Meloxicam Tablets 7.5 mg

Gafacom April 03, 2023

Meloxicam Tablets 7.5 mg

Meloxicam is a non-steroidal anti-inflammatory substance (NSAID) of the oxicam family, with anti-inflammatory, analgesic and antipyretic properties.

The anti-inflammatory property of meloxicam has been proven in classical models of inflammation. As with other NSAIDs, its precise mechanism of action remains unknown.

However, there is at least one common mode of action shared by all NSAIDs (including meloxicam): Inhibition of the biosynthesis of prostaglandins, known inflammation mediators.

Meloxicam Tablets 7.5 mg


Therapeutic indication (s)

  • Short-term symptomatic treatment of exacerbations of osteoarthrosis.
  • Long-term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis.

Posology and method of administration:

The total daily amount should be taken as a single dose with water or another liquid, during a meal. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

The patient’s need for symptomatic relief and response to therapy should be reevaluated periodically, especially in patients with osteoarthritis.

  • Exacerbations of osteoarthrosis: 7.5 mg once daily.

If necessary, in the absence of improvement, the dose may be increased to 15 mg once daily (one 15 mg tablet).

  • Rheumatoid arthritis, ankylosing spondylitis: 15 mg once daily (one 15 mg tablet).

According to the therapeutic response the dose may be reduced to 7.5 mg once daily.

DO NOT EXCEED THE DOSE OF 15 MG/DAY.

Method of administration:

For oral administration only.

Contraindications:

This medicinal product is contraindicated in the following situations:

  • Third trimester of pregnancy and lactation.
  • Children and adolescents aged under 16 years
  • Hypersensitivity to meloxicam or to one of the excipients or hypersensitivity to substances with a similar action, e.g. NSAIDs, acetylsalicylic acid. This medicinal product should not be given to patients who have developed signs of asthma, nasal polyps, angioneurotic oedema or urticaria following the administration of acetylsalicylic acid or other NSAIDs.
  • History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy
  • Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
  • Severely impaired liver function.
  • Non-dialysed severe renal failure.
  • Gastrointestinal bleeding, history of cerebrovascular bleeding or other bleeding disorders.
  • Severe heart failure.

Special warnings and precautions for usage:

Gastrointestinal effects: Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.

The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk.

Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.

Cardiovascular and cerebrovascular effects: Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

Skin Reactions: Life-threatening cutaneous reactions including exfoliative dermatitis, Stevens-Johnson’ syndrome (SJS), and toxic epidermal necrolysis (TEN), have been reported with the use of meloxicam. Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first month of treatment. If symptoms or signs of exfoliative dermatitis, SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) are present, or any other sign of hypersensitivity, meloxicam treatment should be discontinued.

Parameters of liver and renal function: As with most NSAIDs, occasional increases in serum transaminase levels, increases in serum bilirubin or other liver function parameters, as well as increases in serum creatinine and blood urea nitrogen.

The majority of these instances involved transitory and slight abnormalities. Should any such abnormality prove significant or persistent, the administration of meloxicam should be stopped and appropriate investigations undertaken.

Functional renal failure: NSAIDS, by inhibiting the vasodilating effect of renal prostaglandins, may induce a functional renal failure by reduction of glomerular filtration. This adverse event is dose dependent. At the beginning of the treatment, or after dose increase, careful monitoring of diuresis and renal function is recommended.

Sodium, potassium and water retention: Induction of sodium, potassium and water retention and interference with the natriuretic effects of diuretics may occur with NSAIDs. Furthermore, a decrease of the antihypertensive effect of antihypertensive drugs can occur.

Consequently, oedema, cardiac failure or hypertension may be precipitated or exacerbated in susceptible patients as a result. Clinical monitoring is therefore necessary for patients at risk.

Hypokalaemia: Hypokalaemia can be associated with diabetes or concomitant treatment known to increase kalaemia. Regular monitoring of potassium values should be performed in such cases.

Lactose: If you have been told by doctor that you have intolerance to some sugar, contact your doctor before taking this medicinal product.

Paediatric population: This medicine is not use for Paediatric population

Interaction with other medicinal products and other forms of Interactions

Other NSAIDs, including salicylates: Administration of several NSAIDs together may increase the risk of gastrointestinal ulcers and bleeding, via a synergistic effect. The concomitant use of meloxicam with other NSAIDs is not recommended.

Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin.

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.

Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the coadministration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclooxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function before initiation of concomitant therapy, and periodically thereafter.

Other antihypertensive drugs (e.g. Beta-blockers): As for the latter, a decrease of the antihypertensive effect of beta-blockers (due to inhibition of prostaglandins with vasodilatory effect) can occur.

Ciclosporin: Nephrotoxicity of ciclosporin may be enhanced by NSAIDs via renal prostaglandin mediated effects. During combined treatment renal function is to be measured. A careful monitoring of the renal function is recommended, especially in the elderly.

Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding.

Intrauterine devices: NSAIDs have been reported to decrease the efficacy of intrauterine devices. A decrease of the efficacy of intrauterine devices by NSAIDs has been previously reported but needs further confirmation. Pharmacokinetic Interactions (Effect of meloxicam on the pharmacokinetics of other drugs).

Lithium: NSAIDs have been reported to increase blood lithium levels (via decreased renal excretion of lithium), which may reach toxic values. The concomitant use of lithium and NSAIDs is not recommended. If this combination appears necessary, lithium plasma concentrations should be monitored carefully during the initiation, adjustment and withdrawal of meloxicam treatment.

Methotrexate: NSAIDs can reduce the tubular secretion of methotrexate thereby increasing the plasma concentrations of methotrexate. For this reason, for patients on high dosages of methotrexate (more than 15 mg/week) the concomitant use of NSAIDs is not recommended.

The risk of an interaction between NSAID preparations and methotrexate, should be considered also in patients on low dosage of methotrexate, especially in patients with impaired renal function. In case combination treatment is necessary blood cell count and the renal function should be monitored. Caution should be taken in case both NSAID and methotrexate are given within 3 days, in which case the plasma level of methotrexate may increase and cause increased toxicity.

Fertility, pregnancy and lactation:

Pregnancy: It is advisable to avoid the administration of meloxicam during the first two trimesters of pregnancy.

During the final three months, all prostaglandin synthesis inhibitors may expose the fetus to cardiopulmonary (pulmonary hypertension with premature closure of the ductus arteriosus) and renal toxicity or inhibit the contraction of the uterus. This effect on the uterus has been associated with an increase in the incidence of dystocia and delayed parturition in animals.

Thus all NSAIDs are absolutely contra-indicated during the final three months.

Lactation: NSAIDs pass into mother’s milk. Administration is contraindicated, as a precautionary measure, in women who are breast feeding.

Effects on the ability to drive and operate machinery

There are no specific studies on the ability to drive and use machinery. If during the treatment, however, visual disturbances, dizziness, fatigue or any CNS disturbance occur, it is recommended to avoid driving and using machines

Undesirable effects

Blood and the lymphatic system disorders: Anaemia, Disturbances of blood count: leucocytopenia, thrombocytopenia, agranulocytosis.

Immune system disorders: Anaphylactic/anaphylactoid reactions.

Psychiatric disorders: Mood disorders, insomnia and nightmares.

Nervous system disorders: Light-headedness, headache, Vertigo, tinnitus, drowsiness, Confusion.

Eye disorders: Visual disturbances including blurred vision.

Cardiac and vascular disorders: Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.

Vascular disorders: Increase in blood pressure, flushes.

Respiratory, thoracic and mediastinal disorders: Onset of asthma attacks in certain individuals allergic to aspirin or other NSAIDs.

Gastrointestinal disorders: The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur, Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease have been reported following administration. Less frequently, gastritis has been observed.

Hepato-biliary disorders: Transitory disturbance of liver function test, Hepatitis.

Skin and subcutaneous tissue disorders: Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Renal and urinary disorders: Disturbances of laboratory tests investigating renal function, renal failure.

General disorders and administration site conditions: Oedema including oedema of the lower limbs.

Overdose

Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting and epigastric pain, which are generally reversible with supportive care.

Gastrointestinal bleeding can occur. Severe poisoning may result in hypertension, acute renal failure, hepatic dysfunction, respiratory depression, coma, convulsions, cardiovascular collapse and cardiac arrest.

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