300 MG CAPSULE
Maroon opaque and white opaque
capsule with "HD" printed on one end and "GMB300" on the other end of the
Gemfibrozil 300 mg/capsule
Action & Pharmacology
Gemfibrozil reduces plasma
triglyceride ( very low-density lipoprotein [VLDL] ) concentrations and
increases high-density lipoprotein ( HDL ) concentrations. Although
gemfibrozil may slightly reduce total and low-density lipoprotien ( LDL )
cholesterol concentrations, use of gemfibrozil in patients with elevated
triglycerides associated with type IV hyperlipidemia often results in
significant increases in LDL; LDL concentrations are not significantly
affected by gemfibrozil in patients with Type IIb hyperlipidemia ( although
HDL is significantly increase ). The mechanism of this action is not
completely understood but may involve inhibition of peripheral lipolysis;
reduced hepatic extraction of free fatty acid, which reduces hepatic
triglyceride production; inhibition of synthesis and increased
clearance of VLDL carrier, apolipoprotein B, which also reduces VLDL
production; and according to animal studies, reduced incorporation of
long-chain fatty acids into newly formed triglycerides, accelerated turnover
and removal of cholesterol from the liver ( stimulates incorporation of
cholesterol precursors into liver sterols ), and increased excretion of
cholesterol in the faeces.
For the treatment of :
i) Type IIb hyperlipidemia and a
significant risk of coronary artery disease, who have not responded to diet,
other measures, or other pharmacological therapy ( bile acid sequestrants
and niacin ) alone.
ii) Severe primary hyperlipidemia
( types IV and V hyperlipidemia ) and a significant risk of coronary artery
disease, abdominal pain typical of pancreatitis, or pancreatitis, who have
not responded to diet or other measures alone.
It should not be used in patients
with hepatic or severe renal dysfunction, including primary biliary
cirrhosis; pre-existing gallbladder disease and hypersensitivity to
Before instituting gemfibrozil
therapy, attempts should be made to control serum lipids with appropriate
diet, exercise, cessation of smoking, limitation of alcohol intake, weight
loss in obese patients, and treatment of the causes of secondary
hyperlipidaemias such as hypothyroidism and diabetes mellitus. Since
long-term administration of gemfibrozil is recommended, all baseline values
including lipid profile, blood count and liver function tests, should be
measured before treatment and periodic determinations of serum lipids should
It should be withdrawn if after 3
months the response is paradoxical. A further estimation of LDL cholesterol
should be made during treatment to confirm that the desired therapeutic
effect has been achieved.
Use in pregnancy : Safe use in
human pregnancy has not been established. It is not known whether
gemfibrozil is secreted in human milk. Like most drugs, gemfibrozil should
normally be avoided during pregnancy and lactation.
Safety and efficacy in children
have not been established.
Main Side/Adverse Effects
Stomach pain, gas or heartburn,
diarrhoea, nausea or vomiting, skin rash, unusual tiredness, weight gain,
headache, dizziness, pruritus, alopecia, anemia or leukopenia, gallstones
-- Concurrent use with
gemfibrozil incrases the anticoagulant effect of coumarin or indandione-derivative
-- Concurrent use with Chenodiol
or Ursodiol decreases effects of gemfibrozil.
-- Simultaneous use with
Lovastatin leads to acute renal failure.
Clinical feature : Nausea,
abdominal discomfort, diarrhoea, drowsiness, skin rash, fatigue and
weakness, leukopenia and agranulocytosis.
Treat overdosage by emesis or
gastric lavage, if appropriate or by supportive and symptomatic treatment.
Dosage & Administration
Adult : Oral, 1.2g a day in two
divided doses, thirty minutes before morning and evening meals.
Paediatric : Dosage has not been
3 years from the date of
Store below 25°C. Protect from