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Diclofenac Potassium Tablets

Function and Efficacy

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.

Ingredients

Diclofenac Potassium

Name Description Content CAS NO. Manufacturer
Diclofenac potassiumIngredients

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 and triglycerides, reduce the concentration of free arachidonic acid in cells, and indirectly inhibit the synthesis of leukotrienes. Diclofenac sodium is a stronger non-steroidal anti-inflammatory drug. Its inhibitory effect on prostaglandin synthesis is stronger than that of aspirin and indomethacin.

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15307-81-0 24

Appearance

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

Indication

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.

Usage and Dosage

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.

Adverse Reactions

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

Precautions

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.

Special Population Medication

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: The use of diclofenac in pregnant women has not been studied. Therefore, diclofenac potassium is prohibited in the first six months of pregnancy unless the potential benefits to the mother outweigh the risks to the fetus. Like other non-steroidal anti-inflammatory drugs, it is prohibited in the third trimester of pregnancy because it may cause premature closure of the ductus arteriosus or uterine atony. Animal experiments have not found any direct or indirect harmful effects on pregnant women, embryo/fetal development, delivery or postpartum development. Like other non-steroidal anti-inflammatory drugs, a small amount of diclofenac will enter. Therefore, diclofenac potassium should be avoided during lactation to avoid adverse reactions to the fetus. Precautions for the elderly: Elderly patients should use the drug with caution according to the situation. Especially for frail and underweight elderly patients, the lowest effective dose should be taken.

Drug Interactions

(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.

Storage

Store in a cool, dry place.

Packaging Specification

25mg

Validity Period

24 months

Manufacturer

Guangzhou Baiyunshan Pharmaceutical Co., Ltd. Guangzhou Baiyunshan Pharmaceutical General

  • Founded in:

    1973-07-01
  • Address:

    No. 88, Yunxiang Road, Tonghe Street, Baiyun District, Guangzhou
  • Tax NO.:

    91440101714253245D
  • Registered Funds:

    -
  • Website:

  • Email:

Other Drugs of Guangzhou Baiyunshan Pharmaceutical Co., Ltd. Guangzhou Baiyunshan Pharmaceutical General

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