Agrelid: instructions for using the medicine, structure, Contraindications
Agrelid antithrombotic, antineoplastic agent, which affects the decrease in the number of platelets in peripheral blood.
Agrelid: indications and dosage
Agrelide is indicated for the treatment of thrombocythemia in patients with myeloproliferative disorders to reduce platelet counts, reduced risk of thrombosis and limited associated symptoms, including thrombohemorrhagic events (chronic forms of the disease). Agrelide is administered orally. Treatment should be started under constant supervision. The recommended starting dose of anagrelide is 0,5 mg 4 times a day, or 1,0 mg 2 once a day. This dose is maintained for 1 of the week. Through 1 week the dose can be changed individually, dose should be adjusted to the lowest effective, which will be sufficient to lower / keeping platelet count below 600 × 109 / l, and ideally – at the level of 150 × 109 / l to 400 × 109 / l. Increasing the dose of the drug should not exceed 0,5 mg daily for 1 of the week. The maximum single dose of the drug should not exceed 2,5 mg. The maximum daily dose used during the clinical trials of the drug, was 10 mg / d. During the first week of treatment, platelet counts should be measured every 2 day, further, least, every week until a steady dose is reached. Usually, a decrease in the number of platelets is observed during 14-21 days from the start of treatment and in most patients an adequate response to treatment is observed and maintained with a dose 1-3 mg / d. In studies, starting dose in children (7-14 years) ranged from 0,5 mg once daily to 0,5 mg 4 once a day. Because data on the optimal starting dose in children are limited, the starting dose should be followed. 0,5 mg / day. The selection of the minimum effective and maintenance dose in children and adults does not differ.. There are no specific dosing recommendations for elderly patients.. Before initiating treatment in patients with mild hepatic impairment, the risks and benefits of such treatment should be weighed.. It is recommended to start treatment in patients with mild hepatic insufficiency with a dose of 0,5 mg / d, must be maintained for at least a week under the supervision of the cardiovascular system. increase the dose by more than 0,5 mg per week should not be.
Agrelid: overdose
A small number of cases of Agrelide overdose have been reported., symptoms included sinus tachycardia and vomiting. There is no specific antidote for anagrelide.. In case of an overdose, the patient should be closely monitored. It is necessary to control the number of platelets in the blood. In case of an overdose, the drug should be discontinued, until the platelet count returns to normal. Anagrelide at doses, exceeding recommended, caused a decrease in blood pressure with occasional hypotension. Dose of anagrelide c 5 mg may lower blood pressure, accompanied by dizziness.
Agrelid: side effects
Agrelide is well tolerated in low doses. Most side effects are mild and transient., it does not require specific treatment to eliminate them. Side effects in patients with myeloproliferative diseases of various etiologies are almost the same in nature and frequency.. Most adverse reactions are mild and their frequency decreases with continued therapy.. However, in some cases there are serious side effects.: congestive heart failure, myocardial infarction, cardiomyopathy, kardiomegalija, complete heart block, auricular fibrillation, cerebrovascular accident, pericarditis, pulmonary infiltrates, pneumofibrosis, pulmonary hypertension, pancreatitis, gastritis, peptic ulcer, seizures. The frequency of occurrence of adverse reactions increases with increasing dose of the drug..
Agrelid: Contraindications
Contraindications to the use of the drug Agrelide are: hypersensitivity to the drug; moderate or severe liver failure (elevated transaminase levels over 5 times higher than normal); moderate or severe renal failure (creatine clearance <50 ml / m). The drug is not used for the treatment of acute, life-threatening complications of thrombocytosis.
Studies on the safety and effectiveness of Agrelide in pregnant and breastfeeding women, not carried out. The use of anagrelide in pregnant women is not recommended.. If a woman is using anagrelide during pregnancy or becomes pregnant while taking the drug, she should be warned about the risk to the fetus. Women of reproductive age, taking anagrelide, contraceptives should be used. Unknown, passes anagrelide from the mother's body, breast-feeding, into milk, therefore, given the danger of the drug for the child, if there is a need to use the drug during breastfeeding, breastfeeding should be stopped.
Agrelid: interactions with other drugs and alcohol
Agrelid – phosphodiesterase inhibitor III. The concomitant use of anagrelide with other phosphodiesterase III inhibitors is not recommended., such as: milrinon, enoximone, amrinon, olprinone and cilostazol. Fluvoxamine and omeprazole may adversely affect the clearance of anagrelide. In recommended doses, the drug may enhance the effect of other drugs., depress or modify platelet function, eg, acetylsalicylic acid. Some patients with true thrombocythemia, concomitantly treated with acetylsalicylic acid and anagrelide, there were cases of massive bleeding. By the beginning of the simultaneous use of acetylsalicylic acid and anagrelide, it is necessary to assess the potential risk of developing hemorrhage. A pharmacokinetic study with the combined use of anagrelide with warfarin and digoxin did not reveal an interaction between these drugs.. During clinical trials, the following drugs were often used together with anagrelide: acetaminophen, furosemid, iron supplements, ranitidine, hydroxyurethane, allopurinol. Clinical manifestations of the interaction of these drugs with anagrelide were not found.. Known from practice, that sucralfate may interfere with the absorption of anagrelide from the gastrointestinal tract. Co-administration of anagrelide in patients with phlebotomy was effective, like in patients, receiving other combination therapy with anagrelide and hydroxyurea, aspirin, interferon and alkylating agents.
Agrelid: composition and properties
Agrelid: structure
1 Agrelide capsule contains anagrelide 0,5 mg as anagrelide hydrochloride monohydrate. Excipients: lactose, lactose, microcrystalline cellulose, krospovydon, povidone, magnesium stearate. Capsule: silicon dioxide, sodium lauryl, Titanium dioxide (E 171), Purified water, gelatin.
Agrelid: release form
By 50 capsules in vials.
Agrelid: pharmachologic effect
Antithrombotic, antineoplastic agent, which affects the decrease in the number of platelets in peripheral blood. When administered orally, anagrelide causes a dose-dependent and reversible decrease in the number of platelets in peripheral blood.. Machinery, by means of which anagrelide leads to a decrease in the number of platelets, are still being studied.
Clinical studies show, that anagrelide inhibits the overgrowth of megakaryocytes, and this phenomenon is dose dependent.. In blood samples, obtained from healthy volunteers, treated with anagrelide, post-mitotic phases of development of megakaryocytes, reduction in their size and ploidy. At therapeutic doses, anagrelide does not lead to a significant change in the number of leukocytes., causes a slight clinically insignificant decrease in the number of red blood cells. Anagrelide inhibits phosphodiesterase III of cyclic AMP. Phosphodiesterase III cAMP inhibitors may cause a decrease in platelet aggregation. However, a significant decrease in platelet aggregation is observed at higher doses., than it is necessary to reduce the number of platelets. The use of anagrelide does not lead to a significant change in parameters such as blood clotting time and platelet lifespan., does not change the morphology of the bone marrow. Anagrelide does not affect blood pressure, pulse rate, urinalysis and ECG indicators.
Agrelid: storage conditions
general information
- Sales form: on prescription
- Current in-about: Anagrelide
- Manufacturer: Sun Pharmaceutical Industries Ltd, India
