Oxaprozin

Oxaprozin is a prescription medication used for the treatment of osteoarthritis and rheumatoid arthritis.

• Oxaprozin is available under the following different brand names: Daypro

Common side effects of Oxaprozin include:

• nausea,
• upset stomach,
• diarrhea,
• constipation, and
• rash

Serious side effects of Oxaprozin include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• sneezing,
• runny or stuffy nose,
• wheezing,
• fever,
• sore throat,
• burning eyes,
• skin pain,
• red or purple skin rash with blistering and peeling,
• chest pain spreading to the jaw or shoulder,
• sudden numbness,
• weakness on one side of the body,
• slurred speech,
• shortness of breath,
• skin rash (no matter how mild),
• swelling,
• rapid weight gain,
• bloody or tarry stools,
• coughing up blood,
• vomiting that looks like coffee grounds,
• nausea,
• upper stomach pain,
• itching,
• tiredness,
• flu-like symptoms,
• loss of appetite,
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes (jaundice),
• little or no urination,
• swelling in the feet or ankles,
• pale skin,
• unusual tiredness,
• lightheadedness, and
• cold hands and feet

Rare side effects of Oxaprozin include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 600 mg

Osteoarthritis

Adult and geriatric dosage

• Initial in mild to moderate disease: 600mg orally every day
• Usual in moderate to severe disease: 1200mg orally every day
• Maximum 1,800 mg/day or 26 mg/kg/day, whichever is lower, divided orally every 12 hours

Rheumatoid Arthritis

Adult and geriatric dosage

• 1200mg orally every day (individualize)
• Maximum 1,800 mg/day or 26 mg/kg/day, whichever is lower, divided orally every 12 hours

Juvenile rheumatoid arthritis

Pediatric dosage

• Age below 6 years
  • Safety and efficacy not established
• Aged above 6 years
  • 22-31 kg: 600 mg orally every day
  • 32-54 kg: 900 mg orally every day
  • Above 55 kg: 1200 mg orally every day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Oxaprozin has severe interactions with no other drugs.
• Oxaprozin has serious interactions with at least 22 other drugs.
• Oxaprozin has moderate interactions with at least 230 other drugs.
• Oxaprozin has minor interactions with at least 72 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

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)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Oxaprozin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Oxaprozin?”

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 injuries; 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 the 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 an ophthalmologic exam with blurred or diminished vision occur
• Therapy may increase the risk of hyperkalemia in the elderly, renal disease, and diabetes, and when used concomitantly with other agents capable of inducing hyperkalemia; monitor potassium levels closely
• Mild photosensitivity reactions may occur
• This may increase the 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 Reactions 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

Pregnancy and Lactation

• 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 the 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 the first or second trimesters of pregnancy are inconclusive
• The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown
• Avoid the 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 the effects of therapy during labor or delivery
• Females and males reproductive potential
  • Females
  • Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs may delay or prevent the rupture of ovarian follicles, which has been associated with reversible infertility in some women
  • Published animal studies have shown that the 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 the drug is excreted in human milk; the drug should be administered to lactating women only if indicated; developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition