Diclofenac tablets: instructions for use

Diclofenac in different forms of release: indications for use

Medicine in tablets, injections, ointments, gels, suppositories can be used for short-term suppression of painful sensations that arise as a consequence of:

osteochondrosis, rheumatic tissue lesions, osteoarthrosis, arthritis;
sciatica, peripheral nerve damage, lumbago;
gout, migraines;
inflammation in the pelvic area, injuries and surgical interventions.

Suppositories are prescribed as an addition to the main therapy for complex inflammatory processes such as otitis, laryngitis, and pharyngitis.

Injection administration of Diclofenac according to the instructions is recommended to obtain a quick analgesic effect. The drug is administered for renal and hepatic colic, acute pain syndrome in damaged muscles, after surgery. Prevention and treatment of postoperative discomfort is carried out by intravenous infusion of Diclofenac.

Eye drops are prescribed to patients:

to prevent inflammation and swelling during surgical interventions;
with penetrating and non-penetrating injuries of the eyeballs;
to suppress discomfort during laser vision correction.

What does Disclofenac tablets help with: the indications are similar to the injectable forms of the medication. It is sometimes used to relieve toothache. Gel and ointment are used to treat disorders of the locomotor system, rectal suppositories are used when it is impossible to take the medication orally.

Suppositories are safer and are not capable of causing complications from parenteral administration of Diclofenac: necrosis, infiltrates, suppuration at the needle entry site. Suppositories are used in combined regimens: tablets or injections are prescribed during the day, and rectal medications are prescribed at night. In gynecological practice, suppositories are prescribed for acute pain syndrome that occurs against the background of an inflammatory process in the ovaries or painful menstruation.

Diclofenac, 20 pcs., 50 mg, enteric-coated 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 bleeding or perforation in history, 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.

Contraindications and non-standard reactions from Diclofenac

The instructions indicate that the medication is not prescribed:

in case of individual intolerance to the component composition;
bleeding from the gastrointestinal tract, ulcers, perforation and inflammation of the digestive canal;
bronchial asthma arising under the influence of NSAIDs;
liver, kidney, heart failure.

Diclofenac is contraindicated for proctitis (in suppositories), after coronary artery bypass surgery, during pregnancy and for children under 6 years of age. Ointments and gels are not used for skin damage. Suppositories and tablets are prescribed to patients over 14 years of age. Increased caution is needed when treating patients with herpetic keratitis, children, the elderly, and nursing women.

The following side effects may occur when taking tablets:

dyspeptic disorders;
erosions and ulcers of the gastrointestinal tract;
bleeding in the digestive tract;
drowsiness, unreasonable irritability;
attacks of dizziness, allergies.

Diclofenac drops can provoke:

burning, cloudiness of the cornea;
decreased visual acuity (temporary);
allergies, iritis.

Intramuscular administration of the drug is sometimes accompanied by unpleasant sensations, and in difficult cases leads to tissue necrosis and abscess.

Diclofenac

Diclofenac

(lat.
diclofenac
) - non-steroidal anti-inflammatory drug.

Diclofenac is a chemical compound

Diclofenac, as a chemical compound, is 2-[(2,6-dichlorophenyl)amino]benzeneacetic acid. Empirical formula: C14H11Cl2NO2.

Diclofenac - medicine

Diclofenac is the international nonproprietary name (INN) of the drug. According to the pharmacological index, diclofenac belongs to the group “NSAIDs - Derivatives of acetic acid and related compounds”; according to ATC, diclofenac is included in the following groups:

"M01 Anti-inflammatory and antirheumatic drugs", diclofenac code M01AB05
“M02 Preparations for topical use for pain syndrome in diseases of the musculoskeletal system”, code M02AA15
“S01 Drugs for the treatment of eye diseases”, code S01BC03
"D11 Other preparations for the treatment of skin diseases", code D11AX18

Diclofenac is also the trade name of the drug.

Materials for healthcare professionals addressing the effects of diclofenac on the gastrointestinal tract

Articles

Abdulganieva D.I., Belyanskaya N.E. Intragastric pH-metry in the assessment of motor disorders in patients with rheumatoid arthritis and osteoarthritis while taking Diclofenac sodium // Far Eastern Medical Journal. 2011. No. 1. pp. 13–15.
Abdulganieva D.I., Salikhov I.G. Gastroenterological problems in rheumatic diseases // Publishing House "Praktika". - Kazan. – 2011.
Nasonov E.L. The use of non-steroidal anti-inflammatory drugs and cyclooxygenase-2 inhibitors at the beginning of the 21st century // Russian Medical Journal. – 2003. – Volume 11. – No. 7. – p. 375–378.

On the website in the literature catalog there are sections “NSAIDs and other drug-induced gastropathy” and “Non-steroidal anti-inflammatory drugs (drugs)”, containing publications on diseases of the gastrointestinal tract caused by taking NSAIDs (NSAIDs) and their treatment.

Video

Pakhomova I.G., Novikova D.S.
Management of comorbid patients in outpatient settings. Opinion of specialists: cardiologist and gastroenterologist On the website in the “Video” section there is a subsection “For doctors”, containing video recordings of reports, lectures, webinars on various areas of gastroenterology for healthcare professionals.

Use of diclofenac by pregnant and breastfeeding mothers

Diclofen has been assigned risk categories according to the FDA for effects on the fetus:

for pregnant women up to the thirtieth week of pregnancy - "C" (animal studies have shown negative effects of the drug on the fetus, and there have been no adequate studies in pregnant women, but the potential benefits associated with the use of this drug in pregnant women may justify its use despite the existing risk)
for pregnant women from the thirtieth week of pregnancy - “D” (evidence has been obtained of the risk of adverse effects of the drug on the human fetus, but the potential benefits associated with the use of the drug in pregnant women may justify its use, despite the risk)

Diclofenac is not recommended for breastfeeding mothers.

Medicines containing the active ingredient diclofenac

The following trademarks of medicinal products with the active substance diclofenac are registered (have been registered) in Russia: Artrex, Veral, Voltaren, Voltaren Akti, Voltaren Ofta, Voltaren Rapid, Voltaren Emulgel, Diklak Lipogel, Diklak, Diklo-F, Diklobene, Dikloberl, Diklovit, Diclogen, Diclomax, Diclomelan, Diclonac, Diclonat, Dicloran, Dicloran SR, Diclorium, Diclofen, Diclofenac, Diclofenac (Biclopan), Diclofenac (Ortofen), Diclofenac bufus, Diclofenac potassium, Diclofenac sodium, Diclofenac retard Obolenskoe, Diclofenac Sandoz, Diclofenac Stada, Diclofenac-AKOS, Diclofenac-Acri, Diclofenac-Acri retard, Diclofenac-Altfarm, Diclofenac-MFF, Diclofenac-ratiopharm, Diclofenac-UBF, Diclofenac-FPO, Diclofenac-Eskom, Diclofenaclong, Diclofenacol, Difen, Dorosan, Naklof, Naklofen, Naklofen Duo, Naklofen SR, Sodium diclofenac, Ortofen, Ortofen injection solution 2.5%, Ortofen film-coated tablets, Ortofer, Ortoflex, Rapten Duo, Rapten rapid, Revmavek, Revodina retard, Remetan, Sanfinac, SwissJet, SwissJet Duo, Tabuk -Di, Feloran, Feloran retard, Flotak.
US registered brands: Cambia, Cataflam, Voltaren, Voltaren-XR, Zipsor.

Instructions for medical use of diclofenac

Some instructions from manufacturers for the medical use of various drugs with diclofenac as the only active ingredient (pdf):

For Russia:
Diclofenac-Acri, retard film-coated tablets, 100 mg, Akrikhin company
Diclofenac-Acri, gel for external use, Akrikhin company
Diclofenac-Akri, ointment for external use, Akrikhin company
Diclofenac-Teva, gel for external use, Teva

for USA (in English):

guidance on the use of non-steroidal anti-inflammatory drugs and the official instructions of the company Actavis Ellzabeth LCC “Diclofenac sodium extended-release tablets” for healthcare professionals “Diclofenac sodium extended-realeas tablets”
“Voltaren XR (diclofenac sodium extended-realeas tablets). Tablets of 100 mg. Prescribing Information", Novartis
"Voltaren Gel (diclofenac sodium topical gel). For topical use only. Full Prescribing Information,” Novartis, July 2009.
"Voltaren Ophtalmic (diclofenac sodium ophtalmic solusion) 0.1%. Prescribing Information", 2012, Novartis

Diclofenac has contraindications, side effects and application features; consultation with a specialist is necessary. Back to section

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.

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.

Increased danger of diclofenac: truth or black PR?

The incidence of side effects among patients using the painkiller drug Diclofenac is 50% higher compared to users of other painkillers. This conclusion was reached by a joint group of Danish scientists who conducted a meta-analysis of the side effects of NSAIDs. The result of the study, conducted in Denmark, would not have been in doubt if the work had not been funded by competitors of the drug manufacturer.

Currently, Diclofenac is the most commonly used NSAID. The possibility of its negative side effects on the cardiovascular system has never been specifically studied. However, a number of cohort studies were conducted in Denmark, which formed the basis of this meta-analysis. It was financed by the funds of two pharmaceutical companies - Lundbeck, which specializes in the production of drugs for the treatment of disorders of the central nervous system, and Novo Nordisk. Both firms may have a vested interest in the negative findings of this study.

Although the scientists said funding sources had no influence on the results of the meta-analysis, the findings from the side-effect studies of diclofenac compared with other NSAIDs were so alarming that they suggested a covert order for the result. In particular, scientists say that patients using diclofenac are 50% more likely than patients using other NSAIDs to suffer adverse cardiovascular events. According to the study results, the risk of atrial fibrillation increases by 1.2 times, the risk of ischemic stroke by 1.6 times, the risk of heart failure by 1.7 times, and the risk of myocardial infarction by 1.9 times. Overall mortality from cardiovascular accidents, according to the authors, increases by 1.7 times.

In addition, according to scientists, using diclofenac for a month significantly increases the risk of bleeding in the upper gastrointestinal tract. Compared to the group using other NSAIDs, the risk increases by 2.5 times, and compared to the control group not using drugs - by 4.5 times.

Scientists explain their results by the short half-life of the drugs—1-2 hours after administration. For effective pain relief, the drug is prescribed in a dose significantly higher than the required volume. As the concentration falls, the drug continues to inhibit certain types of enzymes, which contributes to thrombosis, causing pathology of the cardiovascular system.

The result of the meta-analysis was the expected statement that Diclofenac should be excluded from pharmacy sales, and if use is necessary, the patient should be informed about the potential risks. Of course, most often the adverse effects of diclofenac use were noted in patients with high cardiovascular risk, however, according to scientists, the side effect of diclofenac is so strong that it manifests itself within a month after stopping its use, as well as when consuming low doses of the drug. Thus, the study declared the threat of side effects of the drug at any dose, excluding the possibility of a “safe level”.

Such work, by its very existence, will most likely cause a significant drop in sales of diclofenac and, as a result, an increase in the turnover of drugs from competing pharmaceutical manufacturers. There are no indications that the study is biased, but the funding sources suggest deliberate publicity that could deprive diclofenac of its status as the “most commonly used NSAID.”

Pharmedu.ru editors

Diclofenac Hemofarm retard Capsules, 20 pcs., 100 mg, for adults, film-coated

special instructions

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).

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 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.

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.

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

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).