Details for: APO-AMBRISENTAN
Company: APOTEX INC
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
02475375 | APO-AMBRISENTAN | AMBRISENTAN | 5 MG | TABLET | ORAL |
02475383 | APO-AMBRISENTAN | AMBRISENTAN | 10 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
APO-AMBRISENTAN is used in adults to treat high blood pressure in the pulmonary arteries (pulmonary arterial hypertension).
What it does
APO-AMBRISENTAN is an endothelin receptor antagonist
(ERA).
It reduces high blood pressure by relaxing the pulmonary
arteries. This makes it easier for the heart to pump blood to the
lungs.
Tests your doctor will do before treatment:
- a blood test to check that your liver is working properly and to check for anemia (reduction in red blood cells).
- a pregnancy test.
When it should not be used
Do not take APO-AMBRISENTAN if you:
- are allergic to ambrisentan or any ingredients in the tablet (see What the nonmedicinal ingredients are).
- are pregnant, are planning to become pregnant, or could get pregnant because you are not using reliable birth control (contraception) (see WARNINGS AND PRECAUTIONS).
- are breastfeeding
- have liver disease or abnormal liver test results. Your doctor will decide if this medicine is suitable for you.
- have a lung condition called idiopathic pulmonary fibrosis (IPF) that makes it hard to breathe, along with a dry cough, and sometimes, joint pain or swelling.
What the medicinal ingredient is
ambrisentan
What the non-medicinal ingredients are
APO-AMBRISENTAN 5 mg: croscarmellose sodium, FD&C
Red # 40, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol,
sunset yellow aluminum lake 40% talc and titanium dioxide.
APO-AMBRISENTAN 10 mg: croscarmellose sodium, FD&C
Red # 40 aluminum lake 38-42%, lactose monohydrate,
magnesium stearate, microcrystalline cellulose, polyethylene
glycol, polyvinyl alcohol, talc and titanium dioxide.
What dosage form it comes in
5 mg and 10 mg film-coated tablets
Warnings and precautions
Serious Warnings and Precautions
APO-AMBRISENTAN may harm your unborn baby if you take it while pregnant. Before you use APO-AMBRISENTAN talk to your doctor or pharmacist if you:
- are pregnant or thinking of becoming pregnant.
- could become pregnant because you are not using reliable birth control (contraceptive) methods.
- are breastfeeding.
Before Treatment
BEFORE you use APO-AMBRISENTAN talk to your doctor or pharmacist if you:
- have or ever had liver problems
- have a low number of red blood cells (anemia)
- have swelling (edema)
During treatment:
Some patients taking APO-AMBRISENTAN were found to have abnormal liver function (increase in liver enzymes) and some patients developed anemia (reduction in red blood cells). Because these findings may not cause symptoms you can feel or observe yourself, your doctor will do regular blood tests to check for any changes in your liver function and for anemia.Liver function:
If your doctor decides it is needed this blood test will be done every month or more frequently.
If you develop abnormal liver function, your doctor may decide to stop treatment with APO-AMBRISENTAN. When your blood test results for liver function return to normal, your doctor may decide to restart treatment with APO-AMBRISENTAN.
Anemia:
This blood test will be done after 1 month and periodically after that.
If you develop anemia, your doctor may decide to perform further tests to investigate the cause.
Pediatrics (< 18 years of age): Safety and efficacy of APO-AMBRISENTAN under 18 years of age have not been established, and should therefore not be used in this age group.
Pregnancy:
If you become pregnant or think you may be pregnant while you’re taking APO-AMBRISENTAN, see your doctor immediately. APO-AMBRISENTAN may harm your unborn baby if you take it while you are pregnant. If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking APO-AMBRISENTAN and regularly while you are taking APO-AMBRISENTAN. You will also have to use a reliable method of birth control.
Driving and using machines:
It is not known whether APO-AMBRISENTAN affects your ability to drive or use machines. Don’t drive or operate machines if you’re feeling unwell.
Interactions with this medication
As with most medicines, interactions with other drugs are
possible. Tell your doctor or pharmacist about all the
medicines you take, including drugs prescribed by other
doctors, vitamins, minerals, natural supplements or
alternative medicines.
The following may interact with APO-AMBRISENTAN:
- cyclosporine A (an autoimmune drug typically used in organ transplants),
- digoxin (a heart drug),
- rifampin (an anti-bacterial drug typically used in lung infections),
- ketoconazole (an anti-fungal drug typically used in skin infections),
- warfarin (typically used to prevent clotting),
- omeprazole (typically used to treat indigestion),
- oral contraceptives (birth control).
Proper use of this medication
Do not stop taking APO-AMBRISENTAN without discussion with your doctor or your pharmacist.
Usual Dose
The usual dose of APO-AMBRISENTAN is 5 mg, once a
day. Your doctor may decide to increase your dose to 10 mg,
once a day. The maximum recommended daily dose is 10
mg.
If you take cyclosporine A, do not take more than 5 mg of
APO-AMBRISENTAN, once a day.
You can take APO-AMBRISENTAN with or witho
Overdose
Missed Dose
If you forget to take a dose of APO-AMBRISENTAN, just take the tablet as soon as you remember, then continue with the next dose at your usual time. Don’t take two tablets at the same time to make up for a forgotten dose.
Side effects and what to do about them
Side effects may include:
- headache
- nasal congestion (runny or blocked nose), red and sore throat, sinusitis
- constipation, abdominal pain, nausea, vomiting
- flushing (redness of the skin),
- fluid retention (edema)
- feeling tired or weak
- palpitations (fast or irregular heartbeat)
- vision changes, (blurry or other changes to vision)
- ringing in the ears (tinnitus)
Some patients taking APO-AMBRISENTAN may have
symptoms related to low blood pressure, like dizziness or
fainting.
If any of these affects you severely, tell your doctor or
pharmacist.
Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
---|---|---|---|
Very Common | |||
Swelling (edema), especially in the ankles and feet | ✔ | ||
Anemia: fatigue, loss of energy, weakness, shortness of breath | ✔ | ||
Flushing (redness of the skin) | ✔ | ||
Worsening shortness of breath shortly after starting APO-AMBRISENTAN | ✔ | ||
Dizziness | ✔ | ||
Palpitations: fast and/or irregular heart beat | ✔ | ||
Common | |||
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✔ | ||
Rare | |||
Liver Disorder: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite | ✔ | ||
Not Known | |||
Heart Failure: shortness of breath, extreme tiredness and swelling in the ankles and legs | ✔ | ||
Chest pain and/or discomfort | ✔ |
This is not a complete list of side effects. For any unexpected effects while taking APO-AMBRISENTAN, contact your doctor or pharmacist.
How to store
Store at room temperature 15°C to 30°C.
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada.html
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa, Ontario
K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about APO-AMBRISENTAN:
- Talk to your healthcare professional
- Find the full product monograph that is prepared
for healthcare professionals and includes this
patient medication information by visiting the
Health Canada website
(https://www.canada.ca/en/healthcanada/services/drugs-health-products/drugproducts/drug-product-database.html); the manufacturer’s website
http://www.apotex.ca/products, or by calling 1- 800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L
1T9.
Last revised: December 18, 2018