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    Albendazole, 400 mg chewable tablets

    Drug formTablets

    ATC categoryAntiparasitic agents

    ATC subcategoryAntihelmintics

    Brand nameAlbendazole

    Generic nameAlbendazole

    Qualitative and quantitative composition

    Each chewable tablet contains:

    active ingredient: Albendazole – 400.0 mg

    For a full list of excipients, (see section List of excipients).

     

    Pharmaceutical form

    Chewable tablet.

    A pink, round, mottled, tablet with beveled edges and with raspberry odor.

     

    Clinical particulars

    Therapeutic indications

    Albendazole is a benzimidazole carbamate anthelmintic for use in the treatment     caused by intestinal and tissue parasites: Roundworm (Ascaris lumbricoides), pinworm (Enterobius vermicularis), hookworm (Necator americanus, Ancylostoma duodenale), whipworm (Trichuris trichiura), threadworm (Strongyloides stercoralis), tapeworm (Taenia spp and Hymenolepis nana only in the case of associated parasitism), Chlonorchiasis (Chlonorchis sinensis), Opisthorchiasis (Opisthorchis viverrini) and cutaneous larva migrans; Giardiasis (G.lamblia, G.duodenalis, G.intestinalis, Lamblia intestinalis) in children, Cystic Echinococcosis (caused by Echinococcus granulosus), Alveolar Echinococcosis (caused by Echinococcus multilocularis), Neurocysticercosis (caused by infection with Taenia solium, a tapeworm), Hepatic capillariasis, caused by Capillaria hepatica, Gnathostomiasis (also known as larva migrans profundus caused by the nematode (roundworm) Gnathostoma spinigerum and/or Gnathostoma hispidum), Trichinellosis (caused by roundworms of the   genus Trichinella),    Toxocarosis (caused by Toxocara spp).

     

    Posology and method of administration

    Route of administration: Oral.

    Dosage: Dosages are dependent on the parasite involved, the weight of the patient, and the severity of the infection:

     

    Intestinal parasites and cutaneous larva migrans

    Indications

    Age

    Dose

    Period

    • Roundworm
    • Pinworm
    • Hookworms
    • Whipworm

    adults and children over 6 years of age

    400 mg

    single dose

    • Strongyloidiasis

    adults and children over 6

    400 mg

    one dose per

     

    • Taeniasis
    • Hymenolepiasis

    years

     

    day for 3 days In cases of proven Hymenolepiasis, retreatment in 10-21 days is

    recommended.

    • Chlonorchiasis
    • Opisthorchiasis

    adults and children over 6

    years of age

    400 mg

    two doses per

    day for 3 days

    • Cutaneous larva migrans

    adults and children over 6 years of age

    400 mg

    one dose per day from1 to 3 days

    • Giardiasis

    children 6 – 12 years of age

    only

    400 mg

    one dose per

    day for 5 days

     

    Systemic helminthic infections (long-term treatment with higher doses)

    Cystic Echinococcosis

    28 days.

    In inoperable form three 28-day treatment cycles recommended, separated by a 14-day break in dosing.

    Before the surgery, it recommended two 28- day cycles, separated by a 14-day break in dosing. If preoperative course of less than 14 days and viable cysts found after surgery it should administer two cycles of 28 days,

    separated by a 14-day break in taking the drug

    Alveolar Echinococcosis

    28 days. The second 28-day course is repeated after two week break in taking the drug.

    Treatment can be continued for months or years.

    Neurocysticercosis

    Course duration from 7 days to 31 days. The second course may be repeated after a two-

    week break in taking the drug.

    Hepatic capillariasis

    400 mg one dose per day for 10 days

    Gnathostomiasis

    400 mg one dose per day for 10-20 days

    Trichinellosis and Toxocarosis

    400 mg two doses per day for 5-10 days

    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.

     

    Method of administration

    Albendazole should be taken with meals. 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.

    Cystic Echinococcosis

    1. Inoperable and multiple cysts

    Up to three 28-day cycles of albendazole 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.

    1. Pre-operative

    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.

    1. Post-operative

    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.

    1. After percutaneous cyst drainage. Treatment as for post-surgery above.

     

    Alveolar Echinococcosis

    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.

     

    Special Populations

    Children

    There has been limited experience to date with the use of albendazole in children under six years of age; therefore, usage in children less than six years is not recommended. The recommended dose for older children is 12 mg/kg body weight/day in divided doses.

     

    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 (see „Hepatic impairment‟ below and „Pharmacokinetic Properties‟).

     

    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 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 evaluated and therapy should be discontinued if liver enzymes are significantly increased or full blood count decreased by a clinically significant level (see „Special Warnings and Precautions for Use‟ and „Undesirable Effects‟).

     

    Contraindications

    Albendazole should not be administered during pregnancy or in women thought to be pregnant. Women of childbearing age should be advised to take effective precautions, with non hormonal contraceptive measures, against conception during and within one month of completion of treatment with Albendazole.

    • Albendazole is contra-indicated in patients with a known history of hypersensitivity to the active substance or to any of the excipients listed in section List of

     

    Special warnings and precautions for use

    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 „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 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 „Posology and Method of Administration‟ and „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.

    Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

     

    Interaction with other medicinal products and other forms of interaction

    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.

     

    Fertility, pregnancy and lactation

    Pregnancy:

    Albendazole should not be administered during pregnancy or in women thought to be pregnant (see Contraindications).

     

    Breast-feeding:

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

     

    Effects on ability to drive and use machines

    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.

     

    Undesirable effects

    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 to <1/10

    Uncommon           ≥ 1/1000 to < 1/100

    Rare                        ≥ 1/10,000 to < 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 „Posology and Method of Administration‟ and „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 and administrative site conditions

    Common:                Fever

     

    Reporting of suspected adverse reactions

    Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the “Report about adverse effect of medicine” at: www.pharm.am.

     

    Overdose

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

     

    Pharmacological properties Pharmacodynamic properties

    Pharmacotherapeutic group: anthelmintic

    ATC code: P02CA03

    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 were considered to be cured and a majority had an improvement or stabilisation of disease due to albendazole.

     

    Pharmacokinetic properties

    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.

     

    Preclinical safety data

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

     

    Pharmaceutical particulars

    List of excipients

    Lactose

    Microcrystalline cellulose Povidone

    Magnesium stearate Sodium starch glycolate Maize starch

    Sodium lauryl sulphate Color red Е-129 Sodium saccharin

    Sodium carboxymethylcellulose Raspberry flavor

     

    Incompatibilities

    None known

     

    Shelf life

    3 years

     

    Special precautions for storage

    Store at temperature not higher than 250C, in a dry place, and protect from light. Keep out of the reach of children.

     

    Nature and contents of container

    4 tablets in a plastic bottle with leaflet in the cardboard box.

     

    Special precautions for disposal and other handling

    None