Lescol

DRUG DESCRIPTION

LESCOL is a water-soluble cholesterol lowering agent which acts through the inhibition of 3-hydroxy-3-methylglutarylcoenzyme A (HMG-CoA) reductase.

Fluvastatin sodium is [R*,S*-(E)]-(?±)-7-[3-(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic acid, monosodium salt. The empirical formula of fluvastatin sodium is C24H25FNO4•Na, its molecular weight is 433.46 and its structural formula is:

Lescol® (fluvastatin) Structural Formula Illustration

This molecular entity is the first entirely synthetic HMG-CoA reductase inhibitor, and is in part structurally distinct from the fungal derivatives of this therapeutic class.

Fluvastatin sodium is a white to pale yellow, hygroscopic powder soluble in water, ethanol and methanol. LESCOL is supplied as capsules containing fluvastatin sodium, equivalent to 20 mg or 40 mg of fluvastatin, for oral administration. LESCOL XL is supplied as extended-release tablets containing fluvastatin sodium, equivalent to 80 mg of fluvastatin, for oral administration.

Active Ingredient: fluvastatin sodium

Inactive Ingredients in capsules: calcium carbonate, gelatin, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), red iron oxide, sodium bicarbonate, talc, titanium dioxide, yellow iron oxide, and other ingredients.

Capsules may also include: benzyl alcohol, black iron oxide, butylparaben, carboxymethylcellulose sodium, edetate calcium disodium, methylparaben, propylparaben, silicon dioxide, sodium lauryl sulfate, and sodium propionate.

Inactive Ingredients in extended-release tablets: microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, potassium bicarbonate, povidone, magnesium stearate, yellow iron oxide, titanium dioxide and polyethylene glycol 8000.

What are the possible side effects of fluvastatin (Lescol, Lescol XL)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fluvastatin and call your doctor at once if you have any of these serious side effects:

  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

Less serious side effects may include:

  • mild stomach pain, gas, bloating, stomach upset, heartburn;
  • nausea;
  • ...

Read All Potential Side Effects and See Pictures of Lescol »

What are the precautions when taking fluvastatin sodium (Lescol)?

Before taking fluvastatin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with fluvastatin. Ask your doctor or pharmacist for more information.

Older adults may be...

Read All Potential Precautions of Lescol »


Lescol Consumer (continued)

SIDE EFFECTS: Stomach upset may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This drug may infrequently cause muscle problems (which can rarely lead to a very serious condition called rhabdomyolysis). Tell your doctor immediately if you develop any of these symptoms: muscle pain/tenderness/weakness (especially with fever or unusual tiredness), change in the amount of urine.

This medication may rarely cause liver problems. If you notice any of the following rare but serious side effects, tell your doctor immediately: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking fluvastatin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with fluvastatin. Ask your doctor or pharmacist for more information.

Older adults may be more sensitive to the side effects of this drug, especially muscle problems.

This medication must not be used during pregnancy. Fluvastatin may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss using at least 2 reliable forms of birth control (such as condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Lescol Patient Information Including Side Effects

Brand Names: Lescol, Lescol XL

Generic Name: fluvastatin (Pronunciation: FLOO va sta tin)

  • What is fluvastatin (Lescol)?
  • What are the possible side effects of fluvastatin (Lescol)?
  • What is the most important information I should know about fluvastatin (Lescol)?
  • What should I discuss with my healthcare provider before taking fluvastatin (Lescol)?
  • How should I take fluvastatin (Lescol)?
  • What happens if I miss a dose (Lescol)?
  • What happens if I overdose (Lescol)?
  • What should I avoid while taking fluvastatin (Lescol)?
  • What other drugs will affect fluvastatin (Lescol)?
  • Where can I get more information?

What is fluvastatin (Lescol)?

Fluvastatin is a cholesterol-lowering medication that blocks the production of cholesterol (a type of fat) in the body.

Fluvastatin reduces low-density lipoprotein (LDL) cholesterol and total cholesterol in the blood. Lowering your cholesterol can help prevent heart disease and hardening of the arteries, conditions that can lead to heart attack, stroke, and vascular disease.

Fluvastatin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fluvastatin (Lescol)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fluvastatin and call your doctor at once if you have any of these serious side effects:

  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.

Less serious side effects may include:

  • mild stomach pain, gas, bloating, stomach upset, heartburn;
  • nausea;
  • constipation; or
  • diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fluvastatin (Lescol)?

In rare cases, fluvastatin can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine.

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Do not take fluvastatin if you have liver disease, or if you are breast-feeding a baby.

Before taking fluvastatin, tell your doctor if you have diabetes, underactive thyroid, kidney disease, a muscle disorder, or a blood disorder:

Avoid eating foods that are high in fat or cholesterol. Fluvastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol while taking fluvastatin. Alcohol can raise triglyceride levels, and may also damage your liver while you are taking fluvastatin.

There are many other drugs that can interact with fluvastatin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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