for peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery; pregnancy (third trimester-contraindicated due to risk of premature closure of the fetal ductus arteriosus).

Warnings & Precautions

Warnings/precautions: use lowest effective dose for shortest duration; CV thrombotic risk (not a substitute for aspirin cardioprotection); serious GI bleeding/ulcer/perforation risk (higher in elderly/prior ulcer); monitor BP and for edema/heart failure; monitor renal function in at-risk patients (renal impairment, HF, dehydration, diuretics/ACEi/ARB); hepatic risk; discontinue at first sign of serious skin reaction; avoid in aspirin-sensitive asthma/NSAID hypersensitivity; caution with anticoagulants/antiplatelets and other interacting drugs.

Age Restriction

Approved for children ≥2 years for juvenile rheumatoid arthritis/juvenile idiopathic arthritis (JRA/JIA); not established <2 years.

Drug Interactions

Drug Interactions

Key interactions: anticoagulants (e.g., warfarin) and antiplatelets (incl. aspirin) ↑ bleeding; other NSAIDs ↑ GI/renal risk; ACEi/ARBs and diuretics ↑ renal risk/↓ antihypertensive/diuretic effect; lithium ↑ levels; fluconazole (CYP2C9 inhibitor) ↑ celecoxib exposure; CYP2D6 substrates (celecoxib inhibits CYP2D6) may need monitoring; SSRIs/SNRIs ↑ GI bleeding risk; methotrexate-monitor for toxicity.

Interaction Severity

MAJOR: Warfarin/other anticoagulants (↑ bleeding/INR risk); concomitant NSAIDs (including high-dose aspirin) (↑ GI bleeding/ulcer risk). MODERATE: ACE inhibitors/ARBs and diuretics (↓ antihypertensive/diuretic effect, ↑ renal risk-"triple whammy"); lithium (↑ lithium levels); methotrexate (↑ MTX toxicity risk); SSRIs/SNRIs (↑ GI bleeding risk); strong CYP2C9 inhibitors (e.g., fluconazole) (↑ celecoxib exposure). MINOR: Aluminum/magnesium antacids (may slightly reduce absorption).

Food Interaction

May be taken with or without food; taking with food or milk can reduce stomach upset (high-fat meals may delay Tmax and increase exposure modestly).

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Avoid in third trimester (contraindicated); earlier trimesters: use only if benefits outweigh risks (formerly Category C)

Children

Juvenile rheumatoid arthritis (≥2 years): 10-25kg: 50mg twice daily; >25kg: 100mg twice daily. Not approved for children under 2 years

Elderly

Start at lowest effective dose (100mg once or twice daily); monitor renal function, blood pressure, and signs of GI bleeding closely; increased risk of adverse events in elderly patients

Kidney Impairment

Mild-moderate renal impairment: no dose adjustment but use caution and monitor renal function; severe renal impairment/advanced renal disease (e.g., CrCl <30 mL/min): avoid/not recommended.

Liver Impairment

Mild hepatic impairment (Child-Pugh Class A): no adjustment needed. Moderate hepatic impairment (Child-Pugh Class B): reduce daily dose by 50%. Severe hepatic impairment (Child-Pugh Class C): contraindicated

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near next dose. Do not double the dose.

Stopping the Medicine

No taper is required; can be stopped when no longer needed, but for chronic use discuss with prescriber to ensure symptom control and alternative therapy.

Overdose

Symptoms may include lethargy/drowsiness, nausea/vomiting, epigastric pain, GI bleeding, hypertension, and acute kidney injury; management is supportive (consider activated charcoal if early), monitor vitals/renal function, and seek urgent medical care; no specific antidote.

Patient Counseling

Take exactly as prescribed; may take with or without food (use food/milk if stomach upset). Use the lowest effective dose for the shortest duration. Avoid taking other NSAIDs (e.g., ibuprofen/naproxen) unless instructed; limit alcohol to reduce GI bleeding risk. Seek urgent care for chest pain, shortness of breath, sudden weakness/slurred speech (CV/stroke), black/tarry stools or vomiting blood (GI bleed), severe rash/swelling (allergy). Tell your clinician about heart disease, high BP, kidney/liver disease, ulcers/bleeding history, and all anticoagulants/antiplatelets/SSRIs; inform providers before surgery.

Monitoring Requirements

Monitor blood pressure; assess renal function (SCr/BUN) especially in elderly, dehydrated, HF, CKD, or with ACEi/ARB/diuretic use; consider periodic CBC and LFTs with long-term therapy; monitor for GI bleeding/ulcer symptoms and cardiovascular thrombotic events.

Pharmacology

Mechanism of Action

Selectively inhibits cyclooxygenase-2 (COX-2), decreasing prostaglandin synthesis to produce analgesic, anti-inflammatory, and antipyretic effects; relative COX-1 sparing reduces (but does not eliminate) platelet and GI mucosal effects compared with nonselective NSAIDs.

Onset of Action

For acute pain, onset is typically within ~30-60 minutes; full anti-inflammatory benefit for chronic arthritis may take several days to weeks.

Duration of Effect

Analgesic effect typically lasts about 12 hours (supporting once- or twice-daily dosing depending on indication).

Half-Life

Approximately 11 hours.

Bioavailability

Absolute oral bioavailability is not well-defined/unknown (estimated ~40%); food has minimal effect on overall exposure (AUC) but may delay Tmax and can increase Cmax.

Metabolism

Primarily hepatic metabolism via CYP2C9 to inactive metabolites (minor contribution from other pathways).

Excretion

Excreted mainly as metabolites: ~57% in feces and ~27% in urine; <3% excreted unchanged.

Protein Binding

>97%

Product Information

Available Dosage Forms

Capsule (hard), oral.

Composition per Dose

Each capsule: 200mg celecoxib

Generic Availability

Yes

Pain Type

Joint, Muscular, General

Nsaid

Yes

Opioid

No

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