Description
Ticagrelor is used alone or together with aspirin to lessen the chance of heart attack or stroke in patients with acute coronary syndrome (ACS) or a history of heart attack. Acute coronary syndrome is a condition where the blood flow to the heart is blocked. It is also used to reduce the risk of blood clots in patients who have received stents to treat ACS.
Ticagrelor is also used alone or together with aspirin to lessen the chance of first heart attack or stroke in patients with coronary artery disease (CAD) who are at risk for having a heart attack or stroke. Coronary artery disease is a condition where the blood flow to the heart is decreased.
Ticagrelor is also used alone or together with aspirin to lessen the chance of stroke in patients with acute ischemic stroke or high-risk transient ischemic attack (TIA). Transient ischemic attack or mini-stroke is a condition where the blood supply to the brain is shortly blocked and lasts for a few minutes.
A heart attack or stroke may occur when a blood vessel in the heart or brain is blocked by a blood clot. Ticagrelor reduces the chance that a harmful blood clot will form by preventing certain cells in the blood from clumping together. This effect of ticagrelor may also increase the chance of serious bleeding in some people.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of ticagrelor in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ticagrelor in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Abrocitinib
- Defibrotide
- Itraconazole
- Levoketoconazole
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Abciximab
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Adagrasib
- Alfentanil
- Alipogene Tiparvovec
- Alteplase, Recombinant
- Amiodarone
- Amtolmetin Guacil
- Anagrelide
- Anileridine
- Anistreplase
- Apalutamide
- Apixaban
- Argatroban
- Aspirin
- Atazanavir
- Avacopan
- Bedaquiline
- Benzhydrocodone
- Betrixaban
- Bivalirudin
- Boceprevir
- Bromfenac
- Bufexamac
- Buprenorphine
- Butorphanol
- Caplacizumab-yhdp
- Carbamazepine
- Celecoxib
- Ceritinib
- Choline Salicylate
- Cilostazol
- Citalopram
- Clarithromycin
- Clonixin
- Clopidogrel
- Cobicistat
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bleeding, pathological and active (eg, from peptic ulcers or head injury) or
- Intracranial hemorrhage (bleeding in the head), history of or
- Liver disease, severe—Should not be used in patients with these conditions.
- Bleeding problems, history of or
- Heart rhythm problems, or history of or
- Lung disease or breathing problems (eg, asthma or COPD)—Use with caution. May make these conditions worse.
- Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Surgery, recent—Use with caution. May cause side effects to become worse.
Proper Use
Take this medicine exactly as directed by your doctor. Ticagrelor will not work properly if you take less of it than directed. Taking more ticagrelor than directed may increase the chance of serious side effects without increasing the helpful effects.
This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
Take this medicine at the same time every day. You may take it with or without food.
If you are unable to swallow the tablets whole:
- You may crush and mix the tablets in a glass of water and swallow it right away.
- Refill the glass with more water, stir, and swallow the mixture again.
- This mixture may also be given through a nasogastric tube. Flush the tube with more water to rinse all of the medicine into the stomach.
Your doctor may tell you to take aspirin while you are using ticagrelor. Do not change the dose or stop taking the aspirin without talking to your doctor first.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For prevention of heart attack or stroke in patients with acute coronary syndrome (ACS) or a history of heart attack:
- Adults—At first, 180 milligrams (mg) taken as a single dose. Followed by, 90 mg 6 to 12 hours after the loading dose. Continue taking 90 mg 2 times a day for 1 year after an ACS event. Then, start 60 mg 2 times a day. Your doctor may also give you a maintenance dose of aspirin 75 to 100 mg once a day to be taken together with this medicine. Do not take more aspirin than is recommended by your doctor.
- Children—Use and dose must be determined by your doctor.
- For prevention of heart attack or stroke in patients with coronary artery disease (CAD):
- Adults—60 milligrams (mg) 2 times a day. Your doctor may also give you a maintenance dose of aspirin 75 to 100 mg once a day to be taken together with this medicine. Do not take more than 100 mg of aspirin per day.
- Children—Do not take more aspirin than is recommended by your doctor.
- For prevention of stroke in patients with a history of stroke or transient ischemic attack (TIA):
- Adults—At first, 180 milligrams (mg) taken as a single dose. Followed by, 90 mg 6 to 12 hours after the loading dose. Continue taking 90 mg 2 times a day for up to 30 days. Your doctor may also give you a loading dose of aspirin 300 to 325 mg and a maintenance dose of aspirin 75 to 100 mg once a day to be taken together with this medicine. Do not take more aspirin than is recommended by your doctor.
- Children—Use and dose must be determined by your doctor.
- For prevention of heart attack or stroke in patients with acute coronary syndrome (ACS) or a history of heart attack:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
Tell all medical doctors, dentists, nurses, and pharmacists you go to that you are taking this medicine. Ticagrelor may increase the risk of serious bleeding during a surgery, other medical procedures (eg, coronary artery bypass graft or CABG), or some kinds of dental work. You may need to stop using this medicine at least 5 days before a surgery, medical procedure, or dental work. The results of some medical tests may also be affected by this medicine.
Do not change your dose or stop taking this medicine without checking first with your doctor. To do so may increase the chance of having a heart attack, blood clotting problems, or other serious conditions.
While you are using this medicine, if you have any kind of bleeding, it may take longer than usual to stop, especially if you hurt yourself. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Be careful when using sharp objects, including razors and fingernail clippers.
This medicine may increase your chance of bleeding or bruising. Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin. Avoid picking your nose. If you need to blow your nose, blow it gently.
Tell your doctor right away if you have chest tightness, or difficult or trouble breathing when asleep or awake. These could be symptoms of a serious lung or breathing problem (eg, central sleep apnea, Cheyne-Stokes respiration).
This medicine may cause heart rhythm problems (eg, bradyarrhythmia). Check with your doctor right away if you have chest pain or discomfort, lightheadedness, dizziness, or fainting, trouble breathing, slow or irregular heartbeat, or unusual tiredness.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Back pain
- bleeding gums
- blurred vision
- chest pain, tightness, or discomfort
- confusion
- cough
- coughing up blood
- difficult or trouble breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, slow, or irregular heartbeat
- headache
- increased menstrual flow or vaginal bleeding
- lightheadedness, dizziness, or fainting
- loss of consciousness
- nausea or vomiting
- nervousness
- nosebleeds
- paralysis
- pounding in the ears
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- sweating
- unusual bleeding or bruising
- unusual tiredness or weakness
Rare
- Change in mental status
- difficulty in speaking
- fever
- pale skin
- pinpoint red spots on the skin
- seizures
- yellow eyes or skin
Incidence not known
- Difficulty with swallowing
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- rash
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Diarrhea
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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