Albendazole
Generic Name: albendazole
Brand Names:
Albendazole
11 DESCRIPTION Albendazole is an orally administered anthelmintic drug. Chemically, it is methyl 5‑(propylthio)‑2‑benzimidazolecarbamate. Its molecular formula is C 12 H 15 N 3 O 2 S. Its molecular weight is 265.34. It has the following chemical structure: Albendazole is a white to yellowish powder. It is freely soluble in anhydrous formic acid and very slightly soluble in ether and in methylene chloride. Albendazole is practically insoluble in alcohol and in water.
Overview
11 DESCRIPTION Albendazole is an orally administered anthelmintic drug. Chemically, it is methyl 5‑(propylthio)‑2‑benzimidazolecarbamate. Its molecular formula is C 12 H 15 N 3 O 2 S. Its molecular weight is 265.34. It has the following chemical structure: Albendazole is a white to yellowish powder. It is freely soluble in anhydrous formic acid and very slightly soluble in ether and in methylene chloride. Albendazole is practically insoluble in alcohol and in water.
Uses
1 INDICATIONS & USAGE Albendazole Tablets is an anthelmintic drug indicated for: Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . ( 1.1 ) Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus . ( 1.2 ) 1.1 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 . 1.2 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
2 DOSAGE & ADMINISTRATION 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. ( 2 ) Hydatid disease: 28‑day cycle followed by 14‑day albendazole‑free interval for a total of 3 cycles. ( 2 ) Neurocysticercosis: 8 to 30 days. ( 2 ) See additional important information in the Full Prescribing Information. ( 2 ) 2.1 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 ( 12.3 ) ].
Side Effects
6 ADVERSE REACTIONS Adverse reactions 1% or greater in hydatid disease: abnormal liver function tests, abdominal pain, nausea/vomiting, reversible alopecia, headache, dizziness/vertigo, fever. ( 6.1 ) Adverse reactions 1% or greater in neurocysticercosis: headache, nausea/ vomiting, raised intracranial pressure, meningeal signs. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Edenbridge Pharmaceuticals, LLC at 1-877-381-3336 or FDA at 1-800-332-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Interactions
7 DRUG INTERACTIONS Dexamethasone: Steady‑state trough concentrations of albendazole sulfoxide were about 56% higher when dexamethasone was coadministered with each dose of albendazole. ( 7.1 ) Praziquantel: In the fed state increased mean maximum plasma concentration and area under the curve of albendazole sulfoxide by about 50% in healthy subjects. ( 7.2 ) Cimetidine: Increased albendazole sulfoxide concentrations in bile and cystic fluid by about 2‑fold in hydatid cyst patients. (7.3) Theophylline: Albendazole induces cytochrome P450 1A in human hepatoma cells; therefore, it is recommended that plasma concentrations of theophylline be monitored during and after treatment.
Warnings
5 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 Tablets 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. 4 CONTRAINDICATIONS Albendazole Tablets are contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of Albendazole Tablets. Patients with known hypersensitivity to the benzimidazole class of compounds or any components of Albendazole Tablets. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Based on findings from animal reproduction studies, Albendazole Tablets 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 1 st trimester of pregnancy, and several published studies on single-dose albendazole use later in pregnancy, have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Albendazole Tablets USP are white to off-white, round, convex, film‑coated tablets, debossed with “110” with an arch overhead on one side and plain on the other side and contain 200 mg of albendazole. Bottles of 2 Tablets NDC 51407-258-02 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Frequently Asked Questions
What is Albendazole used for?▼
1 INDICATIONS & USAGE Albendazole Tablets is an anthelmintic drug indicated for: Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium . ( 1.1 ) Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus . ( 1.2 ) 1.1 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 . 1.2 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 .
What are the side effects of Albendazole?▼
6 ADVERSE REACTIONS Adverse reactions 1% or greater in hydatid disease: abnormal liver function tests, abdominal pain, nausea/vomiting, reversible alopecia, headache, dizziness/vertigo, fever. ( 6.1 ) Adverse reactions 1% or greater in neurocysticercosis: headache, nausea/ vomiting, raised intracranial pressure, meningeal signs. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Edenbridge Pharmaceuticals, LLC at 1-877-381-3336 or FDA at 1-800-332-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Can I take Albendazole during pregnancy?▼
8.1 Pregnancy Risk Summary Based on findings from animal reproduction studies, Albendazole Tablets 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 1 st trimester of pregnancy, and several published studies on single-dose albendazole use later in pregnancy, have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.
What are the important warnings for Albendazole?▼
5 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 Tablets 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. 4 CONTRAINDICATIONS Albendazole Tablets are contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of Albendazole Tablets. Patients with known hypersensitivity to the benzimidazole class of compounds or any components of Albendazole Tablets. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.