LEXIB [Celecoxib] 200 mg Capsules

ARTEFIT

instructions for medical use of the medicinal product

Tradename

Artefit, Artefit

International non-proprietary name

Tenoxicam, Tenoxicam

Compound

Excipients:

Mannitol, disodium edetate, ascorbic acid, tromethamine, sodium hydroxide, or hydrochloric acid.

Each solvent ampoule contains 2 ml of water for injection.

Dosage form

Tablets.

Suppository .

Lyophilized powder for solution for injection.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory drug (NSAID).

Pharmacological properties

Pharmacodynamics

Tenoxicam has anti-inflammatory, analgesic and antipyretic properties. It acts by inhibiting the cyclooxygenase enzymes, which play an important role in the biosynthesis of prostaglandins. The combined analgesic and anti-inflammatory effects make tenoxicam particularly useful for the symptomatic relief of painful and/or inflammatory conditions.

Pharmacokinetics

After oral administration, it is completely absorbed in the gastrointestinal tract. The maximum plasma concentration is reached after 2 hours. After intramuscular injection, peak plasma levels are reached after 15 minutes. Communication with plasma proteins is 98.5%.

The therapeutic effect is observed 2 weeks after the start of use. Penetrates through the blood-brain and placental barrier, found in breast milk. Metabolism in the liver.

The half-life is 60-75 hours. Elimination by the kidneys as inactive metabolites.

Indications for use

Symptomatic treatment as an anti-inflammatory and analgesic agent: rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, articular syndrome with exacerbation of gout, bursitis, tendovaginitis; pain syndrome of low and moderate intensity (arthralgia, myalgia, neuralgia, migraine, toothache and headache, algomenorrhea); pain from injuries, burns. Inflammatory and degenerative diseases of the musculoskeletal system, accompanied by pain, such as sciatica, lumbago, epicondylitis.

Contraindications

- Previously known hypersensitivity to the product or other oxicams.

- Patients who have experienced acute asthma attacks, urticaria, angioedema or rhinitis after taking other NSAIDs or aspirin.

- Patients with active peptic ulcer or active inflammatory diseases of the gastrointestinal tract.

- Patients at risk of renal insufficiency or patients with an increased risk of bleeding, due to an increased risk of acute renal failure and the possibility of homeostasis.

Use during pregnancy or lactation

Contraindicated for use during pregnancy and during breastfeeding.

Interaction with other drugs

As with other NSAIDs:

- The simultaneous use of more than one NSAID (including aspirin) should be avoided due to an increased risk of side effects.

- Co-administration with angiotensin converting enzyme (ACE) inhibitors, cyclosporine, tacrolimus or diuretics may increase the risk of nephrotoxicity.

- Use with ACE inhibitors and potassium-sparing diuretics may also lead to an increased risk of hyperkalemia.

- The hypertensive effects of some antihypertensive drugs, including ACE inhibitors, beta-blockers and diuretics may be reduced.

- Simultaneous use with oral anticoagulants, phenytoin and sulfonylurea antidiabetic agents may increase the effect of these drugs.

- Seizures may occur due to interactions with quinolones.

- With the simultaneous use of tenoxicam enhances the side effects of mineralocorticoids and glucocorticoids, estrogen.

- Simultaneous administration with lithium, methotrexate and cardiac glycosides may increase the plasma concentrations of these drugs.

Special instructions and precautions

When using Artefit, you should carefully monitor the function of the gastrointestinal tract. If the first signs of gastrointestinal bleeding are detected, the drug should be immediately discontinued.

Caution should be used in patients with impaired renal function (including those caused by diabetes mellitus).

During the period of Artefit use, it is necessary to control the prothrombin index (against the background of taking indirect anticoagulants), the concentration of glucose in the blood (against the background of the use of hypoglycemic agents), the picture of peripheral blood and the functional state of the liver and kidneys.

Caution should be used in patients with impaired liver function. If against the background of the use of Artefit there is an excessive increase in the level of transaminases, which persists during therapy, then the drug should be discontinued.

Tenoxicam is able to retain potassium, sodium, and water ions. In this regard, the drug may worsen the course of arterial hypertension or heart failure.

Artephyte reduces platelet aggregation and increases bleeding time, which should be kept in mind for upcoming surgical interventions.

It is not recommended to use the drug in combination with salicylates.

If it is necessary to determine 17-ketosteroids, Artefit should be canceled 48 hours before the study.

Due to the negative effect on fertility, the use of the drug is not recommended for women who want to become pregnant. In patients with infertility (including those undergoing examination), it is recommended to cancel Artefit.

Patients with systemic lupus erythematosus and mixed connective tissue disease have an increased risk of developing aseptic meningitis.

Caution should be used in patients over the age of 65 years (especially in patients receiving diuretics, debilitated patients and patients with low body weight).

Artefit is not recommended for use in patients under 16 years of age as a dose

and indications for this population have not been established.

Influence on the ability to drive vehicles and mechanisms

During the period of use of the drug, patients should be careful when driving vehicles and mechanisms, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Dosage and administration

Inside, rectally, intramuscularly and intravenously.

20 mg 1 time per day after breakfast.

To stop a gout attack - 40 mg 1 time per day for 2 days, then 20 mg 1 time per day for 5 days.

Highest daily dose: 40 mg.

The highest single dose: 40 mg.

Preparation of the solution: dissolve the vial with lyophilized powder in 2 ml of sterile water for injection, then inject intramuscularly or intravenously. The prepared solution should be used immediately.

Side effect

Cardiovascular system: tachycardia, increased blood pressure.

Nervous system: dizziness, headache, sleep disorders, depression, agitation, hallucinations.

Respiratory system : decreased resistance to respiratory tract infections, bronchospasm, shortness of breath, cough.

Hematopoietic system : anemia, agranulocytosis, leukopenia, thrombocytopenia.

Digestive system : dyspepsia (nausea, vomiting, heartburn, diarrhea, flatulence), bleeding gums with prolonged use.

Urinary system : edematous syndrome, renal failure.

Skin and subcutaneous tissues: pruritus, rash, urticaria, erythema.

Overdose

There is no clinical experience with drug overdose.

If necessary, the drug should be discontinued, supportive and symptomatic therapy is carried out.

Storage conditions

Tablets: Store below 30°C.

Suppositories: Store between 2°C and 8°C.

Vials: Store in a place protected from light, at a temperature not exceeding 30°C.

Keep out of the reach of children.

Best before date

3 years. Do not use after the expiry date stated on the package.

Holiday conditions

Released by prescription.

Release form

Tablets: blisters of 10 tablets with instructions for medical use in a cardboard box.

Suppositories: strips of 5 suppositories with instructions for medical use in a cardboard box.

Vials: 3 vials of lyophilized powder and 3 solvent ampoules of 2 ml of water for injection with instructions for medical use in a cardboard box.