Anagrelide Hydrochloride
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Questions & Answers
Side Effects & Adverse Reactions
Anagrelide should be used with caution in patients with known or suspected heart disease, and only if the potential benefits of therapy outweigh the potential risks. Because of the positive inotropic effects and side effects of anagrelide, a pre-treatment cardiovascular examination is recommended along with careful monitoring during treatment. In humans, therapeutic doses of anagrelide may cause cardiovascular effects, including vasodilation, tachycardia, palpitations, and congestive heart failure.
Exposure to anagrelide is increased 8 fold in patients with moderate hepatic impairment (see CLINICAL PHARMACOLOGY). Use of anagrelide in patients with severe hepatic impairment has not been studied. The potential risks and benefits of anagrelide therapy in a patient with mild and moderate impairment of hepatic function should be assessed before treatment is commenced. In patients with moderate hepatic impairment, dose reduction is required and patients should be carefully monitored for cardiovascular effects (see DOSAGE AND ADMINISTRATION for specific dosing recommendations).
Interstitial lung diseases (including allergic alveolitis, eosinophilic pneumonia and interstitial pneumonitis) have been reported to be associated with the use of anagrelide in postmarketing reports. Most cases presented with progressive dyspnea with lung infiltrations. The time of onset ranged from 1 week to several years after initiating anagrelide. In most cases, the symptoms improved after discontinuation of anagrelide (see ADVERSE REACTIONS).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Anagrelide hydrochloride capsules are indicated 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 (see CLINICAL STUDIES, DOSAGE AND ADMINISTRATION).
History
There is currently no drug history available for this drug.
Other Information
Anagrelide hydrochloride is an off white powder that is very slightly soluble in water and sparingly soluble in dimethyl sulfoxide and in dimethylformamide. Anagrelide hydrochloride is a platelet-reducing agent with a chemical name of 6,7-dichloro-1,5-dihydroimidazo[2,1-b] quinazolin-2(3H)-one monohydrochloride monohydrate, and it has the following structural formula:
C10H7Cl2N3O·HCl·H2O M.W. 310.55
Each anagrelide hydrochloride capsule, for oral administration, contains either 0.5 mg or 1 mg of anagrelide base (as anagrelide hydrochloride) and has the following inactive ingredients: black iron oxide, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1/brilliant blue aluminum lake, FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red aluminum lake, gelatin, lactose anhydrous, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, propylene glycol, shellac glaze and titanium dioxide.
Sources
Anagrelide Hydrochloride Manufacturers
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Physicians Total Care, Inc.
![Anagrelide Hydrochloride Capsule [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Anagrelide Hydrochloride | Physicians Total Care, Inc.
Treatment with anagrelide hydrochloride capsules should be initiated under close medical supervision. The recommended starting dosage of anagrelide hydrochloride capsules for adult patients is 0.5 mg q.i.d. or 1 mg b.i.d (2 capsules of 0.5 mg twice a day), which should be maintained for at least one week. Starting doses in pediatric patients have ranged from 0.5 mg per day to 0.5 mg q.i.d. As there are limited data on the appropriate starting dose for pediatric patients, an initial dose of 0.5 mg per day is recommended. In both adult and pediatric patients, dosage should then be adjusted to the lowest effective dosage required to reduce and maintain platelet count below 600,000/µL, and ideally to the normal range. The dosage should be increased by not more than 0.5 mg/day in any one week. Maintenance dosing is not expected to be different between adult and pediatric patients. Dosage should not exceed 10 mg/day or 2.5 mg in a single dose (see PRECAUTIONS).
There are no special requirements for dosing the geriatric population.
It is recommended that patients with moderate hepatic impairment start anagrelide therapy at a dose of 0.5 mg/day and be maintained for a minimum of one week with careful monitoring of cardiovascular effects. The dosage increment must not exceed more than 0.5 mg/day in any one week. The potential risks and benefits of anagrelide therapy in a patient with mild or moderate impairment of hepatic function should be assessed before treatment is commenced. Use of anagrelide in patients with severe hepatic impairment has not been studied. Use of anagrelide in patients with severe hepatic impairment is contraindicated (see CONTRAINDICATIONS).
To monitor the effect of anagrelide and prevent the occurrence of thrombocytopenia, platelet counts should be performed every two days during the first week of treatment and at least weekly thereafter until the maintenance dosage is reached.
Typically, platelet count begins to respond within 7 to 14 days at the proper dosage. The time to complete response, defined as platelet count ≤600,000/µL, ranged from 4 to 12 weeks. Most patients will experience an adequate response at a dose of 1.5 to 3 mg/day. Patients with known or suspected heart disease, renal insufficiency, or hepatic dysfunction should be monitored closely.
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Ivax Pharmaceuticals, Inc.
Anagrelide Hydrochloride | Isomers Laboratories Inc.
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Carilion Materials Management
Anagrelide Hydrochloride | Carilion Materials Management
Treatment with Anagrelide Hydrochloride Capsules should be initiated under close medical supervision. The recommended starting dosage of Anagrelide Hydrochloride Capsules for adult patients is 0.5 mg qid or 1 mg bid (2 capsules of 0.5 mg twice a day), which should be maintained for at least one week. Starting doses in pediatric patients have ranged from 0.5 mg per day to 0.5 mg qid. As there are limited data on the appropriate starting dose for pediatric patients, an initial dose of 0.5 mg per day is recommended. In both adult and pediatric patients, dosage should then be adjusted to the lowest effective dosage required to reduce and maintain platelet count below 600,000/µL, and ideally to the normal range. The dosage should be increased by not more than 0.5 mg/day in any one week. Maintenance dosing is not expected to be different between adult and pediatric patients. Dosage should not exceed 10 mg/day or 2.5 mg in a single dose (see ). PRECAUTIONS
There are no special requirements for dosing the geriatric population.
It is recommended that patients with moderate hepatic impairment start anagrelide therapy at a dose of 0.5 mg/day and be maintained for a minimum of one week with careful monitoring of cardiovascular effects. The dosage increment must not exceed more than 0.5 mg/day in any one week. The potential risks and benefits of anagrelide therapy in a patient with mild or moderate impairment of hepatic function should be assessed before treatment is commenced. Use of anagrelide in patients with severe hepatic impairment has not been studied. Use of anagrelide in patients with severe hepatic impairment is contraindicated (see ). CONTRAINDICATIONS
To monitor the effect of anagrelide and prevent the occurrence of thrombocytopenia, platelet counts should be performed every two days during the first week of treatment and at least weekly thereafter until the maintenance dosage is reached.
Typically, platelet count begins to respond within 7 to 14 days at the proper dosage. The time to complete response, defined as platelet count ≤ 600,000/µL, ranged from 4 to 12 weeks. Most patients will experience an adequate response at a dose of 1.5 to 3 mg/day. Patients with known or suspected heart disease, renal insufficiency, or hepatic dysfunction should be monitored closely.
![Anagrelide Hydrochloride Capsule [Ivax Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9a9a5074-a559-4680-8ce0-e6cd59adbf1b&name=DeoDry-90mlC1412.jpg)
![Anagrelide Hydrochloride Capsule [Carilion Materials Management]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=614b45a3-7f2e-4348-9e20-ecf8dc440314&name=68151-2959.jpg)
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