Universal reference book for medicines
Product name: MATAREN ® (MATAREN)

Active substance: meloxicam

Type: NSAIDs

Manufacturer: NIZHFARM (Russia)
Composition, form of production and packaging
Tablets
from light yellow to yellow color, round, biconvex;
slight marbling is allowed.
1 tab.

meloxicam 15 mg

Excipients: sodium croscarmellose, maltodextrin, dextrin, calcium stearate monohydrate.

10 pieces.
- packings of cellular contour (1) - packs cardboard.
10 pieces.
- packings cellular planimetric (2) - packs cardboard.
Tablets from light yellow to yellow color, round, biconvex;
slight marbling is allowed.
1 tab.

meloxicam 7.5 mg

Excipients: sodium croscarmellose, maltodextrin, dextrin, calcium stearate monohydrate.

10 pieces.
- packings of cellular contour (1) - packs cardboard.
10 pieces.
- packings cellular planimetric (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2008.

PHARMACHOLOGIC EFFECT

Non-steroidal anti-inflammatory drug.
Has anti-inflammatory, antipyretic, analgesic effect. Take the class of oxycomas; a derivative of enolic acid. Meloksikam suppresses the synthesis of prostaglandins in the inflammation region to a greater extent than in the gastric mucosa or kidneys, which is due to the relatively selective inhibition of COX-2. When administered in high doses, prolonged use and individual characteristics of the organism, the selectivity of action against cyclooxygenase type 2 is reduced.
PHARMACOKINETICS

Absorption from the gastrointestinal tract after ingestion - 89%.
Eating does not affect absorption. Concentration in plasma is dose-dependent. The mean C max values ​​for 15 mg of Mataren ® were 1.17 μg / ml. The time to reach C max is 4-6 hours. Equilibrium concentrations are achieved after 3-5 days. The connection with plasma proteins is 99%. Passes through the histogematic barriers, penetrates into the synovial fluid. V d is low, with an average of 11 liters.
Concentration in the synovial fluid is 50% of the concentration in the plasma.
Metabolised in the liver - to inactive metabolites. It is excreted through the intestine and kidneys (approximately in equal proportions), in unchanged form - 5% of the daily dose (through the intestine). T 1/2 - 20 hours. Plasma clearance is an average of 8 ml / min (decreases in old age).
INDICATIONS

- rheumatoid arthritis;

- osteoarthrosis;

- Ankylosing spondylitis (Bechterew's disease) and other inflammatory and degenerative joint diseases accompanied by pain syndrome.

DOSING MODE

Inside, with food, 1 time / day.

With rheumatoid arthritis and Bechterew's disease (ankylosing spondylitis) at 15 mg / day, when a positive therapeutic effect is achieved, the dose can be reduced to 7.5 mg / day.

For osteoarthritis , 7.5 mg / day, if necessary, increase the dose to 15 mg / day.

The maximum daily dose is 15 mg.

The initial dose in patients with an increased risk of side effects is 7.5 mg / day.

In patients with severe renal failure who are on hemodialysis, the maximum daily dose of 7.5 mg.

With a slight or moderate decrease in kidney function (creatinine clearance more than 25 ml / min), as well as with cirrhosis in a stable clinical condition - dose adjustment is not required.

SIDE EFFECT

From the digestive system : more than 1% - dyspepsia, incl.
nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea; 0.1-1% - a transient increase in the activity of "liver" transaminases, hyperbilirubinemia, belching, esophagitis, gastroduodenal ulcer, bleeding from the gastrointestinal tract (including latent), stomatitis;less than 0.1% - perforation of the gastrointestinal tract, colitis, hepatitis, gastritis.
On the part of the organs of hematopoiesis: more than 1% - anemia;
0.1-1% change in the blood formula, incl. leukopenia, tamocytopenia.
From the skin : more than 1% - itching, skin rash;
0,1-1% - urticaria; less than 0.1% - photosensitivity, bullous eruptions, erythema multiforme, incl. Stevens-Johnson syndrome, toxic epidermal necrolysis.
On the part of 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.
From the cardiovascular system: more than 1% - peripheral edema;
0.1-1% - increased blood pressure, palpitations, "tides" of blood to the skin of the face.
From the side of the urinary system: 0.1-1% - hypercreatininaemia and / or increased urea in the blood serum;
less than 0.1% - acute renal failure; connection with the reception of meloxicam is not established - interstitial nephritis, albuminuria, hematuria.
From the sense organs: less than 0.1% - conjunctivitis, visual impairment, incl.
blurred vision.
Allergic reactions : less than 0.1% angioneurotic edema, anaphylactoid / anaphylactic reactions.

CONTRAINDICATIONS

- hypersensitivity to any component of the drug, as well as non-steroidal anti-inflammatory drugs of other groups;

- history of asthma, urticaria or acute rhinitis, provoked by acetylsalicylic acid or other NSAIDs;

- exacerbation of peptic ulcer of the stomach and duodenum;

severe hepatic impairment;

- severe heart failure;

- chronic renal failure in patients not undergoing hemodialysis;

- gastrointestinal, cerebrovascular or other bleeding;

- Children's age (up to 12 years), pregnancy, lactation.

The drug should be used with caution in elderly patients, in patients with an erosive-ulcerative lesion of the gastrointestinal tract in an anamnesis.

PREGNANCY AND LACTATION

The use during pregnancy is contraindicated.

During the lactation period, when the drug is used, the question of stopping breastfeeding should be addressed.

APPLICATION FOR FUNCTIONS OF THE LIVER

In patients with severe renal failure who are on hemodialysis, the maximum daily dose of 7.5 mg.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

The drug is contraindicated in severe hepatic insufficiency.

APPLICATION FOR CHILDREN

The drug is contraindicated for children under 12 years.

APPLICATION IN ELDERLY PATIENTS

The drug should be used with caution in elderly patients.

SPECIAL INSTRUCTIONS

In the event of peptic ulcers or gastrointestinal bleeding, the development of side effects from the skin and mucous membranes, the drug should be discarded.

In patients with reduced circulating blood volume and reduced glomerular filtration (dehydration, chronic heart failure, cirrhosis, nephrotic syndrome, clinically pronounced kidney disease, diuretics, dehydration after major surgery), there may be a clinically pronounced chronic renal failure that is completely reversible after withdrawal of the drug (in these patients at the beginning of treatment should monitor diuresis and renal function).

With a persistent and significant increase in transaminases and changes in other indicators of liver function, the drug should be withdrawn and control tests carried out.
In patients with an increased risk of side effects, treatment starts with a dose of 7.5 mg. In the terminal stage of chronic renal failure in patients on hemodialysis, the dose should not exceed 7.5 mg / day.
During the period of treatment, care must be taken (when dizziness and drowsiness occur) when driving vehicles and taking other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

OVERDOSE

If the recommended dose is not observed when taken orally, an overdose of the drug may occur, manifested in an increase in side effects.

Treatment: gastric lavage and symptomatic therapy.
There are no specific antidotes and antagonists.
DRUG INTERACTION

With the simultaneous administration of other non-steroidal anti-inflammatory drugs, the risk of ulcerative lesions of the gastrointestinal tract and gastrointestinal bleeding increases.

Meloksikam increases the concentration of lithium in plasma.

Reduces the effectiveness of intrauterine contraceptives, hypotensive drugs.

Indirect anticoagulants, ticlopidine, heparin, thrombolytics increase the risk of bleeding.
Methotrexate enhances myelodepressant effect, it is not recommended to share methotrexate in a dose of more than 15 mg per week. Diuretics increase the risk of kidney dysfunction. Cyclosporine increases nephrotoxicity. Kolestyramin accelerates excretion.
Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. Store in a dry place, protected from light and out of the reach of children, at a temperature of no higher than 25 ° C.

Shelf life 2 years.
Do not use the drug after the expiration date.
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