Oxaprozin

Oxaprozin is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). Oxaprozin is also used to relieve pain, tenderness, swelling, and stiffness caused by juvenile rheumatoid arthritis in children 6 years of age and older. Oxaprozin is in a class of medications called nonsteroidal anti-inflammatory medications (NSAIDs). It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Unless your doctor tells you otherwise, continue your normal diet.

Oxaprozin belongs to a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Other members of this class include ibuprofen (Motrin), indomethacin (Indocin), naproxen (Aleve) and several others. These drugs are used for the management of mild to moderate pain, fever and inflammation. They work by reducing the levels of prostaglandins, chemicals that are responsible for pain, fever, and inflammation. Oxaprozin blocks the enzyme that makes prostaglandins (cyclooxygenase), resulting in lower concentrations of prostaglandins. As a consequence, inflammation, pain and fever are reduced. The FDA approved oxaprozin in October 1992.

Daypro

Included as part of the "PRECAUTIONS" Section

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)

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

If a child is using this medicine, tell your doctor if the child has any changes in weight. Oxaprozin doses are based on weight in children, and any changes may affect your child's dose.

If you use this medicine long-term, you may need frequent medical tests.

Store oxaprozin at room temperature, away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Chest pain or pressure or a fast heartbeat.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Feeling very tired or weak.
• Ringing in ears.
• Mood changes.
• Low mood (depression).
• Very upset stomach or throwing up.
• Very bad belly pain.
• Very bad back pain.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Carefully consider the potential benefits and risks of Oxaprozin caplets and other treatment options before deciding to use Oxaprozin caplets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with Oxaprozin caplets, the dose and frequency should be adjusted to suit an individual patient's needs.

Rheumatoid arthritis

For relief of the signs and symptoms of rheumatoid arthritis, the usual recommended dose is 1200 mg (two 600-mg caplets) given orally once a day (see Individualization of dosage).

Osteoarthritis

For relief of the signs and symptoms of osteoarthritis, the usual recommended dose is 1200 mg (two 600-mg caplets) given orally once a day (see Individualization of dosage).

Juvenile rheumatoid arthritis

For the relief of the signs and symptoms of JRA in patients 6–16 years of age, the recommended dose given orally once per day should be based on body weight of the patient as given in Table 3 (see also Individualization of dosage).

Individualization of dosage

As with other NSAIDs, the lowest dose should be sought for each patient. Therefore, after observing the response to initial therapy with Oxaprozin, the dose and frequency should be adjusted to suit an individual patient's needs. In osteoarthritis and rheumatoid arthritis and juvenile rheumatoid arthritis, the dosage should be individualized to the lowest effective dose of Oxaprozin to minimize adverse effects. The maximum recommended total daily dose of OAXPROZIN in adults is 1800 mg (26 mg/kg, whichever is lower) in divided doses. In children, doses greater than 1200 mg have not been studied.

Patients of low body weight should initiate therapy with 600 mg once daily. Patients with severe renal impairment or on dialysis should also initiate therapy with 600 mg once daily. If there is insufficient relief of symptoms in such patients, the dose may be cautiously increased to 1200 mg, but only with close monitoring (see CLINICAL PHARMACOLOGY, Special populations).

In adults, in cases where a quick onset of action is important, the pharmacokinetics of Oxaprozin allow therapy to be started with a one-time loading dose of 1200 to 1800 mg (not to exceed 26 mg/kg). Doses larger than 1200 mg/day on a chronic basis should be reserved for patients who weigh more than 50 kg, have normal renal and hepatic function, are at low risk of peptic ulcer, and whose severity of disease justifies maximal therapy. Physicians should ensure that patients are tolerating doses in the 600 to 1200 mg/day range without gastroenterologic, renal, hepatic, or dermatologic adverse effects before advancing to the larger doses. Most patients will tolerate once-a-day dosing with Oxaprozin, although divided doses may be tried in patients unable to tolerate single doses.

Note: Individualize dosage to lowest effective dose for the shortest duration to minimize adverse effects.

Osteoarthritis, rheumatoid arthritis: Oral: 1,200 mg once daily. Note: Patients with low body weight should start with 600 mg daily. A one-time loading dose of 1,200 to 1,800 mg (≤26 mg/kg) may be used when a quick onset of action is desired.

Maximum doses:

Patient <50 kg: Maximum: 1,200 mg daily

Patient >50 kg with normal renal/hepatic function and low risk of peptic ulcer: Maximum: 1,800 mg daily or 26 mg/kg/day (whichever is lower) in divided doses

Juvenile idiopathic arthritis (JIA): Oral:

Note: Individualize dosage to lowest effective dose for the shortest duration to minimize adverse effects.

Children 6 to 16 years:

22 to 31 kg: 600 mg once daily

32 to 54 kg: 900 mg once daily

≥55 kg: 1,200 mg once daily

Birth defects have been observed following in utero NSAID exposure in some studies; however, data is conflicting (Bloor 2013). Nonteratogenic effects, including prenatal constriction of the ductus arteriosus, persistent pulmonary hypertension of the newborn, oligohydramnios, necrotizing enterocolitis, renal dysfunction or failure, and intracranial hemorrhage, have been observed in the fetus/neonate following in utero NSAID exposure. In addition, nonclosure of the ductus arteriosus postnatally may occur and be resistant to medical management (Bermas 2014; Bloor 2013). Because NSAIDs may cause premature closure of the ductus arteriosus, product labeling for oxaprozin specifically states use should be avoided starting at 30-weeks gestation.

Use of NSAIDs can be considered for the treatment of mild rheumatoid arthritis flares in pregnant women, however use should be minimized or avoided early and late in pregnancy (Bermas 2014; Saavedra Salinas 2015).

The chronic use of NSAIDs in women of reproductive age may be associated with infertility that is reversible upon discontinuation of the medication. Consider discontinuing use in women having difficulty conceiving or those undergoing investigation of fertility. The use of NSAIDs close to conception may be associated with an increased risk of miscarriage (Bermas 2014; Bloor 2013).

6 to 16 years:

22 to 31 kg: 600 mg orally once a day
32 to 54 kg: 900 mg orally once a day
55 kg or greater: 1200 mg orally once a day
Maximum dose: 1200 mg orally per day

Comments:
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.

Use: For the relief of signs and symptoms of juvenile rheumatoid arthritis