Oushod Sheba

Oushod Sheba

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ACORA

ACI LIMITED


TABLET
90 MG

75

Generic Information

Generic name

TICAGRELOR

Indications

Ticagrelor is indicated for the prevention of atherothrombotic events in adult patients with Acute Coronary Syndromes (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).

Therapeutic Class

Anti-platelet drugs

Pharmacology

Tibolone is a synthetic steroid that has estrogenic, androgenic and progestagenic properties. After oral administration, Tibolone is rapidly metabolized into three compounds which contribute to the pharmacological effects of Tibolone. Two of these metabolites (the 388OH and 388OH metabolite) have predominantly estrogenic activity; a third metabolite (84-isomer of Tibolone) and the parent compound have predominantly progestagenic and androgenic activities. Tibolone substitutes for the loss of estrogen production in postmenopausal women and alleviates menopausal symptoms. It prevents bone loss following menopause or ovariectomy. It has estrogenic effects on the vagina, on bone and on the thermoregulatory centers in the brain (hot flushes). It improves vaginal dryness and vaginal atrophy. Tibolone has also effects on mood and libido.'

Dosage & Administration

Ticagrelor treatment should be initiated with a single 180 mg loading dose (two tablets of 90 mg) and then continued at 90 mg twice daily. Patients taking Ticagrelor should also take aspirin daily, unless specifically contraindicated. Following an initial dose of aspirin (usually 325 mg), Ticagrelor should be used with a maintenance dose of aspirin of 75-100 mg. Maintenance dose of Aspirin above 100 mg decreased the efficacy of Ticagrelor. So, maintenance dose of aspirin above 100 mg should be avoided. A patient who misses a dose of Ticagrelor should take only one 90 mg tablet (the next dose) at its scheduled time. Patients treated with Clopidogrel can be directly switched to Ticagrelor if needed. Switching from prasugrel to ticagrelor has not been investigated. Treatment is recommended for up to 12 months unless discontinuation of Ticagrelor is clinically indicated. Ticagrelor can be administered with or without food.

Interaction

CYP3A inhibitors: Avoid use of strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromycin). CYP3A inducers: Avoid use with potent inducers of CYP3A (e.g., rifampin, dexamethasone, phenytoin,carbamazepine and phenobarbital). Aspirin: Use of Ticagrelor with aspirin maintenance doses above 100 mg reduced the effectiveness ofTicagrelor. Simvastatin, Lovastatin: Ticagrelor will result in higher serum concentrations of simvastatin and lovastatin because these drugs are metabolized by CYP3A4. Avoid simvastatin and lovastatin doses greater than 40 mg. Digoxin: Because of inhibition of the P-glycoprotein transporter, monitor digoxin levels with initiation of or any change in ticagrelor therapy. Other Concomitant Therapy: Ticagrelor can be administered with unfractionated or low-molecular-weight heparin, GPIIb/llla inhibitors, proton pump inhibitors, beta-blockers, angiotensin converting enzyme inhibitors, and angiotensin receptor blockers.

Contradictions

Ticagrelor is contraindicated in case of- Hypersensitivity to Ticagrelor or to any of the excipients Active pathological bleeding (peptic ulcer) History of intracranial haemorrhage Moderate to severe hepatic impairment Co-administration of Ticagrelor with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, nefazodone, ritonavir, and atazanavir)

Side Effects

Dyspnea,bleeding,headache,cough,dizziness,nausea,atrial fibrillation, hypertension, non-cardiac chest pain, diarrhea, back pain, hypotension, fatigue, chest pain.

Pregnancy & Lactation

Pregnancy category C. There are no or limited amount of data from the use of Ticagrelor in pregnant women.Ticagrelor is not recommended during pregnancy. Nursing mothers: Available pharmacodynamic/toxicological data in animals have shown excretion of Ticagrelor and its active metabolites in milk. A risk to newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from ticagrelor therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the women.

Overdose Effects

There is currently no known antidote to reverse the effects ofTicagrelor and it is not expected to be dialysable.Treatment of overdose should follow local standard medical practice.The expected effect of excessive ticagrelor dosing is prolonged duration of bleeding risk associated with platelet inhibition. If bleeding occurs appropriate supportive measures should be taken.

Precaution & Warnings

General Risk of Bleeding: Drugs that inhibit platelet function including Ticagrelor increase the risk of bleeding. Concomitant Aspirin Maintenance Dose: Use of Ticagrelor with maintenance doses of aspirin above 100 mg decreased the effectiveness of Ticagrelor. Therefore, after the initial loading dose of aspirin (usually 325 mg), use Ticagrelor with a maintenance dose of aspirin of 75-100 mg. Moderate Hepatic Impairment: Ticagrelor has not been studied in patients with moderate hepatic impairment. Discontinuation of Ticagrelor: Discontinuation of Ticagrelor will increase the risk of myocardial infarction, stent thrombosis, and death.

Storage Conditions

Protect from light & moisture. Store below 258 C. Keep out of reach of children.