FLUVASTATIN

COMMON BRAND NAME(S): Lescol

GENERIC NAME(S): FLUVASTATIN SODIUM

 

Description: Fluvastatin HMG-CoA reductase inhibitor, also known as “statin”.  It works by reducing the production of certain fatty substances in the body, including cholesterol.

Pharmacokinetics:

Absorption: Rapidly and completely absorbed from the GI tract. Absolute bioavailability: Approx 24%. Time to peak plasma concentration: Cap: 1 hr; extended release tab: 3 hr.

Distribution: Volume of distribution: 0.35 L/kg. Plasma protein binding: >98%.

Metabolism: Undergoes extensive first-pass hepatic metabolism. Converted to inactive and active metabolites by oxidative metabolism mainly via CYP2C9 isoenzyme and in small amount via CYP3A4 isoenzyme.

Excretion: Via faeces (approx 90%) and urine (approx 6%). Elimination half-life: Cap: <3 hr; extended release tab: 9 hr.

Fluvastatin is used along with a proper diet to help lower “bad” cholesterol and fats (such as LDL, triglycerides) and raise “good” cholesterol (HDL) in the blood. It belongs to a group of drugs known as “statins.” It works by reducing the amount of cholesterol made by the liver. Lowering “bad” cholesterol and triglycerides and raising “good” cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks.

 

In addition to eating a proper diet (such as a low-cholesterol/low-fat diet), other lifestyle changes that may help this medication work better include exercising, losing weight if overweight, and stopping smoking. Consult your doctor for more details.

 

How to use fluvastatin

Read the Patient Information Leaflet if available from your pharmacist before you start taking fluvastatin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

 

Take this medication by mouth with or without food as directed by your doctor, usually once daily in the evening. Some patients may be directed to take this medication twice daily. Do not open the capsules.

 

The dosage is based on your medical condition, response to treatment, age, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

 

If you also take certain other drugs to lower your cholesterol (bile acid-binding resins such as cholestyramine or colestipol), take fluvastatin at least 1 hour before or at least 4 hours after taking these medications. These products can react with fluvastatin, preventing its full absorption.

 

Take this medication regularly in order to get the most benefit from it. Remember to take it at the same time(s) each day. It is important to continue taking this medication even if you feel well. Most people with high cholesterol or triglycerides do not feel sick.

 

It is very important to continue to follow your doctor’s advice about diet and exercise. It may take up to 4 weeks before you get the full benefit of this drug.

Pregnancy Risk: Category X (Not for use in pregnancy)

You should check with your doctor immediately if any of these side effects occur when taking fluvastatin:

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
  • 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, spasms, or stiffness
  • muscular pain, 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
  • tightness in the chest

Some of the side effects that can occur with fluvastatin may not need medical attention:

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

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 the use of 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.

 

Interactions

 

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

 

Some products that may interact with this drug include: colchicine, gemfibrozil, phenytoin.

 

Do not take any red yeast rice products while you are taking fluvastatin because some red yeast rice products may also contain a statin called lovastatin. Taking fluvastatin and red yeast rice products together can increase your risk of serious muscle and liver problems.

If overdose is suspected, contact a poison control center or emergency room immediately.

 

Notes

Do not share this medication with others.

 

Laboratory and/or medical tests (such as blood cholesterol/triglyceride levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

Storage

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59 and 86 degrees F (15 to 30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

 

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Brands

 

Available Brands

Lescol/Lescol XL [ Novartis Healthcare ]

Fugerel [ Schering-Plough ]

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