Description
Ezetimibe is used alone or combination with diet and other cholesterol-lowering medicines (eg, fenofibrate, statins) to treat high cholesterol and triglyceride (fats) levels in the blood, in patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or homozygous familial sitosterolemia.
Ezetimibe is a cholesterol absorption inhibitor. This medicine will reduce the absorption of cholesterol from foods and the production of cholesterol in your body.
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 ezetimibe for the treatment of heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH) in children younger than 10 years of age, for the treatment of homozygous familial sitosterolemia in children younger than 9 years of age, and for the treatment of high cholesterol in the blood in children. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ezetimibe in the elderly.
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.
- Cyclosporine
- Danazol
- Gemfibrozil
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.
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Bezafibrate
- Cholestyramine
- Ciprofibrate
- Clofibrate
- Colchicine
- Colesevelam
- Colestipol
- Dihydroxyaluminum Aminoacetate
- Dihydroxyaluminum Sodium Carbonate
- Fenofibrate
- Fenofibric Acid
- Magaldrate
- Magnesium Carbonate
- Magnesium Hydroxide
- Magnesium Oxide
- Magnesium Peroxide
- Magnesium Trisilicate
- Simeprevir
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:
- Liver disease, moderate to severe—Use is not recommended in patients with this condition.
- Muscle problems—Use with caution. May make these conditions worse.
Proper Use
Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
This medicine comes with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.
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 orders about any special diet.
You may take the tablet with or without food at about the same time each day.
If you are also using bile acid sequestrants (eg, cholestyramine, colesevelam, colestipol), take it at least 2 hours after or 4 hours before you take this medicine.
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 heterozygous familial hypercholesterolemia (HeFH) or homozygous familial hypercholesterolemia (HoFH)
- Adults and children 10 years of age and older—10 milligrams (mg) once a day.
- Children younger than 10 years of age—Use and dose must be determined by your doctor.
- For high cholesterol:
- Adults—10 milligrams (mg) once a day.
- Children—Use and dose must be determined by your doctor.
- For homozygous familial sitosterolemia:
- Adults and children 9 years of age and older—10 milligrams (mg) once a day.
- Children younger than 9 years of age—Use and dose must be determined by your doctor.
- For heterozygous familial hypercholesterolemia (HeFH) or homozygous familial hypercholesterolemia (HoFH)
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 and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Check with your doctor right away if you have dark urine, fever, muscle cramps or spasms, muscular pain, stiffness, tenderness, wasting or weakness, or unusual tiredness or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis and myopathy.
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:
Less common
- Body aches or pain
- chills
- cough
- diarrhea
- ear congestion
- fever
- general feeling of discomfort or illness
- headache
- loss of appetite
- loss of voice
- muscle aches and pains
- nausea
- shivering
- sneezing
- sore throat
- stuffy or runny nose
- sweating
- trouble sleeping
- unusual tiredness or weakness
- vomiting
Incidence not known
- Black, tarry stools
- bleeding gums
- bloating
- blood in the urine or stools
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest tightness
- constipation
- darkened urine
- difficulty swallowing
- discouragement
- fast heartbeat
- feeling sad or empty
- gaseous stomach pain
- hives, itching, skin rash
- indigestion
- irritability
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light-colored stools
- loss of interest or pleasure
- muscle cramps, pain, spasms, stiffness, tenderness, wasting, or weakness
- pains in stomach, side, or abdomen, possibly radiating to the back
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- stomach pain
- trouble concentrating
- unusual bleeding or bruising
- yellow eyes or skin
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:
Less common
- Back pain
- difficulty in moving
- joint pain
- pain in the arms or legs
- pain or tenderness around the eyes and cheekbones
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.
CON-XXXXXXXX
