Indications

For long– term symptomatic treatment of painful osteoarthritis (arthrosis, degenerative joint disease), rheumatoid arthritis and ankylosing spondylitis.

Present

– Tube of 30 tablets. Box of 1 tube.
– Blister of 10 tablets. Box of 2 blisters.

Composition

Meloxicam ………………………………………15mg
Excipients s.q. for ………………………………………..1 tablet
(Corn starch, lactose, povidone, croscarmellose sodium, crospovidone, magnesium stearate, tablettose).

Pharmacology

Meloxicam, an oxicam derivative, is nonsteroidal anti– inflammation drug (NSAID) exhibiting anti– inflammation, analgesic, and antipyretic actions. It
appears to inhibit synthesis of prostaglandins that play important role in pathogenesis of inflammation, fever, and pain.

Pharmacokinetics

Meloxicam is well absorbed after oral doses, food does not have a substantial effect on the extent of its absorption. Meloxicam is extensively metabolized to inactive metabolites in the liver principally via the cytochrome CYP2C9 with a minor contribution of the CYP3A4. Its metabolites are excreted mainly in the urine and in the feces, only traces of the unchanged parent compound are excreted in the urine (0.2%) and in the feces (1.6%).

Precaution

– Discontinue use immediately if any abnormal clinical sign or symptom occurs on the skin, mucous membrane or signs and symptoms of GI ulceration and bleeding, or abnormal liver tests that progress suggesting liver dysfunction.
– Patients with history of peptic ulcer.
– Patients receiving anticoagulants.
– Patients with reduced renal blood flow, or reduced blood volume as in heart failure, nephrotic syndrome, cirrhosis, severe renal disease, receiving diuretics or undergoing major surgery required monitoring urine volume and renal function before giving meloxicam.
– Drivers and operators of machinery.
– Elderly with decreased renal and hepatic function and cardiac insufficiency should not be given meloxicam.
PREGNANCY & LACTATION:
– ARTHROBIC is contra– indicated in pregnancy.
– Meloxicam should not be given during breast feeding. Discontinue breast feeding if the drug is required.

Interaction

Concomitant administration of meloxicam with:
– Other NSAIDs may increase risk of peptic ulcer.
– Oral anticoagulants such as ticlopidine, heparin, thrombolytic agents may increase risk of bleeding.
– Warfarin: may result in increased prothrombin time.
– Lithium: may increase plasma lithium concentration.
– Methotrexate: may increase methotrexate hematological toxicity.
– IUDs: may decrease the contraceptive efficacy of the intrauterine contraceptive devices.
– Diuretics: may increase potential of acute renal dysfunction in patients with dehydration.
– Furosemide and thiazide: may decrease diuretic effect of these drugs.
– Antihypertensive drugs (such as alpha– adrenergic blockers, ACE inhibitors, vasodilators): may decrease vasodilatory, hypotensive effect of these drugs.
– Colestyramine: may reduce absorption and enhance clearance of meloxicam.
– Cyclosporine: may increase potential of renal toxicity.
OVERDOSAGE:
– There is no specific antidote for overdosage of meloxicam, treatment should include symptomatic and supportive measures, and suitable measures to accelerate its clearance and reduce its absorption such as gastric lavage, oral administration of colestyramine.
– If overdosage occur, turn to the nearest healthcare facility for medical attention of the healthcare professionals.

Shelf life

36 months from the manufacturing date.

Storage

Store in a dry place, protect from light, not exceeding 30^oC.

Dosage

– Take orally once daily.
– As prescribed by the physician.
– Recommended dosage:
* Adults:
+ Rheumatoid arthritis, ankylosing spondylitis: 15mg once daily. For long– term treatment the recommend dosage in particular in patients at risk
of adverse effects is 7.5mg once daily.
+ Acute bout of osteoarthritis: 7.5mg once daily increased if necessary to a maximum of 15mg once daily.
The total daily dose of meloxicam should not exceed 15mg.
* Elderly: the recommend dosage is 7.5mg once daily.
* Patients with mild to moderate hepatic, renal dysfunction: no adjustment.
* Patients with renal dysfunction on renal dialysis: the dose should not exceed 7.5mg once daily.
– To minimize the potential risk for adverse effects with meloxicam the lowest effective dose should be used for the shortest duration possible.