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DIN (Drug Identification Number)
02400235 Sandoz Fluvastatin 20 mg Capsule
02400243 Sandoz Fluvastatin 40 mg Capsule
How does this medication work? What will it do for me?
Fluvastatin belongs to the family of medications known as cholesterol-lowering drugs. It is used in addition to diet and exercise to treat adults with high cholesterol levels and children aged 10 years and older who have been diagnosed with heterozygous familial hypercholesterolemia. It is also recommended for people who have had heart procedures such as angioplasty to help prevent complications after surgery, including heart attacks and death.
This medication works by blocking an enzyme needed to make cholesterol in the liver (HMG-CoA reductase). The result is that less cholesterol is made and levels of cholesterol in the blood are decreased. Reduction of cholesterol levels in the blood has been shown to reduce the risks associated with heart disease, such as heart attack.
This medication usually takes 4 weeks to have a significant effect on the cholesterol level in your blood. After this time, your doctor will likely send you for a lab test to check for changes in your cholesterol levels.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each strong reddish-brown capsule with opaque cap and pale yellow opaque body, imprinted with "XU 20MG" in red ink on the body, contains 20 mg of fluvastatin (from 21.06 mg of fluvastatin sodium). Nonmedicinal ingredients: sodium bicarbonate, calcium carbonate, microcrystalline cellulose, pregelatinized starch, talc, and magnesium stearate. Capsule shell and printing ink: gelatin, iron oxide red, iron oxide yellow, titanium dioxide, sodium laurel sulphate, benzyl alcohol, sodium propionate, edetate calcium disodium, carboxymethyl cellulose sodium, butyl paraben, propyl paraben, and methyl paraben.
Each strong reddish-brown capsule with opaque cap and orange yellow opaque body, imprinted with "XU 40MG" in red ink on the body, contains 40 mg of fluvastatin (from 42.12 mg of fluvastatin sodium). Nonmedicinal ingredients: sodium bicarbonate, calcium carbonate, microcrystalline cellulose, pregelatinized starch, talc, and magnesium stearate. Capsule shell and printing ink: gelatin, iron oxide red, iron oxide yellow, titanium dioxide, sodium laurel sulphate, benzyl alcohol, sodium propionate, edetate calcium disodium, carboxymethyl cellulose sodium, butyl paraben, propyl paraben, and methyl paraben.
How should I use this medication?
Before starting fluvastatin, or at the same time as starting to take it, you should be following a cholesterol-lowering diet. If appropriate, your health care professionals will discuss an individualized program of weight control and physical exercise with you.
The starting dose of fluvastatin for adults depends on the LDL-C level and goal of treatment.
The recommended adult dose of fluvastatin ranges from 20 mg to 80 mg daily. Up to 60 mg daily can be taken as one dose in the evening or at bedtime. The 80 mg daily dose can be taken as one 40 mg capsule twice daily, with or after meals, or as one 80 mg extended-release capsule taken once daily. (The extended-release capsule may be taken at any time of day, but should be taken at the same time every day.)
The recommended dose of fluvastatin to prevent heart attack after angioplasty is 40 mg taken twice a day.
Children 10 years of age and older should be following a cholesterol-lowering diet for 6 months before starting fluvastatin. The recommended starting dose for children and adolescents is 20 mg taken once daily. If necessary, the dose may be gradually increased to 80 mg daily.
Fluvastatin may be taken with or without food, but it should be taken consistently with regard to food (always with food or always without food).
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
For best results in lowering cholesterol, it is important that you closely follow the diet suggested by your doctor. This medication may not change how you feel, but it may help to prevent possible health problems in the future.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
- are allergic to fluvastatin or any ingredients of the medication
- are breast-feeding
- are pregnant
- have active liver disease or unexplained increases in liver function tests
Do not take this medication if you:
Do not give this medication to children under 9 years of age.
What side effects are possible with this medication?
- abdominal pain
- decreased sexual ability
- difficulty sleeping
- memory problems
- signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
- symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
- symptoms of liver damage such as:
- abdominal pain
- clay-coloured stools
- dark urine
- loss of appetite
- nausea and vomiting
- yellow skin or eyes
- symptoms of muscle damage (muscle pain, tenderness or weakness, brown or discoloured urine – especially if you also have a fever or a general feeling of being unwell)
- symptoms of nerve damage such as:
- decreased sensation in the hands and feet
- loss of balance
- muscle weakness
- tingling or prickling sensations
- symptoms of severe abdominal pain (inflamed pancreas)
- severe skin rash, including skin blistering and peeling (possibly with headache, fever, coughing, or aching before the rash begins)
- symptoms of a serious allergic reaction (such as swelling of the face or throat, hives, or difficulty breathing)
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Stop taking the medication and seek immediate medical attention if any of the following occur:
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
- are over the age of 70
- are frail
- are taking other cholesterol-lowering medications such as fibrates (gemfibrozil, fenofibrate) or niacin
- are taking other medications, including prescription, non-prescription, and natural health products, as drug interactions are possible
- do large amounts of physical exercise
- have very low blood pressure
- have a severe metabolic, endocrine or electrolyte disorders
- have sepsis (blood infection)
- have uncontrolled epilepsy
- have a family history of muscular disorders
- have diabetes
- have had any past problems with the muscles (pain, tenderness) after taking a statin
- have kidney or liver problems
- have thyroid problems
- have undergone surgery or other tissue injury
- regularly drink 3 or more alcoholic drinks daily
Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.
Alcohol: People who drink large quantities of alcohol should be closely monitored by their doctor while they are taking this medication.
Diabetes: Fluvastatin, like other medications in this class, may cause a loss of blood glucose control, and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.
If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If you experience symptoms of increased blood sugar, such as increased thirst, need to urinate more often or a fruity odour to your breath, contact your doctor as soon as possible.
Kidney disease: There is little experience with the use of fluvastatin by people with severe kidney disease. It is currently not recommended for people with severely decreased kidney function.
Liver effects: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Muscle effects: In rare cases, serious muscle damage has been associated with the use of statin medications (i.e., cholesterol-lowering drugs whose names end in "statin," such as atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin, or simvastatin), especially at higher doses. Before taking this medication, tell your doctor or pharmacist if you:
Report any unexplained muscle pain, tenderness, weakness or cramps, or any brown or discoloured urine to your doctor immediately, particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.
Pregnancy: Fluvastatin should not be taken by pregnant women. If you become pregnant while taking fluvastatin, stop taking the medication immediately and contact your doctor.
Breast-feeding: It is not known if fluvastatin passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children:The safety and effectiveness of this medication have not been established for children less than 10 years old.
Seniors: If you are older than 70 years of age, your doctor will likely monitor you closely for muscle-related side effects.
What other drugs could interact with this medication?
- antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
- fibrates (e.g., bezafibrate, fenofibrate, gemfibrozil)
- hepatitis C antiviral medications (e.g., boceprevir, daclatasvir, ledipasvir, sofosbuvir, telaprevir)
- hepatitis C antiviral combinations (e.g., ombitasvir - paritaprevir - ritonavir - dasabuvir, ombitasvir - paritaprevir - ritonavir)
- proton pump inhibitors (e.g., lansoprazole, omeprazole)
- sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
- sulfonylureas (e.g., gliclazide, glyburide, tolbutamide)
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
There may be an interaction between fluvastatin and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2018. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Sandoz-Fluvastatin
All material © 1996-2018 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.
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