AMLODIPINE AND ATORVASTATIN (Systemic)?
Some commonly used brand names are:
In the U.S.?
? Not commercially available in Canada.
Category
- Antianginal
- Antihypertensive
- Antihyperlipidemic
Description
Amlodipine (am-LOE-di-peen)and Atorvastatin (a-TOR-va-stat-in)is a combination of a calcium channel blocker and HMG-CoA reductase inhibitor.Amlodipine is used to treat angina (chest pain) or high blood pressure. Atorvastatinis used to lower cholesterol and triglyceride (fat-like substances) levelsin the blood.
High blood pressure adds to the workload of the heart and arteries. Ifit continues for a long time, the heart and arteries may not function properly.This can damage the blood vessels of the brain, heart, and kidneys, resultingin a stroke, heart failure, or kidney failure. High blood pressure may alsoincrease the risk of heart attacks. These problems may be less likely to occurif blood pressure is controlled.
The exact way in which this medicine works is not known. Amlodipine isa type of medicine known as a calcium channel blocker. Calcium channel blockingagents affect the movement of calcium into the cells of the heart and bloodvessels. Atorvastatin is used to lower cholesterol and triglyceride (fat-likesubstances) levels in the blood. The action of both medicines together isto relax blood vessels, lower blood pressure, and decrease the amount of cholesterolin the blood.
Amlodipine and atorvastatin is available only with your doctor's prescription,in the following dosage forms:
Before Using This Medicine
In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For amlodipine and atorvastatin,the following should be considered:
Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to amlodipine or atorvastatin. Also tell your doctorand pharmacist if you are allergic to any other substances, such as foods,preservatives, or dyes.
Pregnancy?Studies with this combination medicine have notbeen done in pregnant women. However, use of any of the HMG-CoA reductaseinhibitors during pregnancy, can cause serious birth defects or other problems. Therefore, it is important that you check with your doctor immediatelyif you think that you may be pregnant. Be sure that you have discussedthis with your doctor before taking this combination medicine.
Breast-feeding?It is not known whether amlodipine passes intobreast milk. Atorvastatin passes into the breast milk of animals. Amlodipineand atorvastatin combination should not be used during breast-feeding becauseit may cause serious unwanted effects in nursing babies.
Children?Studies on this combination medicine have beendone only in adult patients, and there is no specific information comparinguse of amlodipine and atorvastatin in children with use in other age groups.
Atorvastatin alone is safe to use in boys and some girls 10 to 17 yearsof age for treating certain types of high cholesterol.
Adolescent girls taking atorvastatin should be counseled on appropriatecontraceptive methods.
Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. However, elderly people may be especially sensitiveto the effects of amlodipine which may increase the chance of side effectsduring treatment.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingamlodipine and atorvastatin, it is especially important that your doctor andpharmacist know if you are taking any of the following:
- Alcohol?May cause liver problems and should not be used whiletaking atorvastatin
- Azole antifungals (fluconazole [e.g., Diflucan], miconazoleinjection [e.g., Monistat IV], ketoconazole [e.g., Nizoral], itraconazole[e.g., Sporanox], voriconazole [e.g., Vfend]) or
- Cyclosporine (e.g., Sandimmune) or
- Erythromycin (e.g., Erythrocin) or
- Fibric Acid Derivatives, such as
- Clofibrate (e.g., Atromid-S) or
- Fenofibrate (e.g., Tricor) or
- Gemfibrozil (e.g., Lopid) or
- Niacin (nicotinic acid) in lipid-lowering doses?Use of thesemedicines with atorvastatin may increase the risk of developing muscle problems(causing the release of muscle pigment into the urine) that may lead to kidneyfailure
- Digoxin (e.g., Lanoxin)?Using this medicine with atorvastatinmay cause there to be more digoxin in your body
Other medical problems?The presence of other medicalproblems may affect the use of amlodipine and atorvastatin. Make sure youtell your doctor if you have any other medical problems, especially:
- Alcohol abuse (or history of) or
- Liver disease (or history of) or
- Liver enzymes, persistently high levels?Use of this medicinemay make liver problems worse
- Aortic stenosis, severe (abnormally narrow aorta)?Use of thismedicine may increase the chance of low blood pressure
- Congestive heart failure?There is a small chance that amlodipinemay make this condition worse
- Convulsions (seizures), not well-controlled, or
- Electrolyte or metabolic enzyme deficiencies or disorders or
- Infection, severe or
- Low blood pressure or
- Major surgery or trauma, recent or
- Myopathy (a disorder of muscle tissue or muscles)?Patientswith these conditions may be at risk of developing muscle problems (causingthe release of muscle pigment into the urine) that may lead to kidney failure
- Coronary artery disease, severe, obstructive?Use of this medicinemay result in other heart problems
Proper Use of This Medicine
Use thismedicine only as directed by your doctor. Do not use more or less of it, anddo not use it more often or for a longer time than your doctor ordered. Also,this medicine works best if there is a constant amount in the blood. To helpkeep this amount constant, do not miss any doses and take the medicine atthe same time each day.
Before prescribing the atorvastatin and amlodipine combination for yourcondition, your doctor will probably try to control your condition by prescribinga personal diet for you. Follow carefully the specialdiet your doctor gave you. Such a diet may be low in fats, sugars,and/or cholesterol. Many people are able to control their condition by carefullyfollowing their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effectiveonly when a schedule of diet and exercise is properly followed.
Also, this medicine is less effective if you are greatly overweight. Itmay be very important for you to go on a weight-reducing diet. However, checkwith your doctor before going on any diet.
Dosing?The dose of amlodipine and atorvastatin willbe different for different patients. Follow your doctor'sorders or the directions on the label. The following information includesonly the average doses of amlodipine and atorvastatin. If your dose is different, do not change it unless your doctor tellsyou to do so.
- For oral dosage form (tablets):
- Adults?1 tablet a day, tablet strength is determined by yourdoctor.
- Children?Use and dose must be determined by your doctor.
Missed dose?If you miss a dose of this medicine, take itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. Do not doubledoses.
Storage?To store this medicine:
- Keep out of the reach of children.
- Store away from heat and direct light.
- Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
- Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
It is important that your doctor check your progress at regularvisits. This will allow your doctor to make sure the medicine is workingproperly and to change the dosage if needed.
Check with your doctor immediately if you think thatyou may be pregnant. HMG-CoA reductase inhibitors may cause birth defectsor other problems in the baby if taken during pregnancy.
Before having any kind of surgery (including dentalsurgery) or emergency treatment, tell the medical doctor or dentist in chargethat you are taking this medicine.
Do not take over-the-counter (OTC) niacin preparationswithout consulting your doctor. Niacin may increase atorvastatin'sadverse effects on muscle, which can lead to serious kidney problems.
Do not use excessive amounts of alcohol whiletaking atorvastatin because it can worsen the adverse effects of this medicineon the liver.
Check with your doctor immediately if you experienceunexplained muscle pain, tenderness, or weakness, especially if itis accompanied by unusual tiredness or fever, because the medicine's adverseeffects on muscle can lead to serious kidney problems.
Checking with physician before discontinuing medication because a gradual reduction in dose may be necessary
Side Effects of This Medicine
Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.
Check with your doctorimmediately if any of the following side effects occur:
More common-Atorvastatin
Cough; difficulty swallowing; dizziness; fast heartbeat; hives; itching; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; shortness of breath; skin rash; tightness in chest; unusual tiredness or weakness; wheezing
Rare-Amlodipine
Chest pain or discomfort; dilated neckveins; extra heartbeats; extreme fatigue; irregular breathing; irregular heartbeat; pulse irregularity; shortness of breath; swelling of face, fingers, feet, or lower legs; weight gain
Observed post-marketing frequency unknown-Atorvastatin
Blistering, peeling, loosening of skin; chills; dark-colored urine; diarrhea; fever; itching; joint or muscle pain; muscle cramps or spasms; muscle pain or stiffness; red irritated eyes; redskin lesions, often with a purple center; sore throat; sores, ulcers, or white spots in mouth or on lips
Symptoms of overdose
Get emergency help immediately if any of the followingsymptoms of overdose occur
Blurred vision; confusion; dizziness, faintness, or lightheadedness when getting up froma lying or sitting position suddenly; flushing; sweating; unusual tiredness or weakness
Other side effects may occur that usually do not need medical attention.These side effects may go away during treatment as your body adjusts to themedicine. However, check with your doctor if any of the following side effectscontinue or are bothersome.
More common-Atorvastatin
Body aches or pain; congestion; difficulty in moving; dryness or sorenessof throat; fever or chills; hoarseness; lower back or side pain; muscle pain or stiffness; pain in joints; pain or tenderness around eyes and cheekbones; painful or difficult urination; runnynose; stuffy nose; tender,swollen glands in neck;; voice changes
Less common-Amlodipine
Feeling of warmth; nausea; redness of the face, neck, arms and occasionally, upper chest; sleepiness or unusual drowsiness; stomach pain
Rare-Amlodipine
Anxiety; bad unusual or unpleasant (after)taste; blistering, crusting, irritation, itching,or reddening of skin; burning feeling in chest orstomach; burning while urinating; change in near or distance vision; change in taste; change in color of skin; cold and clammy skin; cracked, dry, scaly skin; difficult or painful urination; difficultyin focusing eyes; dry mouth; dryness of eyes; excessive muscle tone; frequent urination; hair loss, thinningof hair; hives or welts; hyperventilation; increased appetite; increased volume of pale, dilute urine; irritability; lack of feeling or emotion; loose stools; loss of memory; muscle tension or tightness; muscleweakness; nervousness; problems with memory;; restlessness; severe and throbbing headache ; shakinessand unsteady walk; sneezing; tenderness in stomach area; transient, mild, pleasantaromatic odor; trembling, or other problems withmuscle control or coordination; trouble sleeping; twitching; uncaring; unsteadiness
Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.
Developed: 11/08/2004
