Hofbic 7.5

HOFBIC 7.5: Yellow to light green, round shape.
Each 1 tablet contains Meloxicam 7.5 mg.
Excipients/Inactive Ingredients: HOFBIC 7.5 mg tablet contains lactose monohydrate, dibasic sodium phosphate, silicon dioxide, starch, microcrystalline cellulose and magnesium stearate.

Pharmacology: Pharmacodynamics: HOFBIC, an oxicam derivative, is an NSAID which is a selective inhibitor of cyclo-oxygenase-2 (COX-2), more than COX-1, which results in decreased prostaglandin precursors associated with anti-inflammatory activity.
Pharmacokinetics: HOFBIC is well absorbed following oral administration. It is 99.5% bound to plasma proteins. HOFBIC has a plasma elimination half-life of approximately 20 hours.
It is extensively metabolized via cytochrome P450 (CYP 2C9 and CYP 3A4) mainly by oxidation and excreted in similar amounts in the urine and in the feces; less than 3% of a dose is excreted unchanged. The volume of distribution is increased in severe renal failure.

Rheumatoid arthritis; Osteoarthritis; Ankylosing spondylitis.

Recommended Dose: Initial: 7.5 mg once daily, may receive additional benefit from increasing dose to 15 mg once daily, maximum dose is 15 mg per day.
Rheumatoid arthritis: HOFBIC 15 mg per day, reduced to 7.5 mg per day if therapeutic good response.
Acute exacerbations of osteoarthritis: HOFBIC 7.5 mg per day, increased if necessary to maximum of 15 mg per day.
Ankylosing spondylitis: HOFBIC 15 mg per day.
Dialysis patient with severe renal failure: HOFBIC 7.5 mg per day.
Mode of Administration: Take drug with water after meal suddenly.

Overdose and Treatment: In case of overdose the standard measures of gastric evacuation and general supportive measures should be used, as there is no known antidote. It has been shown in a clinical trial that cholestyramine accelerates the elimination of meloxicam.

Known hypersensitivity to Meloxicam or any ingredient in the formulation. History of urticaria, angioedema, bronchospasm, severe rhinitis, or shock precipitated by aspirin or other NSAIDs. History of aspirin triad (aspirin sensitivity, asthma, and nasal polyps). Treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. Not to use in patient with renal failure: CrCl ≤20 ml/minute.

Not to be used in patients with hypersensitivity to Meloxicam or any ingredient in the formulation or patient with history of urticaria, angioedema, bronchospasm, severe rhinitis or shock precipitated by aspirin or NSAIDs.
Patients whose renal blood flow and blood volume decreased, administration of the NSAIDs may enhance the renal dysfunction because NSAIDs inhibit the synthesis of renal prostaglandin, which play a supportive role in the maintenance of renal perfusion.
The dose of HOFBIC 7.5 in patients with end-stage renal failure on hemodialysis should not be higher than 7.5 mg. No dose reduction is required in patients with mild or moderate renal impairment (i.e. in patients with a creatinine clearance of greater than 25 ml/min).
Not to be used in dengue fever patient.
Risk of GI ulceration, bleeding. Meloxicam can cause serious gastrointestinal adverse events including inflammation, bleeding, ulceration and perforation of the stomach and intestine.
An increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction and stroke.
Patients who are more likely to be suffering from impaired renal, hepatic or cardiac function include frail or debilitated patients may tolerate side effects less well and such patients should be carefully supervised and monitored.
May cause cardiac failure or hypertension from the induction of sodium potassium, water retention and interference with natriuretic effects of diuretic.
Meloxicam inhibits platelet aggregation and has been shown to prolong bleeding time should be avoided in some patient who may be adversely affected by alteration in platelet function.
If these symptoms occur such as fever, eczema, blister, the extraction of skin and other membranes such as in cavity, e.g. nose, genital and conjunctivitis. Discontinue this drug and consult with a physician because Stevens-Johnson syndrome may occur.
At first appearance of skin rash, fever or other sign of hypersensitivity, discontinue immediately and consult with physician.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.
Use in the Elderly: The consequences of such events are generally more serious in the elderly: Gastrointestinal bleeding, ulceration or perforation, potentially fatal, can occur at any time during treatment.
Monitor carefully in patients reporting mucocutaneous.
Beware use in hypertensive patient or elderly patient.

During the third trimester of pregnancy all prostaglandin-synthesis inhibitors may expose the fetus, should not be used during pregnancy.
Meloxicam may be distributed to breast milk, should be avoided for breastfeeding.

Cardiovascular: Edema 2% to 5%.
Central nervous system: Headache and dizziness occurred in 2% to 8%.
Dermatologic: Rash 1% to 3%.
Gastrointestinal: Diarrhea 3% to 8%, Dyspepsia 5%, Nausea 4%, Flatulence 3%, Abdominal pain 2% to 3%.
Respiratory: Upper respiratory infection 2% to 3%, Pharyngitis 1% to 3%.
Miscellaneous: Flu-like symptoms 5% to 6%.

ACE Inhibitors and Angiotensin II Receptor Antagonists: Potential pharmacologic interaction (antagonized antihypertensive effects).
Bile Acid Sequestrants: Pharmacokinetic interaction (increased meloxicam clearance; clinical importance not established) when meloxicam is used with bile acid sequestrants (e.g., cholestyramine).
Cimetidine: Pharmacokinetic interaction unlikely.
Digoxin: Pharmacokinetic interaction unlikely.
Diuretics: Patients receiving diuretics may have an increased risk of developing renal failure secondary to decreased renal blood flow resulting from prostaglandin inhibition by NSAIDs.
NSAIDs: May reduce the natriuretic effects of furosemide and thiazides. Observe patient for signs of renal failure and for diuretic effects.
Drugs Affecting Hepatic Microsomal Enzyme: Inhibitors or inducers of CYP2C9 or 3A4; interaction unlikely.
Lithium: Pharmacokinetic interaction (increased plasma lithium concentration).
Methotrexate: Potential pharmacokinetic interaction (enhanced toxicity of methotrexate resulting from inhibition of methotrexate renal elimination).
Aspirin: Concomitant use of aspirin increases serum meloxicam concentrations; clinical importance of this interaction is unknown. Concomitant use of aspirin and NSAIDs increases the risk for serious GI events. Because of the potential for increased adverse effects, concurrent use of meloxicam and aspirin generally is not recommended. Meloxicam is not a substitute for aspirin for cardioprophylaxis. There is no consistent evidence that use of low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIDs.
Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic. Concomitant use of NSAIDs and warfarin is associated with a higher risk of GI bleeding compared with use of either agent alone. Caution advised if HOFBIC 7.5 is used concomitantly with warfarin.

Preserve in well-closed containers. Store below 30°C.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AC06 - meloxicam ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, oxicams.

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