M-Kam

General characteristics. Structure:

Active ingredient: 7,5 mg or 15 mg of a meloksikam.

Excipients: lactose, cellulose microcrystallic, sodium citrate, кросповидон, silicon oxide colloid anhydrous, magnesium stearate.

Pharmacological properties:

Pharmacodynamics. M-Kam – nonsteroid antiinflammatory medicine, has antiinflammatory, analgeziruyushchy and febrifugal action at the expense of inhibition of biosynthesis of prostaglandins which are inflammation mediators.

The mechanism of action is connected with the selection inhibition of action of an isoenzyme of cyclooxygenase (TsOG-2) regulating synthesis of prostaglandins (PG) in an inflammation zone. Meloksikam does not influence aggregation of thrombocytes or a bleeding time at use of the recommended doses.

Pharmacokinetics. Meloksikam is well absorbed from digestive tract at oral administration. Meloksikam contacts plasma proteins for 99,5%. Bioavailability of a meloksikam at its oral administration averages 89%. Concentration of medicine at reception orally 7,5 and 15 mg a day, according to a dozozavisima. Stable concentration are reached for 3 - 5 days.

Meloksikam is metabolized with formation of 4 biologically inactive metabolites and allocated with urine and excrements. The elimination half-life (t1/2) makes about 20 hours. It affects the general clearance of plasma which makes from 7 to 8 ml/minute. The clearance decreases at people of advanced age. Distribution volume low, on average 11 l. Pharmacokinetic parameters are linear during one-time administration of drug, at the same time it should be noted that repeated use of drug does not lead to changes of pharmacokinetic parameters. Thus, to meloksika it can be applied once a day.

Liver and renal failure significantly do not influence pharmacokinetics of a meloksikam.

Indications to use:

M-Kam use for treatment of a pseudorheumatism and an osteoarthritis.

Route of administration and doses:

Osteoarthritis: 7,5 mg/days. If it is necessary, in the absence of improvement of a condition of the patient, the dose can be raised to 15 mg/days.

Pseudorheumatism: 15 mg/days.

For patients of advanced age with revmato§dny arthritises at prolonged treatment the dosage of 7,5 mg/days is recommended.

Patients with the increased risk of side reactions have to begin treatment with a dosage – 7,5 mg/days.

The general dose of 15 mg/days should not be exceeded.

The total daily quantity of a meloksikam is accepted once with water or other liquid during food.

For patients with an end-stage of a renal failure on a hemodialysis the dose of a meloksikam demands settlement. At the same time the upper bound of a dose of a meloksikam should not exceed 7,5 mg/days.

Duration of a course of treatment depends on the nature of a disease and efficiency of therapy which is carried out.

Features of use:

Patients to whom it is prescribed M-Kam have to be under medical observation in case of any gastrointestinal frustration. They have to be informed concerning risk of emergence of round ulcers, perforation and the hemorrhages connected using a meloksikam.

Meloksikam should not be registered in parallel with other nonsteroid antiinflammatory medicines.

Skin reactions which were observed at use of a meloksikam include cases of emergence of a syndrome of Stephens-Johnson, various erity and rashes, allergic reactions, similar anaphylactoid or anaphylactic reactions.

NPVP inhibit synthesis of renal prostaglandins which provide renal perfusion at patients with a reduced renal blood-groove. Use of NPVP in such cases can lead to a decompensation of a renal failure. However function of kidneys is returned to initial the status at the treatment termination. The greatest risk of development of such complications is observed at patients of advanced age, patients with congestive heart failure, cirrhosis, a neurotic syndrome or a renal failure, patients with a hypovolemia have hypovolemia.

For such patients it is necessary to control release of urine and function of kidneys during treatment.

Side effects are expressed to a thicket at patients of advanced age therefore such the patient demand careful supervision. As well as with other NPVP, patients of advanced age at whom renal, hepatic and cordial functions are broken have to observe extra care.

In these cases the maximum therapeutic dose which it was recommended should not raise in cases if the therapeutic effect is insufficient because it can lead to increase in toxicity, without achievement of therapeutic effect.

Use of a meloksikam for treatment of children up to 12 years and its safety is not established.

Pregnancy. It is necessary to prevent use of a meloksikam during pregnancy.

Lactation. It is not known, to meloksika gets to mother's milk. Therefore mothers who nurse should not appoint it.

Influence on ability of driving. There are no specific researches of influence of a meloksikam on ability to drive the car. However, if such side effects as dizziness or drowsiness are revealed, it is desirable to refrain from such activity.

ATTENTION! Also, as well as in treatment cases, prior to treatment meloksikamy, the patient has to be inspected by all NPVP types on existence of chronic ulcers of a gullet, stomach, duodenum. During treatment special attention should be paid to possibility of a recurrence at patients with such types of chronic diseases. As well as for all NPVP, the long term of use of a meloksikam is connected with the increased risk of impact on digestive tract. Reception of a meloksikam has to be stopped in cases of development of an ulcer of a duodenum or gastrointestinal bleeding, a glomerulonephritis, a renal serdtsevinny necrosis or a nephrotic syndrome.

As well as for the majority of NPVP, for a meloksikam increase in level of transaminase of serum, increase in bilirubin of serum or other parameters characterizing functions of a liver, also as increase in creatinine of serum, an urea nitrogen in blood and other laboratory parameters was in rare instances observed. Such cases had temporality. Anyway changes of laboratory parameters, use of a meloksikam it has to be suspended and necessary researches are conducted.

Treatment meloksikamy has to be stopped in case of identification of side reactions from skin and mucous membranes. At use of NPVP which include to oksika cases of serious skin reactions and serious reactions which threaten the patient's life are known.

In isolated cases of NPVP can cause developing of intersticial nephrite.

Side effects:

The side effects arising at use of a meloksikam meet quite seldom.

Side effects which are connected with digestive tract: dyspepsia, nausea, vomiting, abdominal pain (in belly area), a lock, a meteorism, diarrhea, a temporary abnormal liver function (increase in transaminase or bilirubin).

Hematologic side effects: disturbance of a blood count, value of differential of white blood cells, anemia, leukopenia, thrombocytopenia. The accompanying use potentially of m і є lotoksichny drugs, especially a methotrexate, promotes development of a cytopenia. It is possible an agranulocytosis, at combined use of a meloksikam and methotrexate.

Dermatological side reactions: stomatitises, irritations of a mucous membrane of a gullet and generative organs, skin rashes, уртикарія, a photosensitization were described.

The side effects connected with respiratory system: an asthmatic attack at some patients with bronchial asthma with hypersensitivity to acetylsalicylic acid and other NPVP.

The side effects connected with the central nervous system: dizziness, a headache, a ring in ears, drowsiness.

The side effects connected with cardiovascular system: hypostasis of legs, heartbeat, inflows.

The side effects connected with urinogenital system: disturbances are observed seldom (increase in creatinine of serum or urea).

Interaction with other medicines:

Combinations which should not be applied. Other NPVP, including use of the raised doses of salicylates or several NPVP together can increase risk of developing of an ulcer or gastrointestinal bleeding owing to their synergism.

Peroral anticoagulants, тиклопидин heparin can also increase risk of bleeding. If use of such combinations cannot prevent, it is necessary to carry out careful control of coagulability of blood.

NPVP increase lithium level in a blood plasma which level can reach toxic value. Therefore this parameter needs to be controlled during the beginning of use of a meloksikam and if necessary to adjust or stop drug use. NPVP can increase hematologic toxicity of a methotrexate. At patients who applied a methotrexate emergence cases агранулоцитозів were observed. The direct impact of a meloksikam was not proved, but care is necessary at purpose of such combination. In such situations control of number of blood cells is also recommended.

NPVP reduce efficiency of contraceptive means.

Combinations which use demands care. Use of diuretics along with NPVP is associated with risk of an acute renal failure at the patients suffering organism dehydration (decrease in glomerular filtering at decrease in synthesis of prostaglandins).

In cases of co-administration of a meloksikam and diuretics, prior to use of a meloksikam it is necessary to check vodno electrolytic balance and to check function of kidneys. Further, at simultaneous use M-Kama and diuretics patients have to receive adequate amount of liquid.

Nephrotoxicity of cyclosporine can be a consequence of influence of NPVP on renal prostaglandins. Therefore during combined use of cyclosporine and a meloksikam it is necessary to control function of kidneys.

For anti-hypertensive means (beta adrenoblockers, inhibitors angiotensin - the turning enzymes, diuretics) which are applied together with NPVS, decrease in anti-hypertensive action at the expense of inhibition of synthesis of vazodilyatorny prostaglandins can be observed.

Trombolitiki at combined use with NPVP can increase risk of hemorrhages. Simultaneous use of antacids, Cimetidinum, digoxin, furosemide does not give to noticeable pharmacological interaction with meloksikamy.

Holestiramin accelerates allocation of a meloksikam due to its binding in a gastrointestinal path.

Contraindications:

M-Kam is contraindicated to patients who have hypersensitivity to a meloksikam or any ingredient of drug. The patients accepting to meloksika have a possibility of sensitivity to acetylsalicylic acid and other NPVP.

M-Kam is contraindicated to patients with stomach ulcer or a duodenum, are active within the last 6 months, chronic stomach ulcer and a duodenum, a heavy liver failure, a heavy renal failure which does not give in to dialysis, gastrointestinal bleeding, cerebrovascular bleeding or bleeding of other nature. Drug is also contraindicated to the pregnant women and women nursing to children aged up to 15 years.

Overdose:

In case of overdose the gastric lavage and the general supporting means is recommended. There are data on acceleration of allocation of a meloksikam under the influence of a holestiramin. Specific antidotes are unknown.

Storage conditions:

To store at the room temperature (15-25 °C). To protect from light and moisture. To store in the place, unavailable to children. A period of validity - 3 years.

Issue conditions:

Without recipe

Packaging:

On 10 tablets in the blister, on 5 blisters in cardboard packaging.