Albenda is effective against a variety of intestinal nematodes, cestodes and trematodes’ infestations including Enterobiasis (pinworms or threadworms), Trichuriasis (whipworms), Ascariasis (large roundworms), Strongyloidiasis (small roundworms), Taeniasis (tapeworms), hookworm infections (Ancylostoma and Necator) and infestations of some species of liver flukes.

It has been designated an orphan product for use in the treatment of hydatid disease and neurocysticercosis.  

Adults and children over 2 years of age:

1.      Enterobiasis, ascariasis, trichuriasis, trichostrongyliasis and hookworm infections: 400mg as a single dose, if reinfection occurs after 3 weeks follow-up, the treatment may be repeated.

2.      Strongyloidiasis and taeniasis: 400mg as a single dose for three days.

3.      Hydatid disease:

-Adults 60 kg or above: 400mg twice a day with meals for 28 days followed by 14 albendazole-free days; up to 3 cycles may be given.

-Adults below 60 kg: 15mg/kg/day in divided doses twice a day with meals for the same period above; maximum total daily dose should not exceed 800mg.

4.      Neurocysticercosis: Same dosage as in case of hydatid disease but the duration of therapy is 8-30 days.

Method of administration:

For oral administration.

Albendazole has been associated with mild to moderate elevations of hepatic enzymes. Hepatic enzymes generally normalise on discontinuation of treatment. Case reports of hepatitis have also been received (see ‘4.8 Undesirable Effects’). 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 should be discontinued. Treatment may be restarted when hepatic enzymes have returned to normal limits, but patients should be carefully monitored for 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 leucopenia and therefore warrant closer monitoring of blood counts. Albendazole should be discontinued if clinically significant decreases in blood cell counts occur (see ‘4.2 Posology and Method of Administration’ and ‘4.8 Undesirable Effects’).

Precautions:

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.

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.

Pregnancy:

Albenda should not be administered during pregnancy or in women thought to be pregnant (see contra-indications).

Lactation:

It is not known whether albendazole or its metabolites are secreted in human breast milk. Thus Albenda should not be used during lactation unless the potential benefits are considered to outweigh the potential risks associated with treatment.

Dizziness is reported as a common reaction. Patients should be advised that if affected they should not drive, operate machinery or take part in activities where this could put them or others at risk.

Data from large clinical studies were used to determine the frequency of very common to rare undesirable reactions. The frequencies assigned to all other undesirable reactions (i.e. those occurring at < 1/1000) were mainly determined using post-marketing data and refer to a reporting rate rather than a true frequency.

The following convention has been used for the classification of frequency:

-   Very common ≥1/10

-   Common ≥1/100 and <1/10

-   Uncommon ≥ 1/1000 and < 1/100

-   Rare ≥ 1/10,000 and < 1/1000

-   Very rare < 1/10,000

Blood and the lymphatic system disorders

Uncommon: Leucopenia.

Very rare: Pancytopenia, aplastic anaemia, agranulocytosis.

Patients with liver disease, including hepatic echinococcosis, appear to be more susceptible to bone marrow suppression (see ‘4.2 Posology and Method of Administration’ and ‘4.4 Special Warnings and Precautions for Use’).

Immune system disorders

Uncommon: Hypersensitivity reactions including rash, pruritus and urticaria.

Nervous system disorders

Very common: Headache.

Common: Dizziness.

Gastrointestinal disorders

Common: Gastrointestinal disturbances (abdominal pain, nausea, vomiting).

Gastrointestinal disturbances have been associated with albendazole when treating patients with echinococcosis.

Hepato-biliary disorders

Very common: Mild to moderate elevations of hepatic enzymes.

Uncommon: Hepatitis.

Skin and subcutaneous tissue disorders

Common: Reversible alopecia (thinning of hair, and moderate hair loss).

Very rare: Erythema multiforme, Stevens-Johnson syndrome.

General disorders

Common: Fever.

To report any side effect(s):

The National Pharmacovigilance and Drug Safety Centre (NPC)

Fax: +966-11-205-7662

Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.

Toll free phone: 8002490000

E-mail: npc.drug@sfda.gov.sa

In case of overdosage, symptomatic therapy (gastric lavage) and general supportive measures should be undertaken.

Pharmacotherapeutic group: Benzimidazole derivatives

Albendazole is a benzimidazole carbamate with anthelmintic effects against tissue parasites.

Albendazole exhibits larvicidal, ovicidal and vermicidal activity, and it is thought to exert its anthelmintic effect by inhibiting tubulin polymerisation.

This causes the disruption of the helminth metabolism, including energy depletion, which immobilises and then kills the susceptible helminth.

Albendazole is effective in the treatment of tissue parasites including cystic echinococcosis and alveolar echinococcosis caused by infestation of Echinococcus granulosus and Echinococcus multilocularis, respectively.

In the treatment of cysts due to E. multilocularis, a minority of patients was considered to be cured and a majority had an improvement or stabilisation of disease due to albendazole.

Absorption and metabolism

In man, albendazole is poorly absorbed (< 5%) following oral administration.

Albendazole rapidly undergoes extensive first-pass metabolism in the liver, and is generally not detected in plasma. Albendazole sulfoxide is the primary metabolite, which is thought to be the active moiety in effectiveness against systemic tissue infections. The plasma half-life of albendazole sulfoxide is 8½ hours.

Following oral administration of a single dose of 400 mg albendazole, the pharmacologically active metabolite, albendazole sulfoxide, has been reported to achieve plasma concentrations from 1.6 to 6.0 micromol/litre when taken with breakfast. The systemic pharmacological effect of albendazole is augmented if the dose is administered with a fatty meal, which enhances the absorption by approximately 5-fold.

Excretion

Albendazole sulfoxide and its metabolites appear to be principally eliminated in bile, with only a small proportion appearing in the urine. Elimination from cysts has been shown to occur over several weeks following high and prolonged dosing.

Special Patient Populations

§ Elderly

Although no studies have investigated the effect of age on albendazole sulfoxide pharmacokinetics, data in 26 hydatid cyst patients (up to 79 years) suggest pharmacokinetics similar to those in young healthy subjects. The number of elderly patients treated for either hydatid disease or neurocysticercosis is limited, but no problems associated with an older population have been observed.

§ Renal Impairment

The pharmacokinetics of albendazole in patients with impaired renal function have not been studied.

§ Hepatic Impairment

The pharmacokinetics of albendazole in patients with impaired hepatic function have not been studied.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

None known

Store below 30˚C

20mL suspension in a bottle, packed in a printed carton along with a leaflet.

No special instructions.