Dicloberte - instructions for use, analogs, reviews and release forms (tablets and candles 50, capsules retard 100, injections in ampoules for injections 75) drugs for the treatment of arthritis, arthrosis and pain relief in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Dicloberte. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Diclobber in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of the Diclobberle in the presence of existing structural analogs.Use for the treatment of arthritis, arthrosis and pain relief in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Dicloberte - non-steroidal anti-inflammatory drug (NSAID), a derivative of phenylacetic acid. The active substance of the drug is Diclofenac sodium. Has a pronounced anti-inflammatory effect by inhibiting the synthesis of prostaglandins. It acts as an antipyretic, analgesic and anti-edematous (swelling of tissues during inflammation) action. Reduces adhesive properties of platelets under the action of collagen and ADP.

Anti-inflammatory effect is due to interference in various parts of the pathogenesis of inflammation: in addition to the main anti-prostaglandin effect, the normal permeability, microcirculation processes are normalized, the influence of histamine, bradykinin and other mediators of inflammation decreases; the formation of ATP is inhibited, the energy of the inflammatory process decreases, etc. Analgesic properties are due to the ability to weaken the algogenicity of bradykinin, antipyretic - a calming effect on the altered excitability of the heat-regulating centersintermediate brain.

Composition

Diclofenac sodium + auxiliary substances.

Pharmacokinetics

After oral administration, diclofenac is absorbed from the intestine completely. After absorption from the intestine, pre-systemic metabolism occurs through the primary passage through the liver. In the posthepatic circulation, 35-70% of the active substance falls. After administration of the suppository in the rectum, Cmax in the blood plasma is observed after 30 minutes.

Approximately 30% of diclofenac is metabolized. Metabolism products are eliminated by the intestine. Inactive metabolites, obtained through the conjugation and hydroxylation of hepatocytes, are eliminated by the kidneys. The half-life period is 2 hours and does not depend on the kidney and liver function. It binds with blood proteins 99% of the drug.

Indications

Symptomatic treatment of pain and inflammation with:

• acute arthritis (including gout attacks);
• chronic arthritis, in particular, with rheumatoid arthritis (chronic polyarthritis);
• ankylosing spondylitis (Bechterew's disease) and other inflammatory rheumatic diseases of the spine;
• painful tissue irritations with arthrosis and spondyloarthrosis;
• inflammatory diseases of rheumatic nature with soft tissue damage;
• edema with pain syndrome or post-traumatic inflammation;
• fever and fever.

Forms of release

Tablets 50 mg.

Rectal Candles 50 mg.

Solution for injections N 75 (injections in ampoules).

Capsules of prolonged action of 100 mg (Diclobert Retard).

Instructions for use and dosage

Ampoules

Adults. Injection of Diclobber N 75 is performed once (75 mg of diclofenac sodium). To continue the treatment, dosage forms for oral or rectal administration are used. Moreover, even on the day of injection, the total dose of diclofenac sodium should not exceed 150 mg.

Method and duration of application

Diclobber N 75 is injected intramuscularly deep into the buttock area. Dicloberla N 75 injection is performed once. In connection with the potential risk of developing anaphylactic reactions (up to a shock), the patient should be watched for at least an hour after the administration of Diclobber 75; At the same time, the necessary for the provision of emergency care and a functioning (functioning) medical instrument should be ready.The patient needs to explain the meaning of these measures.

The duration of the drug is determined by the attending physician.

Pills

Diclobert 50 tablets are taken orally during meals (to exclude irritating effect on the gastric mucosa), squeezed with a small amount of liquid. Do not chew. The daily dose - 50-150 mg - is divided into 2-3 doses. The duration of therapy is determined by the doctor individually.

Retard Capsules

The dose in adults is 1 capsule Dicloberry retard prolonged action per day (equivalent to 100 mg of diclofenac sodium).

Diclobert retard should be taken whole inside, not liquid, and washed down with plenty of liquid. Patients with a sensitive stomach are advised to take Diclobert retard with meals.

The question of the duration of the drug is decided by the attending physician.

Therapy of rheumatic diseases may require a prolonged use of the Dicloberry retard drug.

Undesirable effects can be reduced by prescribing a minimum effective dose of the drug for as short a period of time as necessary to relieve the symptoms of the disease.

Rectal Candles

Diclobber suppositories 50 are injected deep into the rectum after defecation. The dose is determined individually by the doctor depending on the severity of the disease. Usually the daily dose should be in the range of 50-150 mg (for adults and patients over 15 years of age). The daily dose is administered in 2-3 doses.

Side effect

• dyspepsia;
• glossitis;
• esophagitis;
• liver damage;
• exacerbation of gastrointestinal diseases;
• pancreatitis;
• constipation, diarrhea;
• stomach ache;
• nausea, vomiting;
• decreased appetite;
• small gastrointestinal bleeding is possible;
• patients with gastrointestinal diseases may experience bleeding and perforation of the ulcer;
• melena;
• bloody vomiting;
• bloody diarrhea;
• dizziness;
• headache;
• insomnia;
• increased fatigue;
• excitation;
• changes in taste;
• sensitivity disorders;
• changes in the perception of sounds;
• visual impairment;
• disorientation;
• a sense of fear;
• convulsions;
• depression;
• tremor;
• stiff neck (aseptic meningitis);
• confusion of consciousness;
• skin rash;
• bullous eruptions;
• itching;
• burning sensation at the injection site;
• a sterile abscess at the site of administration;
• Lyell's syndrome;
• necrosis of subcutaneous fat at the injection site;
• edema of the tongue, face and larynx;
• Stevens-Johnson syndrome;
• anaphylactic shock;
• bronchospasm;
• thrombocytopenia, anemia, agranulocytosis, leukopenia;
• pain in the chest;
• palpitation;
• lowering blood pressure;
• arterial hypertension;
• pulmonitis.

Contraindications

• hypersensitivity to the active substance or to any of the other components of the drug;
• reactions in the form of bronchospasm, asthma, rhinitis or urticaria rash after taking acetylsalicylic acid or other non-steroidal anti-rheumatic / anti-inflammatory drugs (NSAIDs) in the anamnesis;
• unexplained hematopoiesis;
• the currently existing or transferred recurrent peptic ulcer / bleeding (at least two different episodes of confirmed peptic ulcer or bleeding);
• gastrointestinal bleeding or history of perforation associated with previous NSAID therapy;
• cerebrovascular or other currently available bleeding;
• severe impairment of liver or kidney function;
• severe heart failure;
• the last trimester of pregnancy;
• children under the age of 15 years (candles), up to 18 years (Retard capsules and injections).

Application in pregnancy and lactation

Pregnancy

The suppression of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. According to the results of epidemiological studies, in the early stages of pregnancy the use of drugs that suppress the synthesis of prostaglandin may increase the risk of spontaneous abortion, the appearance of a heart defect in the fetus and the non-growth of the anterior abdominal wall. Thus, the absolute risk of formation of cardiovascular malformations increased from less than 1% to approximately 1.5%. It is believed that the risk of these phenomena increases with an increase in the dose of the drug and the duration of its use.

In animals, the use of a prostaglandin synthesis inhibitor contributed to an increase in pre- and postimplantation rejection and an increase in embryo-fetal mortality. In addition, in animals that received a prostaglandin synthesis inhibitor in the period of organogenesis, the incidence of various malformations of the fetus, including the cardiovascular system, increased.

The appointment of Dicloberla during the first and second trimester of pregnancy is possible only when there is an urgent need for it. In the case of diclofenac, women planning a pregnancy, or in the first and second trimester of pregnancy should choose the smallest possible dose and the smallest possible duration of treatment.

In the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can lead to fetal development:

• phenomena of cardiopulmonary toxicity (eg, premature closure of the arterial duct and hypertension in the pulmonary artery system);
• dysfunction of the kidneys, which can progress up to renal failure with the development of malnutrition;

at the end of pregnancy can lead the mother and fetus to:

• prolonged bleeding time, anti-aggregation effect, which can occur even with very low doses of the drug;
• Suppression of uterine contractile activity, which can lead to delay or prolongation of labor.

In this regard, Dicloberte is contraindicated in the third trimester of pregnancy.

Lactation

The active ingredient diclofenac and its decay products in small amounts fall into the mother's milk. Since currently harmful effects of the drug for newborns are not established, it is usually not necessary to interrupt breastfeeding with short-term use of the drug. However, long-term treatment with diclofenac or when using high doses for rheumatic diseases should consider the possibility of stopping breastfeeding.

Fertility

Dicloberte can reduce female fertility, and therefore it is not recommended to appoint women planning a pregnancy. Women who have difficulty with conception or undergo infertility examinations should consider the possibility of abolishing Dicloberla.

Use in children

Contraindicated in children and adolescents under the age of 18 (injections, Diclobert Retard capsules).

Contraindicated in children under the age of 15 (rectal suppositories).

Application in elderly patients

In elderly patients, the incidence of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, including fatalities, is increased.

special instructions

Precautions for the gastrointestinal tract

Joint use of Diclobberl and other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.

Undesirable effects can be reduced by using the lowest effective doses during the shortest period necessary for relief of symptoms.

Gastrointestinal bleeding, ulcer and perforation of the ulcer

Gastrointestinal bleeding, ulcer formation or perforation, in some cases and with fatalities, were noted for all NSAIDs at any stage of treatment, with or without symptom-precursors and regardless of the presence or absence of a serious gastrointestinal pathology in the anamnesis.

The risk of gastrointestinal bleeding, development of an ulcer or perforation increases with an increase in the dose of a non-steroidal anti-inflammatory drug in patients with a history of an ulcer, especially complicated by bleeding or perforation, and in elderly patients. In such cases, treatment should be started with the lowest possible dose. For these patients, as well as for patients receiving low doses of Aspirin or other drugs,that increase the risk of adverse effects on the gastrointestinal tract, it is necessary to consider the application of combined therapy using drugs with a protective effect on the gastrointestinal (e.g., Misoprostol or proton pump inhibitors).

Patients who have a history there have been toxic effects on the gastrointestinal tract, especially elderly patients, should report any unusual symptoms from abdominal organs (especially of gastrointestinal bleeding); this is most important for the initial stages of treatment. Caution should be used to prescribe diclofenac to patients taking drugs simultaneously, which may increase the risk of ulceration or bleeding; such drugs include corticosteroids, oral anticoagulants, eg., warfarin, selective serotonin reuptake inhibitor, or agents inhibit platelet aggregation (antiplatelet drugs), for example. aspirin.

With the development of gastrointestinal bleeding against the background of diclofenac treatment, the drug should be withdrawn.

Nonsteroidal anti-inflammatory drugs should be administered with caution to patients withdiseases of the gastrointestinal tract in the anamnesis (ulcerative colitis, Crohn's disease) due to the risk of their exacerbation.

Effects from the cardiovascular system and cerebrovascular circulation

Diclofenac should be administered with caution to patients with arterial hypertension and / or decompensated heart failure from mild to moderate severity in history, since the treatment of NSAIDs may cause fluid retention and development of edema.

According to the results of clinical studies and epidemiological data, the use of diclofenac, especially at high doses (150 mg per day) and for a long time, may be accompanied by a slight increase in the risk of arterial thrombosis (eg, myocardial infarction or stroke).

Patients with uncontrolled arterial hypertension, heart failure, coronary heart disease, obliterating endarteritis and / or cerebrovascular pathology, diclofenac should be given only carefully after weighing. The same questions should be resolved before long-term treatment of patients with risk factors for cardiovascular diseases (for example, arterial hypertension, hyperlipidemia, diabetes, smoking).

Skin Reactions

There have been reports of rare cases of serious skin reactions, sometimes fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), against the background of NSAID treatment. The risk of such reactions is highest at the beginning of treatment; most of the phenomena described were observed in the first months of therapy. Diclobber should be withdrawn at the first appearance of skin rash, lesions of mucous or other signs of hypersensitivity.

Effects from the liver

Diclofenac should be administered with caution to patients with impaired liver function, as the condition may worsen during treatment. With prolonged treatment or repeated administration of diclofenac, it is recommended - for the sake of precaution - to check the liver function regularly. When there are clinical signs of liver pathology, the drug should be discarded.

Other instructions

In the following cases, Dicloberl should be administered only after a thorough assessment of the benefit-risk relationship:

• with congenital disorders of porphyrin metabolism (for example, in acute intermittent porphyria);
• with systemic lupus erythematosus (SLE) and mixed collagenoses.

In the following cases, careful monitoring by the attending physician is necessary:

• with a decrease in kidney function;
• when liver function is impaired;
• immediately after extensive surgery;
• with allergies to pollen, polyps in the nose and chronic obstructive airways diseases, as in such patients the risk of allergic reactions is increased. These reactions can be manifested by asthma attacks (so-called analgesic asthma), Quinck's edema or urticaria rash;
• when allergic to other substances, since these patients have increased risk of hypersensitivity reactions, including treatment with Dicloberblom.

Dicloberte should not be injected into a hotbed of inflammation or infection.

Very rarely, severe acute hypersensitivity reactions were observed (for example, anaphylactic shock). When the first signs of hypersensitivity reaction appear, Dicloberl should be abolished, and professional treatment is started in accordance with the developed symptomatology.

Diclofenac can temporarily suppress platelet aggregation. In this regard, it is necessary to monitor the condition of patients with coagulation disorders.

Like other NSAIDs, diclofenac can mask the manifestations of infection due to its pharmacodynamic properties. If, against the backdrop of Diclober's treatment, the symptoms of infection reappear or worsen, the patient is encouraged to consult a doctor immediately, which will determine if there are indications for prescribing anti-infectious therapy or antibiotic therapy.

With prolonged treatment with diclofenac, kidney function and a general blood test should be checked regularly.

With prolonged use of painkillers, there may be a headache. Do not try to eliminate the headache by increasing the dose of the drug.

With long-term use of painkillers, especially with the combination of several analgesic active ingredients, kidney damage of a persistent nature with the risk of renal failure (analgesic nephropathy) is possible.

With the combination of NSAIDs and alcohol, the undesirable effects of the active substance of the drug, especially on the gastrointestinal tract or central nervous system, are possible.

Influence on the ability to drive and maintain machinery

When treating Dicloberblom in high doses, such side effects from the central nervous system as increased fatigue and dizziness may occur; so in some cases, patients may experience a disruption in the reaction and a deterioration in their ability to actively participate in street traffic and to maintain mechanisms. These phenomena are intensified when the drug is combined with alcohol.

Drug Interactions

Other NSAIDs, including salicylates: Concomitant use of certain NSAIDs may increase the risk of ulcers and gastrointestinal bleeding due to synergistic effects of the drugs. In this regard, the combined use of diclofenac and other NSAIDs is not recommended.

Digoxin, phenytoin, lithium: With co-administration, Dicloberte can increase the concentration of digoxin, phenytoin and lithium in the blood. In connection with this, in the treatment of diclofenac, control of serum lithium concentration is mandatory, and Digoxin and phenytoin are recommended.

Diuretics, ACE inhibitors and angiotensin 2 antagonists: NSAIDs may reduce the effectiveness of diuretics and other antihypertensive drugs.In some patients with reduced renal function (eg, with dehydration or in elderly patients with reduced renal function), with the administration of ACE inhibitors or angiotensin 2 antagonists together with the cyclooxygenase inhibiting drug, further deterioration of renal function is possible, including the possible development of acute renal failure, which, however, in most cases is reversible. In this regard, these drugs should be used with caution in combination with diclofenac, especially in elderly patients. With the joint administration of diclofenac and these drugs, care should be taken to ensure that the patient takes an adequate amount of fluid, and also - after starting treatment regularly monitor kidney function.

The concomitant use of Dicloberla and potassium-sparing diuretics can lead to the development of hyperkalemia. In this regard, it is recommended to monitor the concentration of potassium in the blood with the joint administration of these drugs.

Glucocorticoids: With co-administration with diclofenac, the risk of ulcers and gastrointestinal bleeding increases.

Drugs that inhibit platelet aggregation (eg, acetylsalicylic acid), and selective serotonin reuptake inhibitors (SSRIs): When combined with diclofenac, the risk of gastrointestinal bleeding increases.

Methotrexate: When Dicloberte is administered within 24 hours before or after the administration of methotrexate, it is possible to increase the concentration of Methotrexate in the blood and to increase its toxic effects.

Cyclosporine: NSAIDs (eg, diclofenac sodium) can enhance the nephrotoxic effect of cyclosporine.

Anticoagulants: NSAIDs can enhance the action of anticoagulants, such as warfarin.

Sulfonylureas: There are some reports of changes in blood glucose concentrations after diclofenac, requiring dose adjustment for the antidiabetic drug. In this regard, when joint therapy is recommended to monitor the concentration of glucose in the blood.

Probenecid and sulfinpyrazone: Drugs containing probenecid and sulfinpyrazone may delay the excretion of diclofenac from the body.

Studies on the compatibility of diclofenac have not been conducted, so it should not be confused with other drugs.

Analogues of the drug Dicloberry

Structural analogs for the active substance:

• Beliefed;
• Voltaren;
• Diklak;
• Diklo F;
• Diklobene;
• Diclubber N 75;
• Diclobrell Retard;
• Diqlovit;
• Diklogen;
• Diclomax;
• Diclomelan;
• Diclonac;
• Diclonat P;
• Dicloran;
• Diclorium;
• Diclofen;
• Diclofenac;
• Diclofenac sodium;
• Diclofenac retard;
• Diclofenacol;
• Diphene;
• Naklofen;
• Naklofen Duo;
• Orthophene;
• Orthofer;
• Rapten Duo;
• Rapent Rapid;
• Revmavek;
• Redwood retard;
• Remetan;
• Sanfinak;
• SwissSet;
• SwissDjet Duo;
• Tabuk Di;
• Feloran 25;
• Feloran retard;
• Flotac.

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