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Thromboreductin

Thromboreductin

anagrelide

Manufacturer:

AOP Orphan

Distributor:

Indochina Healthcare
Concise Prescribing Info
Contents
Anagrelide
Indications/Uses
Reduction of elevated platelet counts & associated clinical symptoms in at high risk essential thrombocythemia patients (eg, ≥60 yr, platelet count ≥1,000 x 109/L, history of thrombo-haemorrhagic events).
Dosage/Direction for Use
Individualized dosage. Initially, 1 mg/day for 1 wk. Adjust dose individually after 1 wk. Increase of daily dose should not exceed 0.5 mg/wk. Max single dose: Not to exceed 2.5 mg. Normally, therapeutic response is seen w/in 14-21 days in dose range of 1-3 mg/day.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. CV disease grade 3 w/ negative benefit/risk assessment or grade 4. Moderate or severe renal (CrCl <50 mL/min) or hepatic insufficiency.
Special Precautions
Avoid abrupt discontinuation. Monitor CBC (Hb, WBC & platelet counts), LFTs (ALT & AST), renal function (serum creatinine & urea) & electrolytes (K, Mg & Ca); evidence of CV effects. Pre-treatment CV exam including baseline ECG & echocardiography prior to initiating therapy. Evaluate for signs & symptoms of underlying cardiopulmonary disease prior to & during therapy. Correct hypokalaemia or hypomagnesaemia prior to administration & monitor periodically during therapy. Prolongation of QT interval. Serious CV adverse events including Torsade de Pointes, ventricular tachycardia, cardiomyopathy, cardiomegaly & CHF. Patients of any age w/ known or suspected heart disease. Concomitant use w/ CYP1A2 inhibitors. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Hepatic & renal impairment. Women of child-bearing potential should use adequate birth control measures during treatment. Not recommended during pregnancy. Discontinue breast-feeding during treatment. Childn ≤18 yr.
Adverse Reactions
Headache. Anaemia; fluid retention; dizziness; tachycardia, palpitation; diarrhoea, vomiting, abdominal pain, nausea, flatulence; rash; fatigue. Cerebral infarction.
Drug Interactions
Decreased exposure w/ CYP1A2 inducers (eg, omeprazole). Concomitant use w/ medicinal products that can prolong QTc interval & hypokalaemia. Potential interaction w/ theophylline. Exacerbated effects of inotropes milrinone, enoximone, amrinone, olprinone & cilostazol. Potentiated effects of ASA. Intestinal disturbance in some patients & compromised absorption of hormonal OCs.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
L01XX35 - anagrelide ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Thromboreductin cap 0.5 mg
Packing/Price
100's
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