oxaprozin (Rx)

Brand and Other Names:Daypro
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 600mg

Osteoarthritis

Initial in mild to moderate disease: 600mg PO qDay

Usual in moderate to severe disease: 1200mg PO qDay

Maximum 1,800 mg/day or 26 mg/kg/day, whichever is lower, divided PO q12hr  

Rheumatoid Arthritis

1200mg PO qDay (individualize)

Maximum 1,800 mg/day or 26 mg/kg/day, whichever is lower, divided PO q12hr  

Renal Impairment

Severe renal impairment or on dialysis: 600 mg PO qDay; may increase to 1200 mg/day; monitor closely

Hepatic Impairment

Caution in patients with severe liver impairment

Administration

Take with food or 8-12 oz water to avoid GI effects

Other Information

Renal Impairment: 600 mg PO qDay

Dosage Forms & Strengths

tablet

  • 600mg

Juvenile Rheumatoid Arthritis

<6 years

  • Safety and efficacy not established

>6 years

  • 22-31 kg: 600 mg PO qDay
  • 32-54 kg: 900 mg PO qDay
  • >55 kg: 1200 mg PO qDay

Osteoarthritis

Initial in mild to moderate disease: 600mg PO qDay

Usual in moderate to severe disease: 1200mg PO qDay

Maximum 1,800 mg/day or 26 mg/kg/day, whichever is lower, divided PO q12hr  

Rheumatoid Arthritis

1200mg PO qDay (individualize)

Maximum 1,800 mg/day or 26 mg/kg/day, whichever is lower, divided PO q12hr

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Interactions

Interaction Checker

and oxaprozin

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Common

            Edema

            Rash

            Abdominal pain

            Anorexia

            Constipation

            Diarrhea

            Indigestion

            Nausea/Vomiting

            GI ulcer

            Gross bleeding with perforation

            Heartburn

            Anemia

            LFT's increased

            Tinnitus

            Dysuria, Increased frequency of urination

            Myocardial infarction (<2%)

            <1%

            Hypertension (<1%)

            Palpitations (<1%)

            Thrombotic tendency observations

            Erythema multiforme (rare)

            Scaling eczema

            Stevens-Johnson syndrome (rare)

            Toxic epidermal necrolysis (rare)

            Cerebrovascular accident

            Gastrointestinal hemorrhage (<1%)

            Agranulocytosis (rare)

            Leukopenia (<1%)

            Thrombocytopenia (<1%)

            Hepatitis (rare),

            Jaundice, Liver failure

            Anaphylactoid reaction (<1%)

            Amblyopia (<1%)

            Hearing loss (<1%)

            Acute renal failure (rare)

            Hematuria (rare)

            Interstitial nephritis (rare)

            Bronchospasm

            Serum sickness due to drug (rare)

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            Warnings

            Black Box Warnings

            Cardiovascular Risk

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

            Gastrointestinal Risk

            • NSAIDs increase risk of serious GI adverse events including bleeding, ulceration, & perforation of the stomach or intestines, which can be fatal
            • GI adverse events may occur at any time during use & without warning symptoms
            • Elderly patients are at greater risk for serious GI events

            Contraindications

            Absolute: ASA allergy, CABG

            Relative: bleeding disorder, duodenal/gastric/peptic ulcer, stomatitis, SLE, ulcerative colitis, upper GI disease, late pregnancy (may cause premature closure of ductus arteriosus)

            Cautions

            Use caution in asthma (bronchial), CHF, fluid retention, cardiac disease, severe hepatic impairment, hypertension, renal impairment

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

            Factors that increase risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, antiplatelet drugs (such as aspirin), anticoagulants; or selective serotonin reuptake inhibitors (SSRIs); smoking; use of alcohol; older age; and poor general health status

            May cause drowsiness, dizziness, blurred vision, and other neurologic effects, which may impair physical or mental abilities; discontinue use and perform ophthalmologic exam with blurred or diminished vision occur

            Therapy may increase risk of hyperkalemia in the elderly, renal disease, diabetes, and when used concomitantly with other agents capable of inducing hyperkalemia; monitor potassium levels closely

            Mild photosensitivity reactions may occur

            May increase risk of HTN

            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

            Drug reaction with eosinophilia and systemic symptoms (DRESS)

            • Drug Reaction reported in patients taking NSAIDs; some of these events have been fatal or life-threatening; DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling
            • Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis; sometimes symptoms of DRESS may resemble an acute viral infection
            • Eosinophilia is often present; because this disorder is variable in its presentation, other organ systems not noted here may be involved
            • Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident; if such signs or symptoms are present, discontinue therapy and evaluate the patient immediately
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            Pregnancy & Lactation

            Pregnancy

            Use can cause premature closure of fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment; because of these risks, limit dose and duration of use between about 20 and 30 weeks gestation, and avoid use at about 30 weeks of gestation and later in pregnancy

            Premature closure of fetal ductus arteriosus; use at about 30 weeks gestation or later in pregnancy increases risk of premature closure of fetal ductus arteriosus

            Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment

            Data from observational studies regarding other potential embryofetal risks of NSAID use in women in first or second trimesters of pregnancy are inconclusive

            The estimated background risk of major birth defects and miscarriage for indicated population(s) is unknown

            Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy; NSAIDs can cause premature closure of fetal ductus arteriosus

            If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit use to the lowest effective dose and shortest duration possible; if treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios

            If oligohydramnios occurs, discontinue therapy and follow up according to clinical practice

            There are no studies on effects of therapy during labor or delivery

            Animal data

            • In animal reproduction studies, oral administration to pregnant rabbits at doses 0.1-times maximum daily human dose (based on body surface area) resulted in evidence of teratogenicity
            • However, oral administration to pregnant mice and rats during organogenesis at doses equivalent to maximum recommended human dose revealed no evidence of teratogenicity or embryotoxicity
            • In rat reproduction studies in which oxaprozin was administered through late gestation failure to deliver and a reduction in live birth index was observed at doses equivalent to the maximum recommended human dose
            • Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization
            • In animal studies, administration of prostaglandin synthesis inhibitors such as oxaprozin, resulted in increased pre- and post-implantation loss
            • Prostaglandins also have been shown to have an important role in fetal kidney development; in published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses
            • In animal studies, NSAIDS, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth

            Females and males reproductive potential

            • Females
              • Based on mechanism of action, the use of prostaglandin mediated NSAIDs, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women
              • Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation
              • Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation; consider withdrawal of NSAIDs, in women who have difficulties conceiving or who are undergoing investigation of infertility
            • Males
              • Testicular degeneration was observed in beagle dogs treated with 37.5 mg/kg/day (0.7-times the maximum recommended human daily dose based on body surface area) of oxaprozin for 42 days or 6 months

            Lactation

            Lactation studies have not been conducted; it is not known whether drug is excreted in human milk; drug should be administered to lactating women only if clearly indicated; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for drug and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

            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 synthesis of prostaglandins in body tissues by inhibiting at least 2 cyclooxygenase isoenzymes, cyclooxygenase-1 (COX-1) and -2 (COX-2)

            May inhibit chemotaxis, may alter lymphocyte activity, decrease proinflammatory cytokine activity, and may inhibit neutrophil aggregation. These effects may contribute to its anti-inflammatory activity

            Pharmacokinetics

            Half-Life: 44-50 hr

            Protein Bound: 99%

            Vd: 11-17 L/70 kg

            Time to peak: 2-4hr

            Metabolism: Liver (microsomal oxidation (65%); glucuronic acid conjugation (35%)

            Metabolites: Ester, ether glucuronide

            Excretion: Urine (65%); feces (35%)

            Enzymes inhibited: Cyclooxygenase

            Absorption: 95% (PO)

            Dialyzable: Yes, but inefficient

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            Formulary

            FormularyPatient Discounts

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

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            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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.