Albenza

Name: Albenza

What other drugs will affect Albenza (albendazole)?

Other drugs may interact with albendazole, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Albenza Dosage and Administration

Administration

Oral Administration

Administer orally with food.1 Food, especially fatty food, increases bioavailability.1 3 7

In patients (particularly young children) who have difficulty swallowing tablets whole, tablets may be crushed or chewed and swallowed with a drink of water.1

Dosage

Pediatric Patients

Neurocysticercosis Oral

Children weighing <60 kg: 15 mg/kg daily (up to 800 mg daily), administered as 2 equally divided doses with meals, for 8–30 days.1 8 Repeat as necessary.8

Children ≥6 years of age and weighing ≥60 kg: 400 mg twice daily with meals for 8–30 days.1 8 5 Repeat as necessary.8

Hydatid Disease Oral

Children <60 kg: 15 mg/kg daily (up to 800 mg daily), administered in 2 equally divided doses with meals for 28 days, followed by a 14-day albendazole-free interval.1 Repeat for a total of 3 dosage cycles.1

Children ≥6 years of age and weighing ≥60 kg: 400 mg twice daily with meals for 28 days, followed by a 14-day albendazole-free interval.1 Repeat for a total of 3 dosage cycles.1

Alternatively, 15 mg/kg daily (up to 800 mg daily) for 1–6 months has been recommended for treatment of hydatid cyst disease in pediatric patients.8

Ascariasis† Oral

Single 400-mg dose.8

Baylisascariasis† Oral

25–50 mg/kg daily for 10 days.18 Some clinicians recommend a 20-day regimen.8

Immediate treatment is recommended if infection is probable; treatment should not be delayed until patient is symptomatic.18

Enterobiasis† Oral

400-mg initial dose followed by a second 400-mg dose given 2 weeks later.8

Consider treating household contacts, especially in situations in which multiple or repeated symptomatic infections occur.8 13

Filariasis† Filariasis Caused by Mansonella perstans† Oral

400 mg twice daily for 10 days.8

Hookworm Infections† Cutaneous Larva Migrans (Creeping Eruption)† Oral

400 mg once daily for 3 days.8

Intestinal Hookworm Infections† Oral

Single 400-mg dose.8

Perform a repeat stool examination (using a concentration technique) for eggs of Ancylostoma duodenale or Necator americanus 2 weeks after treatment; repeat dose if results are positive.13

Eosinophilic Enterocolitis Caused by Ancylostoma caninum† Oral

Single 400-mg dose.8

Toxocariasis (Visceral Larva Migrans)† Oral

400 mg twice daily for 5 days.8 Optimum duration of therapy not known; some clinicians recommend up to 20 days of treatment.8

Strongyloidiasis† Oral

400 mg twice daily for 2 days.8

Repeated or prolonged therapy or use of other agents may be necessary in immunocompromised individuals or those with disseminated disease.8 13

Trichinellosis† Oral

400 mg twice daily for 8–14 days.8

Trichostrongyliasis† Oral

Single 400-mg dose.8

Trichuriasis† Oral

400 mg once daily for 3 days.8

Capillariasis† Oral

400 mg once daily for 10 days.8

Gnathostomiasis† Oral

400 mg twice daily for 21 days.a

Gongylonemiasis† Oral

10 mg/kg daily for 3 days.8

Trematode (Fluke) Infections† Oral

10 mg/kg daily for 7 days.8

Giardiasis† Oral

400 mg daily for 5 days (alone or in conjunction with metronidazole).8

Adults

Neurocysticercosis Oral

Adults <60 kg: 15 mg/kg daily (up to 800 mg daily), administered in 2 equally divided doses with meals, for 8–30 days.1 8 Repeat as necessary.8

Adults ≥60 kg: 400 mg twice daily with meals for 8–30 days.1 8 5 Repeat as necessary.8

Hydatid Disease Oral

Adults <60 kg: 15 mg/kg daily (up to 800 mg daily), administered in 2 equally divided doses with meals for 28 days, followed by a 14-day albendazole-free interval.1 Repeat for a total of 3 dosage cycles.1

Adults ≥60 kg: 400 mg twice daily with meals for 28 days, followed by a 14-day albendazole-free interval.1 Repeat for a total of 3 dosage cycles.1

Alternatively, 400 mg twice daily for 1–6 months has been recommended for treatment of hydatid cyst disease in adults.8

Ascariasis† Oral

Single 400-mg dose.8

Baylisascariasis† Oral

25–50 mg/kg daily for 10 days.18 Some clinicians recommend a 20-day regimen.8

Enterobiasis† Oral

400-mg initial dose followed by a second 400-mg dose given 2 weeks later.8

Consider treating household contacts, especially in situations in which multiple or repeated symptomatic infections occur.8 13

Filariasis† Filariasis Caused by Mansonella perstans† Oral

400 mg twice daily for 10 days.8

Hookworm Infections† Cutaneous Larva Migrans (Creeping Eruption)† Oral

400 mg once daily for 3 days.8

Intestinal Hookworm Infections† Oral

Single 400-mg dose.8

Perform a repeat stool examination (using a concentration technique) for eggs of Ancylostoma duodenale or Necator americanus 2 weeks after treatment; repeat dose if results are positive.13

Eosinophilic Enterocolitis Caused by Ancylostoma caninum† Oral

Single 400-mg dose.8

Toxocariasis (Visceral Larva Migrans)† Oral

400 mg twice daily for 5 days.8 Optimum duration of therapy not known; some clinicians recommend up to 20 days of treatment.8

Strongyloidiasis† Oral

400 mg twice daily for 2 days.8

Repeated or prolonged therapy or use of other agents may be necessary in immunocompromised individuals or those with disseminated disease.8 13

Trichinellosis† Oral

400 mg twice daily for 8–14 days.8

Trichostrongyliasis† Oral

Single 400-mg dose.8

Trichuriasis† Oral

400 mg once daily for 3 days.8

Capillariasis† Oral

400 mg once daily for 10 days.8

Gnathostomiasis† Oral

400 mg twice daily for 21 days.a

Gongylonemiasis† Oral

10 mg/kg daily for 3 days.8

Trematode (Fluke) Infections† Oral

10 mg/kg daily for 7 days.8

Giardiasis† Oral

400 mg daily for 5 days (alone or in conjunction with metronidazole).8

Microsporidiosis† Intestinal Microsporidiosis† Oral

400 mg twice daily for 21 days.8

Ocular Microsporidiosis† Oral

400 mg twice daily.8

Disseminated Microsporidiosis† Oral

400 mg twice daily.8

Prescribing Limits

Pediatric Patients

Neurocysticercosis Oral

Children weighing <60 kg: Maximum 800 mg daily.1 8

Hydatid Disease Oral

Children weighing <60 kg: Maximum 800 mg daily.1 8

Adults

Neurocysticercosis Oral

Adults weighing <60 kg: Maximum 800 mg daily.1 8

Hydatid Disease Oral

Adults weighing <60 kg: Maximum 800 mg daily.1 8

Special Populations

No special population dosage recommendations at this time.

Actions and Spectrum

  • Broad-spectrum anthelmintic agent.1

  • Benzimidazole derivative1 4 structurally related to thiabendazole and mebendazole.4

  • Principal anthelmintic effect of benzimidazoles appears to be specific, high-affinity binding to free β-tubulin in parasite cells,1 3 4 resulting in selective inhibition of parasite microtubule polymerization,1 3 4 and inhibition of microtubule-dependent uptake of glucose.2 3 6

  • Benzimidazole derivatives bind to the β-tubulin of parasites at much lower concentrations than to mammalian β-tubulin protein;4 the drugs do not inhibit glucose uptake in mammals, and do not appear to have any effect on blood glucose concentrations in humans.2 6

  • Active against the larval forms of Echinococcus granulosus and Taenia solium.1

Uses For Albenza

Albendazole is used to treat neurocysticercosis, an infection of the nervous system caused by pork tapeworms. This medicine is also used to treat cystic hydatid disease of the liver, lung, and peritoneum, an infection caused by dog tapeworms.

Albendazole is used to treat infections caused by worms. It works by keeping the worm from absorbing sugar (glucose), so that the worm loses energy and dies.

This medicine is available only with your doctor's prescription.

Uses of Albenza

  • It is used to treat infections caused by worms.

What are some things I need to know or do while I take Albenza?

  • Tell all of your health care providers that you take Albenza. This includes your doctors, nurses, pharmacists, and dentists.
  • Very bad and sometimes deadly blood problems have rarely happened with this medicine. This may cause more chance of getting an infection, bleeding problems, or anemia. Talk with the doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • If you are taking Albenza to treat tapeworms in the brain, other drugs may be given to help avoid certain health problems. Your eyes may also need to be checked before you start this medicine. Call your doctor right away if you have seizures, very bad headache, or change in eyesight.
  • This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking Albenza, call your doctor right away.
  • If you are a woman of childbearing age, take a pregnancy test before starting this medicine.
  • Use birth control that you can trust to prevent pregnancy while taking Albenza and for 1 month after stopping this medicine.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

What are some other side effects of Albenza?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Belly pain.
  • Headache.
  • Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Albenza, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Albenza (albendazole tablets). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Albenza.

Review Date: October 4, 2017

Dosage Forms and Strengths

  • Tablet: 200 mg
  • Chewable Tablet: 200 mg

PRINCIPAL DISPLAY PANEL - NDC 52054-551-22 - 200 mg Wallet Card (Back)

Albenza 
albendazole tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52054-550
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBENDAZOLE (ALBENDAZOLE) ALBENDAZOLE 200 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX  
HYPROMELLOSES  
LACTOSE MONOHYDRATE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POVIDONES  
SODIUM LAURYL SULFATE  
SACCHARIN SODIUM MONOHYDRATE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
STARCH, CORN  
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (cirular) Size 12mm
Flavor Imprint Code ap;550
Contains     
Packaging
# Item Code Package Description
1 NDC:52054-550-22 2 TABLET, FILM COATED in 1 BOTTLE
2 NDC:52054-550-28 28 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020666 06/11/1996
Albenza 
albendazole tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52054-551
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALBENDAZOLE (ALBENDAZOLE) ALBENDAZOLE 200 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE  
CELLULOSE, MICROCRYSTALLINE  
MANNITOL  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
POVIDONES  
MAGNESIUM STEARATE  
CROSPOVIDONE (19 MPA.S AT 5%)  
POLYVINYL ACETATE  
SUCRALOSE  
SILICON DIOXIDE  
SODIUM LAURYL SULFATE  
D&C RED NO. 30  
Product Characteristics
Color PINK Score no score
Shape ROUND Size 13mm
Flavor BERRY (wild berry) Imprint Code ap;551
Contains     
Packaging
# Item Code Package Description
1 NDC:52054-551-22 2 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207844 09/03/2015 09/03/2015
Labeler - Amedra Pharmaceuticals LLC (961668824)
Revised: 06/2015   Amedra Pharmaceuticals LLC
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