Meloxicam Stada, pills 15mg 20pcs

Composition

1 tablet contains

Active ingredient-meloxicam 7.5 mg and 15.0 mg;

Auxiliary substances:  

Microcrystalline cellulose 65.0 mg/130.0 mg,

Lactose monohydrate 70.0 mg/140.0 mg,

Colloidal silicon dioxide (aerosil) – 1.5 mg/3.0 mg,

Croscarmellose sodium (primellose) — 3.0 mg/6.0 mg,

Talc 1.5 mg/3.0 mg,

Magnesium stearate 1.5 mg / 3.0 mg

Pharmacological action

Pharmaceutical Group:

NSAIDs.

Pharmaceutical action:

NSAIDs have anti-inflammatory, antipyretic, and analgesic effects. Belongs to the class of oxycams; a derivative of enolic acid.

The mechanism of action is inhibition of Pg synthesis as a result of selective suppression of COX-2 enzymatic activity.

When prescribed in high doses, long-term use and individual characteristics of the body, COX 2 selectivity decreases.

Inhibits Pg synthesis in the inflammatory region to a greater extent than in the gastric mucosa or kidneys, which is associated with a relatively selective inhibition of COX-2.

It is less likely to cause erosive and ulcerative diseases

of the gastrointestinal tract. :

Absorption from the gastrointestinal tract after oral or rectal use is 89%; tablets and suppositories are bioequivalent.

Food intake does not affect absorption. The plasma concentration is dose-dependent. TCmax – 5-6 hours. Css is created in 3-5 days. Binding to plasma proteins is 99%.

Passes through histohematic barriers, penetrates synovial fluid. The synovial fluid concentration is 50% of the plasma concentration. Metabolism in the liver – to inactive metabolites.

It is excreted through the intestines and kidneys (in approximately equal proportions), unchanged – 5% of the daily dose (through the intestines). T1 / 2-20 hours Plasma clearance is on average 8 ml / min (decreases in the elderly).

Active ingredients

Meloxicam

Indications

• Osteoarthritis
• rheumatoid arthritis
• ankylosing spondylitis (Ankylosing spondylitis)
• inflammatory and degenerative joint diseases accompanied by pain syndrome

Use during pregnancy and lactation

Meloxicam is contraindicated in children under 15 years of age, during pregnancy and lactation.

Contraindications

• Hypersensitivity to meloxicam and/or to any of the components of the drug, a combination of bronchial asthma and recurrent nasal and paranasal sinus polyposis, intolerance to acetylsalicylic acid and pyrazolone preparations; 

• peptic ulcer of stomach and duodenum in the acute phase, active gastrointestinal bleeding, other bleeding; severe liver disease and active liver disease; severe renal insufficiency (if not possible, dialysis and creatinine clearance less than 30 ml/min),

• progressive kidney disease, hyperkalemia, severe heart failure, as after coronary artery bypass surgery; pregnancy, lactation (breastfeeding); children up to age 12 years, lactase deficiency, galactosemia, glucose-galactose malabsorption syndrome.

With caution

• Age older than 65 years, ischemic heart disease, congestive heart failure, cerebrovascular disease, dyslipidemia, hyperlipidemia, diabetes mellitus, diseases of the

• peripheral arteries, Smoking, creatinine clearance less than 60 ml/min, ulcerative lesions of the gastrointestinal tract in history, infection with Helicobacter pylori, prolonged use of NSAIDs, alcoholism, severe somatic

• diseases, concomitant use of oral glucocorticosteroid drugs (anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), selective inhibitors of serotonin reuptake

• (including citalopram, fluoxetine, paroxetine, and sertraline)inhibitors of angiotensin converting enzyme (ACE) and antagonists of receptors of angiotensin II.

Side effects

From the digestive system: dyspepsia, including nausea, vomiting, abdominal pain, diarrhea, constipation, flatulence, belching; erosive and ulcerative lesions of the gastrointestinal tract, perforation of the stomach or intestines, gastrointestinal bleeding (latent or obvious); transient increase in the activity of hepatic transaminases, hyperbilirubinemia, hepatitis, esophagitis, stomatitis, gastritis, colitis, dryness in the mouth. From the cardiovascular system: peripheral edema, tachyardia, increased or decreased blood pressure, hot flashes, vasculitis. Hematopoietic disorders: anemia, leukopenia, thrombocytopenia. From the respiratory system: bronchospasm, bronchial asthma with aspirin intolerance (unstable bronchial asthma). From the central nervous system: dizziness, headache, tinnitus, sleep disorders (drowsiness/insomnia), disorientation, emotional lability, confusion, anxiety, depression. From the urinary system: hematuria, albuminuria, increased creatinine, acute renal failure. Allergic reactions: anaphylactoid and anaphylactic reactions, pruritus, skin rash, urticaria, erythema multiforme, Stephen-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), photosensitization. Other: impaired taste, conjunctivitis, visual disturbances (blurred vision), weakness, fever. If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor. If you notice signs of allergic reactions to any medication, such as rash, itching, difficulty swallowing and breathing, swelling of the larynx and tongue, immediately stop taking the drug and consult a doctor.

Interaction

When used concomitantly with acetylsalicylic acid and other NSAIDs, the risk of erosive and ulcerative lesions and bleeding from the gastrointestinal tract increases.

When used concomitantly with antihypertensive agents, the effectiveness of the latter may decrease.

When used concomitantly with lithium preparations, lithium can accumulate and increase its toxic effect (monitoring of lithium concentration in the blood is recommended).

Simultaneous use with methotrexate increases the side effect of the latter on the hematopoietic system (there is a risk of anemia and leukopenia.

Periodic monitoring of a general blood test is required). Concomitant use with diuretics and cyclosporine increases the risk of developing renal failure.

When used simultaneously with intrauterine contraceptives, the effectiveness of the latter may decrease.

When used concomitantly with anticoagulants (heparin, ticlopidine, warfarin), as well as with thrombolytic drugs (streptokinase, fibrinolysin), the risk of bleeding increases (blood clotting parameters should be periodically monitored).

Simultaneous use with colestyramine increases the elimination of meloxicam through the gastrointestinal tract (as a result of meloxicam binding). No pharmacokinetic interaction was observed when meloxicam was co-administered with antacids.

How to take, course of use and dosage

Inside, with meals, once a day.

Rheumatoid arthritis: 15 mg per day. If 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 can 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 insufficiency who are on hemodialysis, the maximum daily dose is 7.5 mg. The maximum dose for adolescents is 0.25 mg / kg.

In patients with moderate renal and hepatic insufficiency, as well as clinically stable cirrhosis of the liver, no dose adjustment is required.

Overdose

Symptoms:  increased side effects.

Treatment:  gastric lavage, taking activated charcoal (within the next hour), symptomatic therapy.

Colestyramine accelerates the elimination of the drug from the body. Forced diuresis, urine alkalinization, and hemodialysis are ineffective due to the high binding of meloxicam to blood proteins. No specific antidotes or antagonists were found.

Purpose

Nonsteroidal Anti-inflammatory drug (NSAID)

Description

Tablets from light yellow to yellow with a greenish tinge of color; flat-cylindrical, with a chamfer and with a risk. Marbling is allowed.

Functional features

Meloxicam is well absorbed when taken orally, with a bioavailability of 89%. Food intake does not affect the absorption of the drug. The maximum blood concentration (Cmax) is 1.05 mcg / ml, the time to reach it (Tmax) is 4.9 hours, the half-life (T 1/2) is 20.1 hours, and the clearance is 8.8 ml / min. A steady-state concentration (Css) is created on day 3-5. The volume of distribution is about 10 liters. Binding to plasma proteins (mainly albumin) is 99.4%. Meloxicam penetrates through histohematic barriers, including placental, blood-brain and hematosynovial. Synovial fluid contains 50% of the drug’s plasma concentration.Meloxicam is completely metabolized to four pharmacologically inactive forms with the participation of peroxidase, cytochrome P450 isoenzymes CYP2C9 and CYP3A4. It is excreted equally in urine and faeces, unchanged-in trace amounts (0.2% with urine and 1.6% with faeces).

Complete set

Tablets of 7.5 mg and 15 mg. 10 tablets in a contour cell package made of polyvinyl chloride film and aluminum foil printed varnished. 2 or 3 contour cell packages together with instructions for use in a pack.

Special instructions

Meloxicam is intended for symptomatic therapy, it should not be taken for the purpose of preventing exacerbation of diseases. Caution should be exercised when treating patients with a history of gastrointestinal diseases and in patients receiving anticoagulants. Patients with gastrointestinal symptoms should be monitored regularly. Periodic monitoring of blood clotting parameters is necessary.

If ulcerative lesions of the gastrointestinal tract or gastrointestinal bleeding occur, meloxicam should be discontinued. If allergic reactions (pruritus, urticaria, skin rash, photosensitization) occur during treatment, you should consult a doctor to decide whether to stop taking the drug.

The use of NSAIDs in patients with reduced renal blood flow or reduced circulating blood volume may lead to decompensation of latent renal failure. After NSAID withdrawal, renal function usually returns to its original level.

Elderly patients are most at risk of developing this reaction; patients with dehydration; patients with congestive heart failure, cirrhosis of the liver, nephrotic syndrome or kidney disease; patients receiving diuretics, ACE inhibitors, angiotensin II receptor antagonists; and patients who have undergone major surgical interventions leading to hypovolemia. In such patients, diuresis and renal function should be carefully monitored at the beginning of therapy.

The increase in transaminase activity is usually transient and insignificant. If there is a significant and persistent increase in transaminase activity, meloxicam should be discontinued and liver function monitored. Debilitated or emaciated patients may not tolerate adverse events as well, so such patients should be carefully monitored. Caution should be exercised when treating elderly patients who are more likely to have impaired renal, liver, and heart function.

The use of NSAIDs together with diuretics can lead to sodium, potassium and water retention, and affect the natriuretic effect of diuretics. As a result, predisposed patients may have increased signs of heart failure or hypertension.

Meloxicam, like other NSAIDs, can mask the symptoms of an infectious disease. The use of meloxicam, as well as other drugs that block the synthesis of prostaglandins, can affect fertility, so the drug is not recommended for women who want to become pregnant.

Influence on the ability to drive vehicles and work with mechanisms

Special studies on the effect of the drug on the ability to drive vehicles and mechanisms have not been conducted. You should drive with caution and engage in other potentially dangerous activities that require a high rate of psychomotor reactions, due to possible side effects from the central nervous system, such as visual disturbances, drowsiness, dizziness.

Form of production

Tablets

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf

life is 3 years. Do not use the product after the expiration date indicated on the package.

Active ingredient

Meloxicam

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For children over 15 years of age, For adults as prescribed by a doctor, For Children as prescribed by a doctor

Indications

Osteoarthritis, Rheumatoid Arthritis, Osteoarthritis and Arthritis