Description
Fluvastatin is used together with a proper diet to lower high cholesterol levels and triglycerides (fats) in the blood. This medicine may help prevent medical problems, like atherosclerosis (hardening of the arteries), that are caused by fats clogging the blood vessels. It may also be used to prevent certain types of heart and blood vessel problems in patients with risk factors for heart problems.
Fluvastatin belongs to the group of medicines called HMG-CoA reductase inhibitors, or statins. It works to reduce the amount of cholesterol in the blood by blocking an enzyme that is needed to make cholesterol.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
- Tablet, Extended Release
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluvastatin in children 10 years of age and older. However, safety and efficacy have not been established in children younger than 10 years of age to treat heterozygous familial hypercholesterolemia (HeFH) and in children to treat other types of high cholesterol.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluvastatin in the elderly. However, elderly patients are more likely to have age-related kidney, liver, heart, or muscle problems, which may require caution in patients receiving fluvastatin.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
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.
- Posaconazole
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.
- Asciminib
- Atazanavir
- Bezafibrate
- Capecitabine
- Carbamazepine
- Ceftobiprole Medocaril
- Ceritinib
- Ciprofibrate
- Clarithromycin
- Clofibrate
- Cobicistat
- Cyclosporine
- Dalfopristin
- Danazol
- Daptomycin
- Darolutamide
- Darunavir
- Deutivacaftor
- Elafibranor
- Elexacaftor
- Eltrombopag
- Entacapone
- Fenofibrate
- Fenofibric Acid
- Fluconazole
- Fosphenytoin
- Gemfibrozil
- Letermovir
- Meloxicam
- Phenobarbital
- Phenytoin
- Pixantrone
- Primidone
- Quinupristin
- Sparsentan
- Voclosporin
- Warfarin
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.
- Colchicine
- Fostemsavir
- Glyburide
- Mavacamten
- Mifepristone
- Oat Bran
- Pectin
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:
- Alcohol use disorder, or history of or
- Diabetes or
- Hypothyroidism (an underactive thyroid) or
- Liver disease, history of—Use with caution. May cause side effects to become worse.
- Convulsions (seizures), not well-controlled or
- Electrolyte disorder, severe or
- Endocrine disorder, severe or
- Hypotension (low blood pressure) or
- Hypothyroidism (underactive thyroid), not adequately treated or
- Kidney disease, severe or
- Major surgery or
- Major trauma (injury) or
- Metabolic disorder, severe or
- Sepsis (severe infection)—Patients with these conditions may be at risk of developing muscle and kidney problems.
- Liver disease, (eg, liver failure, decompensated cirrhosis)—Should not be used in patients with these conditions.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a patient information leaflet. Read and follow the 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.
Take the capsule at the same time every evening or if you take it twice a day take it in the morning and evening. You may take the extended-release tablet at any time of the day.
You may take this medicine with or without food.
Do not open the capsule before taking it. Swallow the extended-release tablet whole. Do not crush, break, or chew it.
Do not drink large amounts of alcohol with fluvastatin. This could cause unwanted effects on the liver.
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 high cholesterol:
- For oral dosage form (capsules):
- Adults—At first, 20 or 40 milligrams (mg) once a day in the evening. Some patients may need 40 mg two times a day (one in the morning and one in the evening). Your doctor may increase your dose as needed.
- Children 10 to 16 years of age—At first, 20 mg once a day in the evening. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg two times a day (one in the morning and one in the evening).
- Children younger than 10 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (extended-release tablets):
- Adults and children 10 years of age and older—80 milligrams (mg) once a day.
- Children younger than 10 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (capsules):
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.
Do not take the capsule if it has been more than 12 hours since you missed your last dose.
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 levels and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness. These may be symptoms of serious muscle problems, such as myopathy or immune-mediated necrotizing myopathy (IMNM).
Check with your doctor right away if you have dark urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a muscle condition called rhabdomyolysis, which can lead to serious kidney problems.
Call your doctor right away if you have stomach pain, bloating, nausea, vomiting, dark urine, light-colored stools, or yellow eyes or skin. These could be symptoms of a liver problem.
Make sure any doctor or dentist who treats you knows that you use this medicine. You may need to stop using this medicine if you have major surgery, a major injury, or you develop other serious health problems.
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
- Chills
- diarrhea
- fever
- general feeling of discomfort or illness
- joint pain
- loss of appetite
- muscle aches and pain
- nausea
- runny nose
- shivering
- sore throat
- sweating
- trouble sleeping
- unusual tiredness or weakness
- vomiting
Less common
- Bladder pain
- bloody or cloudy urine
- chest tightness
- cough producing mucus
- dark-colored urine
- difficult, burning, or painful urination
- difficulty with breathing
- difficulty with moving
- difficulty with swallowing
- dizziness
- fast heartbeat
- frequent urge to urinate
- hives
- itching
- lower back or side pain
- muscle cramps, pain, spasms, stiffness, tenderness, wasting, or weakness
- pain, swelling, or redness in the joints
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- skin rash
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
- belching
- headache
- heartburn
- indigestion
- stomach discomfort, upset, or pain
Less common
- Bloated or full feeling
- excess air or gas in the stomach or intestines
- pain or tenderness around the eyes and cheekbones
- passing gas
- unable to sleep
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-20069021
