Oxaprozin 300 mg/1
Oxaprozin · CAPSULE · SOLA Pharmaceuticals, LLC
Oxaprozin is a capsule containing oxaprozin at 300 mg/1, taken oral. Manufactured by SOLA Pharmaceuticals, LLC.
Key Facts
- Brand Name
- Oxaprozin
- Generic Name
- Oxaprozin
- NDC Code (Product)
70512-787- Manufacturer
- SOLA Pharmaceuticals, LLC
- Strength
- 300 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- NDA217927
- Drug Class
- Nonsteroidal Anti-inflammatory Drug [EPC]
- Marketing Start
- 12/03/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Oxaprozin tablets are indicated: For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis For relief of the signs and symptoms of juvenile rheumatoid arthritis
Dosage & Administration
2.1 General Dosing Instructions Carefully consider the potential benefits and risks of oxaprozin tablets and other treatment options before deciding to use oxaprozin tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)]. 2.2 Osteoarthritis For OA, the dosage is 1,200 mg (two 600 mg tablets) given orally once a day [see Dosage and Administration (2.5)]. 2.3 Rheumatoid Arthritis For RA, the dosage is 1,200 mg (two 600 mg tablets) given orally once a day [see Dosage and Administration (2.5)]. 2.4 Juvenile Rheumatoid Arthritis For JRA, in patients 6 to 16 years of age, the recommended dosage given orally once per day should be based on body weight of the patient as given in Table 1 [see Dosage and Administration (2.5)]. Table 1. Recommended Daily Dose of Oxaprozin by Body Weight in Pediatric Patients Body Weight Range (kg) Dose (mg) 22 to 31 600 32 to 54 900 ≥55 1200 2.5 Individualization of Dosage After observing the response to initial therapy with oxaprozin tablets, the dose and frequency should be adjusted to suit an individual patient’s needs. In osteoarthritis and rheumatoid arthrit…
Contraindications
Oxaprozin tablets are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to oxaprozin or any components of the drug product [see Warnings and Precautions (5.7, 5.9)] History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.8)] In the setting of CABG surgery [see Warnings and Precautions (5.1)]
Drug Interactions
See Table 2 for clinically significant drug interactions with oxaprozin [see Clinical Pharmacology (12.3)]. Table 2: Clinically Significant Drug Interactions with Oxaprozin Drugs That Interfere with Hemostasis Clinical Impact: Oxaprozin and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of oxaprozin and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of oxaprozin with anticoagulants (e.g., warfarin), antiplatelet drugs (e.g., aspirin), SSRIs, and SNRIs for signs of bleeding [see Warnings and Precautions (5.11)]. Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspi…
Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1)] GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.2)] Hepatotoxicity [see Warnings and Precautions (5.3)] Hypertension [see Warnings and Precautions (5.4)] Heart Failure and Edema [see Warnings and Precautions (5.5)] Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.6)] Anaphylactic Reactions [see Warnings and Precautions (5.7)] Serious Skin Reactions [see Warnings and Precautions (5.9)] Hematologic Toxicity [see Warnings and Precautions (5.12) ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reaction data were derived from patients who received oxaprozin in multidose, controlled, and open-label clinical trials. Rates for events from clinical trial experience are based on 2,253 patients who took 1,200 mg to 1,800 mg oxaprozin p…
Frequently Asked Questions
What is Oxaprozin used for?
Oxaprozin contains Oxaprozin. It is a capsule taken oral. Consult your doctor for specific uses.
Is Oxaprozin a controlled substance?
Oxaprozin is not classified as a controlled substance by the DEA.
What is the generic name for Oxaprozin?
The generic name for Oxaprozin is Oxaprozin. There are 2 other brand versions of Oxaprozin.
What is the NDC code for Oxaprozin 300 mg/1?
The NDC (National Drug Code) for Oxaprozin 300 mg/1 is 70512-787, listed by SOLA Pharmaceuticals, LLC.