Gemfibrozil -(*) HNG- COA reductase inhibtrs- Antihyperlipmc -(Aug 1998)
Drug Name:
Gemfibrozil -(*) HNG- COA reductase inhibtrs- Antihyperlipmc -(Aug 1998)
List Of Brands:
Indication Type Description:
Pharmacology/ Pharmacokinetics
Drug Interaction:
Interacting drugs- summary
Gemfibrozil +
Anticoagulants
gemifibrozil may increase the antocoagulant effect of Warfarin and anisidione. The risk of bleeding is increased.
Lovastatin
rhobdomylosis has occurred with combined gemfibrozil and lovasatin
Myositis when combined with levosatin.
Indication:
Hypertriglyceridermia
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Gemifibrozil Lipid Lowering agent August 1988
2. Gemifibrozil capsules USP & 05-04-2010
Gemifibrozil Tablet USP
200mg/600mg
Addl.Indctn.
For the treatment of other dyslipdemias
(A) Fredrickson Type III and V
(B) Associated with diabetes
(C) Associated with xanthomata
Adverse Reaction:
Cholelithiasis.
G.I.disturbances,
Rash, headache,
Blood dyscrasias,
Myalgia, impotence,
Painful extremities,
Blurred vision.
Reduction in L.D.cholestrol, reduction in serum triglceride.
Contra-Indications:
Severe hepatic or renal dysfunction, gall bladder diseases, hypersens to the drug.
Special precautions:
Causes of secondary hyperlipidermia such as hyperthyroidism and diabetes must be treated
before initiating therapy.
Discontinue therapy if gallstones found.
Periodic blood cheeks during first year of medication.
Concurrent admn of anticoagulants.
Reduce anticoagualnts dosage to maintain prothrombin time.
Safety in pregnancy, lactation and children not established.
Dosages/ Overdosage Etc:
Indications:
Hypertriglyceridermia, reducing coronary heart disease.
Dosage:
Adults- 1200mg/day in 2 divided doses, 30 minutes before morning and evening meals.
Patient Information:
1. May cause dizziness or blurred vision, patients shouild observe caution while driving or performing other tasks requiring alertness.
2. Medication may cause abdominal or epigastric pain, diarrhea, nausea or vomiting.
Notify physician, if these become pronounced
3.Allergies- tell your doctor if you have ever had any unusual or allergic reaction to gemfubrozil or related products. Also tell your doctor if youare allergic to any other substances, such as foods, presrvatives or dyes. ganciclovir
4.Diet- before prescribing this medicine your doctor will probably to conntrol your condition by prescribing aersonal diet for you. Such a diet may be low in fats,sugar and or cholesterol. Make sure your doctor knows that you are on low sodium diet, low sugar or any other special diet.
5.Pregnancy - make sure your doctor knows if you are pregnant or if you may become pregnant.
6.Breast feeding- studies in animals have shown that high doses of gemfibrozil may iincrease the risk of some kinds of tumors. Therefore you should consider this while deciding whether to breast-feed your baby while taking this medicine.
7. Children - not recommended in childen below 2 years of age since cholesterol is needed for normal development.
8. Elderly- nop specific information comparing use of gemfibrozil in the elderly with use in other age groups
9. Other medicines -
Let your doctor know what other medicines you are taking, so that he can advice you accordingly.
Anticoagulants -use gemfibrozil may increase the effect of the anticoagulants
Lovastatin - use with gemfibrozil may cause muscle or kidney problems or make them worse
10. Other medical problems -
Tell your doctor if you have any other medical problems especially -
Gall bladder disease or
Kidney disease -higher blood levels of gemfibrozil may result , which may increase the chance of side effects.
A decrease in dose may be required
11. Missed dose - If you miss a dose of this medicine, take it as soon as possible. however, if it is almost time for the next dose, skip the missed dose. Do not double doses.
12. Storage - Keep out of reach of children. Store away from heat or direct sunlight. Do not store the capsule in bathroom, near the kitchen sink, or in other damp places.
13. Outdated medicines -
Do not keep outdated medicine or medicine no longer needed. Be sure that any
discarded medicine is out of reach of children.
Pharmacology/ Pharmacokinetics:
Pharmacology:
Gemfibrozil is a lipid regulating agent which decreases serum triglycerides and very low
density lipoprotein (VLDL) cholestrol, and increases high density lipoprotein (HDL) cholestrol.
Pharmacokinetics:
Gemfibrozil is well absorbed from the GI tract. Peak plasma levels occur in 1 to 2 hours .
It has a plasma half-life of 1.5 hours following multiple doses. Approx 70% is excreted in
the urine, with less than 2% excreted unchaged.
Interaction with Food:
None reported
Pregnancy and lactation:
Pregnancy:
Safety in pregnancy, lactation and children not established.
Administer only if needed.
Lactation:
Excercise caution and decide whether to discontinue nusing or disconinue the drug.