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Apo-Atorvastatin
(atorvastatin)

DIN (Drug Identication Number)


02295261 APO-ATORVASTATIN 10MG TABLET
02295288 APO-ATORVASTATIN 20MG TABLET
02295296 APO-ATORVASTATIN 40MG TABLET
02296318 APO-ATORVASTATIN 80MG TABLET

About this Medication

How does this medication work? What will it do for me?

What form(s) does this medication come in?

How should I use this medication?

Who should NOT take this medication?

What side eects are possible with this medication?

Are there any other precautions or warnings for this medication?

What other drugs could interact with this medication?

How does this medication work? What will it do for me?


Atorvastatin belongs to the group of medications known as HMG CoA reductase inhibitors ("statins") or lipid metabolism regulators. It is used to
treat people who have high cholesterol levels, including those people who have certain inherited CHOLESTEROL disorders. When you use
this medication, you also need to make lifestyle changes, including switching to a diet low in fat and cholesterol, quitting smoking, and increasing
the amount of exercise you do.

Atorvastatin works by blocking an enzyme that is used to make CHOLESTEROL in the liver. When that enzyme is blocked, less cholesterol is
produced and the amount of cholesterol in the blood decreases. Atorvastatin lowers the level of total cholesterol and low density lipoprotein (LDL,
or "bad" cholesterol), and raises high density lipoprotein (HDL, or "good" cholesterol) levels. Reduction of cholesterol levels in the blood has been
shown to reduce the risks associated with heart disease, such as heart attack.

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Atorvastatin is used to reduce the risk of heart attack in people experiencing SYMPTOMS associated with heart disease.

Atorvastatin is also used to reduce the risk of heart attack in people with high blood pressure who have at least 3 additional risk factors
for heart disease but not experiencing symptoms associated with heart disease. The risk factors of heart disease for these individuals include:

being male

being 55 years old or older

ENLARGED heart ventricles

family history of heart disease

smoking

specic abnormalities on an ECG

the total cholesterol to HDL-cholesterol ratio that is greater than or equal to 6

type 2 diabetes

specic types of protein in the urine

Atorvastatin is also used to reduce the risk of heart attack and stroke in people with high BLOOD PRESSURE and type 2 diabetes who
have other risk factors for heart disease but not experiencing SYMPTOMS associated with heart disease. The risk factors of heart disease for
these individuals include:

a specic type of protein in the urine

being 55 years old or older

disease of the retina

smoking

Atorvastatin may be used in addition to DIET to reduce cholesterol for adolescents between 10 and 17 years of age with increased
CHOLESTEROL levels and family history of early heart disease or 2 or more risk factors for cardiovascular disease.

The medication usually takes about 2 to 4 weeks to have a signicant eect on the cholesterol level in your blood. After this time, your doctor will
likely send you for a blood test to check for changes in your cholesterol levels.

This medication may be available under multiple brand names and/or in several dierent forms. Any specic brand name of this
medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication
may not be used for all of the conditions discussed here.

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Your doctor may have suggested this medication for conditions other than those listed in these drug INFORMATION articles. If you
have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this
medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same SYMPTOMS as you do. It can be harmful for people to take this
medication if their doctor has not prescribed it.
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What form(s) does this medication come in?


10mg
Each white, oval, lm-coated tablet, embossed with "APO" on one side and "A10" on the other, contains atorvastatin 10mg. Nonmedicinal
ingredients: calcium acetate, croscarmellose sodium, sodium carbonate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide,
hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyethylene glycol, and titanium dioxide.

20mg
Each white, oval, lm-coated tablet, embossed with "APO" on one side and "ATV20" on the other, contains atorvastatin 20mg. Nonmedicinal
ingredients: calcium acetate, croscarmellose sodium, sodium carbonate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide,
hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyethylene glycol, and titanium dioxide.

40mg
Each white, oval, lm-coated tablet, embossed with "APO" on one side and "ATV40" on the other, contains atorvastatin 40mg. Nonmedicinal
ingredients: calcium acetate, croscarmellose sodium, sodium carbonate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide,
hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyethylene glycol, and titanium dioxide.

80mg
Each white, oval, lm-coated tablet, embossed with "APO" on one side and "ATV80" on the other, contains atorvastatin 80mg. Nonmedicinal
ingredients: calcium acetate, croscarmellose sodium, sodium carbonate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide,
hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyethylene glycol, and titanium dioxide.

How should I use this medication?


When you start taking atorvastatin, you should be on a cholesterol-lowering diet. If appropriate, a health care professional will discuss an
individualized program of weight control and physical exercise with you.

The recommended starting dose of atorvastatin for adults is 10mg or 20mg daily, preferably in the evening, with or without food. Your
doctor will do blood tests to tell how well this dose is working for you and may gradually increase the dose to get the desired response. The
maximum recommended dose for adults is 80mg taken once daily.

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For children 10 to 17 years of age who are taking this medication to treat inherited cholesterol disorders, the recommended dose
ranges from 10mg to 20mg daily. Doses greater than 20mg have not been studied.

Many things can aect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If
your doctor has recommended a dose dierent from the ones listed here, do not change the way that you are taking the medication
without consulting your doctor.
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For best results in lowering cholesterol, it is very important to closely follow the diet suggested by your doctor. It is also very important that
atorvastatin be taken regularly and exactly as prescribed by your doctor.

If you miss a dose of this medication, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose,
skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not
sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of
medications that are no longer needed or have expired.

Who should NOT take this medication?


Do not take this medication if you:

are allergic to atorvastatin or any ingredients of the medication

are breast-feeding

are pregnant or plan to become pregnant

have active liver disease or unexplained increases in liver function tests

What side effects are possible with this medication?


Many medications can cause side eects. A side eect is an unwanted response to a medication when it is taken in normal doses. Side eects
can be mild or severe, temporary or permanent.

The side eects listed below are not experienced by everyone who takes this medication. If you are concerned about side eects, discuss the
risks and benets of this medication with your doctor.

The following side eects have been reported by at least 1% of people taking this medication. Many of these side eects can be managed, and
some may go away on their own over time.

Contact your doctor if you experience these side eects and they are severe or bothersome. Your pharmacist may be able to advise
you on managing side eects.

constipation

diarrhea

gas

headache

rash

sexual problems

stomach pain or vomiting

Although most of the side eects listed below don't happen very often, they could lead to serious problems if you do not seek medical
attention.
Check with your doctor as soon as possible if any of the following side eects occur:

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confusion

cough, shortness of breath, fever

memory loss

signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
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symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing,
infections, fruity breath odour)

symptoms of liver damage (such as yellow skin or eyes, abdominal pain, dark urine, clay-coloured stools, loss of appetite, nausea and vomiting,
or itching)

trouble sleeping

Stop taking the medication and seek immediate medical attention if any of the following occur:

symptoms of muscle damage (unexplained muscle pain, tenderness or weakness, or brown or discoloured urine especially if you also have a
fever or a general feeling of being unwell)

symptoms of a serious allergic reaction such as swelling of the face or throat, hives, or diculty breathing

Some people may experience side eects other than those listed. Check with your doctor if you notice any symptom that worries you while
you are taking this medication.

Are there any other precautions or warnings for this medication?


Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any
medications you are taking, whether you are pregnant or breast-feeding, and any other signicant facts about your health. These
factors may aect how you should use this medication.

Alcohol: People who drink large quantities of alcohol should be closely monitored by their doctor while they are taking this medication.

Cardiovascular: There is an increased risk of hemorrhagic stroke if atorvastatin is started within 6 months of having a stroke or transient
ischemic attack (TIA). If you have a history of stroke or have had a recent stroke, discuss with your doctor how this medication may aect your
medical condition, how your medical condition may aect the dosing and eectiveness of this medication, and whether any special monitoring is
needed.

Diabetes: Atorvastatin may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may nd it
necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may aect your medical condition, how
your medical condition may aect the dosing and eectiveness of this medication, and whether any special monitoring is needed.

Diet: Atorvastatin is not intended to be used alone to reduce high cholesterol levels. It is important that a cholesterol-reducing diet along with
appropriate exercise be attempted before taking any medication and continued while taking medication.

Grapefruit juice: Taking atorvastatin and consuming grapefruit juice may result in an increased amount of atorvastatin in the body, and lead to
side eects. If you regularly drink grapefruit juice, talk to your doctor or pharmacist about whether you should change your diet.

Kidney function: If you have decreased kidney function or a history of kidney disease, you may be at an increased risk of developing muscle
eects while taking atorvastatin. The lowest eective dose of atorvastatin should be used and your doctor should follow you closely. If you have
kidney problems, discuss with your doctor how this medication may aect your medical condition, how your medical condition may aect the
dosing and eectiveness of this medication, and whether any special monitoring is needed.

Liver function: Atorvastatin may reduce liver function and can cause liver failure. This medication should not be used by people with active liver
disease or by people whose liver function tests are higher than normal. If you have liver problems, discuss with your doctor how this medication
may aect your medical condition, how your medical condition may aect the dosing and eectiveness of this medication, and whether any
special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes,
dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

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Muscle eects: In rare cases, serious muscle pain, cramps, and weakness have been associated with the use of statin medications (i.e.,
cholesterol-lowering medications whose names end in "statin," such as atorvastatin, uvastatin, lovastatin, pravastatin, rosuvastatin, or
simvastatin), especially at higher doses. Before taking this medication, tell your doctor or pharmacist if you:

have kidney or liver problems

are taking niacin or a brate medication (such as gembrozil, fenobrate)


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have an underactive thyroid gland (hypothyroidism)

regularly drink more than 3 alcoholic drinks per day

have had any past problems with muscles (pain, tenderness) after taking a statin such as atorvastatin, uvastatin, lovastatin, pravastatin,
rosuvastatin, or simvastatin

have a personal or family history of inherited muscle problems

are more than 65 years old

have undergone surgery or suered any traumatic injury

are frail

do excessive physical exercise

have diabetes

Report any unexplained muscle pain, tenderness, weakness, or cramps, or any brown or discoloured urine to your doctor immediately,
particularly if you are also experiencing malaise (a general feeling of being unwell) or fever.

Pregnancy: Cholesterol is necessary for the development of an unborn baby. Taking atorvastatin during pregnancy reduces the amount of
cholesterol reaching the developing baby and may cause harm to the baby. Atorvastatin should not be taken by pregnant women. If you become
pregnant while taking this medication, stop taking it immediately and contact your doctor.

Breast-feeding: It is not known if atorvastatin passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may
aect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: There is limited experience with the use of this medication by children. Atorvastatin has only been studied for use by children aged 10
to 17 years who have inherited cholesterol disorders (also known as familial hypercholesterolemia).

Seniors: If you are more than 70 years old, you may experience more side eects. Your doctor will monitor you closely while you are taking this
medication.

What other drugs could interact with this medication?


There may be an interaction between atorvastatin and any of the following:

abiraterone acetate ledipasvir

aliskiren loperamide

amiodarone lomitapide

antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium macrolide antibiotics (e.g., azithromycin, erythromycin,
hydroxide) clarithromycin)

aprepitant meoquine

aripiprazole metronidazole

"azole" antifungal medications (e.g., itraconazole, ketoconazole) midazolam

birth control pills mifepristone

boceprevir nadolol

bosentan nefazodone

brentuximab niacin (nicotinic acid)

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calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, niacinamide
verapamil)
noroxacin
cancer medications (e.g., daunorubicin, doxorubicin, etoposide,
methotrexate, mitotane, paclitaxel, temsirolimus, vinblastine,
ondansetron
vincristine) paliperidone
carbamazepine PoweredbyCounterflix phenobarbital

carvedilol phenytoin
cetirizine
pimozide

cholestyramine prazosin
ciprooxacin
primidone

cobicistat propranolol
colchicines proton pump inhibitors (PPIs; e.g., lansoprazole, omeprazole,
colestipol pantoprazole)

conivaptan
prucalopride

cyclosporine
quinidine

cyproterone
quinine

dabigatran
ranitidine

danazol
rifabutin

daptomycin
rifampin

deferasirox
rifamycin

desipramine
risperidone

dexamethasone
rivaroxaban

digoxin
romidepsin

dipyridamole
St. John's wort

dofetilide
sertraline

dronedarone
sildenal

eltrombopag
silodosin

enzalutamide
sirolimus

everolimus
sitaxentan

estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)


spironolactone

brates (e.g., bezabrate, gembrozil, fenobrate)


other "statin" anti-cholesterol medications (e.g., lovastatin,
simvastatin)
"gliptin" diabetes medications (e.g., linagliptin, saxagliptin, sitagliptin)
tacrolimus
grapefruit juice
tenofovir
haloperidol
tetracycline
hepatitis C protease inhibitors (e.g., boceprevir, simeprevir,
telaprevir)
tocilizumab

HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g.,


tolvaptan
delaviridine, efavirenz, etravirine, nevirapine) trabectedin
HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, tyrosine kinase inhibitors (e.g., crizotinib, lapatinib, nilotinib,
saquinavir) sunitinib)
hydrocodone

hydrocortisone

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If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specic circumstances, your doctor
may want you to:

stop taking one of the medications,

change one of the medications to another,


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change how you are taking one or both of the medications, or

leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how
any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-
the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caeine,
alcohol, the nicotine from cigarettes, or street drugs can aect the action of many medications, you should let your prescriber know if you use
them.

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