Eskazole

/ GSK

Albendazole should be taken with meals. There has been limited experience to date with the use of Albendazole High Dose in children under six years of age; therefore, use in children less than six years is not recommended. 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. Dosages are dependant on the parasite involved, the weight of the patient, and the severity of the infection.
Cystic Echinococcosis  (caused by Echinococcus granulosus) for patients > 60 kg: 800 mg given in two divided doses of 400 mg, daily for 28 days. Treatment for 28 days may be repeated after a 14 day period without treatment for a total of three cycles.
Cystic Echinococcosis  (caused by Echinococcus granulosus) for patients  < 60 kg: 15 mg/kg, given in two equally divided doses (maximum dose 800 mg/day), Daily for 28 days. Treatment for 28 days may be repeated after a 14 day period without treatment for a total of three cycles.
Inoperable and multiple cysts:  Up to three 28 day cycles of albendazole treatment may be given for the treatment of liver, lung and peritoneal cysts. More prolonged treatment may be required for sites such as bone and brain.
Preoperative: Two 28 day cycles should be given where possible prior to surgery. Where surgical intervention is necessary before completion of two cycles, albendazole should be given for as long as possible.
Postoperative, after percutaneous cyst drainage: Where only a short pre-operative course has been given (less than 14 days) and in cases where emergency surgery is required, albendazole should be given post-operatively for two 28 day cycles separated by 14 drug free days. Additionally, where cysts are found to be viable following pre-surgical treatment or where spillage has occurred, a full-two cycle course should be given.
Alveolar Echinococcosis  for patients > 60 kg: 800 mg, given in two equally divided doses. Daily for 28  days. Treatment for 28 days may be repeated after a 14 day period without treatment. Treatment may need to be prolonged for months or years. Continuous treatment at the same dose has been used for periods of up to 20 months (Treatment is normally given in 28 day cycles as for cystic echinococcosis. It may have to be continued for months or even years. Current follow up suggests that survival times are substantially improved following prolonged treatment. Continuous treatment has been shown in a limited number of patients to lead to apparent cure).
Alveolar Echinococcosis  for patients < 60 kg: 15 mg/kg given in two equally divided doses (maximum dose 800 mg/day). Daily for 28 days. Treatment for 28 days may be repeated after a 14 day period without treatment. Treatment may need to be prolonged for months or years. Continuous treatment at the same dose has been used for periods of up to 20 months (Treatment is normally given in 28 day cycles as for cystic echinococcosis. It may have to be continued for months or even years. Current follow up suggests that survival times are substantially improved following prolonged treatment. Continuous treatment has been shown in a limited number of patients to lead to apparent cure).
Method of administration: The tablet may be swallowed or chewed.
Elderly: 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.
Renal impairment: 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.
Hepatic impairment: Since albendazole is rapidly metabolized 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 evaluated and therapy should be discontinued if liver enzymes are significantly increased or full blood count decreased by a clinically significant level. Further management should be as clinically indicated or as recommended by the national poisons centre, where available.

Albendazole is indicated for the treatment of the following systemic helminth diseases:
Echinococcosis (hydatid disease)
Albendazole is indicated for the treatment of liver, lung and peritoneal cysts. Experience with bone cysts and those in the central nervous system and heart is limited.
Cystic echinococcosis (caused by Echinococcus granulosus)
Albendazole is used in patients with cystic echinococcosis:
1. When surgical intervention is not feasible.
2. As a co-adjunct to surgical treatment.
3. Prior to surgical intervention.
4. If preoperative treatment was too short, if spillage has occurred or if viable cysts were found at surgery.
5. Following percutaneous drainage of cysts for diagnostic or therapeutic reasons.
Alveolar echinococcosis (caused by Echinococcus multilocularis)
Although its efficacy has not been completely demonstrated in clinical trials, albendazole is used in patients with alveolar echinococcosis in the following situations:
1. In inoperable disease, particularly in cases of local or distant metastasis.
2. Following palliative surgery.
3. Following radical surgery or liver transplantation.

Albendazole should not be administered during pregnancy or in women thought to be pregnant. Albendazole is contra-indicated in patients with a known history of hypersensitivity to albendazole or other constituents of the dose form.

Albendazole High Dose treatment has been associated with mild to moderate elevations of hepatic enzymes. Hepatic enzymes generally normalize on discontinuation of treatment. Case reports of hepatitis have also been received. Liver function tests should be obtained before the start of each treatment cycle and at least every two weeks during treatment. If hepatic enzymes are significantly increased (greater than twice the upper limit of normal), Albendazole High Dose should be discontinued. Albendazole High Dose treatment may be restarted when hepatic enzymes have returned to normal limits, but patients should be carefully monitored for a recurrence. Albendazole has been shown to cause bone marrow suppression and therefore blood counts should be performed at the start and every two weeks during each 28 day cycle. Patients with liver disease, including hepatic echinococcosis, appear to be more susceptible to bone marrow suppression leading to pancytopenia, aplastic anaemia, agranulocytosis and leukopenia and therefore warrant closer monitoring of blood counts. Albendazole should be discontinued if clinically significant decreases in blood cell counts occur. In order to avoid administering albendazole during early pregnancy, women of childbearing age should: Initiate treatment only after a negative pregnancy test. These tests should be repeated at least once before initiating the next cycle. Be advised to take effective precautions against conception during and within one month of completion of treatment with albendazole for a systemic infection. Symptoms associated with an inflammatory reaction following death of the parasite may occur in patients receiving albendazole treatment for neurocysticercosis (e.g. seizures, raised intracranial pressure, focal signs). These should be treated with appropriate steroid and anticonvulsant therapy. Oral or intravenous corticosteroids are recommended to prevent cerebral hypertensive episodes during the first week of treatment. Pre-existing neurocysticercosis may also be uncovered in patients treated with albendazole for other conditions, particularly in areas with high taenosis infection. Patients may experience neurological symptoms e.g. seizures, increased intracranial pressure and focal signs as a result of an inflammatory reaction caused by death of the parasite within the brain. Symptoms may occur soon after treatment, appropriate steroid and anticonvulsant therapy should be started immediately.

Headache, dizziness, gastrointestinal disturbances (abdominal pain, nausea, vomiting), mild to moderate elevations of hepatic enzymes, reversible alopecia (thinning of hair, and moderate hair loss), fever.
See prescribing information for full details.

Albendazole has been shown to induce liver enzymes of the cytochrome P450 system responsible for its own metabolism. Drugs that can reduce the effectiveness of albendazole – monitor effect – other dose regimens or therapies may be required. Anticonvulsants (eg phenytoin: fosphenytoin: carbamazepine: phenobarbital:primidone), Levamisole , Ritonavir.
Drugs that may increase levels of the active metabolite of albendazole – monitor to possible increased albendazole adverse effects.
Cimetidine, Dexamethasone (continuous use raises albendazole levels by 50%), Praziquantel.
Grapefruit juice also increases the plasma levels of albendazole sulfoxide.
Other possible interactions: Because of possible alterations in cytochrome P450 activity, there is a theoretical risk of an interaction with the following: oral contraceptives, anticoagulants , oral hypoglycaemics, theophylline Care should be exercised when albendazole is given to patients taking these medicines.
See prescribing information for full details.

Pregnancy: Albendazole should not be administered during pregnancy or in women thought to be pregnant.
Lactation: Adequate human and animal data on use during lactation are not available.

Further management should be as clinically indicated or as recommended by the national poisons centre, where available.