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ALBENDAZOLE

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Albendazole is a benzimidazole carbamate anthelmintic agent.

Specific Substances

    1) Methyl 5-(propylthio)-2-benzimidazolecarbamate
    2) SKF-62979
    3) Molecular Formula: C12-H15-N3-O2-S
    4) CAS 54965-21-8

Available Forms Sources

    A) FORMS
    1) Albendazole is available as 200 mg tablets (Prod Info ALBENZA(R) oral tablets, 2013).
    B) USES
    1) Albendazole is indicated for the treatment of parenchymal neurocysticercosis and cystic hydatid disease (Echinococcus granulosus) (Prod Info ALBENZA(R) oral tablets, 2013).

Overview

Life Support

    A) This overview assumes that basic life support measures have been instituted.

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) USES: A benzimidazole carbamate anthelmintic agent, used for the treatment of parenchymal neurocysticercosis caused by Taenia solium (pork tapeworm) and cystic hydatid disease caused by Echinococcus granulosus (dog tapeworm).
    B) PHARMACOLOGY: While its precise biochemical mechanism of action is not clear, it appears to cause selective degeneration of cytoplasmic microtubules in intestinal and tegmental cells of intestinal helminths and their tissue-dwelling larvae.
    C) EPIDEMIOLOGY: Overdose is rare.
    D) WITH THERAPEUTIC USE
    1) COMMON: Elevated liver enzymes, nausea and vomiting, abdominal pain, and headaches are the most common adverse effects reported.
    2) INFREQUENT: Other effects that may occur less frequently include rashes, alopecia, fever, leukopenia, dizziness/vertigo, and increased intracranial pressure.
    3) RARE: Stevens-Johnson syndrome, fever, agranulocytosis, thrombocytopenia, hepatitis, and acute dystonia have been rarely reported. Granulocytopenia and pancytopenia, sometimes associated with fatalities, have also rarely occurred.
    E) WITH POISONING/EXPOSURE
    1) Limited overdose data. One patient reportedly ingested at least 16 g of albendazole over a 12-hour period. No clinical effects were reported. Overdose effects are anticipated to be an extension of adverse effects at therapeutic doses.
    0.2.3) VITAL SIGNS
    A) WITH THERAPEUTIC USE
    1) Fever has been reported rarely with chronic therapeutic use.
    0.2.20) REPRODUCTIVE
    A) Albendazole is classified as FDA pregnancy category C. There are no adequate and well-controlled studies of albendazole use during pregnancy. In animal studies, albendazole was teratogenic at exposure levels less than that estimated with therapeutic human dosing. However, limited human data from a study of 49 pregnancies and 2 case reports in which albendazole was used during pregnancy suggest that fetal risk is probably small. Data from a study involving 33 nursing mothers found that albendazole is excreted in human milk, but in low concentrations that are unlikely to cause harm to breastfed infants.
    0.2.21) CARCINOGENICITY
    A) At the time of this review, the manufacturer does not report any carcinogenic potential for albendazole in humans.

Laboratory Monitoring

    A) Monitor CBC with differential and platelet count.
    B) Monitor liver enzymes in symptomatic patients.
    C) Monitor serum electrolytes in patients with significant vomiting.
    D) Plasma albendazole concentrations are not readily available or clinically useful in guiding management.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) MANAGEMENT OF MILD TO MODERATE TOXICITY
    1) Treatment is symptomatic and supportive. Correct any significant fluid and/or electrolyte abnormalities in patients with severe vomiting.
    B) MANAGEMENT OF SEVERE TOXICITY
    1) Treatment is symptomatic and supportive. Severe toxicity is not anticipated. Hepatitis has been rarely reported with therapy. Monitor liver enzymes in symptomatic patients. Myelosuppression has been reported. Monitor serial CBC with differential. For severe neutropenia, administer colony stimulating factor (eg; filgrastim, sargramostim). Transfusions as needed for severe thrombocytopenia, bleeding.
    C) DECONTAMINATION
    1) PREHOSPITAL: Consider activated charcoal if the overdose is recent, the patient is not vomiting, and is able to maintain airway.
    2) HOSPITAL: Consider activated charcoal if the overdose is recent, the patient is not vomiting, and is able to maintain airway.
    D) AIRWAY MANAGEMENT
    1) Airway management is unlikely to be necessary unless other toxic agents have been administered concurrently.
    E) ANTIDOTE
    1) None
    F) ENHANCED ELIMINATION PROCEDURE
    1) It is unknown if hemodialysis would be effective in overdose.
    G) PATIENT DISPOSITION
    1) HOME CRITERIA: A patient with an inadvertent exposure, that remains asymptomatic can be managed at home.
    2) OBSERVATION CRITERIA: Patients with a deliberate overdose, and those who are symptomatic, need to be monitored until they are clearly improving and clinically stable.
    3) ADMISSION CRITERIA: Patients with severe symptoms despite treatment should be admitted.
    4) CONSULT CRITERIA: Consult a regional poison center or medical toxicologist for assistance in managing patients with severe toxicity or in whom the diagnosis is not clear.
    H) PITFALLS
    1) When managing a suspected albendazole overdose, the possibility of multidrug involvement should be considered. Symptoms of overdose may be similar to reported side effects of the medication.
    I) PHARMACOKINETICS
    1) Albendazole is poorly absorbed from the gastrointestinal tract. Protein binding is 70%. Rapidly metabolized to its active metabolite, albendazole sulfoxide. Less than 1% of an albendazole dose is excreted in the urine. Biliary elimination is the primary route of excretion. Terminal elimination half-life of albendazole sulfoxide ranges from 8 to 12 hours.
    J) DIFFERENTIAL DIAGNOSIS
    1) Includes other agents that may cause myelosuppression or hepatotoxicity.

Range Of Toxicity

    A) TOXICITY: Minimum toxic dose has not been established. One patient reportedly ingested at least 16 g of albendazole over a 12-hour period. No clinical effects were reported.
    B) THERAPEUTIC DOSE: ADULTS (60 KG OR GREATER): 400 mg orally twice daily. ADULTS AND CHILDREN (LESS THAN 60 KG): 15 mg/kg/day orally in divided doses twice daily; MAX: 800 mg daily.

Clinical Effects

Summary Of Exposure

    A) USES: A benzimidazole carbamate anthelmintic agent, used for the treatment of parenchymal neurocysticercosis caused by Taenia solium (pork tapeworm) and cystic hydatid disease caused by Echinococcus granulosus (dog tapeworm).
    B) PHARMACOLOGY: While its precise biochemical mechanism of action is not clear, it appears to cause selective degeneration of cytoplasmic microtubules in intestinal and tegmental cells of intestinal helminths and their tissue-dwelling larvae.
    C) EPIDEMIOLOGY: Overdose is rare.
    D) WITH THERAPEUTIC USE
    1) COMMON: Elevated liver enzymes, nausea and vomiting, abdominal pain, and headaches are the most common adverse effects reported.
    2) INFREQUENT: Other effects that may occur less frequently include rashes, alopecia, fever, leukopenia, dizziness/vertigo, and increased intracranial pressure.
    3) RARE: Stevens-Johnson syndrome, fever, agranulocytosis, thrombocytopenia, hepatitis, and acute dystonia have been rarely reported. Granulocytopenia and pancytopenia, sometimes associated with fatalities, have also rarely occurred.
    E) WITH POISONING/EXPOSURE
    1) Limited overdose data. One patient reportedly ingested at least 16 g of albendazole over a 12-hour period. No clinical effects were reported. Overdose effects are anticipated to be an extension of adverse effects at therapeutic doses.

Vital Signs

    3.3.1) SUMMARY
    A) WITH THERAPEUTIC USE
    1) Fever has been reported rarely with chronic therapeutic use.
    3.3.3) TEMPERATURE
    A) WITH THERAPEUTIC USE
    1) FEVER has been reported as a rare adverse effect of albendazole (Prod Info ALBENZA(R) oral tablets, 2013; Rossignol & Maisonneuve, 1983) .

Cardiovascular

    3.5.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) TACHYCARDIA
    a) Tachycardia has been reported in animals receiving large doses of albendazole (Prod Info ALBENZA(R) oral tablets, 2013).

Respiratory

    3.6.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) RESPIRATORY DISTRESS SYNDROME
    a) Respiratory distress has been reported in animals receiving large doses of albendazole (Prod Info ALBENZA(R) oral tablets, 2013).

Neurologic

    3.7.2) CLINICAL EFFECTS
    A) DIZZINESS
    1) WITH THERAPEUTIC USE
    a) Dizziness/vertigo have been reported in a small number of patients treated with albendazole (Prod Info ALBENZA(R) oral tablets, 2013; Rossignol & Maisonneuve, 1983; Horton, 1989) .
    B) HEADACHE
    1) WITH THERAPEUTIC USE
    a) Headache has been reported as an adverse effect of albendazole therapy (Rossignol & Maisonneuve, 1983; Horton, 1989) Davis et al, 1989; .
    b) INCIDENCE: Headaches occurred in 11% of patients receiving albendazole therapy for treatment of neurocysticercosis during clinical trials, and in 1.3% of patients given albendazole for treatment of hydatid disease (Prod Info ALBENZA(R) oral tablets, 2013).
    C) RAISED INTRACRANIAL PRESSURE
    1) WITH THERAPEUTIC USE
    a) Increased intracranial pressure has been reported in 1.5% of patients with neurocysticercosis receiving albendazole (Prod Info ALBENZA(R) oral tablets, 2013).
    D) NEUROLOGICAL DEFICIT
    1) WITH THERAPEUTIC USE
    a) CASE REPORT: Severe neurologic deficit was reported in a 32-year-old woman with a subarachnoid cysticercus in the left sylvian region following a complete course of albendazole therapy. The patient initially presented with right hemiparesis and mild hydrocephalus. In addition to albendazole (15 mg/kg), phenytoin and dexamethasone therapy were instituted. Two days after the completion of albendazole therapy, the patient developed a right hemiplegia, conjugated eye deviation to the left side, and stupor. A follow-up computed tomography (CT) scan showed a hypodense lesion in the left frontotemporal region of the brain. The cyst was completely destroyed; however, the patient was left with a profound parenchymal brain reaction resulting in severe neurologic deficit. Albendazole therapy in this patient may have caused this inflammatory reaction with the subsequent neurologic complications. The true association of albendazole and CNS complication discussed in this case is unknown. Other issues such as the initial neurologic condition of the patient and the extensive cerebral involvement of cysticercosis needs to be considered. One case of neurologic impairment has been reported with albendazole therapy, however the evidence establishing the causal relationship is lacking (Noboa, 1993).
    E) DYSTONIA
    1) WITH THERAPEUTIC USE
    a) CASE REPORT: Acute dystonia was reported in a 9-year-old boy receiving albendazole 400 mg for worm infestations. The patient initially presented with involuntary movements characterized by protrusion of the tongue and sideways tuning of the neck, which began 4 hours after receiving albendazole. Physical and neurological examinations were otherwise normal as well as all laboratory findings, cranial CT, and electroencephalography. The patient was not taking any other medications and had no history of recent trauma or infections, other than the worm infestations. Albendazole was discontinued and IV diazepam was administered with complete resolution of symptoms. Following the discontinuation of albendazole, the patient experienced no further dystonic reactions (Incecik et al, 2011).

Gastrointestinal

    3.8.2) CLINICAL EFFECTS
    A) DRUG-INDUCED GASTROINTESTINAL DISTURBANCE
    1) WITH THERAPEUTIC USE
    a) Abdominal pain, anorexia, constipation, diarrhea, dry mouth, epigastric pain, nausea, and vomiting have occurred with albendazole therapy (Rossignol & Maisonneuve, 1983; Horton, 1989; Prod Info Albenza(R), albendazole tablet, 2001). Abdominal pain may be severe (Davis et al, 1989).
    b) INCIDENCE: Nausea and vomiting were reported in 3.7% and 6.2% of patients with hydatid disease and neurocysticercosis disease, respectively, and were treated with albendazole during clinical trials. Abdominal pain occurred in 6% of patients given albendazole for treatment of hydatid disease (Prod Info ALBENZA(R) oral tablets, 2013).
    3.8.3) ANIMAL EFFECTS
    A) ANIMAL STUDIES
    1) VOMITING
    a) Vomiting has been reported in animals receiving large doses of albendazole (Prod Info ALBENZA(R) oral tablets, 2013).
    2) DIARRHEA
    a) Diarrhea has been reported in animals receiving large doses of albendazole (Prod Info ALBENZA(R) oral tablets, 2013).

Hepatic

    3.9.2) CLINICAL EFFECTS
    A) LIVER ENZYMES ABNORMAL
    1) WITH THERAPEUTIC USE
    a) Reversible elevations in serum transaminase (SGOT and SGPT) levels have been observed in several studies (Davis et al, 1989) using albendazole for long-term therapy of hydatid cyst disease at doses of either 400 mg twice a day or 10 mg/kg/day (Morris et al, 1985) Wilson et al, 1987; (Golematis et al, 1989; Cossetto et al, 1989).
    b) Enzyme elevations recurred upon rechallenge (Morris et al, 1985) Wilson et al, 1987).
    c) Transient elevations in serum gamma-glutamyl transpeptidase (GGT) and alkaline phosphatase were reported in one study, but these normalized as treatment continued (Cossetto et al, 1989).
    d) Mild to moderate elevations of hepatic enzymes were reported in approximately 16% of patients given albendazole for treatment of hydatid disease during clinical trials. The hepatic enzymes generally normalized following cessation of albendazole therapy (Prod Info ALBENZA(R) oral tablets, 2013).
    B) JAUNDICE
    1) WITH THERAPEUTIC USE
    a) Jaundice has been reported to occur in association with the use of albendazole (Prod Info Eskazole(R), 1990; El-Mufti et al, 1993; Morris & Smith, 1987).
    b) CASE REPORT: A serious reversible hepatotoxic jaundice was reported in 5% of patients (n=40) receiving albendazole for the treatment of hydatid disease (Echinococcus granulosus). Albendazole 10 to 15 mg/kg/day was given in 4 week cycles separated by 2 weeks without drug. A majority of patients received a total of 3 cycles of albendazole treatment (El-Mufti et al, 1993).
    C) ACUTE HEPATITIS
    1) WITH THERAPEUTIC USE
    a) Hepatitis and acute liver failure have been reported during postmarketing surveillance of patients receiving albendazole therapy (Prod Info ALBENZA(R) oral tablets, 2013).
    b) One patient was reported to have hepatitis with extensive centrilobular and patchy focal liver cell necrosis (Morris & Smith, 1987a).

Genitourinary

    3.10.2) CLINICAL EFFECTS
    A) RENAL FAILURE SYNDROME
    1) WITH THERAPEUTIC USE
    a) Acute renal failure has been reported during postmarketing surveillance of patients receiving albendazole (Prod Info ALBENZA(R) oral tablets, 2013).

Hematologic

    3.13.2) CLINICAL EFFECTS
    A) EOSINOPHIL COUNT RAISED
    1) WITH THERAPEUTIC USE
    a) Eosinophilia has been reported as a rare adverse effect of long-term, high-dose albendazole therapy (Horton, 1989). Eosinophilia may occur as a result of leakage from hydatid cysts (Tech Info Eskazole(R), 1990).
    B) NEUTROPENIA
    1) WITH THERAPEUTIC USE
    a) Reversible neutropenia has been reported to occur in up to 5% of patients receiving high doses of albendazole for hydatid cyst disease (Schantz, 1985; Horton, 1989; JEF Reynolds , 1990; Steiger et al, 1990).
    C) THROMBOCYTOPENIC DISORDER
    1) WITH THERAPEUTIC USE
    a) Thrombocytopenia has been rarely reported in patients receiving albendazole during clinical trials (Prod Info ALBENZA(R) oral tablets, 2013).
    b) CASE REPORT: Amegakaryocytic thrombocytopenic purpura was diagnosed in a 25-year-old woman who had received albendazole 13 mg/kg/day over a 5-month period for hepatic and pulmonary hydatid cysts. Her symptoms included fatigue, gum bleeding, and prolonged menstrual bleeding; ecchymoses and petechiae were noted on her lower extremities (Yildiz et al, 1998).
    D) GRANULOCYTOPENIC DISORDER
    1) WITH THERAPEUTIC USE
    a) Granulocytopenia, including fatalities, has been rarely reported in patients receiving albendazole during clinical trials (Prod Info ALBENZA(R) oral tablets, 2013).
    E) LEUKOPENIA
    1) WITH THERAPEUTIC USE
    a) Leukopenia has been reported in less than 1% of patients receiving albendazole during clinical trials (Prod Info ALBENZA(R) oral tablets, 2013).
    F) PANCYTOPENIA
    1) WITH THERAPEUTIC USE
    a) Pancytopenia, including rare fatalities, has been reported in less than 1% of patients receiving albendazole (Prod Info ALBENZA(R) oral tablets, 2013; Fernandez et al, 1996), (Steiger et al, 1990a; Reynolds, 1990), (Horton, 1989a; Schantz, 1985a).
    b) CASE REPORT: A 71-year-old woman developed pancytopenia following 15 days of albendazole 800 milligrams (mg) daily for the treatment of hepatic hydatidosis. Albendazole was discontinued and intravenous gamma globulin and granulocyte colony-stimulating factor were administered. In 7 days, she was nearly hematologically normal (Fernandez et al, 1996).
    G) AGRANULOCYTOSIS
    1) WITH THERAPEUTIC USE
    a) Agranulocytosis has been rarely reported in patients receiving albendazole during clinical trials (Prod Info ALBENZA(R) oral tablets, 2013).
    H) APLASTIC ANEMIA
    1) WITH THERAPEUTIC USE
    a) Aplastic anemia was reported during postmarketing surveillance of patients receiving albendazole (Prod Info ALBENZA(R) oral tablets, 2013).

Dermatologic

    3.14.2) CLINICAL EFFECTS
    A) ALOPECIA
    1) WITH THERAPEUTIC USE
    a) Reversible alopecia has been reported in greater than 1% of patients treated for hydatid cyst disease (Prod Info ALBENZA(R) oral tablets, 2013; Horton, 1989; JEF Reynolds , 2000; Steiger et al, 1990) .
    b) CASE REPORT: Alopecia as a result of albendazole therapy for hydatid disease was reported in a 59-year-old woman. After being diagnosed with hydatid disease of the liver, the patient was prescribed albendazole 400 mg orally each day. After 1 month of treatment the patient presented with sudden, diffuse hair loss. The dosage of albendazole was decreased to 200 mg a day and was discontinued 4 weeks later, at which time the patient reported that the hair loss had stopped. Examination 1 month later revealed new, normal hair growth (Garcia-Muret et al, 1990).
    B) ITCHING OF SKIN
    1) WITH THERAPEUTIC USE
    a) Pruritus has been reported as an adverse effect of albendazole (Rossignol & Maisonneuve, 1983; Davis et al, 1989).
    C) ERUPTION
    1) WITH THERAPEUTIC USE
    a) Rash, including severe urticaria, has occurred in a small number of patients receiving albendazole (Prod Info ALBENZA(R) oral tablets, 2013; Davis et al, 1989) .
    D) STEVENS-JOHNSON SYNDROME
    1) WITH THERAPEUTIC USE
    a) CASE REPORT: Stevens-Johnson syndrome was reported in a 57-year-old man taking albendazole 400 milligrams per day for 15 days. Symptoms resolved upon discontinuation of albendazole (Dewerdt et al, 1997).

Immunologic

    3.19.2) CLINICAL EFFECTS
    A) ACUTE ALLERGIC REACTION
    1) WITH THERAPEUTIC USE
    a) Allergic reactions have been reported in less than 1% of patients receiving albendazole during clinical trials (Prod Info ALBENZA(R) oral tablets, 2013).

Reproductive

    3.20.1) SUMMARY
    A) Albendazole is classified as FDA pregnancy category C. There are no adequate and well-controlled studies of albendazole use during pregnancy. In animal studies, albendazole was teratogenic at exposure levels less than that estimated with therapeutic human dosing. However, limited human data from a study of 49 pregnancies and 2 case reports in which albendazole was used during pregnancy suggest that fetal risk is probably small. Data from a study involving 33 nursing mothers found that albendazole is excreted in human milk, but in low concentrations that are unlikely to cause harm to breastfed infants.
    3.20.2) TERATOGENICITY
    A) LACK OF EFFECT
    1) Among 49 case histories of first-trimester exposures to albendazole in doses up to 54 grams administered over several weeks, no congenital abnormalities were reported in the 18 live births (Bradley & Horton, 2001).
    B) ANIMAL STUDIES
    1) In animal studies, albendazole has demonstrated teratogenicity (causing embryotoxicity and skeletal malformations) following oral doses of 0.1, 0.32, and 0.6 times the maximum recommended human dose (MRHD) during gestation days 6 to 19. Maternal toxicity with a 33% mortality rate was also observed at 0.6 times the MRHD. In some animals, albendazole did not result in teratogenicity at oral doses up to 0.16 times the MRHD during gestation days 6 to 15 (Prod Info ALBENZA(R) oral tablets oral chewable tablets, 2015).
    3.20.3) EFFECTS IN PREGNANCY
    A) PREGNANCY CATEGORY
    1) Albendazole is classified by the manufacturer as FDA pregnancy category C (Prod Info ALBENZA(R) oral tablets oral chewable tablets, 2015).
    2) The WHO considers all pregnant and lactating women with helmintic infections to be high risk and recommends that individual treatment be offered in order to avoid schistosomiasis-induced organ damage and anemia (Allen et al, 2002).
    3) Use albendazole during pregnancy only when there is no alternative management and the potential maternal benefit outweighs the potential fetal risk (Prod Info ALBENZA(R) oral tablets oral chewable tablets, 2015).
    B) CONTRACEPTION
    1) Advise women to use adequate contraception during treatment and for at least one month after discontinuation (Prod Info ALBENZA(R) oral tablets oral chewable tablets, 2015).
    C) PREGNANCY TESTING
    1) Obtain a pregnancy test prior to initiating treatment (Prod Info ALBENZA(R) oral tablets oral chewable tablets, 2015).
    D) FETAL/NEONATAL ADVERSE REACTIONS
    1) In a randomized, open-label trial of pregnant women (n=834) who received either ivermectin (group A; n=198), albendazole (group B; n=194), or albendazole plus ivermectin (group C; n=199) during the second trimester for soil-transmitted helminth (STH) infections and a reference group with no STH infections (group D; n=241), no significant differences among the groups were reported for mean birth weight, low birth weight (LBW), abortions, premature deliveries, stillbirths, congenital abnormalities, maternal or neonatal hemoglobin (Hb) levels or anemia, or mortality. Cause of death included respiratory tract infection, prematurity-related death, and gastroenteritis/vomiting (Ndyomugyenyi et al, 2008).
    E) LACK OF EFFECT
    1) Among 49 case histories of first-trimester exposures to albendazole in doses up to 54 g administered over several weeks, 31 non-live births were reported. Of these cases, 20 were lost to followup, 6 were voluntarily terminated pregnancies, 3 had not yet delivered, and 2 resulted in fetal death that was not attributed to drug therapy (Bradley & Horton, 2001).
    2) Use of albendazole 400 mg twice daily for 28 days in a pregnant woman during the latter half of her pregnancy resulted in a healthy infant that was delivered without abnormalities and with good development; after 7 years, the child was reportedly healthy and without malformations, although reading and writing skills were considered minimally impaired (Montes et al, 2002). Another case report described a healthy, full-term infant born to a woman who became pregnant while receiving albendazole 400 mg twice daily that was continued through her second week of pregnancy (Auer et al, 1994).
    3.20.4) EFFECTS DURING BREAST-FEEDING
    A) BREAST MILK
    1) Exercise caution when administering albendazole to a lactating woman (Prod Info ALBENZA(R) oral tablets oral chewable tablets, 2015).
    2) A study of 33 nursing mothers, who received a single oral dose of albendazole 400 mg, found that the drug is secreted in breast milk but at low concentrations that are unlikely to harm a breast-fed infant. The median milk-to-serum concentration ratio 6 hours after drug administration was 0.9; 0.6; and 0.7 for albendazole, albendazole sulfoxide and albendazole sulphone, respectively. However, wide variability among women was observed. Only albendazole sulfoxide had a significant correlation between milk and serum concentrations, while no significant correlation was found for albendazole or albendazole sulphone (n=18, Spearman r=0.1, p=0.6568) Based on collective findings from previous investigations and this study, the expected exposure of a breast-fed infant to albendazole sulfoxide through 36 hours was calculated to be 0.1 mg/kg (infant weight) based on a single maternal oral dose of 400 mg (Abdel-tawab et al, 2009).
    B) ANIMAL STUDIES
    1) Albendazole has been shown to be excreted in animal milk (Prod Info ALBENZA(R) oral tablets oral chewable tablets, 2015).
    3.20.5) FERTILITY
    A) ANIMAL STUDIES
    1) During animal studies, albendazole did not adversely affect male or female fertility with oral doses 0.32 times the recommended human dose (Prod Info ALBENZA(R) oral tablets oral chewable tablets, 2015).

Carcinogenicity

    3.21.2) SUMMARY/HUMAN
    A) At the time of this review, the manufacturer does not report any carcinogenic potential for albendazole in humans.
    3.21.4) ANIMAL STUDIES
    A) LACK OF EFFECT
    1) Albendazole was not carcinogenic to rats or mice administered albendazole at doses up to 20 mg/kg/day and 400 mg/kg/day (0.21 and 2 times the recommended human dose based on a mg/m(2) basis, respectively) for 117 and 108 weeks, respectively (Prod Info ALBENZA(R) oral tablets, 2009).

Genotoxicity

    A) There was no evidence of genotoxicity in the following tests: an Ames Salmonella/Microsome Plate mutation assay with and without metabolic activation or with and without pre-incubation, cell-mediated Chinese Hamster Ovary chromosomal aberration test and in vivo mouse micronucleus test. Albendazole did produce weak activity in the presence of metabolic activation in the in vitro BALB/3T3 cells transformation assay; however, in the absence of metabolic activation, no activity was noted (Prod Info ALBENZA(R) oral tablets, 2009).

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) Monitor CBC with differential and platelet count.
    B) Monitor liver enzymes in symptomatic patients.
    C) Monitor serum electrolytes in patients with significant vomiting.
    D) Plasma albendazole concentrations are not readily available or clinically useful in guiding management.
    4.1.2) SERUM/BLOOD
    A) BLOOD/SERUM CHEMISTRY
    1) Monitor liver enzymes in symptomatic patients.
    a) Transient elevations in serum GGT and alkaline phosphatase occurred in one report, but normalized as treatment continued (Cossetto et al, 1989).
    b) Elevations in AST and ALT have occurred; levels rapidly returned to normal upon cessation of albendazole therapy (Morris et al, 1985) Wilson et al, 1987; (Golematis et al, 1989; Cossetto et al, 1989).
    B) HEMATOLOGIC
    1) Monitor CBC with differential and platelet count.

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Patient Disposition

    6.3.1) DISPOSITION/ORAL EXPOSURE
    6.3.1.1) ADMISSION CRITERIA/ORAL
    A) Patients with severe symptoms despite treatment should be admitted.
    6.3.1.2) HOME CRITERIA/ORAL
    A) A patient with an inadvertent exposure, that remains asymptomatic can be managed at home.
    6.3.1.3) CONSULT CRITERIA/ORAL
    A) Consult a regional poison center or medical toxicologist for assistance in managing patients with severe toxicity or in whom the diagnosis is not clear.
    6.3.1.5) OBSERVATION CRITERIA/ORAL
    A) Patients with a deliberate overdose, and those who are symptomatic, need to be monitored until they are clearly improving and clinically stable.

Monitoring

    A) Monitor CBC with differential and platelet count.
    B) Monitor liver enzymes in symptomatic patients.
    C) Monitor serum electrolytes in patients with significant vomiting.
    D) Plasma albendazole concentrations are not readily available or clinically useful in guiding management.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) ACTIVATED CHARCOAL
    1) PREHOSPITAL ACTIVATED CHARCOAL ADMINISTRATION
    a) Consider prehospital administration of activated charcoal as an aqueous slurry in patients with a potentially toxic ingestion who are awake and able to protect their airway. Activated charcoal is most effective when administered within one hour of ingestion. Administration in the prehospital setting has the potential to significantly decrease the time from toxin ingestion to activated charcoal administration, although it has not been shown to affect outcome (Alaspaa et al, 2005; Thakore & Murphy, 2002; Spiller & Rogers, 2002).
    1) In patients who are at risk for the abrupt onset of seizures or mental status depression, activated charcoal should not be administered in the prehospital setting, due to the risk of aspiration in the event of spontaneous emesis.
    2) The addition of flavoring agents (cola drinks, chocolate milk, cherry syrup) to activated charcoal improves the palatability for children and may facilitate successful administration (Guenther Skokan et al, 2001; Dagnone et al, 2002).
    2) CHARCOAL DOSE
    a) Use a minimum of 240 milliliters of water per 30 grams charcoal (FDA, 1985). Optimum dose not established; usual dose is 25 to 100 grams in adults and adolescents; 25 to 50 grams in children aged 1 to 12 years (or 0.5 to 1 gram/kilogram body weight) ; and 0.5 to 1 gram/kilogram in infants up to 1 year old (Chyka et al, 2005).
    1) Routine use of a cathartic with activated charcoal is NOT recommended as there is no evidence that cathartics reduce drug absorption and cathartics are known to cause adverse effects such as nausea, vomiting, abdominal cramps, electrolyte imbalances and occasionally hypotension (None Listed, 2004).
    b) ADVERSE EFFECTS/CONTRAINDICATIONS
    1) Complications: emesis, aspiration (Chyka et al, 2005). Aspiration may be complicated by acute respiratory failure, ARDS, bronchiolitis obliterans or chronic lung disease (Golej et al, 2001; Graff et al, 2002; Pollack et al, 1981; Harris & Filandrinos, 1993; Elliot et al, 1989; Rau et al, 1988; Golej et al, 2001; Graff et al, 2002). Refer to the ACTIVATED CHARCOAL/TREATMENT management for further information.
    2) Contraindications: unprotected airway (increases risk/severity of aspiration) , nonfunctioning gastrointestinal tract, uncontrolled vomiting, and ingestion of most hydrocarbons (Chyka et al, 2005).
    6.5.2) PREVENTION OF ABSORPTION
    A) ACTIVATED CHARCOAL
    1) CHARCOAL ADMINISTRATION
    a) Consider administration of activated charcoal after a potentially toxic ingestion (Chyka et al, 2005). Administer charcoal as an aqueous slurry; most effective when administered within one hour of ingestion.
    2) CHARCOAL DOSE
    a) Use a minimum of 240 milliliters of water per 30 grams charcoal (FDA, 1985). Optimum dose not established; usual dose is 25 to 100 grams in adults and adolescents; 25 to 50 grams in children aged 1 to 12 years (or 0.5 to 1 gram/kilogram body weight) ; and 0.5 to 1 gram/kilogram in infants up to 1 year old (Chyka et al, 2005).
    1) Routine use of a cathartic with activated charcoal is NOT recommended as there is no evidence that cathartics reduce drug absorption and cathartics are known to cause adverse effects such as nausea, vomiting, abdominal cramps, electrolyte imbalances and occasionally hypotension (None Listed, 2004).
    b) ADVERSE EFFECTS/CONTRAINDICATIONS
    1) Complications: emesis, aspiration (Chyka et al, 2005). Aspiration may be complicated by acute respiratory failure, ARDS, bronchiolitis obliterans or chronic lung disease (Golej et al, 2001; Graff et al, 2002; Pollack et al, 1981; Harris & Filandrinos, 1993; Elliot et al, 1989; Rau et al, 1988; Golej et al, 2001; Graff et al, 2002). Refer to the ACTIVATED CHARCOAL/TREATMENT management for further information.
    2) Contraindications: unprotected airway (increases risk/severity of aspiration) , nonfunctioning gastrointestinal tract, uncontrolled vomiting, and ingestion of most hydrocarbons (Chyka et al, 2005).
    6.5.3) TREATMENT
    A) SUPPORT
    1) MANAGEMENT OF MILD TO MODERATE TOXICITY
    a) Treatment is symptomatic and supportive. Correct any significant fluid and/or electrolyte abnormalities in patients with severe vomiting.
    2) MANAGEMENT OF SEVERE TOXICITY
    a) Treatment is symptomatic and supportive. Severe toxicity is not anticipated. Hepatitis has been rarely reported with therapy. Monitor liver enzymes in symptomatic patients. Myelosuppression has been reported. Monitor serial CBC with differential. For severe neutropenia, administer colony stimulating factor (eg; filgrastim, sargramostim). Transfusions as needed for severe thrombocytopenia, bleeding.
    B) MONITORING OF PATIENT
    1) Monitor CBC with differential and platelet count.
    2) Monitor liver enzymes in symptomatic patients.
    3) Monitor serum electrolytes in patients with significant vomiting.
    4) Plasma albendazole concentrations are not readily available or clinically useful in guiding management.
    C) MYELOSUPPRESSION
    1) There is little data on the use of hematopoietic colony stimulating factors to treat neutropenia after drug overdose or idiosyncratic reactions. These agents have been shown to shorten the duration of severe neutropenia in patients receiving cancer chemotherapy (Hartman et al, 1997; Stull et al, 2005). They have also been used to treat agranulocytosis induced by nonchemotherapy drugs (Beauchesne & Shalansky, 1999). They may be considered in patients with severe neutropenia who have or are at significant risk for developing febrile neutropenia.
    a) Filgrastim: The usual starting dose in adults is 5 micrograms/kilogram/day by intravenous infusion or subcutaneous injection (Prod Info NEUPOGEN(R) injection, 2006).
    b) Sargramostim: Usual dose is 250 micrograms/square meter/day infused IV over 4 hours (Prod Info LEUKINE(R) injection, 2006).
    c) Monitor CBC with differential.
    2) Transfusion of platelets and/or packed red cells may be needed in patients with severe thrombocytopenia or hemorrhage.

Enhanced Elimination

    A) HEMODIALYSIS
    1) It is unknown if hemodialysis would be effective in overdose.

Range Of Toxicity

Summary

    A) TOXICITY: Minimum toxic dose has not been established. One patient reportedly ingested at least 16 g of albendazole over a 12-hour period. No clinical effects were reported.
    B) THERAPEUTIC DOSE: ADULTS (60 KG OR GREATER): 400 mg orally twice daily. ADULTS AND CHILDREN (LESS THAN 60 KG): 15 mg/kg/day orally in divided doses twice daily; MAX: 800 mg daily.

Therapeutic Dose

    7.2.1) ADULT
    A) HYDATID DISEASE
    1) LESS THAN 60 KG: Recommended dose is 15 mg/kg/day in 2 divided doses with meals, to a maximum of 800 mg daily (Prod Info ALBENZA(R) oral tablets, 2013).
    2) 60 KG OR GREATER: Recommended dose is 400 mg twice daily with meals (Prod Info ALBENZA(R) oral tablets, 2013).
    3) Each treatment is for 28 days followed by a 14-day drug-free interval for a total of 3 cycles (Prod Info ALBENZA(R) oral tablets, 2013)
    B) NEUROCYSTICERCOSIS
    1) LESS THAN 60 KG: Recommended dose is 15 mg/kg/day in 2 divided doses for 8 to 30 days to a maximum of 800 mg daily (Prod Info ALBENZA(R) oral tablets, 2013).
    2) 60 KG OR GREATER: Recommended dose is 400 mg twice daily for 8 to 30 days (Prod Info ALBENZA(R) oral tablets, 2013).
    7.2.2) PEDIATRIC
    A) HYDATID DISEASE
    1) LESS THAN 60 KG: Recommended dose is 15 mg/kg/day in 2 divided doses with meals, to a maximum of 800 mg daily (Prod Info ALBENZA(R) oral tablets, 2013).
    2) 60 KG OR GREATER: Recommended dose is 400 mg twice daily with meals (Prod Info ALBENZA(R) oral tablets, 2013).
    3) Each treatment is for 28 days followed by a 14-day drug-free interval for a total of 3 cycles (Prod Info ALBENZA(R) oral tablets, 2013)
    B) NEUROCYSTICERCOSIS
    1) LESS THAN 60 KG: Recommended dose is 15 mg/kg/day in 2 divided doses for 8 to 30 days to a maximum of 800 mg daily (Prod Info ALBENZA(R) oral tablets, 2013).
    2) 60 KG OR GREATER: Recommended dose is 400 mg twice daily for 8 to 30 days (Prod Info ALBENZA(R) oral tablets, 2013).

Maximum Tolerated Exposure

    A) One patient reportedly ingested at least 16 g of albendazole over a 12-hour period. No clinical effects were reported (Prod Info ALBENZA(R) oral tablets, 2013).

Serum Plasma Blood Concentrations

    7.5.2) TOXIC CONCENTRATIONS
    A) TOXIC CONCENTRATION LEVELS
    1) GENERAL
    a) THERAPEUTIC LEVELS -
    1) Therapeutic albendazole serum concentrations have not been defined. Plasma levels of unchanged albendazole are undetectable because of rapid hepatic first-pass metabolism (Marriner et al, 1986; Edwards & Breckenridge, 1988; JEF Reynolds , 1990) Tech Info Zentel(R), 1990). However, after a single 400 milligram oral dose, mean peak plasma concentrations of its active sulfoxide metabolite have ranged from 0.22 to 0.25 milligram/liter at 2 to 3 hours post-dosing (Edwards & Breckenridge, 1988).
    2) In patients receiving oral albendazole 10 milligrams/kilogram/day chronically for hydatid cyst disease due to Echinococcus granulosus, peak serum albendazole sulfoxide concentrations ranged from 240 to 1,240 nanograms/milliliter (Morris et al, 1985).

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) ANIMAL DATA
    1) LD50- (ORAL)MOUSE:
    a) 1500 mg/kg (RTECS, 2002)
    2) LD50- (ORAL)RAT:
    a) 2400 mg/kg (RTECS, 2002)

Pharmacology Toxicology

Pharmacologic Mechanism

    A) Albendazole is a benzimidazole carbamate anthelmintic drug similar to mebendazole (Edwards & Breckenridge, 1988).
    1) While its precise biochemical mechanism of action is not clear, it appears to cause selective degeneration of cytoplasmic microtubules in intestinal and tegmental cells of intestinal helminths (Gilman et al, 1990) and their tissue-dwelling larvae (Jagota, 1986).
    2) Secretory substances accumulate intracellularly, cholinesterase secretion and glucose uptake are impaired, and glycogen is depleted (Gilman et al, 1990).
    3) This in turn decreases ATP production (Jagota, 1986), causing energy depletion which immobilizes and kills the worm (Tech Info Zentel(R), 1990).
    B) One group suggested that inhibition of helminth-specific fumarate reductase and malate dehydrogenase may play a role (Jones et al, 1990).

Animal Toxicology

Clinical Effects

    11.1.3) CANINE/DOG
    A) 90 days of treatment with 30 mg/kg produced no toxic effects (Rossignol et al, 1981).
    11.1.9) OVINE/SHEEP
    A) Bone marrow depression was seen in sheep treated with 10 or 20 mg/kg for 6 weeks (Stallbaumer et al, 1983).

Range Of Toxicity

    11.3.1) THERAPEUTIC DOSE
    A) CAT
    1) 50 mg/kg PO per day for 21 days
    B) CATTLE
    1) 7.5 to 15 mg/kg PO
    C) DOG
    1) 25 to 50 mg/kg BID for 5 days; or 50 mg/kg PO per day for 21 days
    D) SHEEP
    1) 7.5 to 15 mg/kg PO
    E) GOAT
    1) 7.5 to 15 mg/kg PO
    F) SWINE
    1) 5 to 10 mg/kg PO
    G) (REFERENCE - Plumb, 1991)
    11.3.2) MINIMAL TOXIC DOSE
    A) LACK OF INFORMATION
    1) No specific information on a minimal toxic dose was available at the time of this review.

References

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