Feprazone Tablets

Feprazone Tablets are indicated for the treatment of active rheumatism, rheumatoid arthritis, scapulohumeral periarthritis, respiratory tract infections, thrombophlebitis, and toothache.

【Drug Name】

Generic Name: Feprazone Tablets

English Name: Feprazone Tablets

【Ingredients】Feprazone

Chemical Name: 1,2 - Diphenyl - 4 - isopentenylpyrazolidine - 3,5 - dione.

Molecular Formula: C₂₀H₂₀N₂O₂

Molecular Weight: 320.39

【Characteristics】 A film-coated tablet. After removing the film coating, it appears white or off-white.

【Indications】Rheumatism, rheumatoid arthritis, scapulohumeral periarthritis, and toothache. This product should only be used when other non-steroidal anti-inflammatory drugs are ineffective or unavailable.

【Specifications】0.1g

【Usage and Dosage】Oral, 0.2g (2 tablets) each time, twice a day, and the treatment course should not exceed 7 days.

【Adverse Reactions】According to post-marketing adverse reaction monitoring and literature reports, the adverse reactions of feprazone mainly include:

1. Gastrointestinal Damage: Mainly manifested as nausea, vomiting, loss of appetite, abdominal pain, diarrhea, stomach discomfort. A small number of patients may experience hyperacidity, acid reflux, dyspepsia, flatulence, etc. There are reports of gastrointestinal bleeding and perforation abroad.

2. Allergic Reactions: Skin rashes and itching are more common. Reported rashes include maculopapules, urticaria, vesicular rashes, fixed drug eruptions, etc., which can spread all over the body. Severe cases may present with bullous epidermal necrolysis, exfoliative dermatitis, and severe erythema multiforme. A small number of patients may experience Henoch-Schönlein purpura, dyspnea, laryngeal edema, and anaphylactic shock.

3. Nervous System Damage: Mainly manifested as dizziness and headache. Others include vertigo, insomnia, somnolence, tremors, etc.

4. Blood System Damage: Individual patients may present with leukopenia. There are reports of leukopenia, granulocytopenia, agranulocytosis, and aplastic anemia abroad.

5. Other Damages: This product can cause edema, mainly facial edema, and can also present as hand, foot, lower limb, and systemic edema.

【Contraindications】

1. Patients with impaired liver and kidney function.

2. Patients known to be allergic to this product.

3. Patients who develop asthma, urticaria, or allergic reactions after taking aspirin or other non-steroidal anti-inflammatory drugs.

4. It is prohibited for the treatment of peri-operative pain in coronary artery bypass grafting (CABG).

5. Patients with a history of gastrointestinal bleeding or perforation after using non-steroidal anti-inflammatory drugs.

6. Patients with active peptic ulcer/bleeding, or those with a history of recurrent ulcers/bleeding.

7. Patients with severe heart failure.

8. Children under 14 years old are prohibited from using this product.

【Precautions】

1. Reduce salt intake during medication.

2. Avoid combined use with other non-steroidal anti-inflammatory drugs, including selective COX-2 inhibitors.

3. Use the lowest effective dose within the shortest treatment time according to the need to control symptoms, which can minimize adverse reactions.

4. At any time during the treatment with all non-steroidal anti-inflammatory drugs, adverse reactions such as gastrointestinal bleeding, ulcers, and perforation may occur, and the risk may be fatal. These adverse reactions may or may not be accompanied by warning symptoms, regardless of whether the patient has a history of gastrointestinal adverse reactions or severe gastrointestinal events. Patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease) should use non-steroidal anti-inflammatory drugs with caution to avoid exacerbating the condition. When a patient experiences gastrointestinal bleeding or ulcers while taking this drug, the drug should be discontinued. The frequency of adverse reactions in elderly patients using non-steroidal anti-inflammatory drugs increases, especially gastrointestinal bleeding and perforation, and the risk may be fatal.

5. Clinical trials of various COX-2 selective or non-selective NSAIDs lasting up to 3 years show that this product may increase the risk of serious cardiovascular thrombotic adverse events, myocardial infarction, and stroke, and this risk may be fatal. All NSAIDs, including COX-2 selective or non-selective drugs, may have similar risks. Patients with cardiovascular diseases or cardiovascular disease risk factors are at a greater risk. Even if there are no previous cardiovascular symptoms, doctors and patients should be vigilant about the occurrence of such events. Patients should be informed of the symptoms and/or signs of serious cardiovascular and the steps to take if they occur. Patients should be alert to symptoms and signs such as chest pain, shortness of breath, weakness, and slurred speech, and should seek medical help immediately if any of these occur.

6. Like all non-steroidal anti-inflammatory drugs (NSAIDs), this product can lead to new-onset hypertension or exacerbate existing hypertension symptoms, either of which can increase the incidence of cardiovascular events. In patients taking thiazide or loop diuretics, taking non-steroidal anti-inflammatory drugs (NSAIDs) may affect the efficacy of these drugs. Hypertensive patients should use non-steroidal anti-inflammatory drugs (NSAIDs), including this product, with caution. Blood pressure should be closely monitored at the start of treatment with this product and throughout the treatment process.

7. Patients with a history of hypertension and/or heart failure (such as fluid retention and edema) should use it with caution.

8. NSAIDs, including this product, may cause fatal and severe skin adverse 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 symptoms and signs of severe skin reactions. This product should be discontinued at the first appearance of skin rashes or other signs of allergic reactions.

9. This product is a pyrazolone antipyretic, analgesic, and anti-inflammatory drug. It may cause serious hematological adverse reactions, such as leukopenia, granulocytopenia, agranulocytosis, and aplastic anemia. It is not suitable for long-term use, and the treatment course should be controlled within 7 days. Hematological tests should be carried out when necessary.

10. This product can cause edema, mainly facial, periorbital, eyelid, and lip edema, and can also cause hand, foot, lower limb, and systemic edema. The edema caused by feprazone may be related to its promotion of sodium and water reabsorption in the renal tubules, leading to water-sodium retention, or it may be related to the allergic reaction of the drug. Patients with existing edema or related diseases (such as congestive heart failure) should use it with caution. Discontinue this product if edema occurs.

【Pregnancy and Lactation】The impact on pregnant and lactating women lacks human research.

【Children】 This product is contraindicated in children under 14 years old.

【Elderly】The situation is not clear.

【Drug Interactions】

This product can enhance the effects of coumarin-type oral anticoagulants, insulin, sulfonylurea-type oral hypoglycemic drugs, methotrexate, and phenytoin sodium. Caution should be exercised and the dosage should be reduced when using them.

【Overdose】The situation is not clear.

【Pharmacokinetics】After oral administration, it is rapidly absorbed from the gastrointestinal tract, enters the blood and binds to plasma proteins. The peak of blood drug concentration is reached in 4 - 6 hours, and the plasma half-life (t_1/2) is 24 hours. This product is excreted in the urine in the form of metabolites after transformation in the body.

【Storage】Store in a dark place and seal.

【Packaging】Packed in medicinal PVC hard sheets and PTP aluminum foil blister packs. Each plate contains 20 tablets, and each small box contains 1 plate.

【Expiry Date】36 months

【Standard】WS - 10001 - (HD - 0718) - 2002

【Approval Number】Guoyao Zhunzi H12021039