Movasin tab 15mg 20 pc

Description

Composition
Active substance:
1 tablet contains: meloxicam (in terms of 100% substance) – 7.5 mg or 15 mg.
Excipients:
12.6 Povidone-th. (Low molecular weight polyvinylpyrrolidone medical 12600 ± 2700), lactose monohydrate (milk sugar), crospovidone (Kollidon CL, Kollidon CL-M), potato starch, talc, magnesium stearate, microcrystalline cellulose.
Product form:
7.5 mg Tablets, 15 mg.
10 tablets in blisters of PVC film and aluminum foil.
1, 2 blisters with instructions for use placed in a pile of cardboard.
Contraindications
Hypersensitivity to excipients or meloxicam formulation; of the drug includes lactose, so patients with rare hereditary diseases such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption, should not take the drug; condition after coronary artery bypass surgery; uncompensated heart failure; complete or incomplete combination of bronchial asthma and nasal polynosis intolerant of aspirin and other NSAIDs; erosive and ulcerative changes of the gastric mucosa or duodenum 12, active gastrointestinal bleeding; inflammatory bowel disease (ulcerative colitis, Crohn’s disease); cerebrovascular bleeding or other bleeding; severe liver failure or active liver disease; chronic renal failure in patients not undergoing dialysis (creatinine clearance (CC) of less than 30 ml / min), progressive renal disease, including confirmed by hyperkalemia; pregnancy, breast-feeding; Children up to age 12 years.
Indications
Symptomatic treatment of osteoarthritis; symptomatic treatment of rheumatoid arthritis; symptomatic treatment of ankylosing spondylitis (Bechterew’s disease).
Interaction with other drugs
While the use of other NSAIDs (and acetylsalicylic acid) increases the risk of erosive ulcers and gastrointestinal bleeding; while the use of antihypertensive drugs may decrease the effectiveness of the latter; In an application with lithium preparations may develop lithium accumulation and increase its toxic effect (recommended control the concentration of lithium in the blood); while the use of methotrexate amplified side effects of the latter on the hematopoietic system (risk of anemia and leukopenia shown periodic blood count control); while the use of diuretics and cyclosporine increases the risk of kidney failure; while the use of intrauterine contraceptive devices may reduce the effectiveness of the latter; while the use of anticoagulants (heparin, ticlopidine, warfarin), as well as thrombolytic agents (streptokinase, fibrinolysin) increases the risk of bleeding (required periodic monitoring parameters of blood clotting); while the use of colestyramine is accelerated excretion of the drug; while the use of selective serotonin reuptake inhibitor increases the risk of bleeding from the gastrointestinal tract.
Overdose
Symptoms: violation of consciousness, nausea, vomiting, epigastric pain, gastrointestinal-bleeding, acute renal failure, liver failure, respiratory arrest, asystole.
Treatment: No specific antidote; with an overdose of the drug should be to gastric lavage, reception activated carbon (during the next hour), symptomatic therapy. Forced diuresis, urinary alkalization, hemodialysis – are ineffective due to high drug connection with blood proteins.
pharmachologic effect
Pharmacodynamics:
Meloxicam – a non-steroidal anti-inflammatory drug (NSAID) having analgesic, antiinflammatory and antipyretic action. The mechanism of action is related to the inhibition of prostaglandin synthesis as a result of selective suppression of the enzymatic activity of cyclooxygenase-2 (COX-2) involved in the biosynthesis of prostaglandins in inflammation. When administered in high doses and long-term use of individual peculiarities of body selectivity for COX-2 is reduced. Inhibits the synthesis of prostaglandins in inflammation to a greater extent than in the gastric mucosa and kidney, which is associated with relatively selective inhibition of COX-2. Less common causes erosive-ulcerous disease of the gastrointestinal tract (GIT). To a lesser extent meloxicam acts on cyclooxygenase-1 (COX-1) participating in the synthesis of prostaglandins that protect mucous membrane of the gastrointestinal tract and involved in the regulation of renal blood flow.
Pharmacokinetics:
Well absorbed from the gastrointestinal tract, the absolute bioavailability of meloxicam – 89%. Simultaneous food intake does not modify absorption. When using the drug orally at doses of 7.5 and 15 mg doses are proportional to its concentration. The equilibrium concentrations are reached within 3 – 5 days. With prolonged use of drugs (for more than 1 year) concentrations similar to those that have been observed after first reaching the steady state pharmacokinetics. Plasma protein binding is more than 99%. The range differences between the maximum and basal concentrations of the drug after receiving once daily is relatively small and is at a dose of 7.5 mg 0.4-1.0 g / ml, and at a dose of 15 mg – 0.8-2, 0 g / ml (shown, respectively, the values ​​of the minimum concentration (Cmin) and maximum concentration (Cmax)). Meloxicam penetrates the blood-tissue barriers, concentrations in synovial fluid reaches 50% of the maximum drug concentration in plasma. Almost completely metabolized in the liver to form four pharmacologically inactive derivatives. The major metabolite 5`-karboksimeloksikam (60% of the dose) is formed by oxidation of the intermediate metabolite 5`-gidroksimetilmeloksikama which is also excreted, but to a lesser extent (9% of the dose). Studies in vitro have shown that in this metabolic conversion plays an important role CYP isozyme 2C9, additional importance CYP 3A4 isozyme. The formation of two other metabolites (components, respectively, 16% and 4% of the dose) participates peroxidase activity which probably varies individually. Displayed equally through the intestine and the kidney, mainly in the form of metabolites. Through the intestine in unaltered form is derived at least 5% of the daily dose in the urine in an unmodified form of the drug is found only in trace amounts. The half-life (T1 / 2) of meloxicam is 15-20 hours. Plasma clearance is an average of 8 ml / min. In the elderly the clearance of the drug is reduced. Volume of distribution is low and an average of 11 liters. Hepatic or renal insufficiency of moderate severity significant effect on the pharmacokinetics of meloxicam has not.
Pregnancy and breast-feeding
Contraindicated.
Conditions of supply of pharmacies
On prescription.
side effects
From the digestive system: more than 1% – indigestion, including nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea; 0.1-1% – transient increase in “hepatic” enzymes, hyperbilirubinemia, belching, esophagitis, gastroduodenal ulcer, bleeding from the gastrointestinal tract (including hidden), stomatitis; less than 0.1% – perforation of the gastrointestinal tract, colitis, hepatitis, gastritis.
From the side of hematopoiesis: more than 1% – anemia; 0.1-1% – changes in blood counts, including leukopenia, thrombocytopenia.
For the skin: more than 1% – itching, skin rash; 0.1-1% – urticaria; less than 0.1% – photosensitivity, bullous eruptions, erythema multiforme, including Stevens-Johnson syndrome, toxic epidermal necrolysis.
The respiratory system: less than 0.1% – bronchospasm.
From the nervous system: more than 1% – dizziness, headache; 0.1-1% – vertigo, tinnitus, drowsiness; less than 0.1% – confusion, disorientation, emotional lability.
On the part of the cardiovascular system (CVS): more than 1% – peripheral edema; 0.1-1% – increase in blood pressure (BP), heart rate, “tides” of blood to the skin.
From the urinary system: 0.1-1% – hypercreatininemia and / or an increase in urea in blood serum; less than 0.1% – acute renal failure; connection with the intake of meloxicam is not installed – interstitial nephritis, albuminuria, hematuria.
From the senses: less than 0.1% – conjunctivitis, impaired vision, including blurred vision.
Allergic reactions: less than 0.1% – angioneurotic edema, anaphylactoid / anaphylactic reactions.
special instructions
Caution should be exercised when using the drug in patients with a history in which the gastric ulcer and 12 duodenal ulcer, as well as in patients on anticoagulant therapy. In these patients, increased risk of erosive and ulcerative diseases of the gastrointestinal tract; care should be taken to monitor renal function when using the drug in elderly patients, patients with chronic heart failure (CHF) patients with signs of circulatory insufficiency in patients with cirrhosis, and in patients with hypovolemia resulting from surgical procedures; in patients with slight or moderate decrease in renal function (creatinine clearance of more than 30 ml / min) did not require a correction mode; Patients taking both diuretics and meloxicam, should take plenty of fluids; if in the course of treatment having an allergic reaction (itching, skin rash, urticaria, photosensitivity) should consult a doctor with a view to resolving the issue of the steroid is discontinued; meloxicam, like other NSAIDs, may mask the symptoms of infectious diseases; use of meloxicam, as well as other drugs that block the synthesis of prostaglandins, can affect fertility, is therefore not recommended for women wishing to become pregnant.
Storage conditions
In a dry, dark place at a temperature not higher than 25 C. Keep out of reach of children.
Dosing and Administration
The drug is taken orally during meal time in a daily dose of 7.5-15 mg.
The recommended dosing regimen: – rheumatoid arthritis: 15 mg per day. Depending on the therapeutic effect, the dose can be reduced to 7.5 mg per day. – osteoarthritis: 7.5 mg. When inefficiency dose may be increased to 15 mg per day. – Ankylosing spondylitis: 15 mg per day.
The maximum daily dose – 15 mg.
In patients with an increased risk of side effects, as well as in patients with severe renal impairment on hemodialysis, the dose should not exceed 7.5 mg per day.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist