Meloxboston 7.5

POSOLOGY AND METHOD OF ADMINISTRATION

Method of administration

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

The maximum recommended daily dose of MELOXBOSTON 7.5 is 15 mg.

Posology

● Osteoarthritis: 7.5 mg/day. If necessary the dose may be increased to 15 mg/day.

● Rheumatoid arthritis: 15 mg/day. According to the therapeutic response, the dose may be reduced to 7.5 mg/day.

● Ankylosing Spondylitis: 15 mg/day. According to the therapeutic response, the dose may be reduced to 7.5 mg/day.

● Patients with increased risks for adverse reactions should start treatment with 7.5 mg per day.

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

CONTRAINDICATIONS

- History of hypersensitivity to meloxicam or any of the excipients of the product.

-Severely impaired liver function.

- Gastrointestinal bleeding, recent cerebral hemorrhage, or other bleeding disorders.

- Severe uncontrolled heart failure.

- Pregnant and breastfeeding women

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

MELOXBOSTON 7.5 should not be used in patients who have developed signs of asthma, nasal polyps, angioedema or urticaria following the administration of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

MELOXBOSTON 7.5 is contraindicated in the treatment of perioperative pain after coronary artery bypass graft (CABG).

Active, or history of gastrointestinal perforation or peptic ulcer.

Progressive inflammatory bowel disease (Crohn's disease or ulcerative colitis)

Non-dialyzed severe renal failure.

Children under 12 years of age.

WARNINGS AND PRECAUTION

Conditions need to be cautious when taking this medication

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

Lactose

This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Gastrointestinal effects

As with other non-steroidal anti-inflammatory drugs, caution should be exercised in patients with a history of gastrointestinal disease or receiving anticoagulant therapy.

Patients with gastrointestinal symptoms should be carefully monitored. MELOXBOSTON 7.5 must be discontinued immediately if a peptic ulcer or gastrointestinal bleeding occurs.

As with other NSAIDs, gastrointestinal bleeding, ulceration, or perforation, which are potentially fatal, can occur at any time during treatment of patients with or without previous warning signs or history of serious complications in the gastrointestinal tract. The consequences of these complications are more severe in elderly patients.

Skin reactions

Serious skin reactions, some of which can be fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of non-steroidal anti-inflammatory drugs. Patients appear to be at the highest risk of these adverse reactions early in the initiation of treatment: The onset of the reaction occurs in the majority of cases within the first month of treatment.

MELOXBOSTON 7.5 should be discontinued immediately at the first appearance of skin rashes, mucosal lesions, or any other signs of hypersensitivity.

Cardiovascular effects

Non-steroidal anti-inflammatory drugs may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase along with the duration of treatment. Patients with cardiovascular disease or with risk factors for cardiovascular disease may be at higher risk.

Kidney

NSAIDs inhibit the biosynthesis of renal prostaglandins that play a compensatory role in the maintenance of renal perfusion. Administration of NSAIDs may cause a dose-dependent reduction in renal blood flow which may precipitate overt renal decompensation in patients with decreased renal blood volume and renal blood flow. Discontinuation of NSAID therapy is usually followed by recovery to the pre-treatment state.

Patients at greatest risk of these reactions are the elderly, patients with dehydration, congestive heart failure, cirrhosis, nephrotic syndrome, significant renal disease, patients receiving concomitant treatment with diuretics, ACE inhibitors, or angiotensin II receptor blockers, or patients with increased risk for hypovolemia after major surgery. At the beginning of the treatment, careful monitoring of diuresis and renal function is recommended in these patients.

More rarely, non-steroidal anti-inflammatory drugs can cause interstitial nephritis, glomerulonephritis, medullary necrosis, or nephrotic syndrome.

The dose of MELOXBOSTON 7.5 in patients with end-stage renal disease on dialysis should not exceed 7.5 mg. No dose reduction is required in patients with mild or moderate renal impairment (i.e. patients with creatinine clearance above 25 ml/min).

Liver

As with most non-steroidal anti-inflammatory drugs, transitory increases in serum transaminases or other parameters of liver function have been reported. In the majority of cases, a slight and transitory increase in the upper limit of normal was observed. If any such abnormality proves significant or persistent, MELOXBOSTON 7.5 should be discontinued and appropriate undertaken tests.

No dose reduction is required in clinically stable cirrhotic patients.

Physical condition

Careful monitoring is required in weak or debilitated patients with poor tolerance of drug side effects. As with other non-steroidal anti-inflammatory drugs, caution should be exercised in elderly patients because they are more likely to have impaired renal, hepatic or cardiac function.

NSAIDs can cause sodium, potassium, and water retention as well as interference with the natriuretic effects of diuretics. Heart failure or hypertension may be precipitated or exacerbated in susceptible patients. Clinical monitoring is therefore necessary for patients at risk.

Meloxicam, like other NSAIDs, may mask the symptoms of bacterial infection.

The use of meloxicam as well as other cyclooxygenase/prostaglandin synthesis inhibitors may adversely affect fertilization and is not recommended in women who wish to become pregnant

Therefore, women who have difficulty becoming pregnant or who are undergoing poor fertility testing should consider discontinuing treatment with meloxicam.

For related drug interactions that require special care, see Interactions.

Recommendations for pregnant and lactating women

Pregnant

Contraindications MELOXBOSTON 7.5 for pregnant women

Inhibition of prostaglandin synthesis may affect pregnancy and/or embryonic development. Data from epidemiological studies suggest an increased risk of miscarriage and heart defects and gastroschisis-type congenital hernia following early prostaglandin use of pregnancy. The absolute risk of heart defects increased from less than 1% to about 1.5%. This risk is believed to increase with increasing dose and duration of treatment. In preclinical studies, treatment with a prostaglandin synthesis inhibitor was shown to increase pre- and post-implantation miscarriage and fetal mortality. In addition, increased rates of other malformations including cardiovascular were reported in preclinical studies using prostaglandin inhibitors during organogenesis.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the foetus to:

Cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary venous hypertension)

Renal dysfunction, which can lead to renal failure, in the presence of oligohydramnios; effects on the mother and on the fetus at the end of pregnancy

Increased bleeding time, antiplatelet effect can occur even at very low doses

Inhibition of uterine contractions slows down labor

The use of meloxicam, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended for use in women planning pregnancy. Meloxicam may delay ovulation. Therefore, discontinuation of meloxicam should be considered in women who are having difficulty conceiving, or are being evaluated for infertility.

Breastfeeding Women

NSAIDs are secreted into breast milk; no specific experience has occurred with MELOXBOSTON 7.5. Therefore, meloxicam is contraindicated for use in lactating women.

Ability to drive and operate machines

The effects of the drug on the ability to drive and use machines have not been studied yet. However, patients should be warned that undesirable effects such as visual disturbances including blurred vision, lightheadedness, somnolence, dizziness and other central nervous system disturbances may occur.

Therefore, patients should be advised to exercise caution when driving or operating machinery

If a patient experiences any of these undesirable effects, potentially hazardous activities such as driving or operating machinery should be avoided

SHELF-LIFE

36 months from the manufacturing date

Aluminium/Aluminium blister. Box 05 blisters x 10 tablets

Aluminium/Aluminium blister. Box 10 blisters x 10 tablets