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Lipistorol

300 MG CAPSULE

 

Description

Maroon opaque and white opaque capsule with "HD" printed on one end and "GMB300" on the other end of the capsule.

 

Composiiton

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.

 

Indications

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.

 

Contraindications

Medical Problems

It should not be used in patients with hepatic or severe renal dysfunction, including primary biliary cirrhosis; pre-existing gallbladder disease and hypersensitivity to gemfibrozil.

 

Precautions/ Warnings

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 be obtained.

 

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 and myositis.

 

Drug Interactions

-- Concurrent use with gemfibrozil incrases the anticoagulant effect of coumarin or indandione-derivative anticoagulants.

-- Concurrent use with Chenodiol or Ursodiol decreases effects of gemfibrozil.

-- Simultaneous use with Lovastatin leads to acute renal failure.

 

Overdosage

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 established.

 

Shell life

3 years from the date of manufacture.

 

Storage

Store below 25C. Protect from moisture.

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