Properties
What is it?
Composition: Each tablet contains: Piroxicam-beta-cyclodextrin (equivalent to 20mg piroxicam); Excipients: lactose monohydrate, crospovidone (Type A), sodium starch glycolate (Type A), colloidal silicon dioxide hydrated, pregelatinized starch, magnesium stearate. Indications: Piroxicam is indicated for the relief of symptoms of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis. Due to its safety profile, piroxicam is not a first-line drug in the selection of non-steroidal anti-inflammatory drugs. The prescription of piroxicam should be based on an overall assessment of the expected risks for the patient. Since a constant effective plasma concentration of piroxicam is achieved only after daily administration of the drug for 5-10 days, this drug is not used to treat diseases that require a rapid effect. Contraindications: Hypersensitivity to the active substance or any of the excipients; gastrointestinal manifestations, bleeding or perforation in history; gastrointestinal disorders that predispose to bleeding, such as ulcerative colitis, Crohn's disease, gastrointestinal tumors or diverticulitis in history. Patients with active peptic ulcer, inflammatory gastrointestinal disorders or bleeding. Patients with gastritis, dyspepsia, acute kidney or liver diseases, moderate or severe heart diseases, acute hypertension, acute blood diseases or hemorrhagic diathesis. Concomitant use of other NSAIDs, including selective COX-2 inhibitors, acetylsalicylic acid at analgesic doses. Concomitant use with anticoagulants. Any type of serious drug allergic reactions in history, especially skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. Previously identified skin reactions (regardless of severity) to piroxicam, other NSAIDs and drugs. Established or suspected pregnancy, lactation, childhood. Dosage and administration: The dose is determined by a doctor experienced in the diagnosis and treatment of patients with inflammatory or degenerative rheumatic diseases. The maximum recommended daily dose is 20mg (1 tablet). To avoid side effects, the minimum effective dose should be prescribed for the shortest possible duration that ensures symptom control. Pregnancy and lactation: Piroxicam is contraindicated during established or suspected pregnancy and lactation. Pregnancy: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic-fetal development. According to epidemiological studies, there is an increased risk of abortion, heart defects, gastroschisis after taking prostaglandin synthesis inhibitors in the first trimester of pregnancy. The risk of heart defects increases by approximately 1%-1.5%. The risk is considered to depend on the dose as well as the duration of treatment. In animals, administration of prostaglandin synthesis inhibitors has led to an increase in pre- and post-implantation loss and embryo-fetal mortality. In animals treated with prostaglandin synthesis inhibitors during organogenesis, an increased incidence of various malformations, including cardiovascular malformations, was observed. In the third trimester of pregnancy, all prostaglandin synthesis inhibitors may cause fetal: cardiovascular toxicity (ductus arteriosus closure and pulmonary hypertension); renal dysfunction leading to renal failure with oligohydramnios; at the end of pregnancy in mothers and fetuses: prolonged bleeding time and antiplatelet effect, which can be caused even by very low doses; inhibition of uterine contractions, leading to delayed or prolonged labor. Storage and expiry date