Details for: MYLAN-ATORVASTATIN
Company: MYLAN PHARMACEUTICALS ULC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02392933 | MYLAN-ATORVASTATIN | ATORVASTATIN (ATORVASTATIN CALCIUM) | 10 MG | TABLET | ORAL |
| 02392941 | MYLAN-ATORVASTATIN | ATORVASTATIN (ATORVASTATIN CALCIUM) | 20 MG | TABLET | ORAL |
| 02392968 | MYLAN-ATORVASTATIN | ATORVASTATIN (ATORVASTATIN CALCIUM) | 40 MG | TABLET | ORAL |
| 02392976 | MYLAN-ATORVASTATIN | ATORVASTATIN (ATORVASTATIN CALCIUM) | 80 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
Your doctor has prescribed these pills to help lower your
cholesterol or other fats in the blood (such as triglycerides) and to
prevent cardiovascular disease such as heart attacks. High
levels of cholesterol and other fats can cause heart disease by
clogging the blood vessels that feed blood and oxygen to the
heart.
Children 10-17 years old with heterozygous familial
hypercholesterolemia (high cholesterol inherited from one of the
parents) and a family history of cardiovascular disease or 2 or
more risk factors of cardiovascular disease, as determined by your
doctor, can also benefit from taking MYLAN-ATORVASTATIN.
MYLAN-ATORVASTATIN is just part of the treatment your
doctor will plan with you/your child to help keep you healthy.
Depending on your/your child’s health and lifestyle, your doctor
may recommend:
- a change in diet to control weight and reduce cholesterol, reduce intake of saturated fats and increase fiber
- exercise that is right for you/your child
- quitting smoking or avoiding smoky places
- giving up alcohol or drinking less
What it does
MYLAN-ATORVASTATIN belongs to the class of medicines
known as “statins”, more specifically called HMG-CoA
reductase inhibitors. HMG-CoA reductase is an enzyme
involved in regulating cholesterol levels in your body. Statins
are used along with changes to exercise and diet to help
control the amount of cholesterol produced by the body.
MYLAN-ATORVASTATIN can help your body:
- Decrease LDL (bad) cholesterol, triglyceride levels and other lipids /fats in the blood.
- Increase HDL (good) cholesterol.
- Decrease the Total Cholesterol HDL-Cholesterol Ratio (TC:HDL-C Ratio). This ratio represents the balance between bad and good cholesterol.
MYLAN-ATORVASTATIN is only available by prescription after seeing a doctor.
When it should not be used
Do not take MYLAN-ATORVASTATIN if you/your child:
- Are/is allergic to any ingredient of this medication (see what the medicinal ingredient is and what the important non medicinal ingredients are).
- Have active liver disease or unexplained increases in liver enzymes.
- Are/is pregnant or breast-feeding.
- Are taking glecaprevir/pibrentasvir (MAVIRETTM).
- Are taking cyclosporine (e.g. SANDIMMUNE® , NEORAL® ).
What the medicinal ingredient is
Atorvastatin calcium trihydrate.
What the non-medicinal ingredients are
MYLAN-ATORVASTATIN tablets contain: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydroxy propyl cellulose, L-arginine, magnesium stearate, microcrystalline cellulose, sodium carbonate anhydrous. Coating: lecithin, polyvinyl alcohol, talc, titanium dioxide and xanthan gum.
What dosage form it comes in
MYLAN-ATORVASTATIN tablets are available in 4 strengths: 10 mg, 20 mg, 40 mg and 80 mg atorvastatin (as atorvastatin calcium trihydrate).
Warnings and precautions
Serious Warnings and Precautions
Tell your doctor if you/your child have any muscle pain, tenderness, soreness or weakness during treatment with MYLANATORVASTATIN.
Before using this medicine:
Before taking MYLAN-ATORVASTATIN, tell your doctor or
pharmacist if you/your child:
- are/is pregnant, intend to become pregnant. Cholesterol compounds are essential elements for the development of a fetus. Cholesterol-lowering drugs can harm the fetus. Females of child-bearing age should discuss with their doctor the potential hazards to the fetus and the importance of birth control methods. MYLAN-ATORVASTATIN should not be used by pregnant women. If you/your child become pregnant, discontinue use immediately and discuss with your doctor.
- are/is breast-feeding or intend to breast-feed. This medicine may be present in breast milk.
- have thyroid problems
- have had a stroke or a mini stroke (TIA)
- regularly drink three or more alcoholic drinks daily
- are taking any other cholesterol lowering medication such as fibrates (gemfibrozil, fenofibrate), niacin or ezetimibe
- have a family history of muscular disorders
- had any past problems with the muscles (pain, tenderness), after using an HMG-CoA reductase inhibitor (“statin”) such as MYLAN-ATORVASTATIN, fluvastatin (LESCOL®), lovastatin (MEVACOR®), pravastatin (PRAVACHOL®), rosuvastatin (CRESTOR®) or simvastatin (ZOCOR®) or have developed an allergy or intolerance to them.
- have kidney or liver problems
- have diabetes (as the dosage of MYLANATORVASTATIN may need to be adjusted)
- have undergone surgery or other tissue injury
- do excessive physical exercise
- are taking fusidic acid
MYLAN-ATORVASTATIN may cause muscle pain, aching or weakness that does not go away even after stopping the drug.
Atorvastatin calcium tablets were studied in boys and girls (girls who already started their period) 10-17 years at a dose of 10 and 20 mg. Atorvastatin calcium tablets have not been studied in pre-pubertal patients or patients younger than 10 years of age. Adolescent girls should discuss with their doctor the potential hazards to the fetus and the importance of birth control while on MYLAN-ATORVASTATIN therapy.
Interactions with this medication
As with most medicines, interaction with other drugs is possible. Tell your doctor or pharmacist if you are taking any other medications, including prescription, non-prescription and natural health products. In particular, these drugs may interact with MYLAN-ATORVASTATIN:
- corticosteroids (cortisone-like medicines)
- cyclosporine (e.g. SANDIMMUNE®, NEORAL®)
- gemfibrozil (e.g. LOPID ®)
- fenofibrate e.g. (LIPIDIL MICRO®) or bezafibrate (e.g. BEZALIP®)
- lipid-modifying doses of niacin (nicotinic acid)
- erythromycin, clarithromycin or azole antifungal agents (ketoconazole or itraconazole)
- nefazodone (e.g. SERZONE®)
- indinavir sulfate (e.g. CRIXIVAN®), nelfinavir mesylate (e.g. VIRACEPT®), ritonavir (e.g. NORVIR®), saquinavir mesylate (e.g. INVIRASETM), lopinavir/ritonavir (e.g. KALETRA®), telaprevir (e.g. INCIVEKTM), tipranavir (e.g. APTIVUS®), darunavir (e.g. PREZISTA®), fosamprenavir (e.g. TELZIR®), boceprevir (e.g. VICTRELIS®), elbasvir/grazoprevir (e.g. ZEPATIER®), simeprevir (e.g. GALEXOS®)
- fusidic acid (e.g. FUCIDIN®)
- digoxin
- diltiazem
- efavirenz, rifampin
- antacids (frequent use) and MYLAN-ATORVASTATIN should be taken 2 hours apart
- colchicine
- grapefruit juice - especially if ingesting upwards of 1.2 litres of grapefruit juice at once
Proper use of this medication
PROPER USE OF THIS MEDICATION We often cannot see or feel the problems that high cholesterol causes until a lot of time has passed. That's why it is important to take these pills just as prescribed. You/your child and your doctor will be watching your/your child’s cholesterol levels to get them down to a safe range. Here are some important tips.
- Follow the plan that you/your child and your doctor make for diet, exercise and weight control.
- Take MYLAN-ATORVASTATIN as a single dose. It does not matter if MYLAN-ATORVASTATIN is taken with food or without food, but it should not be taken with grapefruit juice. Your doctor will usually tell you/your child to take it in the evenings.
- Do not change the dose unless directed by a doctor.
- If you/your child get sick, have an operation, or need medical treatment, inform your doctor or pharmacist that you/your child are taking MYLANATORVASTATIN.
- If you/your child have to take any other medicine
- prescription or non-prescription - while taking MYLAN-ATORVASTATIN, talk to your doctor or pharmacist first.
- If you/your child have to see a different doctor for any reason, be sure to inform him/her that you/your child are/is taking MYLAN-ATORVASTATIN.
- MYLAN-ATORVASTATIN was prescribed for you/your child only. Don't give these pills to anyone else.
Usual Dose
Adults: The recommended starting dose of MYLANATORVASTATIN is 10 or 20 mg once daily, depending on your
required LDL-C reduction. Patients who need a large reduction in
LDL-C (more than 45%) may be started at 40 mg once daily.
The dosage range of MYLAN-ATORVASTATIN is 10 to 80 mg
once daily. The maximum dose is 80 mg/day.
The recommended dose of MYLAN-ATORVASTATIN is 10 to 80
mg/day for people who have already suffered a heart attack.
Children (10-17 years old): the recommended starting dose of MYLAN-ATORVASTATIN is 10 mg/day; the maximum
recommended dose is 20 mg/day.
Overdose
Missed Dose
If you/your child miss taking a pill, take it as soon as possible. But if it is almost time for the next dose, skip the missed dose and just take the next dose. Don't take a double dose.
Side effects and what to do about them
Most people do not have any problems with side effects when taking this medicine. However, all medicines can cause unwanted side effects. Check with your doctor or pharmacist promptly if any of the following persist or become troublesome:
- constipation/diarrhea/gas
- depression (in children)
- headache
- skin rash
- stomach pain or upset
- vomiting or throwing up
Possible side effects reported with some statins:
- breathing problems including persistent cough and/or shortness of breath or fever
- cases of erectile dysfunction (difficulty to achieve or maintain an erection)
- sleep disturbances (difficulty sleeping or staying asleep), including insomnia and nightmares
- mood related disorders including depression
- poor memory, confusion and memory loss
This is not a complete list of side effects. If you/your child notice anything unusual or any unexpected effects while taking MYLANATORVASTATIN, contact your doctor or pharmacist.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking the drug and seek immediate emergency medical attention |
|---|---|---|---|
| Rare | |||
| Muscle pain that you cannot explain | ✔ | ||
| Muscle tenderness or weakness | ✔ | ||
| Generalized weakness, especially if you don’t feel well | ✔ | ||
| Brownish or discoloured urine | ✔ | ||
| Unknown | |||
| Increased blood sugar: frequent urination, thirst and hunger | ✔ | ||
How to store
Always keep medicine well out of the reach of children.
Keep MYLAN-ATORVASTATIN at room temperature (15°C to
30°C), away from warm and damp places, like the bathroom or
kitchen
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugshealth-products/medeffect-canada/adverse-reactionreporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document can be found at: www.mylan.ca.
The full Product Monograph prepared for health professionals can
be obtained by contacting the sponsor, Mylan Pharmaceuticals
ULC at: 1-844 596-9526
This leaflet was prepared by Mylan Pharmaceuticals ULC
Etobicoke, Ontario M8Z 2S6
Date of Revision: November 14, 2019
Mylan Pharmaceuticals ULC
Etobicoke, ON M8Z 2S6
1-844 596-9526
www.mylan.ca