Diclofenac Potassium Tablets

Diclofenac sodium is a non-steroidal anti-inflammatory analgesic derived from phenylacetic acid. Its mechanism of action is to inhibit the activity of cyclooxygenase, thereby blocking the conversion of arachidonic acid to prostaglandins. At the same time, it can also promote the combination of arachidonic acid with triglycerides, reduce the concentration of free arachidonic acid in cells, and indirectly inhibit the synthesis of leukotrienes. Diclofenac sodium is one of the strongest non-steroidal anti-inflammatory drugs. Its inhibitory effect on prostaglandin synthesis is stronger than that of aspirin and indomethacin. Non-clinical toxicology study: Oral administration of diclofenac sodium to rats at 2 mg/kg per day, long-term observation, no increase in tumor incidence was found. In a two-year study on mice, 2 mg/kg was used daily, and no tumor-prone tendency was found. Various mutation studies have not found that diclofenac sodium induces gene mutations. Rats were given 4 mg/kg per day, and no infertility occurred in both males and females.

The main ingredient of this product is diclofenac potassium (C14H10Cl2KNO2).

This product is a film-coated tablet, which appears white or off-white after removing the film coating.

This product is suitable for the short-term treatment of the following acute pain: post-traumatic pain and inflammation, such as sprains, muscle strains, etc.; post-operative pain and inflammation, such as dental or orthopedic surgery, etc.; gynecological pain and inflammation, such as primary dysmenorrhea or adnexitis, etc.; pain caused by spinal syndrome; non-articular rheumatism; severe infectious pain and inflammation of the ear, nose and throat (such as tonsillitis, otitis, sinusitis, etc.), which should be treated with anti-infective drugs at the same time.

Oral administration, before meals. Adults, 100-150 mg/day; patients with mild symptoms and children over 14 years old, 75-100 mg/day, taken in 2-3 times. For primary dysmenorrhea, the general dose is 50-150 mg/day, which can be increased to the maximum dose of 200 mg/day according to the condition, or as directed by the doctor.

1. Occasionally, there may be upper abdominal pain, nausea, vomiting, diarrhea, abdominal cramps, indigestion, abdominal bloating, and anorexia. Rarely, there may be gastrointestinal bleeding, hematemesis, melena, gastrointestinal ulcer, perforation, and bloody diarrhea. 2. Occasionally, there may be headache, dizziness, and vertigo. Rarely, there may be drowsiness. 3. Occasionally, there may be rash. Rarely, there may be urticaria. 4. Occasionally, there may be an increase in serum aminotransferase (SGOT, SGPT), and rarely, there may be hepatitis. 5. Rarely, there may be allergic reactions, such as asthma. 6. Rarely, there may be edema.

1. Patients with peptic ulcers are prohibited from using this product. 2. Patients who are allergic to this product or other nonsteroidal anti-inflammatory drugs are prohibited from using this product. 3. Patients with asthma, urticaria or acute rhinitis caused by acetylsalicylic acid or other prostaglandin synthase inhibitors are prohibited from using this product.

Precautions for children: Diclofenac potassium tablets are not recommended for children and adolescents under 14 years of age. These patients can use other forms of diclofenac preparations, such as oral drops or suppositories. This drug is also not used to treat migraine attacks in children and adolescents. Precautions for pregnancy and lactation: Pregnant women have not studied the use of diclofenac in pregnant women. Therefore, diclofenac potassium is contraindicated in the first six months of pregnancy unless the potential benefit to the mother outweighs the risk to the fetus. Like other nonsteroidal anti-inflammatory drugs, it is contraindicated in the third trimester of pregnancy because it may cause premature closure of the ductus arteriosus or uterine atony (see contraindications). Animal experiments have not found any direct or indirect harmful effects on pregnant women, embryo/fetal development, delivery or postpartum development. Like other nonsteroidal anti-inflammatory drugs, lactating women will have a small amount of diclofenac entering. Therefore, diclofenac potassium should be avoided during lactation to avoid adverse reactions to the fetus. Fertility Like other nonsteroidal anti-inflammatory drugs, the use of diclofenac potassium may impair female fertility, so it is not recommended for women trying to become pregnant. Women who have difficulty conceiving or are undergoing infertility testing should consider stopping the use of diclofenac potassium. Precautions for the elderly: Elderly patients should use the drug with caution according to the situation. In particular, elderly patients who are weak and underweight should take the lowest effective dose.

(1) When used with alcohol or other non-steroidal anti-inflammatory drugs, gastrointestinal adverse reactions may increase, and there is a risk of ulcers. Long-term use with acetaminophen may increase the toxic side effects on the kidneys. (2) When used with anticoagulants such as heparin and dicoumarol and platelet aggregation inhibitors, there is an increased risk of bleeding. (3) When used with potassium-sparing diuretics, it may cause hyperkalemia. (4) When used with verapamil and nifedipine, the blood concentration of this product increases. (5) This product can increase the blood concentration of digoxin and lithium preparations. When used together, it is necessary to pay attention to adjusting the dose of digoxin and lithium preparations. (6) When used together with antidiabetic drugs, this product may affect the efficacy of the latter, so it needs to be considered carefully. (7) When used together with antihypertensive drugs, this product may affect the antihypertensive effect of the latter. (8) This product can reduce the excretion of methotrexate and increase its blood concentration, even to toxic levels, so this product should not be used with medium or large doses of methotrexate. (9) When this product is used in combination with cyclosporine, it can increase the toxicity of the latter.

Keep away from light and store in sealed container.

25 mg

24 months