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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 30°C. 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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