Patient Medication Information: uses, side effects, how to take - Teva-Ambrisentan
What is Teva-Ambrisentan used for?
Teva-Ambrisentan is used in adults to treat high blood pressure in the pulmonary arteries. Theyare blood vessels that carry blood away from the heart to the lungs.
How does Teva-Ambrisentan work?
Teva-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.
What are the ingredients in Teva-Ambrisentan?
Medicinal ingredients: ambrisentan
Non-medicinal ingredients: croscarmellose sodium, lactose monohydrate, lecithin, macrogol/polyethylene glycol 3350/ 4000, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, talc, and titanium dioxide.
Teva-Ambrisentan comes in the following dosage forms:
Tablets: 5 mg and 10 mg
Do not use Teva-Ambrisentan if:
- you are pregnant, are planning to become pregnant, or could become pregnant because you are not using reliable birth control (see Other warnings you should know about).
- you are breastfeeding or plan to breastfeed your baby.
- you are allergic to ambrisentan or to any of the other ingredients in Teva-Ambrisentan. Teva-Ambrisentan contains lactose, lecithin (soya)).
- you have liver disease or abnormal liver test results.
have a lung condition called Idiopathic Pulmonary Fibrosis (IPF). The symptoms of this condition include:
- Shortness of breath
- Dry cough
- Fatigue
- Joint or muscle pain
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Teva-Ambrisentan. Talk about any health conditions or problems you may have, including if you:
- have swelling
- have a low amount of red blood cells (anemia)
- have or ever had liver problems
Other warnings you should know about:
Teva-Ambrisentan can cause serious side effects, including:
Peripheral edema (swelling of the legs or hands caused by fluid retention) : This may happen within weeks after starting Teva-Ambrisentan. You are at a higher risk of experiencing it if you:
- take high doses of Teva-Ambrisentan
- are 65 years of age or older
Tell your healthcare professional if you experience swelling in your hands or legs while taking Teva-Ambrisentan.
- Anemia (decreased number of red blood cells): This may happen within weeks after starting Teva-Ambrisentan. Tell your healthcare professional if you experience signs of anemia while taking Teva-Ambrisentan.
Liver problems: Stoptaking Teva-Ambrisentanand tell your healthcare professional right away if you experience:
- signs and symptoms of liver problems
- Worsening of liver disease.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Driving and operating machinery:
- It is not known whether Teva-Ambrisentan affects your ability to drive or use machines.
- You should not drive or use machines until you know how Teva-Ambrisentan affectsyou.
- If you ever feel sleepy or unwell, do not drive or use machines, and tell your healthcare professional.
Male fertility: During animal studies, reduced fertility was observed in male rats taking ambrisentan, the active ingredient in Teva-Ambrisentan. If you are a man taking Teva-Ambrisentan, it is possible that Teva-Ambrisentan may lower your sperm count. Talk to your healthcare professional if you wish to father a child, or have any questions or concerns about this.
Pregnancy:
- Teva-Ambrisentan should not be used during pregnancy. Taking it during pregnancy may cause injury to your baby
- If you are a woman who could become pregnant, your healthcare professional will ask you to take a pregnancy test before you start taking Teva-Ambrisentan and regularly while you are taking Teva-Ambrisentan.
- Use a highly effective birth control method while taking Teva-Ambrisentan. If you discover that you are pregnant while taking Teva-Ambrisentan, contact your healthcare professional as soon as possible.
Breastfeeding: It isnot known whether Teva-Ambrisentan canpass into breastmilk. Teva-Ambrisentan should not be used during breastfeeding.
Children and adolescents(under 18 years ofage): Teva-Ambrisentan is not to be used in children and adolescents under 18 years of age.
Laboratory tests and monitoring: Your healthcare professional will do tests, including blood tests, before you start Teva-Ambrisentan and regularly during treatment. These tests will check:
- The amount of red blood cells in your body.
- That your liver is working properly.
- If you are pregnant.
Depending on your test results, your healthcare professional may adjust your dose, stop or discontinue your treatment with Teva-Ambrisentan.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Teva-Ambrisentan:
- Cyclosporine A – used to treat certain autoimmune diseases and to prevent rejection of organ transplants
- Sildenafil, tadalafil – used to treat erectile dysfunction or high blood pressure in the lungs
- Ketoconazole – used to treat fungal skin infections
- Digoxin – used totreat heart conditions
How to take Teva-Ambrisentan:
Take Teva-Ambrisentan:
- exactly as your healthcare professional tells you.
with or without food
Usual dose:
- The initial dose of Teva-Ambrisentan is 5 mg, once a day. Your healthcare professional 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 Teva-Ambrisentan, once per day.
Overdose:
Missed Dose:
If you forget to take Teva-Ambrisentan, take the missed dose as soon as you remember, then continue with the next dose at your usual time. Do not take a double dose to make up for the one that you missed.
If you think you, or a person you are caring for, have taken too much Teva-Ambrisentan, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
What are possible side effects from using Teva-Ambrisentan?
These are not all the possible side effects you may have when taking Teva-Ambrisentan. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Headache
- Stuffy nose
- Sore throat
- Constipation
- Pain in the abdomen
- Problems with sinuses
- Feeling sick
- Vomiting
- Feeling weak or tired
- Skin rash
- Hot flashes
- Ringing in the ears
- Changes in vision, including blurry vision
If any of these affects you severely, tell your healthcare professional.
Serious side effects and what to do about them
| Symptom/ effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| VERY COMMON | |||
Peripheral edema (swelling of the legs or hands caused by fluid retention): swollen or puffy legs or hands, feeling heavy, achy or stiff | ✓ | ||
Anemia (decreased number of red blood cells): fatigue, loss of energy, irregular heartbeats, pale complexion, shortness of breath, weakness | ✓ | ||
| Flushing (redness of the skin) | ✓ | ||
| Dyspnea (shortness of breath) | ✓ | ||
| Dizziness | ✓ | ||
Palpitations: fast and/or irregular heart beat | ✓ | ||
| COMMON | |||
Allergic Reaction: difficulty swallowing or breathing, wheezing; drop in blood pressure; feeling sick to your stomach and throwing up; hives or rash; swelling of the face, lips, tongue or throat. | ✓ | ||
Serious side effects and what to do about them
| Symptom/ effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| RARE | |||
| Liver problems: yellowing of your skin and eyes (jaundice), right upper stomach area pain or swelling, nausea or vomiting, unusual dark urine, unusual tiredness, loss of appetite | ✓ | ||
| UNKNOWN | |||
| Heart failure (heart does not pump blood as well as it should): shortness of breath, fatigue and weakness, swelling in ankles, legs and feet, cough, fluid retention, lack of appetite, nausea, rapid or irregular heartbeat, reduced ability to exercise | ✓ | ||
| Hypotension (low blood pressure): dizziness, fainting, light- headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up) | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Storage:
Store between 15-30°C.
Keep out of reach and sight of children.
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/drugs-health-products/medeffect-canada/adverse-reaction-reporting.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.
If you want more information about Teva-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/health-canada/services/drugs-health-products/drug-products/drug- product-database.html; the manufacturer’swebsitewww.tevacanada.com., or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.
Last Approved: March 15, 2023