TICASPAN 90 FILM-COATED TABLETS 90MG [SIN17211P]

Product Info

TICASPAN 90 FILM-COATED TABLETS 90MG

[SIN17211P]

Indication

INDICATIONS
Ticagrelor Tablets co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of thrombotic events (cardiovascular death, myocardial infarction and stroke) in patients with Acute Coronary Syndromes (ACS) (unstable angina, non-ST elevation Myocardial Infarction [NSTEMI], or ST elevation Myocardial Infarction [STEMI]); including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG).

Dosing

DOSAGE & ADMINISTRATION
In patients with Acute Coronary Syndromes, Ticagrelor Tablets treatment should be initiated with a single 180 mg loading dose (two tablets of 90 mg) and then continued at 90 mg twice daily. Treatment is recommended for at least 12 months unless discontinuation of Ticagrelor Tablets is clinically indicated. After one year, patients with MI initiated on 90 mg may continue treatment with 60 mg without interruption if they have a high risk of an atherothrombotic event.
Patients taking Ticagrelor Tablets should also take a daily low maintenance dose of acetylsalicylic acid (ASA) of 75–150 mg, unless specifically contraindicated. An initial loading dose of ASA is recommended for patients with ACS.

Missed dose
Lapses in therapy should be avoided. A patient who misses a dose of Ticagrelor Tablets should take their next dose at its scheduled time.

Switching
Physicians who desire to switch patients, with a prior ACS event to Ticagrelor Tablets, should administer the first 90 mg dose of Ticagrelor Tablets 24 hours following the last dose of other antiplatelet medication.

Premature discontinuation
Premature discontinuation with any antiplatelet therapy, including Ticagrelor Tablets, could result in an increased risk of cardiovascular (CV) death, myocardial infarction (MI), or stroke due to the patient's underlying disease.

Method of administration
For oral use.

Ticagrelor can be administered with or without food.

For patients who are unable to swallow the tablet(s) whole, the tablets can be crushed to a fine powder and mixed in half a glass of water and drunk immediately. The glass should be rinsed with a further half glass of water and the contents drunk. The mixture can also be administered via a nasogastric tube (CH8 or greater). It is important to flush the nasogastric tube through with water after administration of the mixture.

Special populations
Elderly
No dose adjustment is required.

Renal impairment
No dose adjustment is necessary for patients with renal impairment.

Hepatic impairment
No dose adjustment is necessary for patients with mild hepatic impairment. Ticagrelor has not been studied in patients with severe hepatic impairment and there is limited information on treatment of patients with moderate hepatic impairment.

Paediatric population
The safety and efficacy of Ticagrelor in children below the age of 18 years have not been established.

Contraindications

CONTRAINDICATIONS

• Hypersensitivity to the active substance or to any of the excipients.

• Active pathological bleeding.

• History of intracranial haemorrhage.

• Severe hepatic impairment.

• Co-administration of Ticagrelor with strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir), as co-administration may lead to a substantial increase in exposure to Ticagrelor.