Mel-Od

Mel-Od

meloxicam

Manufacturer:

Cadila Healthcare

Distributor:

Metro Drug

Marketer:

Zydus Healthcare Phils
Full Prescribing Info
Contents
Meloxicam.
Description
Meloxicam has a molecular formula of C14H13N3O4S2 and molecular weight of 351.4.
Action
Mel-OD is a nonsteroidal anti-inflammatory drug (NSAID). In contrast with other NSAIDs currently available, it has a greater inhibitory activity against the inducible isoform of cyclooxygenase (COX-2), which is implicated in the anti-inflammatory response than against the constitutive isoform (COX-1), inhibition of which is associated with GI and renal adverse events and inhibition of platelet aggregation.
Pharmacokinetics: Mel-OD is absorbed almost completely when given orally and has an oral bioavailability of 89-93%. Binding to plasma proteins exceeds 99.5% and therefore, the drug has a relatively small volume of distribution of 10.8 L (0.14 L/kg). Linear pharmacokinetics are observed over the entire dose range and steady-state concentrations are reached after 3-5 days. The maximum plasma concentration (Cmax) attained at steady-state range from 0.88-1.92 mg/L.
Meloxicam effectively reaches the synovial fluid in concentrations reflecting 40-50% of the accompanying total plasma concentrations but the free, protein unbound concentrations in synovial fluid are similar to those in plasma. The terminal elimination t½ of Mel-OD is about 20 hrs and total plasma clearance is 0.42-0.48 L/hr. Meloxicam is extensively metabolized by the cytochrome P-450 system in the liver into 4 major inactive metabolites and has a dual excretion, with about half of meloxicam being excreted in the urine and the remainder in the feces. Food intake has no clinically significant impact on the pharmacokinetics of Mel-OD and the drug may therefore be taken concurrently with meals. The pharmacokinetics of Mel-OD are not altered in patients with hepatic dysfunction as well as in patients with mild to moderate renal dysfunction, but a lower dosage is recommended in patients with end-stage renal failure.
Indications/Uses
For pain and inflammation in rheumatic disease; exacerbation of osteoarthritis (short-term); ankylosing spondylitis.
Dosage/Direction for Use
Osteoarthritis: Usual Dose: 7.5 mg once daily at meal times. It can be increased to 15 mg once daily in patients not responding to the mentioned dose.
Rheumatoid Arthritis: Usual Dose: 15 mg once daily.
Elderly: Initial Dose: 7.5 mg once daily.
Maximum Recommended Dose: 15 mg/day.
Dose adjustment using the lowest effective dose and monitoring of renal and liver functions should be instituted.
Overdosage
The stomach should be emptied by gastric lavage and supportive care be instituted. Adequate hydration should be maintained. There is no evidence that meloxicam can be removed by hemodialysis.
Contraindications
Hypersensitivity to meloxicam, acetylsalicylic acid (ASA) or any other NSAIDs. Patients with bleeding disorders and those with active peptic ulcer should not receive Mel-OD.
History of stroke [cerebrovascular accident (CVA)]; heart attack [myocardial infarction (MI)]; coronary artery bypass graft (CABG); uncontrolled hypertension; congestive heart failure (CHF) NYHA II-IV.
Use in pregnancy & lactation: Mel-OD is contraindicated in pregnancy and lactation.
Special Precautions
Mel-OD should be used with caution in patients with a history of allergy or development of asthma with aspirin or other NSAIDs. Mel-OD should be used with extreme caution in patients with severe hepatic and end-stage renal failure. Patients with congestive heart failure, liver cirrhosis, nephrotic syndrome, hypovolemia and renal insufficiency should receive Mel-OD with caution due to the risk of precipitation of renal failure in such patients. Patients with gastritis or past history of ulcer disease should also receive Mel-OD with caution for the fear of precipitating gastrointestinal bleeding in such patients.
Use in children: The safety of Mel-OD in children <15 years has not been established.
Use In Pregnancy & Lactation
Mel-OD is contraindicated in pregnancy and lactation.
Adverse Reactions
The most common reported adverse effects of Mel-OD include abdominal pain, dyspepsia, nausea, vomiting, diarrhea and constipation. However, frank gastrointestinal hemorrhage, ulceration and/or perforation is extremely uncommon with meloxicam. Other reported adverse effects include skin rash and other cutaneo-mucosal reactions, headache, dizziness, vertigo, tinnitus, drowsiness, pedal edema, palpitations and hot flushes. Asthma attacks have been rarely reported in people who are allergic to aspirin or other NSAIDs. Rarely blood dyscrasias and transient disturbances in liver and renal function tests have also been reported.
Reports have been received in Ireland and Germany which include gastrointestinal adverse effects. Irish Medicines Board has received 13 reports of suspected adverse reactions associated with the use of Mel-OD including 8 which involved gastrointestinal disorders (anorexia, dyspepsia, nausea, diarrhea, hematemesis, perforated gastric ulcer and melena), 1 of which is fatal. The Federal Institute for Drugs and Medical Devices, Germany has received 50 reports of adverse reactions associated with meloxicam, mainly concerning the 20 cases on gastrointestinal tract and 6 cases on skin reactions including isolated cases of Stevens-Johnson syndrome, erythema multiforme and exanthema. Six (6) cases of allergic reactions were reported, including anaphylactoid or anaphylactic reactions. Two (2) cases of acute kidney failure were observed.
Drug Interactions
Cholestyramine significantly increases the clearance of Mel-OD which probably undergoes recirculation in the gut. Concomitant administration of antacids, cimetidine, ASA, furosemide, digoxin and warfarin does not affect the pharmacokinetics of meloxicam. Conversely, meloxicam does not affect the pharmacokinetics of furosemide, digoxin, methotrexate and warfarin. However, like other NSAIDs, patients on meloxicam have an increased risk of bleeding if they are on anticoagulants and the hypertensive response of certain drugs eg, ACE inhibitors can be blunted.
Storage
Store at a temperature not exceeding 30°C. Protect from light.
Shelf-Life: 24 months.
ATC Classification
M01AC06 - meloxicam ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, oxicams.
Presentation/Packing
Tab 7.5 mg x 100's. 15 mg x 100's.
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