Index of drugs

Short-term symptomatic treatment of osteoarthritis exacerbations. Long-term symptomatic treatment of rheumatoid arthritis and ankylosing spondylitis.

1 tabl contains 15 mg of meloxicam. The preparation contains lactose.

A non-steroidal anti-inflammatory drug from the oxicam group with anti-inflammatory and analgesic properties. The mechanism of anti-inflammatory action of meloxicam is based on inhibition of COX-2 cyclooxygenase relative to COX-1. After oral administration, it is well absorbed from the gastrointestinal tract (89%) regardless of food intake. After a single dose, the mean maximum plasma concentration is reached within 5-6 h. In about 99%, it is bound to plasma proteins; maximum serum concentration occurs after 5-6 h, with regular dosing, steady state is achieved after 3-5 days. It penetrates into the synovial fluid, where it reaches approximately 50% of the plasma concentration. It is metabolized in the liver, mainly in the oxidation of methyl groups. The CYP2C9 isoenzyme with a lower CYP3A4 contribution plays an important role in the metabolism of meloxicam. It is excreted in the form of metabolites in the urine and faeces. T_0,5 is about 20 h. Moderate renal or hepatic failure does not significantly affect drug kinetics. In the elderly, the rate of excretion of the drug is reduced.

Hypersensitivity to meloxicam or other components of the preparation. Hypersensitivity to substances with a similar effect, eg NSAIDs, Acetylsalicylic acid manifested by bronchial asthma, nasal polyps, angioneurotic edema and urticaria. III trimester of pregnancy and breastfeeding. Active or recurrent peptic ulcer of the stomach and / or duodenum. Severe liver dysfunction. Severe un-dialyzed renal failure. Bleeding from the digestive tract, from cerebral vessels or other bleeding. Severe heart failure.

It should not be used in children under 15 years of age. Use with caution in patients at risk of gastrointestinal bleeding, ulceration or perforation of the gastrointestinal tract, and in elderly patients, the treatment should be started at the lowest effective dose. In these patients, and patients in whom low-dose Aspirin or other medications that may increase the risk of gastrointestinal disorders are necessary, combination therapy with gastric acid-reducing medicines (eg with misoprostol or proton pump inhibitors) should be considered. Caution is advised in patients taking concomitant medications that may increase the risk of stomach ulcers and / or duodenum or bleeding, i.e. oral corticosteroids, anticoagulants such as Warfarin, selective serotonin reuptake inhibitors, antiplatelet agents such as acetylsalicylic acid. Treatment with the preparation should be discontinued in case of bleeding or ulceration of the gastrointestinal tract, skin rash, mucous membrane damage or any symptoms of hypersensitivity and persistent abnormalities of laboratory indicators. Use with caution in patients with a history of gastrointestinal disorders (eg, ulcerative colitis, Crohn's disease) due to the risk of exacerbation of the disease. Patients with a history of hypertension and / or mild or moderate heart failure should be monitored because of the risk of water retention and formation of edema. Very prudently used in patients with uncontrolled hypertension, congestive heart failure, ischemic heart disease, peripheral artery disease and / or cerebrovascular disease, and in patients with risk factors for cardiovascular disease (hyperlipidemia, diabetes and smoking). In patients with heart failure or hypertension, NSAIDs can cause sodium and water retention and affect the natriuretic effect of diuretics, which may lead to exacerbation of the disease symptoms.Use with caution in elderly patients, especially those with impaired renal, hepatic or cardiac function. Meloxicam can mask the symptoms of a concomitant infection. 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 in the third trimester of pregnancy and during breastfeeding. In the I and II trimesters of pregnancy, use only in case of absolute necessity. Meloxicam may adversely affect fertility, hence it is not recommended for women planning pregnancy. In women who have difficulty conceiving or who are being tested for infertility, discontinuation of meloxicam should be considered.

Common: anemia; feeling of emptiness in the head, headache. Uncommon: abnormal blood counts: leukocytopenia, thrombocytopenia, agranulocytosis; dizziness associated with labyrinth disorders, tinnitus, drowsiness; palpitations, heart failure; hypertension, facial flushing. Rare: anaphylactic or anaphylactoid reactions; mood changes, insomnia, nightmares; confusion; blurred vision including blurred vision. The use of some NSAIDs may be associated with a small increase in the risk of artery embolism episodes.

Orally. Adults and youth over 15 years. Exacerbation of osteoarthritis: 7.5 mg once a day, the dose can be increased to 15 mg once a day. Rheumatoid arthritis, ankylosing spondylitis: 15 mg once a day; after a therapeutic response, the dose can be reduced to 7.5 mg once a day. Do not exceed the 15 mg dose per day. Periodic regression of symptoms and response should be periodically monitored, particularly in patients with osteoarthritis. In elderly patients, the recommended dose for long-term treatment of rheumatoid arthritis and ankylosing spondylitis is 7.5 mg once a day. Patients with an increased risk of adverse reactions should start with a daily dose of 7.5 mg. Do not exceed the 7.5 mg dose per day in dialysis patients. No dose adjustment is necessary for patients with mild to moderate renal or hepatic impairment.
Table. take during a meal.