Description
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.
This product is available in the following dosage forms:
- Tablet
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
- Ezetimibe
- Grazoprevir
- 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
- Atrasentan
- Aztreonam
- Baricitinib
- Bexarotene
- Colchicine
- Cyclosporine
- Dabrafenib
- Desloratadine
- Eluxadoline
- Enzalutamide
- Fluvastatin
- Imatinib
- Iptacopan
- Irinotecan
- Irinotecan Liposome
- Lovastatin
- Momelotinib
- Ozanimod
- Paclitaxel
- Paclitaxel Protein-Bound
- Pioglitazone
- Pitavastatin
- Pravastatin
- Resmetirom
- Revefenacin
- Rosiglitazone
- Rosuvastatin
- Seladelpar
- Sulopenem
- Taurursodiol
- Tovorafenib
- Tucatinib
- Vadadustat
- 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
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.
- For high cholesterol or triglycerides:
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
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
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.
DRG-20064018
