What is Meloxicam? Usage and Side effects

What is Meloxicam

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam family with anti-inflammatory, analgesic and antipyretic properties. The anti-inflammatory activity of meloxicam has been proven in classical models of inflammation. As with other NSAIDs, the exact mechanism of action remains unknown. However, there is at least one common mechanism of action that is common to all NSAIDs (including meloxicam): inhibition of the biosynthesis of prostaglandins, known as inflammatory mediators.

Indications for use

  • Short-term symptomatic treatment of exacerbation of osteoarthritis.
  • Long-term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis.

Method of administration and dosage

The drug Meloxicam is used internally.

The daily dose of the drug is taken once with a meal, washed down with water or other liquid. The likelihood of undesirable effects can be minimized by using the lowest effective dose of the drug for the shortest period of time necessary to control symptoms. The need for therapy and the patient’s response to therapy should be periodically assessed, especially in patients with osteoarthritis.

Exacerbations of osteoarthritis: 7.5 mg / day (one 7.5 mg tablet or half a 15 mg tablet). If necessary, in the absence of improvement, the dose can be increased to 15 mg / day (two 7.5 mg tablets or 1 15 mg tablet).

Rheumatoid arthritis, ankylosing spondylitis: 15 mg / day (two 7.5 mg tablets or 1 15 mg tablet). Depending on the severity of the response to therapy, the dosage can be reduced to 7.5 mg / day (one 7.5 mg tablet or half a 15 mg tablet).

Do not exceed the dose of meloxicam 15 mg per day.

Special patient groups

Elderly patients and patients at increased risk of adverse reactions

The recommended dose for long-term treatment of elderly patients with rheumatoid arthritis or ankylosing spondylitis is 7.5 mg per day. Patients with an increased risk of developing adverse reactions should begin treatment with a dosage of 7.5 mg per day.

Impaired renal function

In patients with severe renal failure on dialysis, the dose should not exceed 7.5 mg per day.

No dose reduction is required in patients with mild to moderate renal impairment (i.e., in patients with creatinine clearance more than 25 ml / min.).

Liver dysfunction

In patients with mild to moderate hepatic impairment, dose reduction is not required.

Children and adolescents

Meloxicam is contraindicated in children and adolescents under 16 years of age.

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Side effect

Research data and epidemiological data suggest that the use of some NSAIDs (especially in high doses and with long-term treatment) may be associated with a slight increase in the risk of vascular thrombotic events (such as myocardial infarction or stroke).

With the use of NSAIDs, edema, arterial hypertension and heart failure were observed.

Most of the side effects were observed from the gastrointestinal tract. Possible development of ulcers, perforation or gastrointestinal bleeding, including fatal, especially in elderly patients. After application, cases of nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, vomiting of blood, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease have been reported. Gastritis was observed with a lesser frequency.

Severe adverse skin reactions have been reported: Stevens-Johnson syndrome and toxic epidermal necrolysis.

On the part of the blood and lymphatic system: infrequently: anemia; rarely: deviations of blood test parameters from the norm (including changes in the number of leukocytes), leukopenia, thrombocytopenia.

Very rare cases of agranulocytosis have been reported.

  • From the immune system: infrequently: allergic reactions, excluding anaphylactic and anaphylactoid; unknown: anaphylactic reactions, anaphylactoid reactions.
  • From the side of the psyche: rarely: mood changes, nightmares; unknown: confusion, disorientation.
  • From the nervous system: often: headache; infrequently: dizziness, drowsiness.
  • From the side of the organ of vision: rarely: visual impairment, including blurred vision, conjunctivitis.
  • On the part of the organ of hearing and labyrinth disorders: infrequently: dizziness; rarely: ringing in the ears.
  • From the side of the heart: rarely: palpitations.

Heart failure associated with the use of NSAIDs has been reported.

  • From the side of the vessels: infrequently: increased blood pressure, hot flashes.
  • From the respiratory system, chest and mediastinal organs: rarely: asthma in patients allergic to acetylsalicylic acid and other NSAIDs.
  • From the gastrointestinal tract: very often: dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea; infrequently: latent or grossly visible gastrointestinal bleeding, stomatitis, gastritis, constipation, belching; rarely: colitis, gastroduodenal ulcer, esophagitis; very rare: perforation of the gastrointestinal tract.
  • Gastrointestinal bleeding, ulceration, or perforation can be severe and potentially fatal, especially in elderly patients.
  • From the liver and biliary tract: infrequently: abnormal liver function indicators (for example, increased transaminases or bilirubin); very rare: hepatitis.
  • On the part of the skin and subcutaneous tissue: infrequently: angioedema, itching, rash; rarely: Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria; very rare: bullous dermatitis, erythema multiforme; unknown: photosensitivity.
  • From the urinary system: infrequently: sodium and water retention, hyperkalemia, changes in laboratory tests of renal function (increased serum creatinine and / or urea); very rare: acute renal failure, in particular in patients with risk factors.
  • General disorders and reaction at the injection site: infrequently: edema, including edema of the lower extremities.

Isolated serious and / or frequent adverse reactions

  • Very rare cases of agranulocytosis have been reported in patients taking meloxicam and other potentially myelotoxic drugs.
  • Adverse reactions that were not associated with the use of the drug, but which are generally accepted for other compounds of this class
  • Organic kidney disease, possibly leading to acute renal failure: Very rare cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome and papillary necrosis have been reported.

Contraindications

hypersensitivity reactions to meloxicam or any auxiliary component or hypersensitivity to substances with a similar effect, for example, NSAIDs, acetylsalicylic acid. Meloxicam should not be prescribed to patients who have experienced symptoms of bronchial asthma, polyps of the nasal mucosa, angioedema or urticaria after the administration of acetylsalicylic acid or other NSAIDs;

  • a history of gastrointestinal bleeding or gastrointestinal perforation associated with previous NSAID therapy;
  • active phase or recurrent course of ulcers / bleeding of the gastrointestinal tract (two or more separate episodes in which the presence of an ulcer or bleeding is confirmed);
  • severe liver dysfunction;
  • severe renal failure without dialysis;
  • history of gastrointestinal bleeding, cerebrovascular bleeding, or other bleeding disorders;
  • severe heart failure;
  • pregnancy or breastfeeding;
  • children and adolescents under the age of 16.

Pregnancy and lactation

Meloxicam is contraindicated during pregnancy. Suppression of prostaglandin synthesis can have undesirable effects on pregnancy and fetal development. Epidemiological data indicate an increased risk of spontaneous abortion and fetal heart defects after the use of prostaglandin synthesis inhibitors during pregnancy. The absolute risk of developing heart defects increased from less than 1% to 1.5%. This risk increases with dose and duration of therapy.

In the third trimester of pregnancy, the use of inhibitors of prostaglandin synthesis can lead to the following fetal developmental disorders:

  • premature closure of the ductus arteriosus and pulmonary hypertension due to toxic effects on the cardiopulmonary system;
  • renal dysfunction, with the further development of renal failure with a decrease in the amount of amniotic fluid.

In the mother during childbirth, the duration of bleeding may increase and the contractility of the uterus may decrease, and as a result, the time of delivery may increase. It is known that NSAIDs penetrate into breast milk, therefore, meloxicam is not recommended for use during breastfeeding.

Overdose

Symptoms of acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain, which are generally reversible with maintenance therapy. Gastrointestinal bleeding may occur. Severe poisoning can be accompanied by hypertension, acute renal failure, liver dysfunction, respiratory depression, coma, seizures, cardiovascular failure, and cardiac arrest. With the therapeutic use of NSAIDs, anaphylactoid reactions have been reported, which can also be observed in case of overdose.

In case of an overdose of NSAIDs, patients are recommended symptomatic and supportive therapy. Studies have shown an acceleration of the elimination of meloxicam with oral administration of 4 g of cholestyramine 3 times / day.

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Precautions for use; special warnings

Take special care with MELOXICAM BIOGARAN:

Warnings

Medicines such as MELOXICAM BIOGARAN may increase the risk of a heart attack (“myocardial infarction”) or stroke. The risk is all the more important as the doses used are high and the duration of treatment prolonged.

  • Do not exceed the recommended doses or the duration of treatment.

If you have heart problems, if you have had a stroke or if you think you have risk factors for this type of pathology (for example in case of high blood pressure, diabetes, high cholesterol or if you smoke), talk to your doctor or pharmacist.

Take special care with MELOXICAM BIOGARAN

As your treatment may need to be adjusted, it is important to tell your doctor before taking MELOXICAM BIOGARAN if you have:

  • Kidney, liver or heart problems (hypertension and / or heart failure) or fluid retention ( see section 3 “How to take Meloxicam” );
  • Digestive history (eg: old ulcers of the stomach or duodenum);
  • Intolerance to carbohydrates.

In the event of concomitant treatment with other drugs which increase the risk of peptic ulcer disease or gastrointestinal bleeding such as oral corticosteroids, certain antidepressants (from the SSRI family, i.e. selective inhibitors of reuptake of serotonin), certain substances which prevent the formation of blood clots, such as aspirin, or anticoagulants such as warfarin, consult your doctor before taking MELOXICAM BIOGARAN.

Like any nonsteroidal anti-inflammatory drug, meloxicam may mask symptoms of an underlying infection (such as fever). Therefore, if you observe any signs of infection or worsening of symptoms, consult your doctor.

If you are a woman, MELOXICAM BIOGARAN may affect your fertility. You should therefore not take this medicine if you want to conceive a child, if you have difficulty in procreating or if tests on your reproductive function are underway.

Elderly people have a higher risk of side effects, especially gastrointestinal bleeding, ulcers and perforations. Kidney, liver and heart functions should be closely monitored. The dosage should be reduced.

The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

Interactions with other drugs

Taking or using other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription , as there are some medicines which should not be taken together and others which may require treatment. dose modification when taken together.

You should always tell your doctor or pharmacist if you are using or receiving any of the following medicines before taking MELOXICAM BIOGARAN:

  • Acetylsalicylic acid (aspirin) or other anti-inflammatory drugs,
  • Corticosteroids,
  • Oral anticoagulants such as warfarin, injectable heparin, antiplatelet or other thrombolytics,
  • lithium,
  • Methotrexate
  • Inhibitors of angiotensin-converting enzyme, diuretics, beta blockers and angiotensin II antagonists,
  • Selective inhibitors of serotonin reuptake,
  • Cyclosporine,
  • cholestyramine.

Co-administration of anti-inflammatory agents, corticosteroids, drugs that prevent blood clotting (such as warfarin or heparin, antiplatelet drugs) or that break up blood clots (thrombolytics) and certain antidepressants (selective serotonin reuptake inhibitors) may increase the risk of gastrointestinal ulcers, bleeding, and damage to the gastric and intestinal mucosa.

Women with an intrauterine device (IUD), more commonly known as an IUD, should tell their doctor because the effectiveness of IUDs may be affected by the concomitant use of nonsteroidal anti-inflammatory drugs.

If you have any doubts about taking other medicines with MELOXICAM BIOGARAN, talk to your doctor or pharmacist.

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