Meloxboston 15

POSOLOGY AND METHOD OF ADMINISTRATION

Method of administration 

For oral use.

Meloxicam tablet can be taken with or without food.

Food does not affect drug absorption.

Posology

Adults

Rheumatoid Arthritis, Ankylosing Spondylitis: 15 mg once daily

The recommended dose for long term treatment of rheumatoid arthritis and ankylosing spondylitis in elderly patients or patients with increased risks for adverse reactions is 7.5 mg once daily.

Do not exceed the dose of 15 mg/day.

Exacerbations of Osteoarthritis: 7.5 mg once daily. If necessary, in the absence of improvement, the dose may be increased to 15 mg/day. Do not exceed the dose of 15 mg/day. Patients with increased risks for adverse reactions should start treatment with 7.5 mg/day. Duration of treatment is 2-3 days (this allows, if necessary, to switch to oral or rectal)

Elderly: The recommended dose is 7.5mg once daily

Hepatic impairment, renal impairment: No dose reduction is required in patients with mild to moderate hepatic/renal impairment. For patients with severely impaired liver function, or non-dialysed severe renal failure, do not use meloxicam.

Dialysis patients with severe renal failure: The dose should not exceed 7.5 mg/day

Children under 18 years of age: Safety and efficacy have not been established

CONTRAINDICATIONS

Hypersensitivity to meloxicam or any of the ingredients of the drug.

Hypersensitivity to substances with a similar action, e.g. acetylsalicylic acid (aspirin) and other non-steroidal anti-inflammatory drugs.

Patients who have developed signs of asthma, nasal polyps, angioedema or urticaria following the administration of aspirin or other non-steroidal anti-inflammatory drugs.

Active, or history of recurrent peptic ulcer/haemorrhage.

Gastrointestinal bleeding, cerebrovascular bleeding.

Severe impaired liver function, non-dialysed severe renal failure.

Children under 12 years of age.

Pregnant and breastfeeding women.

WARNING AND PRECAUTIONS

The risk of cardiovascular thrombosis

- Systemic administration of non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs), may increase the risk of cardiovascular thrombotic events, including myocardial infarction and stroke, which can lead to death. This risk can appear in a first few weeks and may increase along with the duration of treatment. The risk of cardiovascular thrombosis is observed mainly in patients with high-dose NSAID therapy.

- Physicians should remain alert for the development of of cardiovascular events, throughout the entire treatment course, even in the absence of previous cardiovascular symptoms. Patients should be warned about the symptoms of serious cardiovascular events and seek medical advice as soon as these symptoms occur.

- To minimize the risk of adverse events, use the lowest effective daily dose of meloxicam for the shortest possible time.

As with other non-steroidal anti-inflammatory drugs, caution should be exercised in patients with gastrointestinal disease or receiving anticoagulant therapy. The drug must be discontinued immediately at the occurrence of peptic ulcer, gastrointestinal bleeding, or adverse reaction on skin and mucous membranes.

Non-steroidal anti-inflammatory drugs inhibit the biosynthesis of renal prostaglandins that play a compensatory role in the maintenance of renal perfusion. Therefore, renal decompensation may occur in patients with dehydration, congestive heart failure, cirrhosis, nephrotic syndrome and renal disease, patients with increased risk for hypovolemia after major surgery, or receiving diuretics. At the beginning of the treatment, careful monitoring of diuresis and renal function is recommended in these patients.

Non-steroidal anti-inflammatory drugs can also cause interstitial nephritis, glomerulonephritis, medullary necrosis, or nephrotic syndrome.

The dose of meloxicam in patients with end-stage renal disease on hemodialysis should not exceed 7.5 mg/day.

As with most non-steroidal anti-inflammatory drugs, it occasionally increases serum transaminases or other liver function indices. Should any such abnormality prove significant or persistent, the administration of Meloxicam should be stopped and appropriate investigations undertaken.

Consideration should be made before treatment for debilitated patients, or elderly due to susceptibility of impaired liver, kidney or heart function.

SHELF LIFE: 36 months from the manufacturing date. Do not use after the expiry date.

Box of 5 blisters x 10 tablets.