Guidelines for Using Gemfibrozil

Type of Drug:

Antihyperlipidemic; fibric acid derivative.

How the Gemfibrozil Product Works:

Gemfibrozil decreases the blood level of triglycerides and some types of cholesterol (LDL) by reducing the production of these items by the liver. It also increases blood levels of HDL cholesterol. High levels of LDL cholesterol and triglycerides may block blood vessels, increasing the risk of heart or blood vessel disease (arteriosclerosis).

Uses of The Gemfibrozil :

As an adjunct to diet to lower elevated triglyceride levels (Types IV and V hyperlipidemia) in adult patients at risk for pancreatitis and who are unable to control triglyceride levels by diet and exercise alone.

As an adjunct to diet to reduce risk of developing coronary artery disease in adult patients with low HDL cholesterol levels and elevated LDL cholesterol and triglycerides (Type lib hyperlipidemia) and who have not responded to weight loss, diet, exercise, and other lipid-lowering drugs.

Precautions:

Before treatment: Before starting treatment with gemfibrozil, an attempt should be made to control high LDL cholesterol and triglycerides with appropriate diet, exercise, and weight reduction (in obese people), and to control any medical problems such as diabetes mellitus or hypothyroidism that are contributing to the lipid abnormalities.

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefits out­weigh the possible hazards to the fetus.

Breastfeodilln: It is not known if gemfibrozil appears in breast milk. Consult your doctor before you begin breastfeeding.

Childern: Safety and effectiveness have not boon established.

Lab Tests: Lab tests may be required during treatment. Tests may include blood counts, cholesterol and triglycerides, liver and kidney function tests.

Drug Interactions:

Tell your doctor or pharmacist if you are taking or planning to take any over­ the-counter or prescription medications or dietary sUpplements with gemfibrozil. Doses of one or both drugs may need to be modified or a different drug may need to be prescribed. The following drugs and drug classes interact with gemfibrozil:

• Anticoagulants (eg, warfarin)

• HMG-CoA reductase inhibitors (eg, lovastatin)

Side Effects:

Every drug is capable of producing side effects. Many gemfibrozil users experience no, or minor, side effects. The frequency and severity of side effects depend on many factors including dose, duration of therapy, and individual susceptibility. Possible side effects include -

Digestive Tract: Indigestion, stomach pain, vomiting, nausea, diarrhea, constipation, acute appendicitis.

Nervous System: Headache, dizziness, vertigo (feeling of whirling motion), fatigue.

Skin: Rash, itching, hives, inflamed or irritated skin, abnormal skin sensations (eg, burning, prickling, tingling), abnormal sensitivity to touch, pain, or other stimuli.

Other: Muscle pain or weakness, changes in taste perception, blurred vision.

Guidelines for Use:

• Dosage is individualized. Take exactly as prescribed.

• Do not change the dose or stop taking this medicine unless advised to do so by your doctor.

• Take this drug 30 minutes before the morning and evening meal.

• Most effective when used with a diet that reduces the intake of cholesterol and saturated fats, and an exercise program.

• If a dose is missed, take it as soon as possible. If several hours have passed or it nearing time for the next dose, do not double the dose to catch up, unless advised to do so by your doctor. If more than one dose is missed or it is necessary to establish a new dosage schedule contact your doctor or pharmacist.

• Avoid alcohol while taking this medicine.

• Inform your doctor if you are pregnant, become pregnant, plan on becoming pregnant, or are breastfeeding.

• May cause dizziness or blurred vision. Use caution when driving or per­forming other tasks requiring alertness, coordination, or physical dexterity.

• Notify your doctor immediately if you experience muscle pain, tender­ness, or weakness.

• May cause stomach pain, diarrhea, nausea, or vomiting. Contact your doctor if these effects become particularly bothersome or severe.

• Lab tests may be required to monitor therapy. Be sure to keep appointments.

• Store below 86°F in a tightly sealed container.