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Medglor

Medglor

Manufacturer:

Exemed Pharmaceuticals

Distributor:

Cosma Trading

Marketer:

Cosma Medical
Concise Prescribing Info
Contents
Ticagrelor
Indications/Uses
Prevention of thrombotic events (CV death, MI & stroke) in patients w/ acute coronary syndromes (ACS) (unstable angina, non-ST elevation MI or ST elevation MI) including those managed medically & w/ percutaneous coronary intervention or CABG. Reduction of risk of stroke in patients w/ acute ischemic stroke (NIH Stroke Scale score ≤5) or transient ischemic attack.
Dosage/Direction for Use
May be given in combination w/ low maintenance dose of ASA 75-150 mg daily, unless specifically contraindicated. ACS Initially 180 mg single loading dose, then continue at 90 mg bid for 12 mth. History of MI 60 mg bid when extended treatment is required. Treatment may be started w/o interruption as continuation therapy after the initial 1 yr treatment w/ 90 mg or other adenosine diphosphate receptor inhibitor therapy in ACS patients w/ high risk of atherothrombotic event.
Administration
May be taken with or without food: Swallow whole. May dissolve tab & administer mixt via nasogastric tube for patients unable to swallow. Take immediately.
Contraindications
Hypersensitivity. Active pathological bleeding. History of intracranial hemorrhage. Co-administration w/ strong CYP3A4 inhibitors eg, ketoconazole, clarithromycin, nefazodone, ritonavir & atazanavir. Severe hepatic impairment.
Special Precautions
Discontinue treatment 5 days prior to elective surgery; in case of new, prolonged or worsened dyspnoea. Avoid premature treatment discontinuation. Treatment beyond 1 yr is not recommended in patients w/ history of MI w/ prior ischaemic stroke. Not recommended in patients w/ uric acid nephropathy. Bradyarrhythmic events & AV blocks; dyspnoea. Central sleep apnoea including Cheyne-Stokes respiration. Increased creatinine levels; hyperuricaemia during treatment. TTP. Patients at increased risk of bleeding (eg, recent trauma or surgery, coagulation disorders, active or recent GI bleeding) or who are at increased risk of trauma; bradycardic events (eg, w/o pacemaker who have sick sinus syndrome, 2nd or 3rd degree AV block or bradycardic-related syncope); history of asthma &/or COPD, hyperuricaemia or gouty arthritis; who have developed heparin-induced thrombocytopenia (HIT). Advise patients to inform physicians & dentists that they are taking ticagrelor before any surgery is scheduled & before any new medicinal product is taken. Check renal function 1 mth after treatment initiation in ACS patients, ≥75 yr, moderate/severe renal impairment & those receiving concomitant treatment w/ ARB. Concomitant administration of medicinal products that may increase risk of bleeding (eg, NSAIDs, oral anticoagulants &/or fibrinolytics) w/in 24 hr of ticagrelor dosing; medicinal products known to induce bradycardia. Not recommended in coadministration w/ high maintenance dose ASA (>300 mg). False -ve results in platelet function test for HIT. May impair ability to drive or operate machinery due to dizziness. Moderate hepatic impairment. Women of childbearing potential should use appropriate contraception during therapy. Not recommended during pregnancy. Lactation. Childn <18 yr. Not to be used in childn w/ sickle cell disease.
Adverse Reactions
Blood disorder bleedings; hyperuricaemia; dyspnoea. Gout/gouty arthritis; dizziness, syncope, headache; vertigo; hypotension; resp system bleedings; GI haemorrhage, diarrhoea, nausea, dyspepsia, constipation; SC or dermal bleeding, rash, pruritus; urinary tract bleeding; increased blood creatinine; post-procedural haemorrhage, traumatic bleedings.
Drug Interactions
Increased Cmax & AUC w/ strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir); moderate CYP3A4 inhibitors (eg, diltiazem, amprenavir, aprepitant, erythromycin, fluconazole); cyclosporine. Decreased Cmax & AUC w/ CYP3A inducers (eg, rifampicin, phenytoin, carbamazepine, phenobarb). Increased Cmax & AUC of simvastatin or lovastatin; digoxin. Potential for reduced efficacy w/ morphine. May increase exposure of CYP3A4 substrates w/ narrow therapeutic indices (ie, cisapride or ergot alkaloids). Affected renal excretion & increased risk of accumulation of rosuvastatin. Potential pharmacodynamic interactions w/ medicinal products known to alter haemostasis. Increased risk of bleeding w/ SSRIs (eg, paroxetine, sertraline, citalopram).
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AC24 - ticagrelor ; Belongs to the class of platelet aggregation inhibitors excluding heparin. Used in the treatment of thrombosis.
Presentation/Packing
Form
Medglor FC tab 90 mg
Packing/Price
6 × 10's
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