Finished product reference
Albendazole
Tablet, Chewable · Oral · 400 mg
- List code
- 26
- Pharmacologic class
- Anthelmintic
What it is and how it works
Mechanism of Action Albendazole is a synthetic, anthelmintic drug of the class benzimidazole [ see Clinical Pharmacology ].
Mechanism class: Cytochrome P450 1A Inducers
Indications
Albendazole tablet is an anthelmintic drug indicated for: Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus . Neurocysticercosis Albendazole tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . Hydatid Disease Albendazole tablets are 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 .
Dosage and administration (summary)
Patients weighing 60 kg or greater, 400 mg twice daily; less than 60 kg,15 mg/kg/day in divided doses twice daily (maximum total daily dose 800 mg). Albendazole tablets should be taken with food. Hydatid disease: 28-day cycle followed by 14-day albendazole-free interval for a total of 3 cycles. Neurocysticercosis: 8 to 30 days. See additional important information in the Full Prescribing Information. Dosage Dosing of albendazole tablets will vary depending upon the indication. Albendazole tablets may be crushed or chewed and swallowed with a drink of water. Albendazole tablets should be taken with food [ see Clinical Pharmacology ].
Contraindications
Albendazole is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of albendazole. Patients with known hypersensitivity to the benzimidazole class of compounds or any components of albendazole.
Warnings and precautions
Bone Marrow Suppression: Fatalities have been reported due to bone marrow suppression; monitor blood counts in all patients at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy. Discontinue albendazole if clinically significant changes in blood counts occur. ( 5.1 , 5.4 ) Embryo-Fetal Toxicity: May cause fetal harm. Pregnancy testing is recommended for females of reproductive potential prior to therapy. Advise females of reproductive potential of the potential risk to a fetus and to use an effective method of contraception.
Pregnancy
Pregnancy Risk Summary Based on findings from animal reproduction studies, albendazole may cause fetal harm when administered to a pregnant woman. However, available human data from a small number of published case series and reports on the use of multiple-dose albendazole in the 1st trimester of pregnancy, and several published studies on single-d…
Storage and supply
How Supplied Albendazole tablets USP, 200 mg are white colored, round shaped, biconvex, film coated tablets debossed with "MA 7" on one side and plain on other side and contains 200 mg of albendazole.
Source: Albendazole (Albendazole) — US FDA prescribing information, 2020-02-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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