Movix - instructions for use, dose, side effects, contraindications

Auxiliary substances (7.5 mg / 15 mg): sodium citrate dihydrate (15.0 mg / 20.0 mg), lactose monohydrate (50.0 mg / 65.0 mg), microcrystalline cellulose (81.5 mg / 100.0 mg), pregelatinized starch (20.0 mg (26.0 mg),povidone (11.0 mg / 14.0 mg), crospovidone (10.0 mg / 13.0 mg), silicon dioxide colloid (3.0 mg / 4.0 mg), magnesium stearate (2.0 mg / 3 , 0 mg).

Description:Round flat pills of light yellow color with a facet and a risk on one side.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

M.01.A.C.06 Meloksikam

M.01.A.C Oksikamy

Pharmacodynamics:Meloksikam - Non-steroidal anti-inflammatory drug, which has analgesic, antipyretic and analgesic 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 mucosa. shell of the gastrointestinal tract and taking 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. doses of 7.5 and .15 mg of its concentration are proportional to the doses. Equilibrium concentrations are achieved within 3 to 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 0.4-1.0 μg / ml, and with a dose of 15 mg 0.8-2, 0 μg / ml, (the values of C_min and C_max). 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 also secreted, but to a lesser extent (9% of the dose value). In vitro studies have shown that CYP 2C9 plays an important role in this metabolic transformation, the CYP 3A4 isoenzyme plays an additional role.In the formation of the other two metabolites (which constitute, respectively, 16% and 4% of the dose value), 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 found only in trace amounts. Period. half-life (T_1/2) 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 has no significant effect on the pharmacokinetics of meloxicam.

Indications:Symptomatic treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis (Bechterew's disease) and other inflammatory and degenerative diseases accompanied by pain syndrome.

Contraindications:

- Hypersensitivity to any component of the drug;

- bronchial obstruction, rhinitis, urticaria, caused by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) (including in the anamnesis);

- exacerbation of peptic ulcer of the stomach and duodenum;

- erosive and ulcerative changes in the mucous membrane of the stomach and duodenum, active gastrointestinal bleeding, inflammatory bowel diseases;

active liver disease;

- condition after aorto-coronary bypass surgery;

- confirmed hyperkalemia;

- severe renal failure (if hemodialysis is not performed);

- severe heart failure;

- children under the age of 15;

- Pregnancy;

lactation period.

Carefully:

Care should be taken when using the drug:

- in patients with dyslipidemia / hyperlipidemia, diabetes mellitus, smoking patients and patients who often use alcohol, with H. pylori infection, severe physical illnesses;

- patients taking oral glucocorticosteroid preparations (incl. prednisolone), antiaggregants (incl. acetylsalicylic acid, clopidogrel), selective inhibitors of serotonin reuptake (incl. citalopram, fluoxetine, laroxetine, sertraline);

- in elderly patients (control of renal function parameters is necessary), in patients with cirrhosis of the liver, as well as with hypovolemia as a result of surgical interventions;

- in patients with chronic heart failure, with a history of hypertension, ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease, with circulatory failure due to reports of edema and fluid retention associated with treatment with NSAIDs and clinical studies that show that the use of some. NSAIDs (in particular in high doses and for a long time) may be associated with an increased risk of arterial thrombotic events (eg myocardial infarction or stroke);

- in patients taking anticoagulants;

- in patients with renal insufficiency, if creatinine clearance (CK) is less than 60 ml / min.

There are not enough data to exclude this risk when using meloxicam.

- in patients with renal failure, if the creatinine clearance is more than 25 ml / min, dosage adjustment is not required;

- in patients on dialysis, the dosage of the drug should not exceed 7.5 mg / day.

Pregnancy and lactation:It is not recommended to take during pregnancy and palpitation.

Dosing and Administration:

The drug is taken orally during meals once a day.

Recommended dosing regimen:

- Rheumatoid arthritis: 15 mg per day. After attaining

The therapeutic effect of the dose can be reduced to 7.5 mg per day.

- Osteoarthritis: 7.5 mg per day. If the dose is ineffective, it can be increased to 15 mg per day.

Ankidosis spondylitis: 15 mg per day.

The maximum daily dose should not exceed 15 mg.

In patients with an increased risk of side effects, as well as in patients with severe renal failure who are on hemodialysis, the dose should not exceed 7.5 mg per day.

Side effects:

Organs of the digestive system: nausea, vomiting, abdominal pain, diarrhea, constipation, flatulence, erosive and ulcerative lesions of the gastrointestinal tract, perforation of the stomach or intestines, gastrointestinal bleeding (latent or apparent), increased activity of "hepatic" enzymes, hepatitis, colitis, stomatitis ,, dry mouth, esophagitis, hyperbilirubinemia, belching.

The cardiovascular system: tachycardia, increased blood pressure, sensation of "hot flashes".

Respiratory system: exacerbation of the course of bronchial asthma, cough.Central nervous system: headache, dizziness, tinnitus, disorientation, confusion of thoughts, sleep disturbance, vertigo, emotional lability.

urinary system: edema, interstitial nephritis, renal medullary necrosis, urinary infection, proteinuria, hematuria, renal failure, hypercreatininaemia and / or urea increase in serum.

The organs of sight: conjunctivitis, blurred vision.

Skin covers: itching, skin rash, urticaria, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), increased photosensitivity, bullous eruptions.

Hemopoietic system: anemia, leukopenia, thrombocytopenia.

Allergic reactions: anaphylactoid reactions (including anaphylactic shock), swelling of the lips and tongue, allergic vasculitis.

Other: fever.

Overdose:

Symptoms: impaired consciousness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, acute renal failure, hepatic insufficiency, respiratory arrest, asystole.

Treatment: there is no specific antidote; when an overdose of the drug should be washedstomach, taking activated charcoal (within the next hour), symptomatic therapy. Kolestyramine accelerates the removal 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:

When used simultaneously with:

- other non-steroidal anti-inflammatory drugs (as well as with acetylsalicylic acid) and glucocorticosteroids increases the risk of erosive and ulcerative lesions and bleeding of the gastrointestinal tract;

- antihypertensive drugs (beta-adrene on locators, ACE inhibitors, vasodilators, diuretics), possibly reducing the effectiveness of the latter;

- Lithium preparations may develop lithium cumulation and increase its toxic effect (it is recommended to control the concentration of lithium in the blood);

- Methotrexate increases the side effect of the latter on the hematopoietic system (the risk of anemia and leukopenia, shows periodic monitoring of the general blood test);

- Diuretics and with cyclosporine, the risk of developing kidney insufficiency increases;

- inside the uterine contraceptive means, the effectiveness of the latter may be reduced;

- anticoagulants (heparin, warfarin) and antiplatelet agents (ticlopidine), as well as with thrombolytic drugs (streptokinase, fibrinolysin) increases the risk of bleeding (periodic monitoring of blood coagulability);

- colestyramine, as a result of binding meloxicam, its excretion through the gastrointestinal tract is intensified;

- Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Special instructions:

Patients taking both diuretics and meloxicam, should take a sufficient amount of fluid. If allergic reactions (itching, skin rash, urticaria, photosensitivity) occur during treatment, stop taking the drug immediately.

Adverse reactions to taking medication can be reduced by using the lowest effective dose for the shortest period of time.

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 in some patients.They are advised to refrain from driving and servicing vehicles and. mechanisms that require concentration of attention.

Form release / dosage:Tablets 7.5 mg and 15 mg.

Packaging:

For 10 tablets in a blister of PVC film / aluminum foil.

2 blisters together with instructions for use in a pack of cardboard.

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

Shelf life:

2 years.

Do not use after the date shown on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-004672/09

Date of registration:10.06.2009

Expiration Date:Unlimited

The owner of the registration certificate:Unifarm JSCUnifarm JSC Bulgaria

Information update date: & nbsp10.06.2018

Illustrated instructions

Instructions

Movix® (Movix®)