Diclofenac Sodium Sustained Release Tablets

Pharmacodynamics Group: Anti-inflammatory and anti-rheumatic drugs, non-steroidal, acetic acid derivatives and related substances (ATC code: M01AB05). Mechanism of action This product contains diclofenac sodium, which is a non-steroidal anti-inflammatory drug with significant analgesic, anti-inflammatory and antipyretic effects. Experiments have shown that this product produces analgesic, anti-inflammatory and antipyretic effects by inhibiting the synthesis of prostaglandins. Diclofenac sodium does not inhibit the synthesis of proteoglycans in cartilage tissue when the in vitro concentration is equivalent to the concentration in the human body. Pharmacodynamics In the treatment of rheumatic diseases, diclofenac has good anti-inflammatory and analgesic effects, which can significantly relieve the following symptoms and effectively improve function: pain at rest, pain during movement, morning stiffness, joint edema. In the case of inflammation, such as inflammation caused by trauma or surgery, it can quickly relieve pain and pain during movement at the same time, and reduce inflammatory edema and traumatic edema. This product is particularly suitable for patients receiving daily doses of 75mg and 100mg. The daily tablet dosage method not only greatly simplifies the prescription troubles in the long-term treatment process, but also avoids possible errors in dosage. This product can be taken twice a day to reach a maximum daily dose of 150 mg.

The main ingredient of this product is diclofenac sodium.

This product is white or off-white tablets.

1. Relieve acute attacks or persistent joint swelling and pain in rheumatoid arthritis, osteoarthritis, spondyloarthritis, gouty arthritis, rheumatoid arthritis and other chronic arthritis; 2. Various soft tissue rheumatic pains, such as shoulder pain, tenosynovitis, bursitis, myalgia and pain after sports injuries; 3. Acute mild and moderate pains such as pain after surgery, trauma, strain, primary dysmenorrhea, toothache, headache, etc.

As a general recommendation, the dosage should be adjusted according to different individuals, and the minimum effective amount should be given in the shortest possible time interval. The tablets should be swallowed whole, with liquid, and should not be divided or chewed. It is suitable for taking with food. Adults: The recommended dose of this product is once a day, 75 mg (1 tablet) each time; the maximum dose is 150 mg (2 tablets), taken twice or as directed by the doctor. For mild and long-term treatment patients, take 75 mg daily. For patients with more severe symptoms at night and in the early morning, 75 mg should be taken in the evening. Children and adolescents: Due to the large dose of this product, children and adolescents should not use it.

Including individual case reports, adverse reactions are ranked by frequency as follows, with the most frequent ones ranked first (Table 1): common (ge; 1/100, 1/10); uncommon (ge; 1/1,000; 1/100); rare (ge; 1/10,000; 1/1,000); very rare (1/10,000). The following table lists adverse reactions to this product and/or other dosage forms of diclofenac during short-term or long-term use.

1. Patients with known allergies to this product. 2. Patients who have asthma, urticaria or allergic reactions after taking aspirin or other non-steroidal anti-inflammatory drugs. 3. Contraindicated for the treatment of perioperative pain in coronary artery bypass grafting (CABG). 4. Patients with a history of gastrointestinal bleeding or perforation after the use of non-steroidal anti-inflammatory drugs. 5. Patients with active peptic ulcers/bleeding, or patients with recurrent ulcers/bleeding in the past. 6. Patients with severe heart failure. Patients with severe liver, kidney and heart failure (see Precautions). 7. Three months after pregnancy (see Pregnant and lactating women).

Precautions for children: Due to the high dose of this product, it is not suitable for children and adolescents. Precautions for pregnancy and lactation: The use of diclofenac in pregnant women has not been studied. Therefore, unless the potential benefit to the mother outweighs the risk to the fetus, this product is contraindicated for women in the first two months of pregnancy. Like other nonsteroidal anti-inflammatory drugs, diclofenac may cause uterine atony and premature closure of the ductus arteriosus in the last three months of pregnancy (see contraindications), so diclofenac is contraindicated in the last three months of pregnancy. Animal experiments have not found any direct or indirect harmful effects on pregnant women, embryo/fetal development, delivery or postpartum development (see preclinical safety data). Like other nonsteroidal anti-inflammatory drugs, diclofenac will also enter breast milk in small amounts in lactating women, so this product should be avoided during lactation to avoid adverse effects on the fetus. Fertility Like other nonsteroidal anti-inflammatory drugs, the use of diclofenac sodium may impair female fertility, so this product is not recommended for women who are preparing to become pregnant, and women who have difficulty conceiving and are undergoing infertility tests should also consider stopping this product. Elderly precautions: When using the drug for the elderly, attention should be paid to the basic medical principles. Especially for patients with physical weakness and low body weight, the minimum effective dose should be given. Like all non-steroidal anti-inflammatory drugs, patients with gastrointestinal diseases or a history of gastrointestinal ulcers, bleeding or perforation should be closely monitored by medical staff (see adverse reactions). Because the risk of gastrointestinal bleeding increases significantly with the increase in the dosage of the drug when the drug is used in patients with a history of ulcer disease, especially for patients with combined bleeding or perforation and elderly patients. Patients with a history of gastrointestinal toxicity, especially elderly patients, must record all abnormal abdominal symptoms (especially gastrointestinal bleeding). In patients with a history of ulcers, especially those with bleeding or perforation and elderly patients, in order to reduce gastrointestinal toxicity, both the initial dose and the maintenance dose should be kept at the lowest effective dose level. As with other NSAIDs, due to reports of fluid retention and edema associated with NSAID treatment, patients with impaired heart or kidney function, patients with a history of hypertension, elderly patients, patients taking diuretics or medications that can significantly affect renal function, and patients with any cause of extracellular fluid loss (such as patients before and after major surgery) should be particularly careful when using this drug (see Contraindications). When such patients take this drug, it is recommended to monitor renal function as a preventive measure. If adverse renal reactions occur, the patient will usually return to the pre-treatment condition after discontinuation of this drug.

The following interactions exist with this product and/or other formulations of diclofenac. Lithium preparations: Diclofenac may increase plasma lithium concentrations when used concomitantly with lithium. Plasma lithium levels should be monitored. Digoxin: Diclofenac may increase plasma digoxin concentrations when used concomitantly with digoxin. Plasma digoxin levels should be monitored. Diuretics and antihypertensive drugs: As with other NSAIDs, diclofenac may have reduced antihypertensive effects when used in combination with diuretics and antihypertensive drugs (e.g., beta-blockers, ACE inhibitors). Therefore, when used in combination, it should be administered with caution and blood pressure should be checked regularly, especially in elderly patients. Patients should be adequately hydrated and renal function monitoring should be considered after the initial combination therapy and periodically thereafter, especially for patients taking diuretics and ACE inhibitors because these two drugs can increase the risk of nephrotoxicity. When used in combination with potassium-sparing diuretics, serum potassium levels may increase, causing hyperkalemia, so it is necessary to monitor serum potassium concentrations (see Precautions). When used with furosemide, the latter's sodium excretion and hypotensive effects are weakened. Other nonsteroidal anti-inflammatory drugs and corticosteroids: When diclofenac is used in combination with other nonsteroidal anti-inflammatory drugs or corticosteroids, the frequency of gastrointestinal adverse reactions may increase. (See Precautions). Anticoagulants and antiplatelet drugs: When used in combination, the risk of bleeding may increase, so caution should be used (see Precautions). Although clinical studies have not found that diclofenac has an effect on the effect of anticoagulants, there are individual reports that when diclofenac is used in combination with anticoagulants, the risk of bleeding may increase. Therefore, such patients should be closely monitored. Selective serotonin reuptake inhibitors (SSRIs): The risk of gastrointestinal bleeding may be increased when used in combination with nonsteroidal anti-inflammatory drugs (including diclofenac) (see Precautions). Antidiabetic drugs: Clinical studies have shown that diclofenac can be used in combination with oral hypoglycemic drugs without affecting their clinical efficacy. However, there are case reports that oral hypoglycemic and hyperglycemic reactions during diclofenac use require adjustment of the dose of oral hypoglycemic drugs. Therefore, as a precautionary measure for co-administration, it is necessary to monitor blood glucose levels. Methotrexate: Nonsteroidal anti-inflammatory drugs (including diclofenac) should be used with caution within 24 hours before and after methotrexate treatment, because the blood concentration of methotrexate may be increased and its toxicity may also increase. Cyclosporine: Diclofenac, like other nonsteroidal anti-inflammatory drugs, may increase the nephrotoxicity of cyclosporine due to its effects on renal prostaglandins. Therefore, the dosage for patients receiving cyclosporine treatment should be lower than that for non-users. Quinolone antibiotics: There are case reports that quinolone antibiotics may produce convulsions when used in combination with nonsteroidal anti-inflammatory drugs. When used in combination with alcohol or certain nonsteroidal anti-inflammatory drugs, the incidence of side effects may increase and there is a risk of ulcers. Long-term use with acetaminophen may increase the toxic side effects on the kidneys. When used with verapamil and nifedipine, the blood concentration of this product increases. Probenecid can reduce the excretion of this product, increase the blood concentration, and thus increase the toxicity, so it is advisable to reduce the dosage of this product when used together.

Keep tightly closed. Keep out of reach of children.

0.1g

24 months.

Sichuan Huaxin Pharmaceutical Co., Ltd.

• Founded in:

  1994-10-28

• Address:

  No. 866, Che'an Road, Leshan High-tech Development Zone, Sichuan Province

• Tax NO.:

  91511100621103715R

• Registered Funds:

  3.96 million yuan

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