Anagrelide Hydrochloride Watson lowers the number of blood clotting cells (platelets) in the body, which helps prevent blood clots from forming.
Anagrelide Hydrochloride Watson is used to treat a condition called thrombocythemia (also called thrombocytosis). Thrombocythemia is a blood cell disorder in which too many platelet cells are produced, causing bleeding or blood-clotting problems.
Anagrelide Hydrochloride Watson may also be used for purposes not listed in this medication guide.
Anagrelide Hydrochloride Watson indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Anagrelide Hydrochloride Watson is a medicine which interferes with the development of platelets. It reduces the number of platelets produced by the bone marrow, which results in a decrease in the platelet count in the blood towards a more normal level. For this reason it is used to treat patients with essential thrombocythaemia.
Essential thrombocythaemia is a condition which occurs when the bone marrow produces too many of the blood cells known as platelets. Large numbers of platelets in the blood can cause serious problems with blood circulation and clotting.
How should I use Anagrelide Hydrochloride Watson?
Use Anagrelide Hydrochloride Watson as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Anagrelide Hydrochloride Watson by mouth with or without food.
Take Anagrelide Hydrochloride Watson on a regular schedule to get the most benefit from it. It may take several weeks (4 to 12 weeks) before you get the full effect from Anagrelide Hydrochloride Watson.
If you miss a dose of Anagrelide Hydrochloride Watson, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Anagrelide Hydrochloride Watson.
Uses of Anagrelide Hydrochloride Watson in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Essential thrombocythemia: Treatment of thrombocythemia secondary to myeloproliferative neoplasms to reduce elevated platelets and the risk of thrombosis and to reduce associated symptoms (including thrombo-hemorrhagic events).
Note: The use of hydroxyurea and low-dose aspirin may be preferred over Anagrelide Hydrochloride Watson for the initial treatment of essential thrombocythemia; however, Anagrelide Hydrochloride Watson may be appropriate in patients who are resistant or intolerant to hydroxyurea (ESMO [Vannucchi 2015]).
Anagrelide Hydrochloride Watson description
Anagrelide Hydrochloride Watson is a drug used for the treatment of essential thrombocytosis (ET; essential thrombocythemia). It also has been used in the treatment of chronic myeloid leukemia. [Wikipedia]
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Starting Dose
Adults: The recommended starting dosage of Anagrelide Hydrochloride Watson is 0.5 mg four times daily or 1 mg twice daily.
Pediatric Patients: The recommended starting dosage of Anagrelide Hydrochloride Watson is 0.5 mg daily.
Titration
Continue the starting dose for at least one week and then titrate to reduce and maintain the platelet count below 600,000/µL, and ideally between 150,000/µL and 400,000/µL. The dose increment should not exceed 0.5 mg/day in any one week. Dosage should not exceed 10 mg/day or 2.5 mg in a single dose. Most patients will experience an adequate response at a dose of 1.5 to 3.0 mg/day. Monitor platelet counts weekly during titration then monthly or as necessary.
Dose Modifications for Hepatic Impairment
In patients with moderate hepatic impairment (Child Pugh score 7-9) start Anagrelide Hydrochloride Watson therapy at a dose of 0.5 mg/day and monitor frequently for cardiovascular events. Patients with moderate hepatic impairment who have tolerated Anagrelide Hydrochloride Watson therapy for one week may have their dose increased. The dose increase increment should not exceed 0.5 mg/day in any one week. Avoid use of Anagrelide Hydrochloride Watson in patients with severe hepatic impairment.
Clinical Monitoring
Anagrelide Hydrochloride Watson therapy requires clinical monitoring, including complete blood counts, assessment of hepatic and renal function, and electrolytes.
To prevent the occurrence of thrombocytopenia, monitor platelet counts every two days during the first week of treatment and at least weekly thereafter until the maintenance dosage is reached. Typically, platelet counts begin to respond within 7 to 14 days at the proper dosage. In the clinical trials, the time to complete response, defined as platelet count ≤ 600,000/µL, ranged from 4 to 12 weeks. In the event of dosage interruption or treatment withdrawal, the rebound in platelet count is variable, but platelet counts typically will start to rise within 4 days and return to baseline levels in one to two weeks, possibly rebounding above baseline values. Monitor platelet counts frequently.
More about Anagrelide Hydrochloride Watson (Anagrelide Hydrochloride Watson)
Limited PK and/or PD studies investigating possible interactions between Anagrelide Hydrochloride Watson and other medicinal products have been conducted. In vivo interaction studies in humans have demonstrated that digoxin and warfarin do not affect the PK properties of Anagrelide Hydrochloride Watson, nor does Anagrelide Hydrochloride Watson affect the PK properties of digoxin or warfarin.
In two clinical interaction studies in healthy subjects, co-administration of single-dose Anagrelide Hydrochloride Watson 1mg and aspirin 900mg or repeat-dose Anagrelide Hydrochloride Watson 1mg once daily and aspirin 75mg once daily showed greater ex vivo anti-platelet aggregation effects than administration of aspirin alone. Co-administered Anagrelide Hydrochloride Watson 1mg and aspirin 900mg single-doses had no effect on bleeding time, prothrombin time (PT) or activated partial thromboplastin time (aPTT). The potential risks and benefits of concomitant use of Anagrelide Hydrochloride Watson with aspirin should be assessed, particularly in patients with a high risk profile for haemorrhage, before treatment is commenced.
Drug interaction studies have not been conducted with the other common medications used concomitantly with Anagrelide Hydrochloride Watson in clinical trials which were acetaminophen, furosemide, iron, ranitidine, hydroxyurea, and allopurinol.
Anagrelide Hydrochloride Watson is metabolized at least in part by CYP1A2. It is known that CYP1A2 is inhibited by several medicinal products, including fluvoxamine, and such medicinal products could theoretically adversely influence the clearance of Anagrelide Hydrochloride Watson. Anagrelide Hydrochloride Watson demonstrates some limited inhibitory activity towards CYP1A2 which may present a theoretical potential for interaction with other coadministered medicinal products sharing that clearance mechanism e.g. theophylline.
Anagrelide Hydrochloride Watson is an inhibitor of cyclic AMP PDE III. The effects of medicinal products with similar properties such as inotropes milrinone, enoximone, amrinone, olprinone and cilostazol may be exacerbated by Anagrelide Hydrochloride Watson.
There is a single case report which suggests that sucralfate may interfere with Anagrelide Hydrochloride Watson absorption. Food has no clinically significant effect on the bioavailability of Anagrelide Hydrochloride Watson.
Analysis of the adverse events in a population consisting of 942 patients in 3 clinical studies diagnosed with myeloproliferative diseases of varying etiology (ET: 551; PV: 117; OMPD: 274) has shown that all disease groups have the same adverse event profile. While most reported adverse events during Anagrelide Hydrochloride Watson therapy have been mild in intensity and have decreased in frequency with continued therapy, serious adverse events were reported in these patients. These include the following: congestive heart failure, myocardial infarction, cardiomyopathy, cardiomegaly, complete heart block, atriala fibrillation, cerebrovascular accident, pericarditis, pericardial effusion, pleural effusion, pulmonary infiltrates, pulmonary fibrosis, pulmonary hypertension, pancreatitis, gastric/duodenal ulceration, and seizure.
Of the 942 patients treated with Anagrelide Hydrochloride Watson for a mean duration of approximately 65 weeks, 161 (17%) were discontinued from the study because of adverse events or abnormal laboratory test results. The most common adverse events for treatment discontinuation were headache, diarrhea, edema, palpitations, and abdominal pain. Overall, the occurrence rate of all adverse events was 17.9 per 1,000 treatment days. The occurrence rate of adverse events increased at higher dosages of Anagrelide Hydrochloride Watson. The most frequently reported adverse reactions to Anagrelide Hydrochloride Watson (in 5% or greater of 942 patients with myeloproliferative disease) in clinical trials were:
Headache................................43.5%
Palpitations............................26.1%
Diarrhea.................................25.7%
Asthenia.................................23.1%
Edema, other..........................20.6%
Nausea....................................17.1%
Abdominal Pain.....................16.4%
Dizziness................................15.4%
Pain, other..............................15.0%
Dyspnea.................................11.9%
Flatulence...............................10.2%
Vomiting................................9.7%
Fever......................................8.9%
Peripheral Edema...................8.5%
Rash, including urticaria........8.3%
Chest Pain..............................7.8%
Anorexia................................7.7%
Tachycardia............................7.5%
Pharyngitis.............................6.8%
Malaise...................................6.4%
Cough.....................................6.3%
Paresthesia.............................5.9%
Back Pain...............................5.9%
Pruritus...................................5.5%
Dyspepsia...............................5.2%
Adverse events with an incidence of 1% to < 5% included:
Body as a Whole System: Flu symptoms, chills, photosensitivity.
Skin and Appendages System: Skin disease, alopecia.
Special Senses: Amblyopia, abnormal vision, tinnitus, visual field abnormality, diplopia.
Urogenital System: Dysuria, hematuria.
Renal abnormalities occurred in 15 patients (ET: 10; PV: 4; OMPD: 1). Six ET, 4 PV and 1 with OMPD experienced renal failure (approximately 1%) while on Anagrelide Hydrochloride Watson treatment; in 4 cases, the renal failure was considered to be possibly related to Anagrelide Hydrochloride Watson treatment. The remaining 11 were found to have pre-existing renal impairment. Doses ranged from 1.5-6.0 mg/day, with exposure periods of 2 to 12 months. No dose adjustment was required because of renal insufficiency. The adverse event profile for patients in three clinical trials on Anagrelide Hydrochloride Watson therapy (in 5% or greater of 942 patients with myeloproliferative diseases) is shown in the following bar graph:
All Patients with Myeloproliferative Disease (N=942)
Postmarketing Reports
Interstitial lung diseases (including allergic alveolitis, eosinophilic pneumonia and interstitial pneumonitis) have been reported in patients who have taken Anagrelide Hydrochloride Watson treatment in post-marketing reports
• If you are allergic (hypersensitive) to Anagrelide Hydrochloride Watson or any of the other ingredients of Anagrelide Hydrochloride Watson. Check the ingredients of Anagrelide Hydrochloride Watson listed in Section 6 of this leaflet. An allergic reaction may be recognised as a rash, itching, swollen face or lips, or shortness of breath.
• If you have moderate or severe liver problems.
• If you have moderate or severe kidney problems.
Take special care with Anagrelide Hydrochloride Watson
Before treatment with Anagrelide Hydrochloride Watson, tell your doctor
• If you have or think you might have a problem with your heart.
• If you have any problems with your liver or kidneys.
• If you are pregnant or breastfeeding.
• If you have been told by a doctor that you have an intolerance to some sugars.
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