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BROZIL

Brozil Film Coated tablet contains Gemfibrozil, a synthetic antihyperlipidemic agent which is structurally related to clofibrate. It has been shown to be 10 times as potent in reducing triglycerides in animals studies and three times more active than clofibrate in reducing platelet aggregation. Preliminary studies in human volunteers indicate that Gemfibrozil is a safe and effective antihyperlipidemic agent in selected causes of primary hyperlipidemia.

Ingredient(s):
Each tablet contains : ------ Gemfibrozil 600mg

Pharmacology (Summary of Pharmacodynamics and Pharmacokinetics):
1. Gemfibrozil is a lipid regulating agent which lowers elevated serum lipid primarily by decreasing serum triglycerides with variable reductions in total serum cholesterol. These decrease occur primarily in the very low density lipoprotein (VLDL) fraction. It has been reported that Gemfibrozil may increase levels of high density lipoprotein (HDL) subfractions, HDL2 and HDL3, as well as apolipoprotein AI and AII.

2. The mechanism of action is not completely understood but may involve inhibition of peripheral lipolysis; reduced hepatic extraction of free fatty acids which reduces hepatic triglycerides production; inhibition of synthesis and increased clearance of VLDL carrier apolipoprotein B, which also reduces VLDL production; and, according to animal studies, reduces incorporation of long-chain fatty acids into newly formed triglycerides, accelerated turnover and removal of the cholesterol from the liver (stimulates incorporation of cholestreol precursor into liver sterols), and increases excretion of cholesterol in the feces.

3. Gemfibrozil is well absorbed from the gastrointestinal tract after oral administration. Peak plasma levels occur in 1 or 2 hours with a plasma half life of 1.5 hours following single doses and 1.3 hours following multiple doses. Plasma levels appear proportional to dose and do not demonstrate accumulation over time following multiple doses.

4. Gemfibrozil mainly undergoes oxidation of the ring methyl group to successively form a hydroxymethyl and carboxyl metabolite. Approximately 70% of the administered human dose is excreted in the urine, mostly of the glucuronide conjugate, with less than 2% excreted as unchanged Gemfibrozil. Six percent of the dose is accounted for in the feces.

Indication(s):
Hyperlipidaemias of type IIa, IIb, III, IV and V. It is indicated in patient who has not responded adequately to weight loss and specific dietary, or when other non-drug measures have failed.

Dosage and Administration:
1200 mg (2 tablets) per day in 2 divided doses, 30 minutes before the morning and evening meals.
To be dispensed on physician's prescription.

Contraindication(s):
1. Hypersensitivity to Gemfibrozil.
2. Alcoholism.
3. Pre-existing gallstones.
4. Primary biliary cirrhosis.
5. In patient with hepatic or severe renal dysfunction.

Precaution(s) / Warning(s):
1. Before substituting Brozil Film Coated Tablet therapy, every attempt should be made to control serum lipids with appropriate diet, exercise, weight loss in obese patients, and to control other medical problems such as diabetes mellitus and hypothyroidism.

2. Pre-treatment laboratories studies should be performed to ensure that patients have abnormal levels of serum lipids. Periodic determination of serum lipids should be obtained during administration. The drug should be withdrawn after 3 months if the lipid response is inadequate.

3. Blood count and liver function tests to be conducted before initiating long-term treatment.

4. Safety in pregnancy & nursing mothers have not been established. Therefore, it should not be used in pregnant women unless potential benefit justifies the potential risk to the fetus. Mother taking the drug should not breast-feed.

5. Safety and efficacy in children have not been established.

Drug Interaction(s):
1. Concurrent use of anticoagulants with Gemfibrozil may significantly increase the anticoagulant effect of these medications; adjustment of anticoagulant dosage based on frequent prothrombin-time determination are recommended.

2. Concurrent use of Lovastatin with Gemfibrozil may be associated with an increased risk of rhabdomyolysis, significant increases in creatine kinase concentrations, and myoglobinuria that lead to acute renal failure; may be seen as early as 3 weeks or as late as several months after initiation of combined therapy; monitoring of creatine kinase has not been shown to prevent severe myopathy or renal damage.

Side Effect(s) / Adverse Reaction(s):
Gemfibrozil is well tolerated in most patients. The most frequent side effects noted in clinical trials are:-
Gastrointestinal: abdominal pain, diarrhea and occasionally nausea in 3 ~ 5% of patients.

Less common side effects include:
Eye: blurred vision.
Skin: rashes, dermatitis, pruritus.
Musculoskeletal: muscle pain, tenderness and weakness.
Central Nervous System: headache, dizziness, drowsiness, somnolence and depression.
Genitourinary: cholecystitis, gall-stones, impotence.

Biochemical changes are uncommon that include eosinophilia, decreases in the plasma of alkaline phosphatase and occasionally rises in transaminases. Gemfibrozil potentiates the effects of oral anticoagulants, and may increase lithogenicity with a predicted longterm may increase in the incidence of gallstones.

Symptoms and Treatment for Overdosage, and Antidote(s):
Symptoms of overdose include severe stomach pain with nausea & vomiting, muscle pain or weakness. If patient receive this symptoms, evaluation for gallstones and myositis is recommended. Symptoms and supportive treatment should be taken when an overdose occurs.

Storage Condition(s):
Keep in a tight container. Store at temperature below 30C. Protect from light and moisture.

Shelf-Life:
3 years from the date of manufacture.

Product Description and Packing(s):
A white elliptical film coated tablets, one side impressed with a score.
Plastic bottle of 500's and 1000's
Blister packing of 10's x 10.

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