Eskazole

/ GSK

There is limited experience of use of albendazole in children under 6 years of age; therefore use in children under this age is not recommended.
Dosages are dependent on the parasites involved, the weight of the patient, and the seriousness 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 for patients  > 60 kg: Total daily dose of 800 mg, given in two divided doses of 400 mg for a total of 28 days.
Cystic 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 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.

-Hypersensitivity to the active substance or to any of the excipients.
– Albendazole should not be administered during pregnancy or in women thought to be pregnant.

Treatment with albendazole has been associated with mild to moderate elevations of hepatic enzymes. Hepatic enzymes generally normalized after treatment discontinuation. Cases of hepatitis have been reported. Therefore, hepatic 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), treatment should be discontinued. Treatment may be restarted when hepatic enzymes have returned to normal limits, but patients should be carefully monitored for recurrence.
Patients with abnormal hepatic function test results prior to initiating treatment should be closely monitored due to the hepatotoxic potential of albendazole.
Albendazole has been shown to cause bone marrow suppression and therefore, blood counts should be performed at the start of treatment and every two weeks during each 28-day cycle. Patients with hepatic disease, including hepatic echinococcosis, appear to be more susceptible to bone marrow suppression leading to pancytopenia, aplastic anemia, agranulocytosis and leukopenia, and therefore warrant closer monitoring of blood counts. Treatment with albendazole should be discontinued if clinically significant decreases in blood cell counts occur (see sections 4.2 and 4.8).
In order to avoid administering albendazole during early pregnancy, women of child-bearing 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 contraceptive measures during and for one month after completion of treatment with albendazole for a systemic infection.
Pre-existing neurocysticercosis may also be detected in patients treated with albendazole for other conditions, particularly in areas with high taenosis infection. Patients may experience neurological symptoms such as 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, and the appropriate treatment with anticonvulsant drugs and steroids should be started immediately.
In rare cases of retinal neurocysticercosis, the patient should be examined for retinal lesions before beginning treatment. If these lesions are observed, the benefit of the therapy should be weighed against the possibility of retinal damage.
Warnings for excipients:
This medicinal product contains lactose. Patients with hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains 0.98 mg benzyl alcohol in each tablet. Benzyl alcohol may cause allergic reactions. Large amounts of benzyl alcohol can accumulate in the body and may cause side effects (called “metabolic acidosis”), especially in pregnant or breastfeeding women.
Large amounts of benzyl alcohol can accumulate in the body and may cause side effects (called “metabolic acidosis”), especially in patients with liver or kidney failure. Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children.
This medicinal product may cause allergic reactions because it contains Colour FD&C Yellow #6 Aluminum Lake 20-24% FDA (E110) colorant.
It can cause asthma, especially in patients allergic to aspirin.

Very common: Headache, mild to moderate elevation of hepatic enzymes.
Common: Dizziness, gastrointestinal disturbances (abdominal pain, nausea, vomiting), reversible alopecia (thinning of hair and moderate hair loss), fever.
See prescribing information for full details.

It has been observed that cimetidine, praziquantel and dexamethasone increase the plasma levels of the albendazole active metabolite.
Ritonavir, phenytoin, carbamazepine and phenobarbital may reduce plasma concentrations of the albendazole active metabolite, albendazole sulfoxide. The clinical relevance of this is unknown, but may result in decreased efficacy, especially in the treatment of systemic helminth infections. Patients should be monitored for efficacy and may require alternative regimens or treatments.

Pregnancy: Albendazole should not be administered during pregnancy or in women thought to be pregnant.
Lactation: There is insufficient information available regarding the excretion of albendazole in breast milk. Therefore, it should not be used during breast-feeding.

There is insufficient information available about overdose with albendazole.
In case of overdose, symptomatic treatment and medical monitoring should be initiated.