Meloksikam STADA - instructions for use, doses, side effects, contraindications

Excipients: cellulose microcrystalline 65.0 mg / 130 mg, lactose (milk sugar) - 70.0 mg / 140.0 mg, silicon dioxide colloid (aerosil) -1.5 mg / 3.0 mg, croscarmellose sodium (impellose) 3 , 0 mg / 6.0 mg, talc 1, 5 mg / 3.0 mg, magnesium stearate 1, 5 mg / 3.0 mg.

Description:Tablets from light yellow to yellow with a greenish tinge; flat-cylindrical, with a facet and with a risk. Presence of marble is admissible.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug

ATX: & nbsp

M.01.A.C.06 Meloksikam

M.01.A.C Oksikamy

Pharmacodynamics:Meloksikam - Non-steroidal anti-inflammatory drug (NSAID), belongs to the class of oxycomams; has anti-inflammatory, analgesic and antipyretic effects. The mechanism of action of NSAIDs is associated with inhibition of cyclooxygenase (COX) activity, an enzyme that catalyzes the biotransformation of arachidonic acid into prostaglandins, prostacyclin (PGI₂) and thromboxane (ThA₂). Meloksikam predominantly inhibits COX-2, the isoform involved in the biosynthesis of prostaglandins in the inflammatory region. To a much lesser degree meloxicam acts on COX-1, which is involved in the synthesis of prostaglandin, which protects the mucous membrane of the gastrointestinal tract (GIT), and takes part in the regulation of blood flow in the kidneys. Meloksikam in a therapeutic dose does not affect platelet aggregation and clotting time.

Pharmacokinetics:

Meloksikam at intake is well absorbed, bioavailability makes 89%. Food intake for absorption of the drug is not affected. The maximum concentration in the blood (C_max) is 1.05 μg / ml, the time to achieve it (T_max) - 4.9 hours, half-life (T_1/2) - 20.1 hours, clearance - 8.8 ml / min. The steady-state concentration (C_ss) is created on the 3-5th day. The volume of distribution is about 10 liters. The connection with plasma proteins (mainly with albumin) is 99.4%. Meloksikam penetrates through gistogematicheskie barriers, incl. placental, hematoencephalic and hematosynovial. In the synovial fluid, 50% of the plasma concentration of the drug is detected. Meloksikam is completely metabolized to four pharmacologically inactive forms with the participation of peroxidase, isozymes CYP2C9, and CYP3A4 cytochrome P450. It is excreted equally with urine and feces, unchanged in trace amounts (0.2% in urine and 1.6% in feces).

Moderately expressed hepatic and renal insufficiency does not have a significant effect on the pharmacokinetics of meloxicam.

In elderly people, the clearance is somewhat reduced. There is no gender difference in the pharmacokinetics of meloxicam.

Indications:

- Osteoarthritis;

- rheumatoid arthritis;

ankylosing spondylitis (Bekhterev's disease);

- inflammatory and degenerative diseases of the joints, accompanied by pain syndrome.

Contraindications:Hypersensitivity to meloxicam and / or to any of the components of the drug, a combination of bronchial asthma and recurrent nasal polyposis and paranasal sinuses, intolerance to acetylsalicylic acid and preparations of pyrazolone series; peptic ulcer of the stomach and duodenum in the phase of exacerbation, active gastrointestinal bleeding, other bleeding; severe hepatic insufficiency and active liver disease; severe renal failure (if hemodialysis and creatinine clearance is less than 30 ml / min), progressive kidney disease, hyperkalemia; severe heart failure, condition after aortocoronary shunting; pregnancy, lactation (breastfeeding); children under 12 years of age, lactase deficiency, galactosemia, glucose-galactose malabsorption syndrome.

Carefully:Age over 65 years, ischemic heart disease, chronic heart failure, cerebrovascular disease, dyslipidemia,hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, creatinine clearance less than 60 ml / min, history of gastrointestinal lesions, presence of Helicobacter pylori infection, prolonged use of NSAIDs, alcoholism, severe somatic diseases, simultaneous intake of oral glucocorticosteroid agents (including prednisolone), anticoagulants (including warfarin), antiaggregants (including clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), angiotensin inhibitors enzyme-converting enzyme (ACE) and angiotensin II receptor antagonists.

Pregnancy and lactation:The drug is not recommended for use during pregnancy and lactation.

Dosing and Administration:

Inside, with food, once a day.

Rheumatoid arthritis: 15 mg per day. When a positive therapeutic effect is achieved, the dose can be reduced to 7.5 mg per day.

Osteoarthritis: 7.5 mg per day. If necessary, the dose may be increased to 15 mg per day.

Ankylosing spondylitis: 15 mg per day. Depending on the therapeutic effect, the dose can be reduced to 7.5 mg per day.

The maximum daily dose of meloxicam is 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 maximum daily dose is 7.5 mg. The maximum dose for adolescents is 0.25 mg / kg.

With moderately expressed renal and hepatic insufficiency, as well as with clinically stable cirrhosis, dose adjustment is not required.

Side effects:

From the digestive system: dyspepsia, incl. nausea, vomiting, abdominal pain, diarrhea, constipation, flatulence, belching; erosive and ulcerative lesions of the digestive tract, perforation of the stomach or intestines, gastrointestinal bleeding (latent or apparent); transient increase in hepatic transaminase activity, hyperbilirubinemia, hepatitis, esophagitis, stomatitis, gastritis, colitis, dry mouth.

From the side of the cardiovascular system: peripheral edema, tachyardia, increase or decrease in blood pressure, hot flashes, vasculitis.

On the part of the organs of hematopoiesis: anemia, leukopenia, thrombocytopenia.

From the respiratory system: bronchospasm, bronchial asthma with intolerance to aspirin (unstable bronchial asthma).

From the central nervous system: dizziness, headache, tinnitus, sleep disturbances (drowsiness / insomnia), disorientation, emotional lability, confusion, anxiety, depression.

From the urinary system: hematuria, albuminuria, increased level of creatinine, acute renal failure.

Allergic reactions: anaphylactoid and anaphylactic reactions, pruritus, skin rash, urticaria, erythema multiforme exudative, Stephen-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), photosensitivity.

Other: violation of taste sensations, conjunctivitis, visual impairment (indistinctness), weakness, fever.

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 the doctor about it.

If you notice any manifestations of allergic reactions of any medication, such as a rash, itching, difficulty swallowing and breathing, swelling of the larynx and tongue, immediately stop taking the drug and consult a doctor.

Overdose:

Symptoms: lethargy, drowsiness, nausea and vomiting, pain in epigastrium.Gastrointestinal bleeding is possible.

Treatment: gastric lavage and standard maintenance therapy. Kolestyramine accelerates the excretion of meloxicam. The antidote is not known.

Interaction:

If you are taking any other medications, you should notify the doctor.

With simultaneous use with other NSAIDs, including acetylsalicylic. acid in small doses, the risk of erosive and ulcerative gastrointestinal lesions and bleeding increases.

When used simultaneously with anticoagulants (heparin, warfarin, ticlopidine) and thrombolytics (streptokinase, fibrinolysin) increases the likelihood of bleeding.

The combination of NSAIDs with glucocorticosteroids increases the risk of gastrointestinal side effects and bleeding, especially in people older than 65 years.

The combined use of meloxicam and selective serotonin reuptake inhibitors leads to an increased risk of gastrointestinal lesions and bleeding.

With simultaneous use with antihypertensive drugs, it is possible to reduce the effect of the latter.

With the simultaneous administration of meloxicam with diuretics, as with cyclosporine, the risk of hyperkalemia and renal insufficiency increases.

With simultaneous use with lithium preparations, it is possible to develop lithium cumulation and increase its toxic effect.

With simultaneous use with methotrexate, as well as other myelotoxic agents, side effects on the part of the hematopoietic system increase, the risk of anemia and leukopenia increases.

Kolestyramin accelerates the excretion of meloxicam, increasing the clearance of the latter by 50%. T_1/2 decreases to 12.5 h, the area under the pharmacokinetic curve (AUC) decreases by 35%.

Antacid preparations do not change the pharmacokinetics of meloxicam.

There was no interaction between meloxicam and cimetidine, oral contraceptives, digoxin. The interaction between meloxicam and oral hypoglycemic agents has not been described. There are no sufficient grounds for a significant effect of sulfasalazine and preparations of gold on the pharmacokinetics of meloxicam.

Reduces the effectiveness of intrauterine contraception.

Special instructions:

Meloxicam is intended for symptomatic therapy, it should not be taken with the purpose of preventing exacerbation of diseases.

Caution should be exercised in the treatment of patients with a history of gastrointestinal disease and in patients,receiving anticoagulants. Patients who have GI symptoms should be observed regularly. Periodic monitoring of blood coagulability is necessary. If there is a ulcerative lesion of the gastrointestinal tract or gastrointestinal bleeding meloxicam should be canceled.

If allergic reactions (itching, urticaria, skin rashes, photosensitization) occur during treatment, it is necessary to consult a doctor to resolve the issue of discontinuing the drug.

The use of NSAIDs in patients with reduced renal blood flow or a reduced volume of circulating blood can lead to decompensation of the secretive renal failure. After the abolition of NSAIDs, the kidney function is usually restored to its original level. The elderly are at greatest risk of developing this reaction; patients who are dehydrated; patients with congestive heart failure cirrhosis, nephrotic syndrome or kidney disease; patients receiving diuretic drugs, ACE inhibitors, angiotensin II receptor antagonists; as well as patients who underwent serious surgical interventions,leading to hypovolemia. In such patients at the beginning of therapy, diuresis and renal function should be carefully monitored. Increase in the activity of transaminases, as a rule, is transitory and insignificant. If there is a significant and persistent increase in transaminase activity, meloxicam and control the function of the liver.

Weakened or depleted patients can tolerate undesirable events worse, so these patients should be carefully observed. Caution should be observed in the treatment of elderly patients who are more likely to have impaired renal, hepatic and cardiac function.

The use of NSAIDs in conjunction with diuretics can lead to a delay in sodium, potassium and water, and affect the natriuretic effect of diuretics. As a result, predisposing patients may have signs of heart failure or hypertension.

Meloksikam, as well as other NSAIDs, can mask the symptoms of an infectious disease.

The use of meloxicam, as well as other drugs blocking the synthesis of prostaglandins, can affect fertility, so the drug is not recommended for women who want to become pregnant.

Effect on the ability to drive transp. cf. and fur:

Special studies on the effect of the drug on the ability to drive vehicles and mechanisms were not carried out.

Care should be taken to drive the car and engage in other potentially hazardous activities requiring high rates of psychomotor reactions, due to possible side effects from the CNS, such as visual impairment, drowsiness, dizziness.

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

Packaging:10 tablets in a planar cell packaging made of polyvinylchloride film and aluminum foil printed lacquered. 2 or 3 contour packagings together with instructions for use in the pack.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-000613

Date of registration:10.06.2010 / 14.07.2011

Expiration Date:Unlimited

The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia

Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia

Information update date: & nbsp22.04.2018

Illustrated instructions

Instructions

Meloksikam STADA (Meloxicam STADA)