Albendazole

Albendazole
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]

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Overview

Albendazole is {{{aOrAn}}} Anthelmintic that is FDA approved for the {{{indicationType}}} of Neurocysticercosis, hydatid disease. Common adverse reactions include abdominal pain, nausea, vomiting, headache..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

lbendazole is indicated for the treatment of the following infections:

• Neurocysticercosis

• Albendazole is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium.

• Lesions considered responsive to albendazole therapy appear as nonenhancing cysts with no surrounding edema on contrast-enhanced computerized tomography. Clinical studies in patients with lesions of this type demonstrate a 74% to 88% reduction in number of cysts; 40% to 70% of albendazole-treated patients showed resolution of all active cysts.

• Hydatid Disease

• Albendazole is indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus.

• This indication is based on combined clinical studies which demonstrated non-infectious cyst contents in approximately 80 to 90% of patients given Albendazole for 3 cycles of therapy of 28 days each. Clinical cure (disappearance of cysts) was seen in approximately 30% of these patients, and improvement (reduction in cyst diameter of ≥25%) was seen in an additional 40%.

• NOTE: When medically feasible, surgery is considered the treatment of choice for hydatid disease. When administering Albendazole in the pre- or post-surgical setting, optimal killing of cyst contents is achieved when 3 courses of therapy have been given.

• NOTE: The efficacy of albendazole in the therapy of alveolar hydatid disease caused by Echinococcus multilocularis has not been clearly demonstrated in clinical studies.

Dosing of Albendazole will vary, depending upon which of the following parasitic infections is being treated. In young children, the tablets should be crushed or chewed and swallowed with a drink of water.

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This image is provided by the National Library of Medicine.

Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of treatment.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

• Ancylostomiasis - Necatoriasis
• Ascariasis
• Capillaria infection
• Clonorchiasis
• Cutaneous larva migrans
• Enterobiasis
• Giardiasis
• HIV infection - Infection by Microsporida
• Infection by Gnathostoma
• Infection by Loa loa

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Albendazole in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Albendazole FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Albendazole in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Albendazole in pediatric patients.

Contraindications

There is limited information regarding Albendazole Contraindications in the drug label.

Warnings

There is limited information regarding Albendazole Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Albendazole Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Albendazole Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Albendazole Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Albendazole in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Albendazole in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Albendazole during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Albendazole in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Albendazole in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Albendazole in geriatric settings.

Gender

There is no FDA guidance on the use of Albendazole with respect to specific gender populations.

Race

There is no FDA guidance on the use of Albendazole with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Albendazole in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Albendazole in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Albendazole in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Albendazole in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Albendazole Administration in the drug label.

Monitoring

There is limited information regarding Albendazole Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Albendazole and IV administrations.

Overdosage

There is limited information regarding Albendazole overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Albendazole Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Albendazole Mechanism of Action in the drug label.

Structure

There is limited information regarding Albendazole Structure in the drug label.

Pharmacodynamics

There is limited information regarding Albendazole Pharmacodynamics in the drug label.

Pharmacokinetics

Pharmacokinetics Absorption and Metabolism

Albendazole is poorly absorbed from the gastrointestinal tract due to its low aqueous solubility. Albendazole concentrations are negligible or undetectable in plasma as it is rapidly converted to the sulfoxide metabolite prior to reaching the systemic circulation. The systemic anthelmintic activity has been attributed to the primary metabolite, albendazole sulfoxide. Oral bioavailability appears to be enhanced when albendazole is coadministered with a fatty meal (estimated fat content 40 g) as evidenced by higher (up to 5-fold on average) plasma concentrations of albendazole sulfoxide as compared to the fasted state.

Maximal plasma concentrations of albendazole sulfoxide are typically achieved 2 to 5 hours after dosing and are on average 1.31 mcg/mL (range 0.46 to 1.58 mcg/mL) following oral doses of albendazole (400 mg) in 6 hydatid disease patients, when administered with a fatty meal. Plasma concentrations of albendazole sulfoxide increase in a dose-proportional manner over the therapeutic dose range following ingestion of a fatty meal (fat content 43.1 g). The mean apparent terminal elimination half-life of albendazole sulfoxide typically ranges from 8 to 12 hours in 25 normal subjects, as well as in 14 hydatid and 8 neurocysticercosis patients.

Following 4 weeks of treatment with albendazole (200 mg three times daily), 12 patients’ plasma concentrations of albendazole sulfoxide were approximately 20% lower than those observed during the first half of the treatment period, suggesting that albendazole may induce its own metabolism.

Distribution

Albendazole sulfoxide is 70% bound to plasma protein and is widely distributed throughout the body; it has been detected in urine, bile, liver, cyst wall, cyst fluid, and cerebral spinal fluid (CSF). Concentrations in plasma were 3- to 10-fold and 2- to 4-fold higher than those simultaneously determined in cyst fluid and CSF, respectively. Limited in vitro and clinical data suggest that albendazole sulfoxide may be eliminated from cysts at a slower rate than observed in plasma.

Metabolism and Excretion

Albendazole is rapidly converted in the liver to the primary metabolite, albendazole sulfoxide, which is further metabolized to albendazole sulfone and other primary oxidative metabolites that have been identified in human urine. Following oral administration, albendazole has not been detected in human urine. Urinary excretion of albendazole sulfoxide is a minor elimination pathway with less than 1% of the dose recovered in the urine. Biliary elimination presumably accounts for a portion of the elimination as evidenced by biliary concentrations of albendazole sulfoxide similar to those achieved in plasma.

Nonclinical Toxicology

There is limited information regarding Albendazole Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Albendazole Clinical Studies in the drug label.

How Supplied

There is limited information regarding Albendazole How Supplied in the drug label.

Storage

There is limited information regarding Albendazole Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Albendazole Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Albendazole interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Albendazole Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Albendazole Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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