Meloxicam

FORMULATION
Each uncoated tablet contains:
Meloxicam BP …15 mg

DESCRIPTION
An oxicam derivative, is a member of the enolic acid group of nonsteroidal anti-inflammatory drugs (NSAlDs). Meloxicam is chemically designated as 4-hydroxy-2-methyl-N(5-methyl-2-thiazoly)-2H-1,2-benzothiazine-3-carboxamide-1, 1 – dioxide

MODE OF ADMINISTRATION
To be taken orally.

MECHANISM OF ACTION
Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic and antipyretic activities in animal models. The mechanism of action of meloxicam, like that of other NSAlDs, may be related to prostaglandin synthetase (cyclo-oxygenase) inhibition.

INDICATION
Meloxicam is indicated for the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

DOSAGE & ADMINISTRATION
Rheumatoid arthritis – 15 mg daily as single dose.
Osteoarthritis – 7 5 mg, increased if necessary, to a maximum of 15 mg daily as single dose.
Ankylosing spondylitis- 15 mg daily
Or as prescribed by the physician

CONTRAINDICATIONS
Patients having hypersensitivity to meloxicam. Patients who have developed signs of asthma, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or other NSAIDs, patients with active peptic ulcer during the last six months, a history or recurrent peptic ulcer disease, severe hepatic failure, non-dialyzed
severe renal failure, gastrointestinal bleeding, cerebrovascular bleeding or other bleeding disorders, pregnant women and lactating mothers, co-prescription with other NSAIDs.

PRECAUTIONS
NSAI DS should not be given to patients with peptic ulceration and should be used within caution in patients with a history of such disorders_ To reduce the risk of gastro- intestinal effects, the drug may be taken with or after food or milk.

PREGNANCY
In late pregnancy, as with other NSAlDs, Meloxicam should be avoided because it may cause premature closure ofthe ductus arteriosus.

PHARMACOKINETICS
Meloxicam is well absorbed following oral administration. It is 99% bound to plasma proteins. Meloxicam has a plasma elimination half-life approximately 20 hours. It is extensively metabolised mainly by oxidation and excreted in similar amounts in the urine and in the faeces; less than 3% of a dose is excreted unchanged. The volurne of distribution is increased in severe renal failure.

ADVERSE EFFECTS
Adverse effect are generally gastro-intestinal discomfort, nausea and diarrhoea. Central Nervous System related side-effects include headache, vertigo, dizziness, nervousness, tinnitus, depression, drowsiness and insomnia.

OVERDOSE
There is limited experience with meloxicam overdose Cholestyramine is known to accelerate the clearance of meloxicam. Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care Gastrointesntinal bleeding can occur.

DRUG INTERACTION
ACE-inhibitors Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inibitors. This interaction should be given consideration in patients taking NSAlDs concomitantly with ACE inhibitors.

CAUTION
Foods, Drugs, Devices, and Cosmetics Act prohibits dispensing without prescription.

AVAILABILITY
Alu/AIu Blister Pack x 10 ‘s (Box of 50’s); Alu-Alu Blister Pack x 10’s individually box by 50’s (Boxof ICs)

STORAGE CONDITION
Store at temperatures not exceeding 300-degree Celsius.

Keep all medicines out of children ‘s reach.

“For suspected adverse drug reaction, report to the F DA: www.fda.gov.ph“.