CEBO 200/MG 20/CAP

Indications

Approved Uses

Osteoarthritis, rheumatoid arthritis, acute pain, primary dysmenorrhea, ankylosing spondylitis, juvenile rheumatoid arthritis (in patients ≥2 years)

Off-Label Uses

Familial adenomatous polyposis (FAP)/colorectal adenoma risk reduction (context-dependent), and adjunct in multimodal perioperative/acute pain protocols (institution-specific).

Dosage & Administration

Dosing by Condition

Osteoarthritis: 200mg once daily or 100mg twice daily. Rheumatoid Arthritis: 100-200mg twice daily. Ankylosing Spondylitis: 200mg once daily or 100mg twice daily, may increase to 400mg daily if no response after 6 weeks. Acute Pain/Primary Dysmenorrhea: 400mg initially, followed by a 200mg dose if needed on day one, then 200mg twice daily as needed.

Initial Dose

200 mg once daily (osteoarthritis) or 400 mg initially followed by an additional 200 mg if needed on first day (acute pain)

Maintenance Dose

100-200 mg twice daily depending on indication

Maximum Dose

400 mg daily (may trial for ankylosing spondylitis if no response after 6 weeks on 200 mg; 400 mg initially for acute pain followed by 200 mg if needed on first day)

Children's Dosage

Juvenile rheumatoid arthritis (≥2 years, ≥10 kg to ≤25 kg): 50 mg twice daily; (>25 kg): 100 mg twice daily

Dose Adjustment Notes

Reduce dose by 50% in moderate hepatic impairment (Child-Pugh Class B). Avoid in severe hepatic impairment. Use lowest effective dose in elderly. Not recommended in severe renal impairment

How to Take

Swallow capsule whole with water; may be taken with or without food. If unable to swallow, the capsule may be opened and the contents sprinkled on a teaspoon of applesauce (or similar soft food) and swallowed immediately, followed by water; do not crush/chew the pellets.

Side Effects

Common Side Effects

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

Safety & Warnings

Contraindications

Contraindications: hypersensitivity to celecoxib; history of asthma/urticaria/other allergic-type reactions after aspirin or other NSAIDs; perioperative pain in the setting of CABG surgery; (also avoid in late pregnancy-especially ≥30 weeks-due to fetal ductus arteriosus risk).

Warnings & Precautions

Use lowest effective dose for shortest duration; monitor for CV events and blood pressure; GI bleeding risk (higher in elderly, prior ulcer, anticoagulants/antiplatelets/SSRIs); renal risk (higher with CKD, HF, dehydration, ACEi/ARB/diuretics); fluid retention/edema and HF exacerbation; severe skin reactions-stop at first rash; anaphylactoid reactions; may mask fever/inflammation; caution with hepatic impairment and sulfonamide allergy history.

Age Restriction

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

Drug Interactions

Drug Interactions

Key interactions: anticoagulants/antiplatelets (e.g., warfarin) ↑ bleeding; aspirin/other NSAIDs ↑ GI risk; ACEi/ARB/diuretics ↑ renal risk and may blunt antihypertensive effect; lithium ↑ levels; CYP2C9 inhibitors (e.g., fluconazole) ↑ celecoxib exposure; methotrexate ↑ toxicity; cyclosporine/tacrolimus ↑ nephrotoxicity; SSRIs/SNRIs ↑ GI bleeding risk.

Interaction Severity

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

Food Interaction

No food restriction: may be taken with or without food; taking with food can reduce dyspepsia, while a high-fat meal may delay Tmax and increase exposure.

Special Populations

Pregnancy

Avoid in late pregnancy (≥30 weeks); earlier use if potential benefit justifies risk

Children

Juvenile rheumatoid arthritis (≥2 years, ≥10 kg to ≤25 kg): 50 mg twice daily; (>25 kg): 100 mg twice daily

Elderly

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

Kidney Impairment

No dose adjustment for mild-moderate renal impairment, but use with caution and monitor; avoid/not recommended in severe renal impairment (CrCl <30 mL/min).

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.

Overdose

Symptoms: lethargy/drowsiness, nausea/vomiting, epigastric pain; may progress to GI bleeding, hypertension, acute kidney injury, and rarely respiratory depression. Management: supportive care; consider activated charcoal if early after ingestion; dialysis is unlikely to help due to high protein binding; urgent medical evaluation required.

Patient Counseling

Use the lowest effective dose for the shortest duration; may take with or without food (take with food if stomach upset). Avoid combining with other NSAIDs unless prescriber advises; seek urgent care for chest pain/shortness of breath/weakness or black stools/vomiting blood; report rash, facial swelling, or breathing difficulty; monitor/mention history of heart disease, hypertension, kidney disease, GI ulcer/bleeding; limit alcohol; avoid in late pregnancy (especially 3rd trimester) and discuss if pregnant/trying to conceive.

Monitoring Requirements

Monitor blood pressure; renal function (SCr/BUN) in at-risk patients and periodically with longer use; liver function with prolonged therapy or if symptoms arise; CBC if long-term or if anemia/bleeding suspected; monitor for GI bleeding and cardiovascular thrombotic symptoms.

Pharmacology

Mechanism of Action

Selectively inhibits cyclooxygenase-2 (COX-2), decreasing prostaglandin synthesis to reduce pain and inflammation, with relatively less COX-1 inhibition than nonselective NSAIDs.

Onset of Action

Analgesic effect typically begins within about 1 hour (often 30-60 minutes); full anti-inflammatory benefit may take several days of regular dosing.

Duration of Effect

Effective half-life approximately 11 hours

Half-Life

Approximately 11 hours.

Bioavailability

Approximately 40% (oral bioavailability); high-fat meals can increase AUC and delay Tmax.

Metabolism

Hepatic metabolism primarily via CYP2C9 (minor CYP3A4) to inactive metabolites.

Protein Binding

Approximately 97% protein bound, mainly to albumin.

Product Information

Available Dosage Forms

Capsule, hard (oral).

Composition per Dose

Each capsule: 200 mg celecoxib

Generic Availability

Yes

Pain Type

Joint, Muscular, General

Nsaid

Yes

Opioid

No

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