Oxaprozin enteric-coated tablets

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Indications are suitable for rheumatoid arthritis, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, periarthritis of the shoulder, neck, shoulder and wrist syndrome, gout, and antibiotic analgesia after trauma and surgery.

Main ingredients

Osapuchin.

Functional indications

Suitable for rheumatoid arthritis, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, periarthritis of the shoulder, neck, shoulder and wrist syndrome, gout, and antibiotic analgesia after trauma and surgery.

Dosage

Take orally, 0.2~0.4g (1~2 tablets) once a day, take the medicine continuously for more than 1 week or as directed by your doctor, after meals…

Pharmacological effects

Pharmacological effects: This product is a propionic acid non-steroidal anti-inflammatory drug with anti-inflammatory, analgesic and antipyretic effects. By inhibiting cyclooxygenase, prostaglandin biosynthesis is inhibited. The effect of this product is longer lasting. Toxicological studies: Acute toxicity: LD50 in mice is 1342 mg/kg by oral administration and 342 mg/kg by intraperitoneal injection. Rats were administered 25 to 400 mg/kg/day by gavage for six months. The high-dose group inhibited weight gain, gastrointestinal reactions, mild anemia, hepatocyte enlargement, and renal toxicity. The maximum non-toxic dose is 25mg/kg/day. Dogs were given 6.4 to 40 mg/kg/day by gavage for six months. The high-dose group caused milder anemia and gastrointestinal reactions. The maximum non-toxic dose is 6.4mg/kg/day.

drug interactions

(1) Combining this product with aspirin may increase the toxicity of aspirin because this product can displace salicylates bound to plasma proteins. (2) In the elderly and those with reduced renal function, the clearance rate of digoxin will be reduced, which will increase the blood concentration of the drug and increase its toxicity. (3) When large doses are used to treat tumors, it affects the excretion of methotrexate and increases the blood concentration of methotrexate, causing poisoning. (4) Affect the antihypertensive effect of antihypertensive drugs (angiotensin-converting enzyme inhibitors and beta-receptor inhibitor blockers). (5) Reduce the diuretic and natriuretic effects of diuretics.

Medication for special populations

Pregnant and lactating women: Disabled. Medication for children: Prohibited. Medication for the Elderly: Elderly patients are prone to adverse reactions due to decreased liver and kidney function, and should be used with caution or at an appropriate dose reduction.

Precautions

1. Avoid coadministration with other NSAIDs, including selective COX-2 inhibitors.  2. Adverse effects can be minimized by using the lowest effective dose for the shortest treatment time as needed to control symptoms.  3. Adverse effects of gastrointestinal bleeding, ulceration, and perforation may occur at any time during treatment with all NSAIDs, and the risk may be fatal. These adverse reactions may be accompanied by warning symptoms or not, and regardless of whether the patient has a history of gastrointestinal adverse reactions or serious gastrointestinal events, patients with a previous history of gastrointestinal tract (ulcerative colitis, Crohn’s disease) NSAIDs should be used with caution to avoid worsening the condition. When patients taking this drug develop gastrointestinal bleeding or ulcers, the drug should be discontinued. Elderly patients have an increased frequency of adverse reactions to NSAIDs, particularly gastrointestinal bleeding and perforation, which may be fatal.  4. Clinical trials of a variety of COX-2 selective and non-selective NSAIDs lasting up to 3 years have been shown. This product may cause serious cardiovascular thrombotic adverse events, an increased risk of myocardial infarction and stroke, and the risk may be fatal. All NSAIDs, including COX-2 selective or non-selective drugs, may have similar risks; patients with cardiovascular disease or risk factors for cardiovascular disease may have a greater risk. Physicians and patients should remain alert to the occurrence of such events even in the absence of previous cardiovascular symptoms. Patients should be informed of the signs and/or symptoms of serious cardiovascular safety and the steps to take if they occur.  Patients should be alert to signs and symptoms such as chest pain, shortness of breath, weakness, and slurred speech, and should seek medical help immediately if any of these symptoms or signs occur.  5. Like all nonsteroidal anti-inflammatory drugs (NSAIDs), this drug can cause new onset of hypertension or worsen the symptoms of existing hypertension, either of which can lead to an increased incidence of cardiovascular events. Taking nonsteroidal anti-inflammatory drugs (NSAIDs) in patients taking thiazides or loop diuretics may affect the effectiveness of these drugs. Patients with hypertension should use nonsteroidal anti-inflammatory drugs (NSAIDs), including this product, with caution. Blood pressure should be monitored closely during initiation and throughout treatment with this product.  6. Use with caution in patients with a history of hypertension and/or heart failure (e.g., fluid retention and edema).  7. NSAIDs, including this product, may cause fatal and serious adverse skin reactions, such as exfoliative dermatitis, Stevens Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). These serious events can occur without warning. Patients should be informed of the signs and symptoms of serious skin reactions and should discontinue use of this product at the first occurrence of skin rash or other signs of allergic reaction.

Adverse reactions

Mainly gastrointestinal symptoms: including stomach pain, stomach discomfort, loss of appetite, nausea, diarrhea, constipation, thirst and stomatitis, with an incidence rate of about 3% to 5%, and most of them can be tolerated without stopping the medication or giving symptomatic drugs. Dizziness, headache, drowsiness, tinnitus, convulsions, and transient liver function abnormalities are rare.

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