Dexketoprofen-SZ, 25 mg 10 pcs

It has analgesic, anti-inflammatory and antipyretic effects. The mechanism of action of the drug is associated with inhibition of proslaglandin synthesis at the level of cyclooxygenases (COX-1 and COX-2).

The analgesic effect comes within 30 minutes after oral administration; therapeutic effect lasts for 4-6 hours.

In combined therapy with opioid analgesics, the drug significantly (up to 30-45%) reduces the need for opioids.

Indications

Pain syndrome management of different genesis (including postoperative pain, pain from bone metastases, post-traumatic pain, pain from renal colic, algodysmenorrhea, sciatica, radiculitis, neuralgia, toothache, etc.).);

– symptomatic treatment of acute and chronic inflammatory, inflammatory degenerative and metabolic diseases of the musculoskeletal system (including rheumatoid arthritis, spondyloarthritis, osteoarthritis, osteochondrosis).

The tablets are intended as symptomatic therapy, to reduce pain and inflammation at the time of use.

Active ingredient

Dexectoprofen

Composition

1 film-coated tablet contains:

Active ingredient:

dexketoprofen trometamol – 36.9 mg, in terms of dexketoprofen – 25 mg,

excipients (core):

microcrystalline cellulose – 135.2 mg;

pregelatinized starch (Starch 1500) – 50.0 mg,

How to take, the dosage

The drug tablets are taken orally with meals. Depending on the intensity of the pain syndrome, the recommended dose for adults is 12.5 mg (1/2 tablet) every 4-6 hours or 25 mg (1 tablet) every 8 hours.

The maximum daily dose is 75 mg.

In elderly patients and patients with impaired hepatic and/or renal function, therapy should be started with lower doses. The maximum daily dose is 50 mg.

The drug is not intended for long-term therapy; the course of treatment should not exceed 3-5 days.

Interaction

Undesirable combinations of the drug.

With other NSAIDs, including salicylates in high doses (more than 3 g per day):

The simultaneous use of several NSAIDs due to synergistic effects increases the risk of gastrointestinal bleeding and ulcers.

With oral anticoagulants, heparin in doses greater than prophylactic, and ticlopidine: increased risk of bleeding due to inhibition of platelet aggregation and gastrointestinal mucosa damage.

With lithium preparations: NSAIDs increase the concentration of lithium in blood, up to and including toxic, in connection with which this indicator should be controlled during use, change of dose and after cancellation of NSAIDs.

With methotrexate at high doses (15 mg per week or more): increased hematological toxicity of methotrexate due to decreased renal clearance with NSAID therapy.

With hydantoins and sulfonamides: risk of increased toxicity of these drugs.

Combinations requiring caution.

With diuretics, angiotensin-converting enzyme inhibitors: NSAID therapy is associated with the risk of acute renal failure in dehydrated patients (decreased glomerular filtration due to reduced prostaglandin synthesis). Administration of the drug may decrease the angihypertensive effect of some drugs.

Special Instructions

During treatment with the drug, caution should be exercised when driving vehicles and engaging in potentially hazardous activities requiring increased concentration and rapid psychomotor reactions.

Patients with gastrointestinal disorders or gastrointestinal diseases in the anamnesis should be closely monitored. In case of gastrointestinal bleeding or ulcers the therapy should be stopped.

It is clinically proved that concomitant use with preparations of low molecular weight heparin in prophylactic doses during the postoperative period does not change the coagulation rates. However, when concomitant use with other drugs that affect blood clotting, careful medical monitoring of the clotting system is required.

Like other NSAIDs, the drug may lead to an increase in plasma creatinine and nitrogen concentrations. Like other inhibitors of prostaglandin synthesis, it may have adverse effects on the urinary system, which may lead to the development of glomerulonephritis. interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure.

Synopsis

Round, biconvex, film-coated tablets are yellow. On cross section the core of the tablet is white or almost white.

Contraindications

– hypersensitivity to any of the components of the drug;

– gastric and duodenal ulcer in the acute phase;

– gastrointestinal bleeding in the history, other active bleeding (including suspected intracranial bleeding). suspected intracranial bleeding), anticoagulant therapy;

– inflammatory bowel disease (Crohn’s disease, ulcerative colitis) in the acute phase;

p> – severe liver function disorders (10-15 points on the Child-Pugh scale);

– moderate or severe renal function disorders (creatinine clearance < 50 ml/min);

– Complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, and intolerance to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (including a history);

– severe heart failure;

– period after coronary artery bypass grafting;

– hemorrhagic diathesis or other coagulation disorders;

– age less than 18 years (no data on the effectiveness and safety of the drug).

With caution

– allergic reactions;

– disorder of the blood clotting system;

– systemic lupus erythematosus or mixed connective tissue diseases;

concurrent therapy with other medicinal products (see

– concomitant therapy with other drugs (see section ‘Interaction with other medicinal products’);

– a state of marked hypovolemia;

– coronary heart disease;

– cerebrovascular disease;

– diabetes mellitus, hyperlipidemia;

– peripheral artery disease;

– history of gastrointestinal ulcers;

– long-term use of NSAIDs;

– alcoholism, heavy smoking;

– older age (over 65 years).

The use during pregnancy and during breast-feeding is contraindicated.

Side effects

Blood and lymphatic system disorders: very rarely – neutropenia, thrombocytopenia.

Nervous system disorders: infrequent – headache, dizziness, insomnia, somnolence, rarely – paresthesias.

Visual organ disorders: very rare – blurred vision.

Hearing organ disorders and labyrinth disorders: rarely – tinnitus. Cardio-vascular system disorders: infrequent – fever, hyperemia of the skin, rare – extrasystole, increased blood pressure, very rare – tachycardia, decreased blood pressure.

Respiratory system, thoracic and mediastinal organs: rare – bradypnoea, very rare – bronchospasm, shortness of breath.

Gastro-intestinal tract disorders: common – nausea, vomiting, abdominal pain, dyspepsia, diarrhea, infrequent – constipation, dry mouth. flatulence, rarely – erosive-ulcerative lesions of the gastrointestinal tract, bleeding from ulcers or their perforation, anorexia, very rare – pancreatic lesions.

Liver and biliary tract disorders: rare – increased activity of liver enzymes, including aspartate aminotransferase and alanine aminotransferase (ACT and ALT), jaundice, very rare – liver damage. Renal and urinary tract disorders: rare – polyuria, very rare – nephritis or nephrotic syndrome.

Reproductive system disorders: rare – in women – menstrual disorders, in men – transient prostate disorders with prolonged use.

Musculoskeletal and connective tissue disorders: rarely – back pain, muscle spasm, difficulty in moving the joints.

Skin and subcutaneous tissue disorders: infrequent – dermatitis, rash, rarely – urticaria, acne, sweating, very rare – severe skin reactions (Stevens-Johnson syndrome, Lyell syndrome), angioedema, allergic dermatitis, photosensitization.

Metabolic disorders: rarely – hyperglycemia, hypoglycemia, hypertriglyceridemia.

Laboratory and instrumental data: rarely – ketonuria, proteinuria. General disorders and disorders at the place of administration: infrequent – fever, fatigue, very rare – anaphylactic shock, facial edema.

Other disorders: infrequent – aseptic meningitis, occurring mainly in patients with systemic lupus erythematosus or mixed connective tissue diseases, hematological disorders (purpura, aplastic and hemolytic anemia), rarely – agranulocytosis and bone marrow hypoplasia.

Overdose

Symptoms: nausea, anorexia, abdominal pain, headache, dizziness, disorientation, insomnia.

Treatment: symptomatic therapy, if necessary – gastric lavage, hemodialysis.

Pregnancy use

Use during pregnancy and lactation is contraindicated.

Similarities

Dexalgin 25, Dexalgin, Flamadex, Ketodexal, Dexonal, Veldexal