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CELEBREX
Arthritis/rheumatic disorders
Dysmenorrhea
Nonnarcotic analgesics
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Drug Name:

CELEBREX Rx

Generic Name and Formulations:
Celecoxib 50mg, 100mg, 200mg, 400mg; caps.

Company:
Pfizer Inc.

Therapeutic Use:

Indications for CELEBREX:

Osteoarthritis (OA). Rheumatoid arthritis (RA). Ankylosing spondylitis (AS). Juvenile rheumatoid arthritis (JRA).

Adult:

Use lowest effective dose for shortest duration. ≥18yrs: OA: 200mg once daily or 100mg twice daily. RA: 100–200mg twice daily. AS: 200mg in 1–2 divided doses; if no response after 6 weeks, 400mg once daily may be tried. <50kg: start at lowest recommended dose. Moderate hepatic impairment, CYP2C9 poor metabolizers: reduce dose by 50%.

Children:

<2yrs or <10kg: not studied. Use lowest effective dose for shortest duration. May sprinkle capsule contents into applesauce. See full labeling. JRA: ≥2yrs (≥10kg to ≤25kg): 50mg twice daily; (>25kg): 100mg twice daily. CYP2C9 poor metabolizers: consider alternatives.

Contraindications:

Sulfonamide, aspirin or other NSAID allergy. Coronary artery bypass graft surgery.

Warnings/Precautions:

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver or renal disease develop, or if abnormal liver function tests persist or worsen. Dehydration. Hypovolemia. Advanced renal disease: not recommended. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, renal, and ocular function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C: <30 weeks gestation); (Cat.D: ≥30 weeks gestation; avoid). Nursing mothers.

Interactions:

Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors (eg, captopril), ARBs (eg, losartan), or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Caution with CYP2C9 inhibitors (eg, fluconazole), CYP2C9 inducers (eg, rifampin), or drugs that are metabolized by CYP2D6 (eg, atomoxetine).

Pharmacological Class:

NSAID (COX-2 inhibitor).

Adverse Reactions:

Abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper RTI; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypertension, anaphylaxis, anemia; also children: headache, fever, cough.

Generic Availability:

YES

How Supplied:

Caps 100mg, 200mg—100, 500; 50mg, 400mg—60

Indications for CELEBREX:

Dysmenorrhea.

Adult:

Use lowest effective dose for shortest duration. ≥18yrs: 400mg once then 200mg more on 1st day if needed, then 200mg twice daily. <50kg: start at lowest recommended dose. Moderate hepatic impairment, CYP2C9 poor metabolizers: reduce dose by 50%.

Children:

<18yrs: not recommended.

Contraindications:

Sulfonamide, aspirin or other NSAID allergy. Coronary artery bypass graft surgery.

Warnings/Precautions:

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver or renal disease develop, or if abnormal liver function tests persist or worsen. Dehydration. Hypovolemia. Advanced renal disease: not recommended. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, renal, and ocular function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C: <30 weeks gestation); (Cat.D: ≥30 weeks gestation; avoid). Nursing mothers.

Interactions:

Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors (eg, captopril), ARBs (eg, losartan), or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Caution with CYP2C9 inhibitors (eg, fluconazole), CYP2C9 inducers (eg, rifampin), or drugs that are metabolized by CYP2D6 (eg, atomoxetine).

Pharmacological Class:

NSAID (COX-2 inhibitor).

Adverse Reactions:

Abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper RTI, rash (may be serious); cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypertension, anaphylaxis, anemia.

Generic Availability:

YES

How Supplied:

Caps 100mg, 200mg—100, 500; 50mg, 400mg—60

Indications for CELEBREX:

Acute pain.

Adult:

Use lowest effective dose for shortest duration. ≥18yrs: 400mg once then 200mg more on 1st day if needed, then 200mg twice daily. <50kg: start at lowest recommended dose. Moderate hepatic impairment, CYP2C9 poor metabolizers: reduce dose by 50%.

Children:

<18yrs: not recommended.

Contraindications:

Sulfonamide, aspirin or other NSAID allergy. Coronary artery bypass graft surgery.

Warnings/Precautions:

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver or renal disease develop, or if abnormal liver function tests persist or worsen. Dehydration. Hypovolemia. Advanced renal disease: not recommended. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, renal, and ocular function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C: <30 weeks gestation); (Cat.D: ≥30 weeks gestation; avoid). Nursing mothers.

Interactions:

Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors (eg, captopril), ARBs (eg, losartan), or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Caution with CYP2C9 inhibitors (eg, fluconazole), CYP2C9 inducers (eg, rifampin), or drugs that are metabolized by CYP2D6 (eg, atomoxetine).

Pharmacological Class:

NSAID (COX-2 inhibitor).

Adverse Reactions:

Abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper RTI, rash (may be serious); cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypertension, anaphylaxis, anemia.

Generic Availability:

YES

How Supplied:

Caps 100mg, 200mg—100, 500; 50mg, 400mg—60

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