Index of drugs

Symptomatic treatment of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis.

1 tabl contains 191.2 mg of Piroxicam with β-cyclodextrin, corresponding to 20 mg of piroxicam. The drug contains lactose.

A non-steroidal drug in the complex with β-cyclodextrin with analgesic, anti-inflammatory and antipyretic effects. The mechanism of action is the inhibition of cyclooxygenase, which participates in the synthesis of prostaglandins. The special construction of the complex dissolves very well in water, which allows faster absorption of the preparation, and thus faster and increased analgesic and anti-inflammatory effect in comparison to the free piroxicam. The maximum serum concentration occurs after 1 / 2-1 h. T_0,5 is 35-50 h. The preparation is strongly bound to plasma proteins (99%). It is metabolised in the liver mainly by hydroxylation and conjugation with glucuronic acid, it is excreted in the urine (2/3 of the administered dose) and faeces.

Hypersensitivity to piroxicam or other components of the preparation. Active or in history: ulceration of the gastrointestinal tract, gastric and / or duodenal ulcer disease, inflammatory disease of the gastrointestinal tract, gastrointestinal bleeding, gastrointestinal perforation. Diseases of the gastrointestinal tract with an increased risk of bleeding, i.e. ulcerative colitis, Crohn's disease, gastrointestinal tumors or diverticulitis. Patients with severe hepatic or renal impairment, moderate or severe heart failure, high blood pressure, hemorrhagic diathesis or bleeding disorders. Concomitant use with: other NSAIDs, including selective COX-2 inhibitors and Acetylsalicylic acid at painkillers. Simultaneous use with anticoagulants. Serious allergic reactions to the preparation in a history, especially skin reactions, such as: erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. Previous skin reaction (regardless of severity) to Piroxicam, other NSAIDs and other medicines. Finding or suspecting an existing pregnancy, breastfeeding period and use in children. Hypersensitivity to acetylsalicylic acid and other NSAIDs that can cause asthma, rhinitis, nasal polyps, angioneurotic edema, urticaria.

The preparation should be immediately discontinued if the first signs of skin reaction or significant gastrointestinal adverse reactions occur. Patients at risk of serious gastrointestinal adverse reactions should be treated only after careful consideration of indications and contraindications. The need for combination therapy with drugs that protect the gastric mucosa (eg with misoprostol or with proton pump inhibitors) should be considered. The risk of severe gastrointestinal complications increases with age (high risk occurs in patients over 70 years of age, and in patients over 80 years should be avoided) and when co-administered with oral corticosteroids, selective serotonin reuptake inhibitors or inhibitors platelet aggregation like low-dose acetylsalicylic acid. If a gastrointestinal complications are suspected during treatment, piroxicam should be discontinued immediately and additional clinical judgment should be considered and additional treatment included. Control adequately and cure patients with history of hypertension, mild to moderate congestive heart failure, fluid retention and edema, ischemic heart disease, peripheral artery disease, cerebrovascular disease and long-term treatment of patients with hyperlipidaemia, diabetes or smoking. Patients with reduced circulating volume and impaired renal flow (dehydration, congestive heart failure, nephrotic syndrome, renal dysfunction, cirrhosis) should be carefully monitored. Piroxicam reduces platelet aggregation and prolongs bleeding time, which should be considered when performing blood tests and in patients treated concomitantly with platelet aggregation inhibitors. Due to the effect of the preparation on arachidonic acid metabolism, the preparation may cause paroxysmal bronchospasm as well as shock and other allergic reactions in patients with asthma or susceptibilities to this type of reaction.Due to the lactose content, the preparation should not be used in patients with galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

The preparation is contraindicated during pregnancy and if it is suspected and during breastfeeding. The product may cause an increased risk of miscarriages, congenital heart defects and gastroschisis after use in the first stages of pregnancy. In the third trimester of pregnancy, it may expose the fetus to toxic effects on the heart, lungs and kidneys, and the mother and fetus to prolong bleeding time and inhibit platelet aggregation and suppression of uterine contractions resulting in delay or prolongation of labor. Piroxicam is excreted in breast milk at a concentration of approximately 1-3% of maternal plasma. The use of piroxicam may adversely affect female fertility and it is not recommended for women who are planning to become pregnant. For women who have difficulty conceiving, the termination of piroxicam should be considered.

Common: abdominal discomfort, abdominal pain, constipation, diarrhea, abdominal pain, discomfort, flatulence, nausea, vomiting, indigestion, anemia, thrombocytopenia, leukopenia, eosinophilia, anorexia, hyperglycemia, dizziness and headache, drowsiness, dizziness of labyrinthine origin, tinnitus, rash, pruritus, edema, increase in transaminases, weight gain. Uncommon: hypoglycaemia, blurred vision, palpitations, inflammation of the mouth. Rare: interstitial nephritis, renal papillary necrosis, nephrotic syndrome, renal failure. Very rare: severe cutaneous adverse reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Not known: aplastic anemia, hemolytic anemia, serum sickness, anaphylaxis, fluid retention, depression, sleep disorders, hallucinations, insomnia, confusion, mood changes, nervousness, paresthesia, eye irritation, eyelid edema, hearing loss, hypertension, vasculitis, contraction bronchitis, shortness of breath, nosebleeds, gastritis, gastrointestinal bleeding, gastrointestinal perforation, tarry stools, bloody vomiting, peptic ulcer disease, pancreatitis, dry mouth, jaundice, hepatitis, alopecia, angioedema, exfoliative inflammation dermatitis, erythema multiforme, hypersensitivity to light, separation of the nail from the placenta, urticaria, vesiculic bladder changes, non-platelet macula, glomerulonephritis, weight loss, increased alkaline phosphatase, positive antibody titers hemoglobin, a decreased hematocrit value.

Orally. The initiation of piroxicam treatment should be ordered by doctors with experience in the diagnosis and treatment of patients with inflammatory or degenerative rheumatic diseases. The maximum recommended daily dose is 20 mg. Taking the medicine in the lowest effective dose for the shortest period necessary to relieve symptoms reduces the risk of side effects. The need to administer the preparation in combination with medicines that protect the gastric mucosa (eg with misoprostol or with proton pump inhibitors) should be considered, especially in elderly patients.Way of giving. Table. should be taken with a meal; Table. you can share.