Thrombonorm

Trade Name:

Thrombonorm

Composition

Anagrelide hydrochloride 0,57 mg

Equivalent to anagrelide 0,50 mg

Inactive ingredients:

Lactose monohydrate, PVP K30, croscarmellose sodium, microcrystalline cellulose 101, magnesium stearate, tween 80, gelatin, titanium dioxide, brilliant blue, carmoisine.

Properties

The mechanism by which anagrelide reduces blood platelet count is still under investigation. Studies in patients support a hypothesis of dose-related reduction in platelet production resulting from a decrease in megakaryocyte hypermaturation. In blood withdrawn from normal volunteers treated with anagrelide a disruption was found in the postmitotic phase of megakaryocyte development and a reduction in megakaryocyte size and ploidy.

Indication

For the treatment of patients with thrombocythemia secondary to myeloproliferative disorders to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events.

Dosage and administration

Adult

Thrombocythemia

Indicated for essential thrombocythemia and for thrombocythemia secondary to myeloproliferative disorders to decrease risk thrombosis and thrombo-hemorrhagic event:

Side effects

Common: Bloating or swelling of the face, arms, hands, lower legs, or feet

body aches or pain, burning, crawling, itching, numbness, prickling, «pins and needles», or tingling feelings, chest pain, congestion, cough, difficult or labored breathing, dryness or soreness of the throat, fast, irregular, pounding, or racing heartbeat or pulse, fever, hoarseness

rapid weight gain, runny nose, tender, swollen glands in the neck, tightness in the chest,trouble with swallowing, voice changes.

Contraindications

Anagrelide is contraindicated in patients with severe hepatic impairment. Exposure to anagrelide is increased 8-fold in patients with moderate hepatic impairment. Use of anagrelide in patients with severe hepatic impairment has not been studied.

Warnings and precautions:

Anagrelide therapy requires close clinical supervision of the patient. While the platelet count is being lowered (usually during the first two weeks of treatment), blood counts (hemoglobin, white blood cells), and renal function (serum creatinine, BUN) should be

Storage

Store at a temperature not exceeding 30°C in a dry place.

Package:

Carton box contains 10 strips each of 10 hard gelatin capsules and inner leaflet.