MOVASIN

Active material: Meloxicam
When ATH: M01AC06
CCF: NSAIDs. Of selective COX-2 inhibitor
ICD-10 codes (testimony): M05, M15, M45
When CSF: 05.01.01.07.01
Manufacturer: Synthesis of (Russia)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Pills round, Valium, without risk, light yellow, permissible slight marbling surface.

Excipients: microcrystalline cellulose, polyvinylpyrrolidone (povidone), lactose, potato starch, krospovydon (kollidon CL-M), talc, magnesium stearate.

10 PC. – packings Valium planimetric (1) – packs cardboard.
10 PC. – packings Valium planimetric (2) – packs cardboard.

Pills round, Valium, with Valium, light yellow, permissible slight marbling surface.

Excipients: microcrystalline cellulose, polyvinylpyrrolidone (povidone), lactose, potato starch, krospovydon (kollidon CL-M), talc, magnesium stearate.

10 PC. – packings Valium planimetric (1) – packs cardboard.
10 PC. – packings Valium planimetric (2) – packs cardboard.

Pharmacological action

NSAIDs. Anti-inflammatory, antipyretic and analgesic action. The mechanism of anti-inflammatory action is associated with inhibition of the Cox-2 enzyme activity, participating in the biosynthesis of prostaglandins in areas of inflammation. To a lesser extent meloxicam acts on Cox-1, participating in the synthesis of prostaglandins, protect the mucous membranes of the DIGESTIVE TRACT and involved in the regulation of blood flow in the kidneys.

Pharmacokinetics

Absorption

After taking the drug, Meloxicam is inside well absorbed from the digestive tract, the absolute bioavailability of 89%. Reception simultaneously with food intake does not affect the skin. The amount of concentration in the employment drug meloxicam oral doses 7.5 and 15 mg is proportional to dose.

Distribution

The equilibrium is achieved within 3-5 regular admission days. Prolonged (more 1 year) application of meloxicam concentrations value is similar to C_ss, established after the first reach a steady state pharmacokinetics. Linking plasma protein is more 99%. Before the drug 1 time / day C_ss^min and C_ss^max differ to a small extent and form when taken in the dose of 7.5 mg 0.4-1.0 ug / ml, and when taken in the dose of 15 mg - 0.8-2.0 ug / ml, respectively. Meloxicam permeates through gistogematicalkie barriers, concentration in synovial fluid reaches 50% C_max plasma. V_d averages 11 l.

Metabolism

Meloxicam is almost completely metabolized in the liver with the formation of four pharmacologically active metabolites. The main metabolite is 5′-karʙoksimeloksikam, which is formed by oxidation of the intermediate metabolite (5′-gidroksimetilmeloksikama). In in vitro studies found, that biotransformation occurs when participation CYP2S9, additional importance of CYP3A4. In the formation of two other metabolites participates peroxidase, activity is, probably, individually varies.

Deduction

Is displayed equally in the feces and urine, primarily as metabolites (5′-karʙoksimeloksikam – to 60%, 5′-gidroksimetilmeloksikam – 9%, and 2 other- 16% and 4% respectively). Faeces in unaltered form appears less 5% from daily dose, in the urine as unchanged drug is detected in only trace amounts. T_1/2 – 15-20 no. The plasma clearance averages 8 ml / min.

Pharmacokinetics in special clinical situations

In the elderly the ground clearance of the drug is reduced.

In patients with hepatic or renal insufficiency moderately pharmacokinetics Meloxicam is not significantly changed.

Testimony

Symptomatic therapy of rheumatic diseases, accompanied by sore syndrome, including:

-osteoarthritis;

-Rheumatoid arthritis;

-ankylosing spondylitis (ankylosing spondylitis).

Dosage regimen

The drug is taken 1 time / day during a meal.

At revmatoidnom ARTHRO The recommended dose is 15 mg / day; Depending on the therapeutic effect dose can be reduced to 7.5 mg / day.

At osteoarthritis the drug is prescribed in a dose 7.5 mg / day, in the absence of effective dose can be increased up to 15 mg / day.

At ankylosing spondylitis daily dose is 15 mg. The maximum daily dose should not exceed 15 mg.

In patients with an increased risk of developing side effects, and y patients with severe renal insufficiency, hemodialysis, dose should not exceed 7.5 mg / day.

In patients with impaired renal function (CC > 25 ml / min) correction dosing regime is not required.

Side effect

From the digestive system: nausea, vomiting, abdominal pain, diarrhea, constipation, flatulence, erosive and ulcerative lesions of the gastrointestinal tract, perforation of the stomach or intestines, bleeding from the gastrointestinal tract (implicit or explicit), increase in liver enzymes, hepatitis, colitis, stomatitis, dry mouth, esophagitis.

Cardio-vascular system: tachycardia, increased blood pressure, feeling the tides.

The respiratory system: exacerbation of bronchial asthma, cough.

CNS: headache, dizziness, noise in ears, disorientation, confusion of thought, sleep disturbance.

On the part of the organ of vision: conjunctivitis, blurred vision.

From the urinary system: swelling, interstitial nephritis, renal medullary necrosis, urinary tract infection, proteinuria, hematuria, renal failure.

Dermatological reactions: itch, skin rash, hives, increased photosensitivity, erythema multiforme exudative (incl. Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

From the hematopoietic system: anemia, leukopenia, thrombocytopenia.

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

Other: fever.

Contraindications

- “Aspirin” bronchial asthma;

- Gastric ulcer and duodenal ulcer in the acute phase;

-bleeding different Genesis (incl. from the gastrointestinal tract, as cerebrovascular);

- Severe renal insufficiency (unless hemodialysis);

- Severe hepatic impairment;

- Severe heart failure;

- Children up to age 15 years;

- Pregnancy;

- Lactation (breast-feeding);

- Hypersensitivity to the drug.

FROM caution the drug should be used in the elderly and in patients with erosive-ulcerous lesions of DIGESTIVE TRACT disorder.

Pregnancy and lactation

Not recommended to appoint drug in pregnancy and lactation (breast-feeding).

Use Movasina^®, as well as other drugs, blocking prostaglandin synthesis, It can affect fertility, Therefore, it is not recommended to appoint women, wishing to get pregnant.

Cautions

Caution must be exercised in applying the drug in patients, have a history of ulcer disease of the stomach and duodenum, and patients, receiving anticoagulant therapy, tk. This category of patients have increased risk of erosivno-yazvennah losses BLOOD.

You should use caution and monitor indicators of kidney function in the application of the drug in the elderly, patients with chronic heart failure, with cirrhosis of the liver, as well as in patients with gipovolemiei as a result of surgical interventions.

Patients, at the same time receiving dioretiki and meloxicam, should be getting enough fluids.

When allergic reactions (itch, skin rash, hives, photosensitivity) should stop taking the drug.

Meloxicam, Like other NSAIDs, may mask the symptoms of infectious diseases.

Effects on ability to drive vehicles and management mechanisms

Against the background of the use of the drug, the patient should not engage in potentially hazardous activities, require attention, tk. You may experience headaches, dizziness, drowsiness.

Overdose

Symptoms: disturbance of consciousness, nausea, vomiting, epigastric pain, bleeding from the gastrointestinal tract, acute renal failure, hepatic failure, respiratory arrest, asistolija.

Treatment: gastric lavage, administration of activated charcoal (during 1 h after dosing); if necessary, symptomatic therapy. Kolestiramin hastens excretion of meloxicam from the body. Forced diuresis, alkalization of urine, haemodialysis ineffective because of the high degree of binding of meloxicam blood protein. No specific antidote.

Drug Interactions

Together with the use of other NSAIDS (incl. acetylsalicylic acid) increases the risk of erosivno-yazvennah losses and bleeding of the GASTROINTESTINAL TRACT.

If you are applying with antigipertenzivei drugs may reduce the effectiveness of the past.

Together with the use of lithium may develop cumulation of lithium and toxicity (It recommended to control the concentration of lithium in the blood).

Together with methotrexate increases the likelihood of toxic effects on the blood and the emergence of anemia and leukopenia (shows the periodic General blood analysis).

Together with the use of diuretics and with ziklosporinom increases the risk of kidney failure.

Together with the use of uterine contraceptive devices may reduce the effectiveness of the past.

While the use of anticoagulants (incl. Heparin, ticlopidine, varfarinom), as well as thrombolytic agents (incl. streptokinazoy, fiʙrinolizinom) It increases the risk of bleeding (a periodic monitoring of blood coagulability).

Together with the use of kolestiraminom increases the excretion of meloxicam through blood (through linking).

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored in a dry, protected from light and away from children at a temperature no higher than 25 ° C. Shelf life - 2 year.