M-Kam - instructions for use, dose, side effects, contraindications

Composition:Each tablet contains: active ingredient: meloxicam 7, 5 mg or 15 mg; auxiliary substances: lactose monohydrate 182.65 mg, 365.30 mg, microcrystalline cellulose 37,50 mg, 75,00 mg, sodium citrate 11,10 mg, 22,20 mg, crospovidone 7.50 mg, 15.00 mg, silicon dioxide colloid 2.50 mg, 5.00 mg, magnesium stearate 1.25 mg, 2.50 mg.

Description:Tablets 7, 5 mg: round tablets of light yellow color with bevelled edges, on the one hand the surface of tablets is convex with engraving 7.5, on the other hand - concave with deep risk.
Tablets 15 mg: round tablets of light yellow color with bevelled edges, on the one hand the surface of tablets is convex with engraving 15, on the other hand - concave with deep risk.

Pharmacotherapeutic group:nonsteroidal anti-inflammatory drug.

ATX: & nbsp

M.01.A.C.06 Meloksikam

M.01.A.C Oksikamy

Pharmacodynamics:Meloksikam - Non-steroidal anti-inflammatory drug, which has analgesic, anti-inflammatory, antipyretic effect. Anti-inflammatory effect is associated with inhibition of the enzymatic activity of cyclooxygenase-2 (COX-2), involved in the biosynthesis of prostaglandins in the inflammatory region. Less meloxicam acts on cyclooxygenase-1 (COX-1), involved in the synthesis of prostaglandin, which protects the mucous membrane of the gastrointestinal tract and takes part in the regulation of blood flow in the kidneys.

Pharmacokinetics:It is well absorbed from the gastrointestinal tract, the absolute bioavailability of meloxicam is 89%.Simultaneous food intake does not change the intake. When using the drug inside at doses of 7.5 and 15 mg, its concentrations are proportional to the doses. Equilibrium concentrations are achieved within 3-5 days. With prolonged use of the drug (more than 1 year), the concentrations are similar to those observed after the first achievement of a steady state of pharmacokinetics. Binding to plasma proteins is more than 99%. The range of differences between the maximum and basal concentrations of the drug after its administration once a day is relatively small and is 7.5 mg 0.4-0.0 μg / ml, and with a dose of 15 mg 0.8-2, 0 μg / ml, (Cmin and Stach, respectively). Meloksikam penetrates through the histohematological barriers, the concentration in the synovial fluid reaches 50% of the maximum concentration of the drug in the plasma. Almost completely metabolized in the liver with the formation of four pharmacologically inactive derivatives. The main metabolite, 5 carboxymeloxicam (60% of the dose value), is formed by oxidation of the intermediate metabolite, 5 hydroxymethylmeloxicam, which is excreted, but to a lesser degree (9% of the dose value).In vitro studies have shown that CYP 2C9 plays an important role in this metabolic transformation, the CYP isoenzyme ZA4 is of additional importance. In the formation of the other two metabolites (which constitute, respectively, 16% and 4% of the dose), peroxidase takes part, the activity of which probably varies individually. It is excreted equally with feces and urine, mainly in the form of metabolites. With feces, less than 5% of the daily dose is excreted unchanged, in urine in unchanged form the drug is detected only in trace amounts. The half-life (T Y2) of meloxicam is 15-20 hours. Plasma clearance is an average of 8 ml / min. In elderly people, the clearance of the drug is reduced. The volume of distribution is low, and averages 11 liters. Hepatic or renal insufficiency of moderate severity, in a significant way, has no significant effect on the pharmacokinetics of meloxicam.

Indications:- Symptomatic treatment of osteoarthritis;
- Symptomatic treatment of rheumatoid arthritis;
- Symptomatic treatment of ankylosing spondylitis (Bekhterev's disease).

Contraindications:- hypersensitivity to any component of the drug;
- hereditary lactose intolerance, impaired absorption of glucose-galactose, deficiency of lactase;
- a combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid and drugs of pyrazolone series;
- exacerbation of peptic ulcer of the stomach and duodenum; inflammatory bowel disease;
- gastrointestinal, cerebrovascular bleeding or other bleeding;
- chronic renal failure in patients not undergoing dialysis (creatinine clearance less than 30 ml / min), progressive kidney disease;
severe hepatic impairment;
- severe heart failure, condition after aortocoronary shunting; confirmed hyperkalemia
- under 12 years of age (effectiveness and safety not established);
- pregnancy and lactation.

Carefully:Elderly age, ischemic heart disease, chronic heart failure, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking,chronic renal failure (creatinine clearance 30-60 ml / min), ulcerative lesions of the gastrointestinal tract in history, presence of H. pylori infection, prolonged use of non-steroidal anti-inflammatory drugs, alcoholism, severe somatic diseases, simultaneous intake of oral glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiaggregants (including clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).
If you have any of these diseases, consult a doctor before taking the drug.

Pregnancy and lactation:There are no data on the use of meloxicam in pregnancy. When appointing during lactation, a decision should be made whether to stop breastfeeding or stop treatment with M-Kam®.

Dosing and Administration:Inside, during a meal, the frequency of reception - 1 time per day.
When rheumatoid arthritis the average daily dose is 15 mg. In some cases, to achieve a therapeutic effect, the dose can be reduced to 7.5 mg per day.With osteoarthritis, the average daily dose is 7.5 mg. In some cases, to achieve a greater effect, the dose is increased to 15 mg per day.
When ankylosing spondyloarthritis the average daily dose is 15 mg. The maximum daily dose should not exceed 15 mg.
Patients with an increased risk of side effects, as well as patients with severe renal failure who are on hemodialysis, the dose should not exceed 7.5 mg per day.
Children over 12 years of age:
The maximum dose for adolescents is 0.25 mg / kg. The maximum recommended daily dose is 15 mg.

Side effects:The incidence of adverse reactions listed below was determined according to the following (World Health Organization classification):
very often - more than 1/10
often from more than 1/100 to less than 1/10
infrequently - from more than 1/1000 to less than 1/100,
rarely from more than 1/10000 to less than 1/1000,
very rarely - from less than 1/10000, including individual messages.
* There are side effects, the incidence of which is comparable to placebo.
The association of side effects occurring with a frequency of less than 1% of cases with the use of meloxicam has not been proven.
In most cases, M-Kam® is well tolerated, side effects are transient and do not require drug withdrawal.
From the nervous system and sensory organs: often headache, dizziness; not often, noise in the ears, vertigo, drowsiness; Rarely disorientation, confusion, emotional lability.
From the respiratory system: rarely bronchospasm.
On the part of the organs of the gastrointestinal tract: often - nausea, vomiting, abdominal pain, diarrhea *, constipation, flatulence; infrequent - transient increase in the activity of "liver" enzymes, hyperbilirubinemia, eructation, esophagitis erosive and ulcerative lesions of the gastrointestinal tract, gastrointestinal bleeding (latent or apparent) *, stomatitis; rarely - perforation of the stomach or intestinal colitis, hepatitis, gastritis.
From the cardiovascular system: often - peripheral edema, infrequent tachycardia, increased blood pressure, a feeling of "tides" of blood to the skin of the face.
From the genitourinary system: infrequently - hypercreatininaemia and / or increased urea concentration in blood serum, rarely - acute renal failure, communication with the use of meloxicam not established - interstitial nephritis, proteinuria, hematuria.
On the part of the organs of vision: rarely - conjunctivitis, impaired vision, incl.blurred vision.
From the skin: often - itching, skin rash; infrequently - hives; rarely - increased photosensitivity, multi-form exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome). From the hemopoietic system: often - anemia; infrequently - leukopenia *, thrombocytopenia.
Allergic reactions: rarely - anaphylactoid reactions (including anaphylactic shock), swelling of the lips and tongue, allergic vasculitis.
If any adverse reactions occur, contact your doctor as soon as possible.
If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:Symptoms: impaired consciousness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, acute renal failure, acute liver failure, respiratory arrest, asystole.
Treatment: there is no specific antidote; with an overdose of the drug should be washed stomach, taking activated charcoal (within the next hour), symptomatic therapy.Cholestyramine accelerates the excretion of the drug from the body. Forced diuresis, alkalinization of urine, hemodialysis - ineffective because of the high connection of the drug with blood proteins.

Interaction:The risk of erosive and ulcerative lesions and bleeding of the gastrointestinal tract increases with simultaneous use with other non-steroidal anti-inflammatory drugs (as well as with acetylsalicylic acid).
It is possible to reduce the effect of antihypertensive drugs with simultaneous application. It is possible to develop cumulation of lithium and increase its toxic effect (it is recommended to control the concentration of lithium in the blood) when combined with lithium preparations.
The side effect of methotrexate on the hematopoietic system is increasing (the risk of anemia and leukopenia, periodic monitoring of the general blood test is shown) with joint application.
Increases the risk of developing kidney failure with simultaneous use with diuretics and cyclosporine.
It is possible to reduce the effect with simultaneous use with intrauterine contraceptives.
Increases the risk of bleeding (requires periodic monitoring of coagulation rates)when combined with anticoagulants (heparin, ticlopidine, warfarin), as well as with thrombolytic drugs (streptokinase, fibrinolysin).
Intensifies the excretion through the gastrointestinal tract of colestyramine when combined, as a result of the binding of meloxicam.

Special instructions:Patients who have an anamnesis in which peptic ulcer or duodenal ulcer, as well as patients who are on anticoagulation therapy should be careful when using the drug. In such patients, the risk of ulcerative-erosive diseases of the gastrointestinal tract is increased.
When the drug is used by elderly patients, patients with chronic heart failure with circulatory failure, patients with cirrhosis of the liver, and patients with hypovolemia as a result of surgical interventions, care should be taken and the indicators of renal function should be monitored.
In patients with renal insufficiency, if the creatinine clearance is more than 30 ml / min, dosage adjustment is not required.
In patients on dialysis, the dosage of the drug should not exceed 7.5 mg / day.
Patients taking both diuretics and meloxicam, should take a sufficient amount of fluid.
If allergic reactions (itching, skin rash, urticaria, photosensitization) occur during treatment, you should contact your doctor to resolve the issue of stopping the drug.
Meloksikam, as well as other NSAIDs, can mask symptoms of infectious diseases.
The use of meloxicam, as well as other drugs that block the synthesis of prostaglandins, can affect fertility, so it is not recommended for women who want to become pregnant.

Effect on the ability to drive transp. cf. and fur:The use of the drug can cause the occurrence of undesirable effects in the form of headaches and dizziness, drowsiness. It should abandon the management of vehicles and maintenance of machines and mechanisms that require concentration of attention.

Form release / dosage:Tablets of 7.5 mg, 15 mg.

Packaging:Tablets of 7.5 mg, 15 mg: 10 tablets are placed in a blister of PVC and aluminum foil. For 1.2 or 3 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:At a temperature of no higher than 25 ° C in a dry, dark place.
Keep out of the reach of children.

Shelf life:3 years.
Do not use later than the date shown on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-002081

Date of registration:23.01.2013

The owner of the registration certificate:Unikem Laboratories Ltd.Unikem Laboratories Ltd. India

Representation: & nbspUNICEM LABORATORIES LTD. UNICEM LABORATORIES LTD. India

Information update date: & nbsp07.08.2015

Illustrated instructions

Instructions

M-Kam® (M-Kam®)