TICAGRELOR 90 mg/1
TICAGRELOR · TABLET · AvPAK
TICAGRELOR is a tablet containing ticagrelor at 90 mg/1, taken oral. Manufactured by AvPAK.
Key Facts
- Brand Name
- TICAGRELOR
- Generic Name
- TICAGRELOR
- NDC Code (Product)
50268-826- Manufacturer
- AvPAK
- Strength
- 90 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA208596
- Drug Class
- P2Y12 Platelet Inhibitor [EPC]
- Marketing Start
- 10/29/2025
Recall History
AstraZeneca Pharmaceuticals, LP
Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Ticagrelor is a P2Y 12 platelet inhibitor indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction (MI). For at least the first 12 months following ACS, it is superior to clopidogrel. Ticagrelor tablets also reduces the risk of stent thrombosis in patients who have been stented for treatment of ACS. ( 1.1 ) to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high risk for such events. While use is not limited to this setting, the efficacy of ticagrelor was established in a population with type 2 diabetes mellitus (T2DM). ( 1.2 ) to reduce the risk of stroke in patients with acute ischemic stroke (NIH Stroke Scale score ≤5) or high-risk transient ischemic attack (TIA). ( 1.3 ) 1.1 Acute Coronary Syndrome or a History of Myocardial Infarction Ticagrelor tablets are indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of MI. For at least the first 12 months following ACS, it is superior to clop…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION ACS or History of MI Initiate treatment with 180 mg oral loading dose of ticagrelor tablets. Then administer 90 mg twice daily during the first year. After one year, administer 60 mg twice daily. ( 2.2 ) Patients with CAD and No Prior Stroke or MI Administer 60 mg ticagrelor tablets twice daily. ( 2.3 ) Acute Ischemic Stroke Initiate treatment with a 180 mg loading dose of ticagrelor tablets then continue with 90 mg twice daily for up to 30 days. ( 2.4 ) Use ticagrelor tablets with a daily maintenance dose of aspirin of 75 to 100 mg. ( 2 ) However, in patients who have undergone PCI, consider single antiplatelet therapy with ticagrelor tablets based on the evolving risk for thrombotic versusbleeding events. ( 2.2 ) 2.1 General Instructions Advise patients who miss a dose of ticagrelor tablets to take their next dose at its scheduled time. For patients who are unable to swallow tablets whole, ticagrelor tablets can be crushed, mixed with water, and drunk. The mixture can also be administered via a nasogastric tube (CH8 or greater) [see Clinical Pharmacology ( 12.3 )]. Do not administer ticagrelor tablets with another oral P2Y 12 platelet inhibitor. Avoid …
Contraindications
4 CONTRAINDICATIONS • History of intracranial hemorrhage. ( 4.1 ) • Active pathological bleeding. ( 4.2 ) • Hypersensitivity to ticagrelor or any component of the product. ( 4.3 ) 4.1 History of Intracranial Hemorrhage Ticagrelor tablets are contraindicated in patients with a history of intracranial hemorrhage (ICH) because of a high risk of recurrent ICH in this population [see Clinical Studies ( 14.1 ) ,( 14.2 )]. 4.2 Active Bleeding Ticagrelor tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage [see Warnings and Precautions ( 5.1 ) and Adverse Reactions (6.1 )]. 4.3 Hypersensitivity Ticagrelor tablets are contraindicated in patients with hypersensitivity (e.g., angioedema) to ticagrelor or any component of the product.
Drug Interactions
7 DRUG INTERACTIONS • Avoid use with strong CYP3A inhibitors or CYP3A inducers. ( 7.1 , 7.2 ) • Opioids: Decreased exposure to ticagrelor. Consider use of parenteral anti-platelet agent. ( 7.3) • Patients receiving more than 40 mg per day of simvastatin or lovastatin may be at increased risk of statin-related adverse effects. ( 7.4 ) • Rosuvastatin plasma concentrations may increase. Monitor for statin-related adverse effects. ( 7.4 ) • Monitor digoxin levels with initiation of or any change in ticagrelor. ( 7.5 ) 7.1 Strong CYP3A Inhibitors Strong CYP3A inhibitors substantially increase ticagrelor exposure and so increase the risk of dyspnea, bleeding, and other adverse events. Avoid use of strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromycin) [see Clinical Pharmacology ( 12.3 )] . 7.2 Strong CYP3A Inducers Strong CYP3A inducers substantially reduce ticagrelor exposure and so decrease the efficacy of ticagrelor. Avoid use with strong inducers of CYP3A (e.g., rifampin, phenytoin, carbamazepine and phenobarbital) [see Clinical Pharmacology ( 12.3) ]. 7.3 Opio…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: •Bleeding [see Warnings and Precautions ( 5.1 )] •Dyspnea [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (>5%) are bleeding and dyspnea. ( 5.1 , 5.3 , 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088or www .fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Ticagrelor has been evaluated for safety in more than 58,000 patients. Bleeding in PLATO (Reduction in risk of thrombotic events in ACS) Figure 1 is a plot of time to the first non-CABG major bleeding event. Figure 1- Kaplan-Meier estimate of time to first non-CABG PLATO-defined major bleeding event (PLATO) Frequency of bleeding in PLATO is summarized in Tables 1 and 2. About half of the non-CABG major bleeding events were in the first 30 days. Table 1 - Non-CABG related bleeds…
Frequently Asked Questions
What is TICAGRELOR used for?
TICAGRELOR contains TICAGRELOR. It is a tablet taken oral. Consult your doctor for specific uses.
Is TICAGRELOR a controlled substance?
TICAGRELOR is not classified as a controlled substance by the DEA.
What is the generic name for TICAGRELOR?
The generic name for TICAGRELOR is TICAGRELOR. There are 10 other brand versions of TICAGRELOR.
What is the NDC code for TICAGRELOR 90 mg/1?
The NDC (National Drug Code) for TICAGRELOR 90 mg/1 is 50268-826, listed by AvPAK.