Meloxicam-Teva, tablets 7.5 mg 20 pcs.

Pharmacodynamics:

Meloxicam is a nonsteroidal anti-inflammatory drug with anti-inflammatory and antipyretic effects. Its anti-inflammatory effect is associated with inhibition of the enzymatic activity of cyclooxygenase-2 (COX-2), involved in prostaglandin biosynthesis in the area of inflammation. To a lesser extent, meloxicam acts on cyclooxygenase-1 (COX-1), involved in the synthesis of prostaglandin, which protects the mucosa of the gastrointestinal tract (GIT) and is involved in the regulation of blood flow in the kidneys.

Pharmacokinetics:

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Indications

Osteoarthritis and arthritis, Osteoarthritis, Back pain, Pain, Pain in the neck, Rheumatoid arthritis, Joint pain (arthralgia)

Symptomatic treatment:

• osteoarthritis (osteoarthritis, degenerative joint disease), including with a pain component;
• rheumatoid arthritis;
• ankylosing spondylitis.

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Active ingredient

Meloxicam

Composition

1 tablet contains: the active substance meloxicam 7.5/ 15.0 mg; excipients: 77.2/69.7 mg lactose monohydrate, 56.0/56.0 mg microcrystalline cellulose, 18.0/18.0 mg sodium citrate dihydrate, 6.0/6.0 mg povidone K30, 12.0/12.0 mg crosspovidone, 1.5/1.5 mg colloidal silicon, 1.8/1.8 mg magnesium stearate.

How to take, the dosage

Ingestion.

The total daily dose should be taken in one sitting, with a meal, with water or other liquid.

Osteoarthritis: 7.5 mg daily. If necessary, this dose can be increased to 15 mg per day.

Rheumatoid arthritis: 15 mg per day. Depending on the therapeutic effect, this dose may be reduced to 7.5 mg per day.

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

In patients with an increased risk of adverse reactions, it is recommended to start treatment with a dose of 7.5 mg daily.

In patients with severe renal impairment who are on hemodialysis, the dose should not exceed 7.5 mg daily.

General recommendations

Because the potential risk of adverse reactions depends on the dose and duration of treatment, the lowest possible dose and shortest possible duration of use should be used.

The maximum recommended daily dose is 15 mg.

Combined use

The drug should not be used simultaneously with other NSAIDs.

The total daily dose of Meloxicam-Teva used in different dosage forms should not exceed 15 mg.

Children and adolescents

The maximum dose in adolescents is 0.25 mg/kg.

The drug is contraindicated in children under 12 years of age.

Interaction

• Other prostaglandin synthesis inhibitors, including glucocorticoids and salicylates: Simultaneous use with meloxicam increases the risk of gastrointestinal ulcers and gastrointestinal bleeding (due to synergistic action). Concomitant use with other NSAIDs is not recommended.
• Anticoagulants for oral administration, heparin for systemic use, thrombolytics: Concomitant use with meloxicam increases the risk of bleeding. In case of concomitant use, close monitoring of the clotting system is required.
• Antiplatelet drugs, serotonin reuptake inhibitors: concomitant use with meloxicam increases the risk of bleeding due to inhibition of platelet function. In case of concomitant use, close monitoring of the clotting system is required.
• Lithium preparations: NSAIDs increase plasma levels of lithium by reducing its excretion by the kidneys. Concomitant use of meloxicam with lithium preparations is not recommended. If concomitant use is necessary, careful monitoring of plasma lithium concentrations is recommended throughout the course of lithium medications.
• Methotrexate: NSAIDs reduce renal secretion of methotrexate, thereby increasing its plasma concentrations. Concomitant use of meloxicam and methotrexate (at a dose greater than 15 mg per week) is not recommended. In case of concomitant use, careful monitoring of renal function and blood counts is required. Meloxicam may increase hematological toxicity of methotrexate, especially in patients with impaired renal function. Co-administration of meloxicam and methotrexate for 3 days increases the risk of increased toxicity of the latter.
• Contraception: There is evidence that NSAIDs may reduce the effectiveness of intrauterine contraceptive devices, but this has not been proven.
• Diuretics: Use of NSAIDs if patients are dehydrated is accompanied by a risk of acute renal failure.
• Antihypertensive agents (beta-adrenoblockers, angiotensin-converting enzyme inhibitors, vasodilators, diuretics): NSAIDs reduce the effect of antihypertensive agents, due to inhibition of prostaglandins that have vasodilatory properties.
• Angiotensin-II receptor antagonists: When combined with NSAIDs, they increase decreased glomerular filtration, which may lead to acute renal failure, especially in patients with impaired renal function.
• Cholestyramine: By binding meloxicam in the gastrointestinal tract, cholestyramine leads to its faster excretion.
• Cyclosporine:NSAIDs, by acting on renal prostaglandins, may increase the nephrotoxicity of cyclosporine.
• When used together with meloxicam, drugs that have a known ability to inhibit CYP2C9 and/or CYP3A4 (or are metabolized with the participation of these enzymes), the possibility of pharmacokinetic interaction should be taken into account.
• The possibility of interaction with antidiabetic drugs for oral administration cannot be excluded.
• No significant pharmacokinetic interactions have been observed with concomitant use of antacids, cimetidine, digoxin and furosemide.

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Special Instructions

Patients with gastrointestinal diseases should be monitored regularly. If gastrointestinal ulceration or gastrointestinal bleeding occurs, the drug Meloxicam-Teva should be discontinued.

Gastrointestinal ulcers, perforations or bleeding can occur during the use of NSAIDs at any time, with or without a history of alarming symptoms or serious gastrointestinal complications. The consequences of these complications are generally more serious in the elderly.

When using the drug Meloxicam-Teva serious skin reactions such as: exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis may develop. In this regard, special attention should be paid to patients who report adverse reactions of the skin and mucous membranes, as well as hypersensitivity reactions to the drug, especially if such reactions were observed during the previous courses of treatment. The development of such reactions is usually observed during the first month of treatment. In case of the first signs of skin rash, mucous membrane changes or other signs of hypersensitivity the question of discontinuing the drug Meloxicam-Teva should be considered.

There are cases of increased risk of serious cardiovascular thrombosis, myocardial infarction, angina attack, possibly with fatal outcome, when taking NSAIDs. This risk increases with long-term use of the drug, as well as in patients with the above-mentioned diseases in the history and predisposition to such diseases.

NSAIDs inhibit the renal synthesis of prostaglandins, which are involved in maintaining renal perfusion. Use of NSAIDs in patients with decreased renal blood flow or reduced circulating blood volume may lead to decompensation of latent renal insufficiency. After discontinuation of NSAIDs, renal function usually returns to baseline. Elderly patients; patients with dehydration, chronic heart failure, cirrhosis, nephrotic syndrome or acute renal dysfunction; patients taking diuretics, angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists simultaneously; and patients who have undergone serious surgical interventions that lead to hypovolemia are at highest risk for this reaction. In such patients, diuresis and renal function should be carefully monitored at the beginning of therapy.

The use of NSAIDs together with diuretics may lead to retention of sodium, potassium and water, as well as to reduction of the natriuretic action of diuretics. As a result, in predisposed patients there may be increased signs of heart failure or arterial hypertension. In this regard, close monitoring of such patients is required, and they should be kept adequately hydrated. Before initiating treatment it is necessary to study renal function.

In case of combined therapy, renal function should also be monitored.

When using the drug Meloxicam-Teva (as well as most other NSAIDs) there may be occasional increases in serum transaminase activity or other indicators of liver function. In most cases, these increases were small and transient. If the changes detected are significant or do not decrease over time, the drug Meloxicam-Teva should be discontinued and the laboratory changes detected should be monitored.

Weakened or debilitated patients may have a worse tolerance to adverse events, so these patients should be monitored closely.

Like other NSAIDs, Meloxicam-Teva may mask the symptoms of an underlying infectious disease.

As a drug that inhibits cyclooxygenase/prostaglandin synthesis, Meloxicam-Teva may affect fertility and therefore is not recommended for women who have difficulty conceiving. Therefore, in women undergoing evaluation for this reason, withdrawal of Meloxicam-Teva is recommended.

In patients with mild to moderate renal impairment (creatinine clearance greater than 25 ml/min) no dose adjustment is required.

In patients with cirrhosis (compensated) no dose adjustment is required.

Influence on driving and operating ability

There have been no special studies regarding the effect of the drug on driving and operating ability. However, when driving motor transport and mechanisms one should take into account the possibility of dizziness, somnolence, visual impairment or other disorders of the nervous system. Patients should use caution when driving vehicles and mechanisms.

Synopsis

Tablets 7.5 mg. Round yellow, flat-cylindrical, beveled tablets with a slight marbling; with a separating ridge on one side and “MLX 7.5” engraved on the other side.

Contraindications

• Hypersensitivity to the active ingredient or excipients of the drug. There is a possibility of cross-sensitivity to acetylsalicylic acid and other NSAIDs.
• The complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history).
• Erotic ulcers of the stomach and duodenum, acute or recent.
• Inflammatory bowel disease (Crohn’s disease, ulcerative colitis), acute.
• Severe liver failure.
• Severe renal failure (unless hemodialysis, creatinine clearance less than 30 mL/min, and confirmed hyperkalemia), advanced renal disease.
• Active gastrointestinal bleeding, recent cerebrovascular bleeding or established diagnosis of blood clotting disorders.
• Severe uncontrolled heart failure.
• Pregnancy.
• Breastfeeding period.
• Therapy of perioperative pain during coronary artery bypass grafting.
• Children under 12 years of age.
• Rare hereditary galactose intolerance (the maximum daily dose of meloxicam 7.5 mg and 15 mg contains 47 mg and 20 mg of lactose, respectively).

Cautions

• Ischemic heart disease.
• Cerebrovascular disease.
• Cronic heart failure.
• Renal insufficiency (creatinine clearance 30-60 ml/min).
• Dyslipidemia/hyperlipidemia.
• Diabetes mellitus.
• Peripheral artery disease.
• Smoking.
• Gastrointestinal history (gastric and 12 duodenal ulcer, liver disease).
• Elderly age.
• Long-term use of NSAIDs.
• Frequent use of alcohol.
• Compatible therapy with the following drugs: anticoagulants (including warfarin), antiplatelet agents, oral glucocorticoids (e.g., prednisolone), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline).

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Side effects

The following are the adverse reactions whose association with the use of meloxicam was considered possible.

The incidence of adverse reactions within the systemic-organ classes was determined in accordance with the recommendations of the World Health Organization: Very common (≥ 1/10); common (≥ 1/100 < 1/10); infrequent (≥ 1/1000 < 1/100); rare (≥ 1/10000 < 1/1000); very rare (< 1/10000); frequency unknown (cannot be estimated based on available data).

Blood and lymphatic system disorders: infrequent – anemia; rare – changes in blood cell count, including changes in the leukocyte formula, leukopenia, thrombocytopenia; very rare: agranulocytosis*.

In immune system disorders: infrequent – other immediate-type hypersensitivity reactions; frequency unknown – anaphylactic shock (intramuscular injection), anaphylactoid reactions.

Nervous system disorders:often – headache; infrequently – dizziness, somnolence.

Mental disorders:often – mood changes, nightmares; frequency unknown – confusion, disorientation.

Visual organs: rarely – conjunctivitis, visual disturbances, including blurred vision.

Hearing organ: infrequent – vertigo; rarely – tinnitus.

From the gastrointestinal tract: frequent – abdominal pain, dyspepsia, diarrhea, nausea, vomiting; infrequent – constipation, bloating, stomatitis, gastritis, belching, hidden or overt gastrointestinal bleeding**; rare – gastroduodenal ulcers, colitis, esophagitis; very rare – gastrointestinal tract perforation; frequency unknown – pancreatitis.

Hepatic disorders: frequent – transient changes in liver function parameters (e.g., increased activity of transaminases or bilirubin); very rare – hepatitis.

Skin and subcutaneous tissue: infrequent – angioedema, pruritus, skin rash; rare – toxic epidermal necrolysis, Stevens-Johnson syndrome, urticaria; very rare – bullous dermatitis, erythema multiforme; frequency is unknown – photosensitization reactions.

Responses to the respiratory system: frequent – bronchial asthma in patients with allergy to acetylsalicylic acid or other NSAIDs.

Cardiac side: frequent – feeling of palpitations, frequency unknown – heart failure (associated with taking NSAIDs).

vascular disorders: infrequent – increase in blood pressure, feeling of “rush” of blood to the face.

Recreational and urinary tract disorders: frequent – hyperkalemia, changes of renal function parameters (increased serum creatinine and/or urea), urinary disorders, including acute retention of urine; very rare – acute renal failure in patients with risk factors (see. Special Indications>).

General disorders: infrequently – edema, including edema of the lower extremities.

Description of individual adverse reactions

*A predisposing factor for the occurrence of agranulocytosis is the simultaneous use of potentially myelotoxic drugs, particularly methotrexate.

**Gastrointestinal bleeding, ulceration or perforation can be fatal.

As with other NSAIDs, the possibility of interstitial nephritis, glomerulonephritis, renal medullary necrosis, and nephrotic syndrome cannot be excluded.

Overdose

There are not enough data on cases associated with drug overdose. Symptoms characteristic of NSAID overdose are likely to be present in severe cases: drowsiness, impaired consciousness, nausea, vomiting, epigastric pain, gastrointestinal bleeding, blood pressure changes, acute renal failure, respiratory arrest, asystole. Treatment: no antidote is known; in case of drug overdose, gastric contents should be evacuated and general supportive therapy should be carried out. Cholestyramine accelerates excretion of meloxicam.

Pregnancy use

Pregnancy

The use of Meloxicam-Teva is contraindicated during pregnancy.

Breastfeeding

It is known that NSAIDs penetrate into the breast milk, so the use of the drug Meloxicam-Teva during breastfeeding is contraindicated.

Fertility

As a drug that inhibits cyclooxygenase/ prostaglandin synthesis, Meloxicam-Teva may affect fertility and is therefore not recommended for women planning a pregnancy. Meloxicam may cause delayed ovulation. Therefore, withdrawal of Meloxicam-Teva is recommended in women who have problems with conception and are undergoing evaluation for such problems.

Similarities

Movalis, Meloxicam, Amelotex, Movasin, Arthrosan, Meloxicam-Teva, Meloxicam DS, Meloxicam Stada, Petcam Tabs, Meloxidil, Elox-SOLofar