Piroxicam capsules 10mg, 20pcs

Composition

Composition per capsule:

Piroxicam (in terms of 100% substance) – 10 mg.

Excipients: – microcrystalline cellulose, potato starch, talc, colloidal silicon dioxide. Solid gelatin capsules: gelatin, titanium dioxide, iron oxide yellow, indigo carmine, water.

Pharmacological action

Pharmacotherapy group: Nonsteroidal anti-inflammatory drug (NSAID)ATX Code: M02AA07 Pharmacodynamics :

Piroxicam is a nonsteroidal anti-inflammatory drug (NSAID) with anti-inflammatory analgesic and antipyretic effects.

Non-selectively suppresses cyclooxygenase 1 and cyclooxygenase 2 (COX 1 and COX 2) inhibits prostaglandin synthesis in the inflammatory focus and in the central nervous system suppresses the exudative and proliferative phase of inflammation. Inhibits the aggregation of neutrophils and the formation of superoxide anions in them, as well as the migration of polymorphonuclear cells and monocytes to the focus of inflammation. Reduces the release of lysosomal enzymes from stimulated white blood cells. Reduces the pyrogenic effect of prostaglandins on the thermoregulatory center. Reduces the severity of moderate-intensity pain syndrome by increasing the threshold of pain sensitivity to biological amines. The analgesic effect appears 30 minutes after oral use. After a single dose, the effect persists for 24 hours.

With joint syndrome, it reduces or stops inflammation and pain at rest when moving, reduces morning stiffness and swelling of the joints, and increases the volume of movement. With algodismenorrhea (being an inhibitor of prostaglandin synthesis in the endometrium), it relieves pain.

Pharmacokinetics:

When taken orally, the drug is well absorbed from the gastrointestinal tract, the maximum plasma concentration is proportional to the dose used. The maximum plasma concentration is reached 3-5 hours after ingestion of the drug. After a single dose of 20 mg, the Cmax is 15-2 mcg / ml after a regular intake of 20 mg / day-3-8 mcg / ml. Food slows down the rate of absorption but does not affect the volume of absorption. Bioavailability is almost 100%. The time to reach the equilibrium concentration is 7-12 days. Penetrates the synovial fluid (40-50%) is excreted in breast milk – 1-3%. Easily binds to plasma proteins (almost 98%).

The elimination half-life is 24-50 hours and may be prolonged in liver diseases. The drug is metabolized in the liver by hydroxylation of the pyridine ring of the side chain, followed by conjugation with glucuronic acid and the formation of inactive metabolites. It is excreted in the form of conjugates by the kidneys and to a lesser extent-through the intestines. About 5% is displayed unchanged.

Indications

Diseases of the musculoskeletal system: rheumatoid arthritis osteoarthritis spondylitis sciatica psoriatic arthropathy gout tendovaginitis bursitis Ankylosing spondylitis pain in the spine neuralgia myalgia postoperative and post-traumatic pain extra-articular rheumatic diseases soft tissue inflammation. Algodismenorrhea. It is intended for symptomatic therapy of reducing pain and inflammation at the time of use and does not affect the progression of the disease.

Contraindications

• hypersensitivity to piroxicam other NSAIDs components of the drug;
• complete or incomplete combination of bronchial asthma, recurrent polyposis of the nasal mucosa or paranasal sinuses and intolerance of acetylsalicylic acid and other NSAIDs (including history);
• erosive and ulcerative changes in the mucous membrane of the stomach or 12 duodenal ulcer, active gastrointestinal bleeding; cerebrovascular or other bleeding;
• inflammatory bowel disease (Crohn’s disease ulcerative colitis) in the acute phase;
• hemophilia and other blood clotting disorder;
• decompensated heart failure;
• liver failure or any active liver disease;
• severe renal insufficiency (creatinine clearance less than 30 ml/min), progressive kidney diseases, confirmed hyperkalemia;
• the period following the coronary artery bypass surgery;
• pregnancy, lactation;
• children up to age 15 years.

With caution:

• age older than 65 years;
• coronary heart disease, cerebrovascular disease, congestive
• heart failure;
• dyslipidemia/hyperlipidemia;
• hypertension;
• diabetes mellitus;
• peripheral arterial disease;
• asthma;
• the presence of hepatic porphyria;
• creatinine clearance 30-60 ml/min;
• postoperative period;
• dehydration;
• Smoking;
• anamnestic information about the development of ulcerative lesions of the gastrointestinal tract, the presence of Helicobacter pylori infection, prolonged use of NSAIDs, frequent alcohol consumption severe somatic diseases concomitant therapy with the following drugs:

– anticoagulants (e. g. warfarin);- antiplatelet agents (e. g. acetylsalicylic acid clopidogrel);- oral glucocorticosteroids (e. g. prednisone);- selective serotonin reuptake inhibitors (e. g. citalopram fluoxetine paroxetine sertraline).

Side effects

The most common side effects of the gastrointestinal tract and digestive organs: epigastric pain belching nausea decreased appetite vomiting constipation or diarrhea flatulence erosive and ulcerative lesions of the gastrointestinal tract bleeding in the gastrointestinal tract which in exceptional cases can cause anemia perforation of the gastrointestinal tract; dry mouth stomatitis.

From the side of the hepatobiliary system:  liver function disorders increased activity of “hepatic” transaminases; increased concentration of nitrogen and creatinine in plasma.

From the urinary system:  renal dysfunction interstitial nephritis papillary necrosis nephrotic syndrome erythrocyturia proteinuria hyper-or hypokalemia glomerulonephritis nephrosis.

From the central nervous system:  dizziness headache tinnitus drowsiness insomnia less often-depression irritability hallucinations paresthesia lethargy mood changes.

From the hematopoietic and hemostatic system: anemia including aplastic and hemolytic decreased hemoglobin index decreased hematocrit; leukopenia eosinophilia rarely-thrombocytopenia hemorrhages thrombocytopenic purpura (Schonlein-Henoch disease); suppression of bone marrow function.

From the cardiovascular system:  increased or decreased blood pressure signs of heart failure rarely – palpitations shortness of breath.

Allergic reactions:  skin rash pruritus erythema reactions photosensitization Lyell’s syndrome facial laryngeal edema bronchospasm malignant exudative erythema (Stevens-Johnson syndrome) anaphylactic shock vasculitis serum sickness.

Other services:  visual impairment swelling of the legs and feet increased sweating increased urea concentration; increased or decreased body weight.

The frequency of the above disorders increases with increasing daily dose of the drug.

Interaction

With simultaneous use of piroxicam and:

• corticosteroids and/or NSAIDs – increased risk of side effects from the gastrointestinal tract, including bleeding;
• phenobarbital lowers the concentration of piroxicam in serum;
• cimetidine and probenecid sulfinpirazon – may increase the concentration of piroxicam in serum leading to increased side effects of piroxicam;
• phenytoin and/or lithium and potassium-sparing diuretics and donors To+ – may increase the level of concentration of phenytoin in plasma lithium and potassium;
• diuretics and antihypertensives – weakens the effect of the latter;
• anticoagulants reduces the ability of platelets to aggregate (risk of bleeding) is necessary to monitor blood clotting;
• acetylsalicylic acid decreases the concentration of piroxicam in the blood serum increases the risk of erosive and ulcerative lesions of the gastrointestinal tract;
• selective reuptake inhibitors of serotonin (citalopram fluoxetine paroxetine sertraline) increases the risk of erosive and ulcerative lesions of the gastrointestinal tract;
• methotrexate – may increase the concentration of methotrexate and increased its toxicity.

How to take it, course of use and dosage

Adults and children over 15 years of age-inside during meals.

Diseases of the musculoskeletal system joint diseases (rheumatoid arthritis osteoarthritis spondylitis) the initial and maintenance dose is 10-20 mg per day in 1 or 2 doses.

If necessary, the dose can be temporarily increased to 30 mg per day (once or in divided doses) or reduced to 10 mg per day.

Acute diseases of the musculoskeletal system: for the first 2 days,40 mg per day once or in several doses. The maintenance dose is 20 mg per day for 1-2 weeks.

Acute attack of gout: take 40 mg for 4-6 days.

Postoperative and post-traumatic pain: the initial dose is 20 mg once a day.

In some cases, it is possible to increase the dose with the appointment in the first two days of 40 mg once or in divided doses.

In case of algodismenorrhea: treatment should be started when the first symptoms appear at an initial dose of 40 mg / day in 1 or several doses for 2 days. In the next 1-3 days-20 mg in 1 reception.

The maximum daily dose of the drug for adults and children over 15 years of age should not exceed 40 mg.

Do not exceed the recommended daily dose as this increases the risk of side effects.

Overdose

Symptoms: abdominal pain nausea vomiting drowsiness visual impairment when taking very large doses-loss of consciousness coma. Treatment: gastric lavage using activated charcoal to slow absorption, antacids are used. In case of severe poisoning, the patient should be hospitalized. There is no specific antidote. Treatment is symptomatic.

Special instructions

To prevent undesirable effects, the drug should be used only as prescribed by a doctor at the lowest effective dose in the shortest possible course.

Simultaneous use of several nonsteroidal anti-inflammatory drugs increases the risk of side effects, while the therapeutic effect does not improve.

The drug can change the properties of platelets, but it does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases.

With extreme caution, the drug should be prescribed to patients with impaired liver or kidney function who use diuretics after extensive surgical interventions in the elderly. Such patients need to monitor blood cell composition and kidney function.

After 2 weeks of using the drug, monitoring of liver function indicators (transaminase) is necessary.

To reduce the risk of gastrointestinal adverse events, the lowest effective dose should be used in the shortest possible course.

If during therapy with the drug the patient shows signs of ulcers in the gastrointestinal tract, then treatment should be interrupted; if the use of the drug is absolutely necessary, then treatment should be carried out under the supervision of a doctor with the simultaneous use of antacids.

It is not recommended to prescribe the drug to patients with bronchial asthma allergic rhinitis nasal polyps and chronic obstructive airway diseases.

The use of the drug may negatively affect female fertility and is not recommended for women planning pregnancy.

During treatment with the drug, alcohol consumption is unacceptable.

Recommendations for use in children under 15 years of age are currently not developed.

Influence on the ability to drive vehicles and mechanisms:

During the treatment period, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

Store in a dry place protected from light and out of reach of children at a temperature not exceeding 25 ° C.

Shelf

life is 2 years. Do not use after the expiration date indicated on the package.

Active ingredient

Piroxicam

Conditions of release from pharmacies

By prescription

Dosage form

Capsules