Albenza
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Questions & Answers
Side Effects & Adverse Reactions
Rare fatalities associated with the use of ALBENZA have been reported due to granulocytopenia or pancytopenia (see PRECAUTIONS). Albendazole has been shown to cause bone marrow suppression, aplastic anemia, and agranulocytosis in patients with and without underlying hepatic dysfunction. Blood counts should be monitored at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy with albendazole in all patients. Patients with liver disease, including hepatic echinococcosis, appear to be more at risk for bone marrow suppression leading to pancytopenia, aplastic anemia, agranulocytosis, and leukopenia attributable to albendazole and warrant closer monitoring of blood counts. Albendazole should be discontinued in all patients if clinically significant decreases in blood cell counts occur.
Albendazole should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. Patients should not become pregnant for at least 1 month following cessation of albendazole therapy. If a patient becomes pregnant while taking this drug, albendazole should be discontinued immediately. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.
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
ALBENZA is indicated for the treatment of the following infections:
ALBENZA is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium.
Lesions considered responsive to albendazole therapy appear as nonenhancing cysts with no surrounding edema on contrast-enhanced computerized tomography. Clinical studies in patients with lesions of this type demonstrate a 74% to 88% reduction in number of cysts; 40% to 70% of albendazole-treated patients showed resolution of all active cysts.
ALBENZA is indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus.
This indication is based on combined clinical studies which demonstrated non-infectious cyst contents in approximately 80 to 90% of patients given ALBENZA for 3 cycles of therapy of 28 days each (see DOSAGE AND ADMINISTRATION). Clinical cure (disappearance of cysts) was seen in approximately 30% of these patients, and improvement (reduction in cyst diameter of ≥25%) was seen in an additional 40%.
NOTE: When medically feasible, surgery is considered the treatment of choice for hydatid disease. When administering ALBENZA in the pre- or post-surgical setting, optimal killing of cyst contents is achieved when 3 courses of therapy have been given.
NOTE: The efficacy of albendazole in the therapy of alveolar hydatid disease caused by Echinococcus multilocularis has not been clearly demonstrated in clinical studies.
History
There is currently no drug history available for this drug.
Other Information
ALBENZA (albendazole) is an orally administered broad-spectrum anthelmintic. Chemically, it is methyl 5-(propylthio)-2-benzimidazolecarbamate. Its molecular formula is C12H15N3O2S. Its molecular weight is 265.34. It has the following chemical structure:
Albendazole is a white to off-white powder. It is soluble in dimethylsulfoxide, strong acids, and strong bases. It is slightly soluble in methanol, chloroform, ethyl acetate, and acetonitrile. Albendazole is practically insoluble in water. Each white to off-white, film-coated tablet contains 200 mg of albendazole.
Inactive ingredients consist of: carnauba wax, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium saccharin, sodium starch glycolate, and starch.
Sources
Albenza Manufacturers
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Amedra Pharmaceuticals Llc
![Albenza (Albendazole) Tablet, Film Coated [Amedra Pharmaceuticals Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Albenza | Amedra Pharmaceuticals Llc
2.1 DosageDosing of ALBENZA will vary depending upon the indication. ALBENZA tablets may be crushed or chewed and swallowed with a drink of water. ALBENZA chewable tablets are also available for children and patients who may experience swallowing difficulties. ALBENZA tablets and ALBENZA chewable tablets should be taken with food [see Clinical Pharmacology (12.3)].
Table 1: ALBENZA Dosage Indication Patient Weight Dose Duration Hydatid Disease 60 kg or greater 400 mg twice daily, with meals 28-day cycle followed by a 14-day albendazole-free interval, for a total of 3 cycles Less than 60 kg 15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg) Neurocysticercosis 60 kg or greater 400 mg twice daily, with meals 8 to 30 days Less than 60 kg 15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg) 2.2 Concomitant Medication to Avoid Adverse ReactionsPatients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of treatment [see Warnings and Precautions (5.3)].
2.3 Monitoring for Safety Before and During Treatment Monitor blood counts at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy with ALBENZA in all patients [see Warnings and Precautions (5.1)]. Monitor liver enzymes (transaminases) at the beginning of each 28-day cycle of therapy, and at least every 2 weeks during treatment with ALBENZA in all patients [see Warnings and Precautions (5.5)]. Obtain a pregnancy test in women of reproductive potential prior to therapy [see Warnings and Precautions (5.2)]. -
Rxpak Division Of Mckesson Corporation
Albenza | Rxpak Division Of Mckesson Corporation
Dosing of ALBENZA will vary, depending upon which of the following parasitic infections is being treated. In young children, the tablets should be crushed or chewed and swallowed with a drink of water.
Indication
Patient Weight
Dose
Duration
Hydatid Disease
60 kg or greater
400 mg twice daily, with
meals28-day cycle followed by a
14-day albendazole-free
interval, for a total of 3
cyclesless than 60 kg
15 mg/kg/day given in
divided doses twice daily
with meals (maximum total
daily dose 800 mg)NOTE: When administering ALBENZA in the pre- or post-surgical setting, optimal
killing of cyst contents is achieved when 3 courses of therapy have been given.Neurocysticercosis
60 kg or greater
400 mg twice daily, with
meals8 to 30 days
less than 60 kg
15 mg/kg/day given in
divided doses twice daily
with meals (maximum total
daily dose 800 mg)Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of treatment.
![Albenza (Albendazole) Tablet, Film Coated [Rxpak Division Of Mckesson Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ff679b27-bdf5-4ccc-a57e-6a4d7e77d90c&name=albenza-tablets-2.jpg)
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