Oxaprozin
Generic: OXAPROZIN
Basic Information
Manufacturer
SOLA Pharmaceuticals, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
450f5941-7f10-42fe-e063-6394a90a4803
Indications & Usage
1 INDICATIONS AND USAGE OXAPROZIN is 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 OXAPROZIN CAPSULES is a non-steroidal anti-inflammatory drug indicated for: Relief of signs and symptoms of Osteoarthritis (OA) (1) Relief of signs and symptoms of Rheumatoid Arthritis (RA) (1) Relief of signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) (1)
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elswhere in 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)] Most common adverse reactions (incidence > 3%) are: constipation, diarrhea, dyspepsia, nausea, rash (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Solubiomix, LLC at 1-844-551-9911 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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, the active component of OXAPROZIN CAPSULES, in multidose, controlled, and open-label clinical trials.
Rates for events from clinical trial experience are based on 2253 patients who took 1,200 mg to 1800 mg of the active component of OXAPROZIN CAPSULES per day in clinical trials.
Of these, 1721 patients were treated for at least 1 month, 971 patients for at least 3 months, and 366 patients for more than 1 year.
Incidence Greater than 1%: In clinical trials of oxaprozin, the active component of OXAPROZIN CAPSULES, or in patients taking other NSAIDs, the following adverse reactions occurred at an incidence greater than 1%.
Cardiovascular system: edema.
Digestive system: abdominal pain/distress, anorexia, constipation, diarrhea, dyspepsia, flatulence, gastrointestinal ulcers (gastric/duodenal), gross bleeding/perforation, heartburn, liver enzyme elevations, nausea, vomiting.
Hematologic system: anemia, increased bleeding time.
Nervous system: CNS inhibition (depression, sedation, somnolence, or confusion), disturbance of sleep, dizziness, headache.
Skin and appendages: pruritus, rash.
Special senses: tinnitus.
Urogenital system: abnormal renal function, dysuria or frequency.
Incidence Greater than 1%: The following adverse reactions were reported in clinical trials or in patients taking other NSAIDs.
Body as a whole: appetite changes, death, drug hypersensitivity reactions including anaphylaxis, fever, infection, sepsis.
Cardiovascular system: arrhythmia, blood pressure changes, congestive heart failure, hypertension, hypotension, myocardial infarction, palpitations, tachycardia, syncope, vasculitis.
Digestive system: alteration in taste, dry mouth, eructation, esophagitis, gastritis, glossitis, hematemesis, jaundice, liver function abnormalities including liver failure, stomatitis, hemorrhoidal or rectal bleeding.
Hematologic system: aplastic anemia, ecchymoses, eosinophilia, hemolytic anemia, lymphadenopathy, melena, purpura, thrombocytopenia, leukopenia.
Metabolic system: hyperglycemia, weight changes.
Nervous system: anxiety, asthenia, coma, convulsions, dream abnormalities, drowsiness, hallucinations, insomnia, malaise, meningitis, nervousness, paresthesia, tremors, vertigo, weakness.
Respiratory system: asthma, dyspnea, pulmonary infections, pneumonia, sinusitis, symptoms of upper respiratory tract infection, respiratory depression.
Skin: alopecia, angioedema, urticaria, photosensitivity, sweat.
Special senses: blurred vision, conjunctivitis, hearing decrease.
Urogenital: cystitis, hematuria, increase in menstrual flow, oliguria/ polyuria, proteinuria, renal insufficiency, decreased menstrual flow.
Adverse Reactions in Pediatric Patients with Juvenile Rheumatoid Arthritis In a 3-month open label study in 59 pediatric patients with juvenile rheumatoid arthritis treated with oxaprozin, the active component of OXAPROZIN CAPSULES, adverse events were reported by 58% of patients.
Gastrointestinal symptoms were the most frequently reported adverse effects and occurred at a higher incidence than those historically seen in controlled studies in adults.
Of 30 patients who continued treatment for more than 3 months (19 to 48 weeks range total treatment duration), nine (30%) experienced rash on sun-exposed areas of the skin and five of those discontinued treatment.
6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of oxaprozin, the active component of OXAPROZIN CAPSULES.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as a whole: serum sickness.
Digestive system: hepatitis, pancreatitis.
Hematologic system: agranulocytosis, pancytopenia.
Skin: pseudoporphyria, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, fixed drug eruption (FDE), toxic epidermal necrolysis (Lyell's syndrome).
Urogenital: acute interstitial nephritis, nephrotic syndrome, acute renal failure.
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, the active component of OXAPROZIN CAPSULES, in multidose, controlled, and open-label clinical trials.
Rates for events from clinical trial experience are based on 2253 patients who took 1,200 mg to 1800 mg of the active component of OXAPROZIN CAPSULES per day in clinical trials.
Of these, 1721 patients were treated for at least 1 month, 971 patients for at least 3 months, and 366 patients for more than 1 year.
Incidence Greater than 1%: In clinical trials of oxaprozin, the active component of OXAPROZIN CAPSULES, or in patients taking other NSAIDs, the following adverse reactions occurred at an incidence greater than 1%.
Cardiovascular system: edema.
Digestive system: abdominal pain/distress, anorexia, constipation, diarrhea, dyspepsia, flatulence, gastrointestinal ulcers (gastric/duodenal), gross bleeding/perforation, heartburn, liver enzyme elevations, nausea, vomiting.
Hematologic system: anemia, increased bleeding time.
Nervous system: CNS inhibition (depression, sedation, somnolence, or confusion), disturbance of sleep, dizziness, headache.
Skin and appendages: pruritus, rash.
Special senses: tinnitus.
Urogenital system: abnormal renal function, dysuria or frequency.
Incidence Greater than 1%: The following adverse reactions were reported in clinical trials or in patients taking other NSAIDs.
Body as a whole: appetite changes, death, drug hypersensitivity reactions including anaphylaxis, fever, infection, sepsis.
Cardiovascular system: arrhythmia, blood pressure changes, congestive heart failure, hypertension, hypotension, myocardial infarction, palpitations, tachycardia, syncope, vasculitis.
Digestive system: alteration in taste, dry mouth, eructation, esophagitis, gastritis, glossitis, hematemesis, jaundice, liver function abnormalities including liver failure, stomatitis, hemorrhoidal or rectal bleeding.
Hematologic system: aplastic anemia, ecchymoses, eosinophilia, hemolytic anemia, lymphadenopathy, melena, purpura, thrombocytopenia, leukopenia.
Metabolic system: hyperglycemia, weight changes.
Nervous system: anxiety, asthenia, coma, convulsions, dream abnormalities, drowsiness, hallucinations, insomnia, malaise, meningitis, nervousness, paresthesia, tremors, vertigo, weakness.
Respiratory system: asthma, dyspnea, pulmonary infections, pneumonia, sinusitis, symptoms of upper respiratory tract infection, respiratory depression.
Skin: alopecia, angioedema, urticaria, photosensitivity, sweat.
Special senses: blurred vision, conjunctivitis, hearing decrease.
Urogenital: cystitis, hematuria, increase in menstrual flow, oliguria/ polyuria, proteinuria, renal insufficiency, decreased menstrual flow.
Adverse Reactions in Pediatric Patients with Juvenile Rheumatoid Arthritis In a 3-month open label study in 59 pediatric patients with juvenile rheumatoid arthritis treated with oxaprozin, the active component of OXAPROZIN CAPSULES, adverse events were reported by 58% of patients.
Gastrointestinal symptoms were the most frequently reported adverse effects and occurred at a higher incidence than those historically seen in controlled studies in adults.
Of 30 patients who continued treatment for more than 3 months (19 to 48 weeks range total treatment duration), nine (30%) experienced rash on sun-exposed areas of the skin and five of those discontinued treatment.
6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of oxaprozin, the active component of OXAPROZIN CAPSULES.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as a whole: serum sickness.
Digestive system: hepatitis, pancreatitis.
Hematologic system: agranulocytosis, pancytopenia.
Skin: pseudoporphyria, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, fixed drug eruption (FDE), toxic epidermal necrolysis (Lyell's syndrome).
Urogenital: acute interstitial nephritis, nephrotic syndrome, acute renal failure.