LESCOL XL (Fluvastatin) 80 MG

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LESCOL XL is manufactured by NOVARTIS

LESCOL XL  (Fluvastatin) 80 MG

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What is Lescol xl?
Lescol xl (fluvastatin) is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Lescol xl reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).Lescol xl is used to treat high cholesterol in adults and children who are at least 10 years old. Lowering your cholesterol can help prevent heart disease and hardening of the arteries, conditions that can lead to heart attack, stroke, and vascular disease.Lescol xl may also be used for other purposes not listed in this medication guide.


Important information about Lescol xl
You should not take Lescol xl if you are allergic to fluvastatin, if you are pregnant or breast-feeding, or if you have liver disease. Stop taking Lescol xl and tell your doctor right away if you become pregnant.Before taking Lescol xl, tell your doctor if you have ever had liver or kidney disease, diabetes, or a thyroid disorder, or if you drink more than 2 alcoholic beverages daily.In rare cases, Lescol xl can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.Avoid eating foods that are high in fat or cholesterol. Lescol xl will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.There are many other drugs that can increase your risk of serious medical problems if you take them together with Lescol xl. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.Lescol xl is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.


Before taking Lescol xl
You should not take Lescol xl if you are allergic to fluvastatin, if you are pregnant or breast-feeding, or if you have liver disease.If you have any of these other conditions, you may need to adjust the dose of Lescol xl or have special tests:history of liver disease; history of kidney disease; diabetes;a thyroid disorder; orif you drink more than 2 alcoholic beverages daily.In rare cases, Lescol xl can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).Tell your doctor about all other medications you use. Certain other drugs can increase your risk of serious muscle problems, and it is very important that your doctor knows if you are using any of them:erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin);fluconazole (Diflucan)gemfibrozil (Lopid), fenofibric acid (Fibricor, Trilipix), or fenofibrate (Antara, Fenoglide, Lipofen, Lofibra, Tricor, Triglide);medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others); ordrugs that weaken your immune system, such as steroids, cancer medicine, or medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf).FDA pregnancy category X. Lescol xl can harm an unborn baby or cause birth defects. Do not take Lescol xl if you are pregnant. Stop taking this medication and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking Lescol xl. Fluvastatin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking Lescol xl.


How should I take Lescol xl?
Take Lescol xl exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.Lescol xl is usually taken once or twice daily, with or without food. Take the medicine at the same time each day. Your doctor may occasionally change your dose to make sure you get the best results.Do not crush, chew, break, or open a Lescol xl tablet or capsule. Swallow it whole. Tell your doctor if you have trouble swallowing the pill. You may need to stop using Lescol xl for a short time if you have:uncontrolled seizures;an electrolyte imbalance (such as high or low potassium levels in your blood);severely low blood pressure;a severe infection or illness; orsurgery or a medical emergency.To be sure Lescol xl is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.Lescol xl is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.You may need to take Lescol xl on a long-term basis for the treatment of high cholesterol. Store at room temperature away from moisture, heat, and light.


What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 12 hours away. Do not take extra medicine to make up the missed dose.


What happens if I overdose?
Seek emergency medical attention or call the Poison Help line.


What should I avoid while taking Lescol xl?
If you also take cholestyramine (Prevalite, Questran) or colestipol (Colestid), avoid taking them within 2 hours before you take Lescol xl.Avoid eating foods that are high in fat or cholesterol. Lescol xl will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.Grapefruit and grapefruit juice may interact with Lescol xl and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.


Side effects of Lescol xl 
Get emergency medical help if you have any of these signs of an allergic reaction to Lescol xl: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Lescol xl and call your doctor at once if you have any of these serious side effects:unexplained muscle pain, tenderness, or weakness;fever, unusual tiredness, and dark colored urine;pain or burning when you urinate;swelling, weight gain, urinating less than usual or not at all; ornausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).


Less serious Lescol xl side effects may include:
headache;mild muscle pain;diarrhea;mild nausea;stomach pain or indigestion;sleep problems (insomnia); orcold symptoms such as stuffy nose, sneezing, sore throat.This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. 


What other drugs will affect Lescol xl?
Before taking Lescol xl, tell your doctor about all other medicines you are using, especially:cimetidine (Tagamet);a blood thinner such as warfarin (Coumadin);glyburide (DiaBeta, Glynase, Micronase);omeprazole (Prilosec);phenytoin (Dilantin);ranitidine (Zantac);spironolactone (Aldactone, Aldactazide);any other "statin" medication such as atorvastatin (Lipitor, Caduet), lovastatin (Altoprev, Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor), or simvastatin (Zocor, Simcor, Vytorin).This list is not complete and other drugs may interact with Lescol xl. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Generic Name Fluvastatin
Search Name LESCOL XL Brand 80 MG TAB
Supply Name LESCOL XL
Brand Generic BRAND NAME
Presentation Blister in Box
Dosage TAB
USA Brand LESCOL XL
Manufacture NOVARTIS
Strength 80 MG
Search Terms LESCOL XL,LESCOL XL ,Fluvastatin
Origin TURKEY

Use spaces to separate tags. Use single quotes (') for phrases.

For the Consumer

Applies to fluvastatin: oral capsule, oral tablet extended release

Along with its needed effects, fluvastatin (the active ingredient contained in Lescol) 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 while 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 side effects of fluvastatin 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
USUAL ADULT DOSE FOR HYPERLIPIDEMIA

Initial dose: 20 to 40 mg orally once a day at bedtime.
Maintenance dose: 20 to 80 mg/day.

USUAL PEDIATRIC DOSE FOR HYPERLIPIDEMIA

9 to 16 years:
Initial dose: 20 mg orally once a day at bedtime.
Maintenance dose: 20 to 80 mg/day.

RENAL DOSE ADJUSTMENTS

No adjustment is recommended in patients with mild to moderate renal impairment.

Fluvastatin has not been studied at doses greater than 40 mg in patients with severe renal impairment; therefore, caution should be exercised when treating such patients at higher doses.

LIVER DOSE ADJUSTMENTS

Fluvastatin is considered contraindicated in patients with active liver disease or elevations in liver function tests. If it must be used, the dose should be reduced and titrated slowly.

DOSE ADJUSTMENTS

Adjustments in dosage should be made in intervals of 4 weeks or more.

PRECAUTIONS

Fluvastatin is considered contraindicated in patients with active liver disease or with unexplained elevations in liver function tests.

Fluvastatin and other HMG-CoA reductase inhibitors are associated with elevations in liver function tests. Safety in patients with active liver disease or with unexplained elevations in liver function tests is unknown. It is recommended that liver function tests be conducted before the initiation of treatment and at 12 weeks following initiation of treatment or elevation in dose. Patients who develop transaminase elevations or signs and symptoms of liver disease should be monitored to confirm the finding and should be followed thereafter with frequent liver function tests until the levels return to baseline. If an increase in AST or ALT of three times the upper limit of normal or greater persist (found on two consecutive occasions) withdrawal of fluvastatin therapy is advised. Fluvastatin should be used with caution in any patient who consumes substantial quantities of alcohol and/or has a history of liver disease. Such patients should be monitored closely.

Rhabdomyolysis with acute renal failure secondary to myoglobinuria has been associated with fluvastatin and other HMG-CoA reductase inhibitors. Fluvastatin should be used cautiously, if at all, in patients who are at risk of developing renal failure from rhabdomyolysis (for example, patients with severe acute infection, hypotension, major surgery, trauma, severe metabolic, endocrine, or electrolyte disorders, and uncontrolled seizures). Patients should be counseled to promptly report the occurrence of myalgia and/or muscle tenderness or weakness, particularly if accompanied by fever or malaise. Fluvastatin should be discontinued if myopathy occurs or if markedly elevated creatine phosphokinase (CPK) levels develop.

HMG-CoA reductase inhibitors are reported to be less effective in patients with rare homozygous familial hypercholesterolemia, possibly because these patients have few functional low density lipoprotein receptors.

The HMG-CoA reductase inhibitors may cause elevation of CPK and transaminase levels. This should be considered in the differential diagnosis of chest pain in a patient on therapy with fluvastatin.

DIALYSIS

There are limited data on the pharmacokinetic disposition of fluvastatin in patients undergoing hemodialysis. One study reported fluvastatin plasma concentrations before and during hemodialysis to be identical. In addition, fluvastatin could only be detected in the dialysate of one patient in this study. This data indicates that fluvastatin is not easily removed by dialysis.

OTHER COMMENTS

Cholesterol levels should be monitored periodically with consideration given to reducing the dosage if cholesterol levels fall significantly below the targeted range.

It has been suggested that prior to initiating statin therapy, all patients should have a baseline serum CPK enzyme level measured and if at any time after initiating therapy a patient complains of muscle soreness, tenderness, or pain another CPK level should be drawn for comparison. If elevated, the drug should be discontinued.

The results of one study indicate that withdrawal of HMG-CoA reductase inhibitors (statins; atorvastatin, fluvastatin, pravastatin, simvastatin) during the perioperative period in patients with acute coronary syndromes is associated with an increased risk for perioperative adverse cardiac events (i.e., increase postoperative troponin release and the combination of myocardial infarction and cardiovascular death). Patients receiving statins with extended-release formulations (i.e., fluvastatin) appeared to be associated with more favorable outcomes. Other studies appear to confirm these findings.