celecoxib (Rx)

Brand and Other Names:Celebrex
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 50mg
  • 100mg
  • 200mg
  • 400mg
more...

Acute Pain & Primary Dysmenorrhea

400 mg PO initially, then 200 mg PRN on first day; 200 mg q12hr PRN on subsequent days

Ankylosing Spondylitis

200 mg PO once daily or divided q12hr; if no effect after 6 weeks, may increase to 400 mg/day; if no adequate resonse observed after 6 weeks of taking 400 mg/day consider discontinuing therapy

Osteoarthritis

200 mg PO once daily or divided q12hr

Rheumatoid Arthritis

100-200 mg PO q12hr

Familial Adenomatous Polyposis (Off-label)

400 mg PO q12hr, taken with food

Usual medical care should be continued during celecoxib therapy

Dosage Modifications

Hepatic impairment

  • Moderate (Child-Pugh class B): Decrease dose by 50%
  • Severe (Child-Pugh class C): Not recommended

Renal impairment

  • Relative contraindication to use

Dosage Forms & Strengths

capsule

  • 50mg
  • 100mg
  • 200mg
  • 400mg
more...

Juvenile Rheumatoid Arthritis

<2 years: Safety and efficacy not established

≥2 years and 10-25 kg: 50 mg PO q12hr

≥2 years and >25 kg: 100 mg PO q12hr

Consider alternative management in patients who are poor CYP2C9 metabolizers

Pediatric Juvenile Idiopathic Arthritis (Orphan)

Oral liquid suspension: Orphan designation for juvenile idiopathic arthritis

Sponsor

  • NuBioPharma, LLC; 111 Dennis Drive, Suite 121; Sanford, North Carolina 27330

Dosage Modifications

Poor CYP2C9 Metabolizers

  • May consider reducing the initial dose by 50%; consider alternative therapy in patients that are poor CYP2C9 metabolizers
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Interactions

Interaction Checker

and celecoxib

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache (10-16%)

            Hypertension (13%)

            1-10%

            Fever (9%)

            Dyspepsia (8.8%)

            Upper respiratory tract infection (8.1%)

            Arthralgia (7%)

            Cough (7%)

            Vomiting (6%)

            Diarrhea (5.6%)

            Gastroesophageal reflux (5%)

            Sinusitis (5%)

            Abdominal pain (4.1%)

            Nausea (3.5%)

            Back pain (2.8%)

            Insomnia (2.3%)

            Pharyngitis (2.3%)

            Flatulence (2.2%)

            Rash (2.2%)

            Dizziness (2%)

            Peripheral edema (2%)

            <1%

            Anemia

            Erythema multiforme

            Exfoliative dermatitis

            Hepatitis

            Jaundice

            Stevens-Johnson syndrome

            Toxic epidermal necrolysis

            Frequency Not Defined

            Increased serum asparate aminotransferase concentration

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            Warnings

            Black Box Warnings

            Cardiovascular risk

            • Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal
            • Risk may increase with duration of use
            • Patients with existing cardiovascular disease or risk factors for such disease may be at greater risk
            • NSAIDs are contraindicated for perioperative pain in setting of coronary artery bypass graft (CABG) surgery

            Gastrointestinal risk

            • NSAIDs increase risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and gastric or intestinal perforation, which can be fatal
            • GI adverse events may occur at any time during use and without warning symptoms
            • Elderly patients are at greater risk for serious GI events

            Contraindications

            Aspirin allergy, chronic hepatitis, perioperative pain resulting from coronary artery bypass graft surgery

            Cautions

            Congestive heart failure, hypertension

            Increased risk of adverse cardiovascular events and skin reactions

            Caution in asthma (bronchial), bleeding disorder, bronchospasm, duodenal/gastric/peptic ulcer, renal impairment

            Risk of GI bleeding, ulceration, and perforation

            Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include elderly individuals; those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion, and those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers

            Anemia may occur; monitor hemoglobin or hematorcrit in long term treatment patients

            Heart Failure(HF) risk

            • NSAIDS have the potential to trigger HF by prostaglandin inhibition that leads to sodium and water retention, increased systemic vascular resistance, and blunted response to diuretics
            • NSAIDS should be avoided or withdrawn whenever possible
            • AHA/ACC Heart Failure Guidelines; Circulation. 2016; 134
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            Pregnancy & Lactation

            Pregnancy category: C; D at ≥30 weeks' gestation (may cause premature closure of ductus arteriosus)

            Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks' gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to nonaspirin NSAIDs during pregnancy was documented in ~7.5% of cases of spontaneous abortions and in ~2.6% of controls

            Lactation: Drug enters breast milk; use caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Inhibits cyclooxygenase (COX)-2; does not affect COX-1 (at therapeutic concentrations), thereby decreasing formation of prostaglandin synthesis

            Absorption

            Bioavailability: Undetermined

            Peak plasma time: ≤3 hr

            Peak plasma concentration: 705 ng/mL

            Distribution

            Protein bound: 97% (principally to albumin; to a lesser extent, to alpha1-acid glycoprotein)

            Vd: 400 L

            Metabolism

            Metabolized in liver by CYP2C9

            Metabolites: Carboxylic acid (SC-62807), glucuronide

            Enzymes inhibited: COX-2

            Elimination

            Half-life: Mild hepatic impairment, 11 hr; chronic renal insufficiency or moderate hepatic impairment, 13.1 hr

            Dialyzable: Undetermined

            Clearance: 500 mL/min

            Excretion: Feces (57%), urine (27%)

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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