CELECT 200/MG CAP 20/CAP

Indications

Approved Uses

Osteoarthritis; rheumatoid arthritis; juvenile rheumatoid arthritis (in patients 2 years and older); ankylosing spondylitis; acute pain; primary dysmenorrhea.

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 needed. Acute Pain/Primary Dysmenorrhea: 400mg initially, followed by a 200mg dose if needed on the first day, then 200mg twice daily as needed.

Initial Dose

200 mg once daily (osteoarthritis); 400 mg for acute pain

Maintenance Dose

100-200mg twice daily for arthritic conditions.

Maximum Dose

400 mg per day for OA/AS/RA/AP/PD; higher doses (up to 400 mg BID) evaluated in some trials but use lowest effective dose

Children's Dosage

Not approved for children under 18 years for general indications; approved for juvenile rheumatoid arthritis in children ≥2 years (10-25 kg: 50 mg twice daily; >25 kg: 100 mg twice daily) - not applicable for this SKU indication

Dose Adjustment Notes

Hepatic impairment: reduce dose by ~50% in moderate hepatic impairment (Child-Pugh B) and avoid in severe hepatic impairment (Child-Pugh C). Consider lower starting dose in known/suspected CYP2C9 poor metabolizers. Use the lowest effective dose for the shortest duration.

How to Take

Swallow the capsule whole with water; may be taken with or without food (take with food/milk if GI upset). Do not routinely open/crush; if a patient cannot swallow, follow the product-specific label guidance-some celecoxib capsule formulations allow opening and sprinkling on cool applesauce and swallowing immediately with water.

Side Effects

Common Side Effects

Abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, dizziness, headache, insomnia, rash, sinusitis, upper respiratory tract infection.

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to celecoxib; history of asthma/urticaria or other allergic-type reactions after aspirin/other NSAIDs; use for peri-operative pain in the setting of CABG surgery; and (commonly per labeling/guidelines) late pregnancy (≥30 weeks/third trimester) due to fetal ductus arteriosus/renal risks.

Warnings & Precautions

Key warnings/precautions: CV thrombotic risk (avoid in CABG; caution in CV disease/risk factors), serious GI bleeding/ulceration (higher risk elderly/prior PUD/GI bleed), hypertension and fluid retention/edema/heart failure worsening, renal toxicity (monitor in at-risk patients; avoid dehydration), hepatic effects, serious skin reactions, anaphylactoid reactions, and may mask fever/inflammation.

Age Restriction

Approved in pediatrics ≥2 years only for juvenile idiopathic arthritis (JIA); for other indications (e.g., OA/RA/acute pain) use is generally adult-only and not established <18 years.

Drug Interactions

Interaction Severity

MAJOR: Warfarin/other anticoagulants (↑ bleeding/INR); concomitant NSAIDs (including high-dose aspirin) (↑ GI/renal toxicity); ACEi/ARB/diuretics in at-risk patients (↓ antihypertensive/diuretic effect and ↑ AKI risk-"triple whammy"). MODERATE: Fluconazole (↑ celecoxib via CYP2C9 inhibition); lithium (↑ lithium levels); methotrexate (↑ MTX toxicity risk); SSRIs/SNRIs (↑ bleeding risk). MINOR: Aluminum/magnesium antacids (small ↓ absorption).

Special Populations

Pregnancy

Contraindicated

Children

Not approved for children under 18 years for general indications; approved for juvenile rheumatoid arthritis in children ≥2 years (10-25 kg: 50 mg twice daily; >25 kg: 100 mg twice daily) - not applicable for this SKU indication

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

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

Liver Impairment

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

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near the time of the next dose; do not double the dose

Stopping the Medicine

Safe to stop anytime; no tapering required for short-term use; consult physician before stopping long-term therapy

Overdose

Symptoms: lethargy/drowsiness, nausea/vomiting, epigastric pain; possible GI bleeding, hypertension, acute kidney injury, and (rarely) respiratory depression. Management: supportive care, consider activated charcoal if early, monitor renal/hepatic function and vitals; dialysis is unlikely to be effective due to high protein binding.

Monitoring Requirements

Monitor blood pressure; renal function (SCr/BUN) especially in elderly, dehydrated, HF/CKD, or with ACEi/ARB/diuretics; assess for GI bleeding; consider LFTs and CBC with prolonged therapy or if clinically indicated.

Pharmacology

Mechanism of Action

Selective COX-2 inhibition leading to reduced prostaglandin synthesis (analgesic/anti-inflammatory/antipyretic effects) with relative sparing of COX-1 compared with nonselective NSAIDs.

Metabolism

Hepatic metabolism primarily via CYP2C9 (minor CYP3A4) to inactive metabolites; metabolites excreted mainly in feces and urine.

Product Information

Available Dosage Forms

Capsule, hard (oral).

Composition per Dose

Each capsule: 200 mg celecoxib

OTC Alternatives

Acetaminophen/paracetamol; ibuprofen (OTC strengths); naproxen (OTC where available).

Pain Type

Joint/Muscular

Nsaid

Yes

Opioid

No

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