Tuesday, October 4, 2016

Lescol XL


Generic Name: fluvastatin (Oral route)

floo-va-STAT-in

Commonly used brand name(s)

In the U.S.


  • Lescol

  • Lescol XL

Available Dosage Forms:


  • Capsule

  • Tablet, Extended Release

Therapeutic Class: Antihyperlipidemic


Pharmacologic Class: HMG-COA Reductase Inhibitor


Uses For Lescol XL


Fluvastatin is used together with proper diet to treat high cholesterol levels in the blood. Using this medicine may help prevent medical problems caused by such substances clogging the blood vessels. This medicine may also be used to prevent certain types of heart problems in patients with risk factors for heart problems .


Fluvastatin belongs to the group of medicines called 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors. It works by blocking an enzyme that is needed by the body to make cholesterol, thereby reducing the amount of cholesterol in the blood .


Fluvastatin is available only with your doctor's prescription .


Importance of Diet


Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed .


Before Using Lescol XL


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


Fluvastatin is safe to use in children and adolescents (9 to 16 years of age) for treating certain types of high cholesterol .


Adolescent girls taking fluvastatin should be counseled on appropriate contraceptive methods .


Geriatric


Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of fluvastatin in the elderly .


Pregnancy








Pregnancy CategoryExplanation
All TrimestersXStudies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding


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.


Interactions with Medicines


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 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.


  • Bezafibrate

  • Ciprofibrate

  • Clofibrate

  • Dalfopristin

  • Danazol

  • Daptomycin

  • Fenofibrate

  • Gemfibrozil

  • Quinupristin

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

  • Eltrombopag

  • Oat Bran

  • Pectin

  • Warfarin

Interactions with Food/Tobacco/Alcohol


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 abuse (or history of) or

  • Liver disease, history—Use with caution. These conditions may increase the amount of fluvastatin in your blood .

  • Kidney disease, severe—Use with caution. This medicine may make the condition worse .

  • Liver disease, active or

  • Liver enzymes, persistently high levels—This medicine should NOT be used in these conditions. Use of this medicine may make liver problems worse .

  • Convulsions (seizures), uncontrolled or

  • Electrolyte disorder, severe or

  • Endocrine disorder (such as diabetes mellitus), severe or

  • Infection, severe or

  • Low blood pressure or

  • Major surgery or trauma or

  • Metabolic disorder, severe—Patients with these conditions may be at risk of developing muscle problems (causing the release of muscle pigment into the urine) that may lead to kidney failure .

Proper Use of fluvastatin

This section provides information on the proper use of a number of products that contain fluvastatin. It may not be specific to Lescol XL. Please read with care.


Take this medicine only as directed by your doctor. Do not take more or less of it, and do not take more or less often than your doctor ordered .


Follow carefully the special diet your doctor gave you. This is the most important part of controlling your condition and is necessary if the medicine is to work properly .


Do not open the capsule before taking it. Swallow the extended-release tablet whole. Do not crush, break, or chew it .


Remember that this medicine will not cure your condition but it does help control it. Therefore, you must continue to take it as directed if you expect to keep your cholesterol levels down .


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 milligrams (mg) or 40 mg once a day in the evening, as instructed by your doctor. Your doctor may increase your dose if needed. The recommended dosage range is 20 to 80 mg per day.

      • Children (9 to 16 years of age)—At first, 20 mg once a day in the evening. Your doctor may increase your dose up to a maximum of 80 mg per day.

      • Children (less than 9 years of age)—Use and dose must be determined by your doctor .


    • For oral dosage form (extended-release tablets):
      • Adults and children (9 to 16 years of age)—80 mg once daily.

      • Children (less than 9 years of age)—Use and dose must be determined by your doctor .



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.


Precautions While Using Lescol XL


It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests will be needed to check for unwanted effects.


Your doctor will need to check your liver before you start using this medicine .


Do not take this medicine if you are pregnant. Check with your doctor immediately if you think that you may be pregnant. This medicine may cause birth defects or other problems in the baby if taken during pregnancy. Do not breastfeed while you are using this medicine .


Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine .


Do not use excessive amounts of alcohol while taking fluvastatin because it can worsen the adverse effects of this medicine on the liver .


Check with your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if it is accompanied by unusual tiredness or fever. These may be symptoms of a muscle condition called rhabdomyolysis, which can lead to serious kidney 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 .


Lescol XL 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
  • Accidental injury

  • chills

  • cough

  • diarrhea

  • fever

  • general feeling of discomfort or illness

  • headache

  • 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 breathing

  • difficulty in moving

  • difficulty 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 joints

  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

  • shortness of breath

  • skin rash

  • tightness in chest

  • wheezing

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

  • heartburn

  • indigestion

  • stomach discomfort, upset or pain

Less common
  • Bloated full feeling

  • excess air or gas in stomach or intestines

  • pain or tenderness around eyes and cheekbones

  • passing gas

  • sleeplessness

  • stuffy nose

  • 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.

See also: Lescol XL side effects (in more detail)



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More Lescol XL resources


  • Lescol XL Side Effects (in more detail)
  • Lescol XL Use in Pregnancy & Breastfeeding
  • Drug Images
  • Lescol XL Drug Interactions
  • Lescol XL Support Group
  • 0 Reviews for Lescol XL - Add your own review/rating


  • Lescol XL Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Fluvastatin Professional Patient Advice (Wolters Kluwer)

  • Fluvastatin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Fluvastatin Sodium Monograph (AHFS DI)

  • Lescol Prescribing Information (FDA)

  • Lescol Consumer Overview



Compare Lescol XL with other medications


  • High Cholesterol
  • High Cholesterol, Familial Heterozygous
  • Hyperlipoproteinemia
  • Hyperlipoproteinemia Type IIa, Elevated LDL
  • Hyperlipoproteinemia Type IIb, Elevated LDL VLDL

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