Source: Registered Drug Product Database (NG) Publisher: Me Cure Industries Limited, Plot 6 Block H Debo Industries Compound, Oshodi Industrial Scheme, Oshodi, Lagos, Nigeria
FLUSHOF (albendazole) is indicated for the treatment of the following infections:
Neurocysticercosis. FLUSHOF 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.
Hydatid disease. FLUSHOF 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 80-90% of patients given FLUSHOF for 3 cycles of therapy of 28 days each.
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 FLUSHOF in the pre- or post-surgical setting, optimal killing of cyst contents is achieved when three 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
400 mg (one FLUSHOF tablet) as a single dose in both adults and children over two years of age.
In heavy mixed infestation involving Strongyloides or Taeniasis, a single daily dose may be inadequate and the dose may be given for three consecutive days.
Note: If the patient is not cured after three weeks, a second course of treatment may be given. No special procedures, such as fasting or purging, are required. Albendazole has not been adequately studied in children under one year of age.
A single 400 mg (one FLUSHOF tablet) daily dose for five days. Some people, particularly young children, may experience difficulties swallowing the tablets whole and should be encouraged to chew the tablets with a little water; alternatively tablets may be crushed and mixed with food.
Experience in patients 65 years of age or older is limited. Reports indicate that no dosage adjustment is required; however albendazole should be used with caution in elderly patients with evidence of hepatic dysfunction (see Hepatic Impairment below).
Since renal elimination of albendazole and its primary metabolite, albendazole sulfoxide, is negligible, it is unlikely that clearance of these compounds would be altered in these patients. No dosage adjustment is required; however patients with evidence of renal impairment should be carefully monitored.
Since albendazole is rapidly metabolised by the liver to the primary pharmacologically active metabolite, albendazole sulfoxide, hepatic impairment would be expected to have significant effects on the pharmacokinetics of albendazole sulfoxide. Patients with abnormal liver function test results (transaminases) prior to commencing albendazole therapy should be carefully monitored.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
3 years.
This medicinal product does not require any special storage conditions.
Albendazole Caplets are packaged in clear PVC – Aluminum foil blister pack.
Pack size: Blisters pack of 1 uncoated caplet.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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