Pronunciation:

jem-FYE-broe-zil

Brand Names:

• Lopid

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antihyperlipidemic

Chemical—

Fibric Acid

Uses of This Medicine:

Gemfibrozil is used together with a proper diet to treat high cholesterol and triglyceride (fat) levels in the blood. This may help prevent the development of pancreatitis (inflammation or swelling of the pancreas) caused by high levels of triglycerides in the blood. Gemfibrozil may also be used to prevent certain types of heart problems in patients with risk factors for heart problems.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of gemfibrozil in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of gemfibrozil in geriatric patients. However, elderly patients are more likely to have age-related kidney problems and may be more sensitive to certain side effects, which may require caution.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ciprofibrate
• Daprodustat
• Dasabuvir
• Elagolix
• Repaglinide
• Selexipag
• Simvastatin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone
• Apalutamide
• Atogepant
• Atorvastatin
• Baricitinib
• Bexarotene
• Colchicine
• Dabrafenib
• Eluxadoline
• Enzalutamide
• Ezetimibe
• Fluvastatin
• Imatinib
• Lovastatin
• Momelotinib
• Ozanimod
• Pioglitazone
• Pitavastatin
• Pravastatin
• Revefenacin
• Rosiglitazone
• Rosuvastatin
• Taurursodiol
• Tucatinib
• Warfarin
• Zavegepant

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Dicumarol
• Glipizide
• Glyburide
• Loperamide
• Lopinavir
• Montelukast

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cataracts or
• Muscle problems (eg, muscle pain, tenderness, or weakness), history of—Use with caution. May make these conditions worse.

• Diabetes or
• Hypothyroidism (an underactive thyroid)—Use with caution. May cause side effects to become worse.

• Gallbladder disease or
• Kidney disease, severe or
• Liver disease (including cirrhosis)—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor ordered.

In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's order about any special diet.

This medicine is usually taken two times a day. If you are taking two doses per day, it is best to take the medicine 30 minutes before your breakfast and evening meal.

If you are taking colestipol, take it at least 2 hours before or after taking gemfibrozil.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For high cholesterol or triglycerides:
    • Adults—600 milligrams (mg) two times a day, taken 30 minutes before the morning and evening meals.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride (fat) levels and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine together with dasabuvir, repaglinide, or simvastatin. Using these medicines together may cause serious unwanted effects.

This medicine may increase your risk of having gallstones. Check with your doctor right away if you have severe stomach pain with nausea and vomiting.

Check with your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These could be symptoms of a serious muscle problem called myopathy.

Check with your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Do not stop taking this medicine without first checking with your doctor. When you stop taking this medicine, your blood cholesterol levels may increase again. Your doctor may want you to follow a special diet to help prevent this from happening.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bladder pain

bloody or cloudy urine

cough or hoarseness

difficult, burning, or painful urination

fever or chills

frequent urge to urinate

lower back or side pain

Incidence not known

Black, tarry stools

chest pain

dark-colored urine

indigestion

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

muscle cramps or spasms

muscle pain or stiffness

muscular pain, tenderness, wasting, or weakness

pale skin

severe nausea or vomiting

shortness of breath

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stomach pain

swollen glands

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

bad, unusual, or unpleasant (after) taste

belching

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in taste

diarrhea

heartburn

stomach discomfort or upset

Less common

Difficulty having a bowel movement (stool)

dizziness or lightheadedness

feeling of constant movement of self or surroundings

headache

nausea

sensation of spinning

skin rash, encrusted, scaly and oozing

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.