THROMBOREDUCTIN

Generic Name/API: anagrelide

Manufacturer: Demilac Turkey

Dosage Forms & Strength & Pack Size:
Capsules: 0.5 mg, 100’s

Storage:
Store at 25°C (77°F) excursions permitted to 15°C to 30°C (59°F to 86°F), [See USP Controlled Room Temperature]. Store in a light resistant container.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS

What THROMBOREDUCTIN is and what it is used for
THROMBOREDUCTIN contains the active substance anagrelide. THROMBOREDUCTIN is a medicine that inhibits the development of platelets (thrombocytes) in the bone marrow.
THROMBOREDUCTIN is used to reduce the number of platelets in patients with essential thrombocythaemia (which is disease when the bone marrow produces too many platelets). An excessive number of platelets can cause problems with blood circulation and clotting.

WARNINGS AND PRECAUTIONS
1 Cardiovascular Toxicity
Torsades de pointes and ventricular tachycardia have been reported with AGRYLIN.
Obtain a pre-treatment cardiovascular examination including an ECG in all patients.
During treatment with AGRYLIN monitor patients for cardiovascular effects and evaluate as necessary.
AGRYLIN increases the QTc interval of the electrocardiogram and increases the heart rate in healthy volunteers [see Clinical Pharmacology (12.2)].
Do not use AGRYLIN in patients with known risk factors for QT interval prolongation, such as congenital long QT syndrome, a known history of acquired QTc prolongation,
medicinal products that can prolong QTc interval and hypokalemia [see Drug Interactions Hepatic impairment increases anagrelide exposure and could increase the risk of QTc
prolongation. Monitor patients with hepatic impairment for QTc prolongation and other cardiovascular adverse reactions. The potential risks and benefits of AGRYLIN therapy in a patient with mild and moderate hepatic impairment should be assessed before treatment is commenced. Reduce AGRYLIN dose in patients with moderate hepatic impairment. Avoid use of AGRYLIN in patients with severe hepatic impairment.
In patients with heart failure, bradyarrhythmias, or electrolyte abnormalities, consider periodic monitoring with electrocardiograms [see Clinical Pharmacology (12.2)].
AGRYLIN is a phosphodiesterase 3 (PDE3) inhibitor and may cause vasodilation, tachycardia, palpitations, and congestive heart failure. Other drugs that inhibit PDE3 have caused decreased survival when compared with placebo in patients with Class III-IV congestive heart failure [see Drug Interactions (7.2)].
In patients with cardiac disease, use AGRYLIN only when the benefits outweigh the risks.

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