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Albendazole: Side Effects

See also Benzimidazoles

Albendazole, a benzimidazole derivative closely related to mebendazole (qv), is used in the treatment of helminth infections, such as gastrointestinal roundworms, hydatid disease, neurocysticercosis, larva migrans cutanea, and strongyloidiasis. Provided that an adequate concentration is attained within the cyst, it is scolicidal. In high doses given for prolonged periods or cyclically, it is effective in echinococcosis, in which it is given in a dosage of 10 mg/kg/day for 4 weeks, repeated in six cycles with 2-week rest periods between each cycle, although even with this high dose only about one-third of patients enjoy a complete cure, some 70% having a partial response. Albendazole is also active against Pneumocystis jiroveci, and is effective in prophylaxis and treatment in immunosuppressed mice. In hydatid disease a combination of albendazole and praziquantel is effective when either agent has failed when used alone.

Albendazole: Observational studies

Albendazole: Comparative Studies

Placebo-controlled studies

Albendazole has been used in the treatment and prophylaxis of microsporidiosis in patients with AIDS. In a small, double-blind, placebo-controlled trial from France the efficacy and safety of treatment with albendazole was studied in four patients treated with albendazole 400 mg bd for 3 weeks and in four patients treated with placebo. Microsporidia were cleared in all patients given albendazole but in none of those given placebo. Afterwards all eight patients were again randomized to receive either maintenance treatment with albendazole 400 mg bd or no treatment for the next 12 months; none of the three patients taking maintenance treatment had a recurrence, while three of the five who took no maintenance therapy developed a recurrence. During the double-blind part of the trial there were no serious adverse effects in the patients who took albendazole, although two complained of headache, one of abdominal pain, one had raised transaminase activities, and one had thrombocytopenia. However, half the patients were also taking anti-HIV triple therapy, which makes it difficult to assess these abnormalities. The authors concluded that the adverse effects were not serious and did not hinder maintenance therapy. The tentative conclusion derived from these findings is that albendazole may be useful in the treatment of microsporidiosis, which in patients with AIDS often leads to debilitating chronic diarrhea and is difficult to treat.

Use in non-infective conditions

The efficacy of albendazole has been evaluated in a few patients with either hepatocellular carcinoma or colorectal cancer and hepatic metastases refractory to other forms of treatment. Apart from hematological and biochemical indices, the tumor markers car-cinoembryonic antigen (CEA) and alpha-fetoprotein (AFP) were measured to monitor treatment efficacy. One other patient with a neuroendocrine cancer and a mesothelioma was treated on a compassionate basis and only monitored for adverse effects. Albendazole was given orally in a dose of 10 mg/kg/day in two divided doses for 28 days. Albendazole reduced CEA in two patients and in the other five patients with measurable tumor markers, serum CEA or AFP was stabilized in three. In the seven patients who completed this pilot study, albendazole was well tolerated and there were no significant changes in any hematological, kidney, or liver function tests. However, three patients were withdrawn because of severe neutropenia, which resulted in the death of one. Neutropenia was more frequent than is usually experienced in the treatment of hydatid disease. The authors speculated that this may relate to reduced metabolism in patients with liver cancer or liver metastases, leading to the passage of unmetabolized drug into the circulation.

General adverse effects

As with other antihelminthic drugs, the general adverse effects of albendazole can reflect the destruction of the parasite rather than a direct action of the drug; pyrexia is likely to be seen, even in the absence of other problems. Albendazole was well tolerated in 30-day courses of 10-14 mg/kg/day separated by 2-week intervals.

Its adverse effects are similar to those of mebendazole and are possibly more common because of better and more reliable absorption.

The direct adverse effects of albendazole are few and usually minor, and consist of gastrointestinal upsets, dizziness, rash, and alopecia, which usually do not require drug withdrawal. Early pyrexia and neutropenia can also occur. Cyst rupture can also occur, as with mebendazole. About 15% of patients treated with albendazole at higher doses develop raised serum trans-aminases, necessitating careful monitoring and sometimes withdrawal of treatment after prolonged use. Careful monitoring of leukocyte and platelet counts is also indicated. The possibility of teratogenicity and embryotoxicity from animal studies suggests that the drug should be avoided in pregnancy.

Albendazole: Organs and Systems

Second-Generation Effects Teratogenicity

It has been emphasized that albendazole is teratogenic in animals and should not be used in pregnancy.

Drug-Drug Interactions

Antiepileptic drugs

The pharmacological interactions of the antiepileptic drugs phenytoin, carbamazepine, and phenobarbital with albendazole have been studied in 32 adults with active intraparenchymatous neurocysticercosis:

  • nine patients took phenytoin 3-4 mg/kg/day;
  • nine patients took carbamazepine 10-20 mg/kg/day;
  • five patients took phenobarbital 1.5-4.5 mg/kg/day;
  • nine patients took no antiepileptic drugs.

All were treated with albendazole 7.5 mg/kg every 12 hours on 8 consecutive days. Phenytoin, carbamazepine, and phenobarbital all induced the oxidative metabolism of albendazole to a similar extent in a non-enantioselective manner. In consequence, there was a significant reduction in the plasma concentration of the active metabolite of albendazole, albendazole sulfoxide.

Cimetidine

The poor intestinal absorption of albendazole, which may be enhanced by a fatty meal, contributes to difficulties in predicting its therapeutic response in echinococcosis. The effect of cimetidine co-administration on the systemic availability of albendazole has been studied in six healthy men. After an overnight fast, a single oral dose of albendazole (10 mg/kg) was administered on an empty stomach with water, a fatty meal, grapefruit juice, or grapefruit juice plus cimetidine. The systemic availability of albendazole was reduced by cimetidine. There were no adverse events. These results are consistent with presystemic metabolism of albendazole by CYP3A4.

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