Diclofenac 100 mg (extended release tablets)


Use in drug addicts

Diclofenac belongs to the group of non-narcotic analgesics (unlike morphine, codeine, fentanyl and tramadol).
Even in large doses, it is not a psychoactive drug and has no addictive potential, that is, with short- or long-term use it does not cause either physiological or psychological dependence. However, you should be aware that diclofenac can delay the active breakdown products of morphine in the blood. This is important to remember for those taking morphine - a side effect such as respiratory depression may occur.

Diclofenac 25 mg/ml (solution)

The risk of adverse reactions when using diclofenac increases with increasing dose and duration of treatment. In order to reduce the risk of adverse events, the drug should be used at the minimum effective dose for the shortest period necessary to relieve symptoms. With regular use of the drug, the need for symptom relief, response to treatment should be periodically assessed and the dose adjusted in a timely manner.

Damage to the gastrointestinal tract

When using diclofenac, phenomena such as bleeding or ulceration/perforation of the gastrointestinal tract, in some cases with fatal outcome, were observed. These events may occur at any time when using drugs in patients with or without previous symptoms and a history of serious gastrointestinal diseases. In older patients, such complications can have serious consequences. If bleeding or gastrointestinal ulceration develops in patients receiving diclofenac, the drug should be discontinued.

To reduce the risk of toxic effects on the gastrointestinal tract in patients with gastrointestinal ulcers. especially with a history of complicated bleeding or perforation, as well as in elderly patients, the drug should be used in the minimum effective dose. Patients at increased risk of developing gastrointestinal complications, as well as patients receiving therapy with low doses of acetylsalicylic acid (Aspirin), should take gastroprotectors (proton pump inhibitors or misoprostol) or other medications to reduce the risk of unwanted effects on the gastrointestinal tract.

Patients with a history of gastrointestinal lesions, especially the elderly, should report all abdominal symptoms to the doctor.

Patients with bronchial asthma

Exacerbation of asthma (NSAID intolerance/NSAID-induced asthma), angioedema and urticaria are most often observed in patients with bronchial asthma, seasonal allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease or chronic infectious diseases of the respiratory tract (especially those associated with allergic rhinitis). rhinitis-like symptoms). In this group of patients, as well as in patients with allergies to other drugs (rash, itching or urticaria), special caution should be observed when using diclofenac (preparedness for resuscitation measures).

Skin reactions

Serious dermatological reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, in some cases fatal, have been reported very rarely with the use of diclofenac. The highest risk and incidence of severe dermatological reactions were observed in the first month of treatment with diclofenac. If patients receiving diclofenac develop the first signs of skin rash, damage to the mucous membranes or other symptoms of hypersensitivity, the drug should be discontinued.

In rare cases, anaphylactic/anaphylactoid reactions may develop in patients who are not allergic to diclofenac.

Effects on the liver

Since during the period of use of diclofenac there may be an increase in the activity of one or more liver enzymes, monitoring of liver function is indicated as a precautionary measure during long-term therapy with the drug. If liver dysfunction persists or progresses or signs of liver disease or other symptoms occur (for example, eosinophilia, rash, etc.), the drug should be discontinued. It should be borne in mind that hepatitis during the use of diclofenac can develop without prodromal phenomena.

Effects on the kidneys

During therapy with diclofenac, it is recommended to monitor renal function in patients with hypertension, impaired cardiac or renal function, the elderly, patients receiving diuretics or other drugs that affect renal function, as well as in patients with a significant decrease in the volume of circulating blood plasma of any etiology, for example, in the period before and after major surgical interventions. After cessation of drug therapy, normalization of renal function indicators to initial values ​​is usually observed.

Effects on the cardiovascular system

Therapy with NSAIDs, including diclofenac, particularly long-term therapy and high-dose therapy, may be associated with a small increase in the risk of serious cardiovascular thrombotic complications (including myocardial infarction and stroke).

Patients with cardiovascular disease and a high risk of developing cardiovascular disease (eg, hypertension, hyperlipidemia, diabetes mellitus, smokers) should be prescribed the drug only after careful consideration and used with extreme caution, at the lowest effective dose when the minimum possible duration of treatment, since the risk of thrombotic complications increases with increasing dose and duration of treatment. With long-term therapy (more than 4 weeks), the daily dose of diclofenac in such patients should not exceed 100 mg. The effectiveness of treatment and the patient's need for symptomatic therapy should be periodically assessed, especially in cases where its duration is more than 4 weeks.

The patient should be instructed to immediately seek medical attention if the first symptoms of thrombotic disorders (eg, chest pain, shortness of breath, weakness, speech disturbances) appear. Impact on the hematopoietic system

Diclofenac may temporarily inhibit platelet aggregation. Therefore, in patients with hemostasis disorders, it is necessary to carefully monitor relevant laboratory parameters. With long-term use of diclofenac, it is recommended to conduct regular clinical tests of peripheral blood.

Masking signs of an infectious process

The anti-inflammatory effect of diclofenac may complicate the diagnosis of infectious processes.

Use simultaneously with other NSAIDs

Diclofenac should not be used concomitantly with other NSAIDs, including selective COX-2 inhibitors, due to the risk of increased adverse events.

Impact on women's fertility

Diclofenac may have a negative effect on women's fertility, so diclofenac is not recommended for women wishing to become pregnant. In women experiencing difficulty conceiving (including those undergoing testing), the possibility of discontinuing the use of diclofenac should be considered.

The sodium metabisulfite contained in the drug can rarely cause severe hypersensitivity reactions and bronchospasm.

Information for Patients on a Sodium Controlled Diet

The sodium content in one ampoule (3 ml) of Diclofenac solution for injection does not exceed 1 mmol (23 mg), i.e. practically “sodium-free”.

Side effects

Diclofenac (and most other nonsteroidal anti-inflammatory drugs) blocks the production of prostaglandins. These same substances are included in the layer that protects the gastric mucosa from damage and chemical irritants. That is, long-term use of the analgesic diclofenac can lead to the development of gastritis and ulcers of the stomach and duodenum. Other rare side effects:

  • nausea, discomfort in the upper abdomen, abdominal pain
  • excess gas, constipation or diarrhea
  • headaches and dizziness
  • insomnia, tinnitus, irritability, malaise and fatigue

Some side effects are specific: they depend on the form of use of diclofenac. So, if you use external agents (gel, ointment), redness or rash on the skin is possible, and when administering rectal suppositories, inflammation of the rectum is possible (very rare); with intramuscular administration, a small inflammatory focus may form at the injection site.

Diclofenac 100 mg (extended release tablets)

In order to reduce the risk of adverse events, the drug should be used at the lowest effective dose for the shortest period necessary to relieve symptoms.

Therapy with NSAIDs, including diclofenac, particularly long-term and high-dose therapy, may be associated with a small increased risk of serious cardiovascular thrombotic events (including myocardial infarction and stroke).

In patients with significant risk factors for cardiovascular events (eg hypertension, hyperlipoproteinemia, diabetes mellitus and smoking), treatment with diclofenac-containing products should only be initiated after careful evaluation and analysis.

Because of the important role of prostaglandins in maintaining renal blood flow, special caution should be exercised when prescribing the drug to patients with cardiac or renal failure, hypertension, elderly patients, patients taking diuretics or other drugs that affect renal function, and patients with For some reason, there is a decrease in circulating blood volume (for example, after extensive surgery). If diclofenac is prescribed in such cases, monitoring of renal function is recommended as a precaution. After cessation of drug therapy, normalization of renal function indicators to initial values ​​is usually observed.

When using diclofenac, phenomena such as bleeding or ulceration/perforation of the gastrointestinal tract, in some cases fatal, were observed. These phenomena may occur at any time when using the drug in patients with or without previous symptoms and a history of serious gastrointestinal diseases. In elderly patients, such complications can have serious consequences. If patients receiving diclofenac develop bleeding or ulceration of the gastrointestinal tract, the drug should be discontinued. To reduce the risk of toxic effects on the gastrointestinal tract, the drug should be used in the minimum effective dose for the shortest possible time, especially for patients with gastrointestinal ulcers, especially complicated by a history of bleeding or perforation, as well as elderly patients.

Patients with an increased risk of developing gastrointestinal complications, as well as those receiving therapy with low doses of acetylsalicylic acid or other drugs that can increase the risk of damage to the gastrointestinal tract, should take gastroprotectors.

Patients with a history of gastrointestinal disorders, especially the elderly, should report all symptoms of the digestive system to their doctor.

When carrying out long-term therapy, it is necessary to monitor liver function, peripheral blood patterns, and stool analysis for occult blood.

With long-term use of diclofenac, there may be an increase in the activity of one or more liver enzymes. If liver dysfunction persists or progresses or signs of liver disease or other symptoms occur (for example, eosinophilia, rash, etc.), the drug should be discontinued. It should be borne in mind that hepatitis during the use of diclofenac can develop without prodromal phenomena.

Caution must be exercised when using diclofenac in patients with hepatic porphyria, since the drug can provoke attacks of porphyria.

Diclofenac can reversibly inhibit platelet aggregation, therefore, in patients with hemostasis disorders with long-term use, careful monitoring of relevant laboratory parameters is necessary.

In patients with bronchial asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (including nasal polyps), chronic obstructive pulmonary disease, chronic respiratory tract infections (especially those associated with allergic rhinitis-like symptoms), as well as in patients with allergies to other medications (rash, itching, urticaria) when prescribing diclofenac, special care should be taken (preparedness for resuscitation measures).

Severe, in some cases fatal, skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been very rarely reported with the use of diclofenac. The highest risk and incidence of severe dermatological reactions were observed in the first month of treatment with diclofenac. If patients receiving the drug develop the first signs of skin rash, damage to the mucous membranes or other symptoms of hypersensitivity, diclofenac should be discontinued.

The anti-inflammatory effect of NSAIDs, including diclofenac, may complicate the diagnosis of infectious processes.

Due to the negative effect on fertility, the drug is not recommended for women planning pregnancy. In patients with infertility (including those undergoing examination), it is recommended to discontinue the drug.

When taking 100 mg tablets, patients with diabetes should take into account the sucrose content in the drug (1 tablet contains 94.7880 mg of sucrose).

pharmachologic effect

Diclofenac is a representative of the group of non-steroidal anti-inflammatory drugs.

Reduces the production of arachidonic acid and disrupts the synthesis of prostaglandins, therefore it has a triple effect:

  • relieves inflammation;
  • relieves pain;
  • reduces high temperature.

When used externally, it reduces pain in joints both at rest and during movement, relieves swelling and stiffness in the morning, and allows you to increase physical activity.

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