ALBENZA Film-coated tablet Ref.[50383] Active ingredients: Albendazole

Source: FDA, National Drug Code (US)  Revision Year: 2019 

1. Indications and Usage

1.1 Neurocysticercosis

ALBENZA is 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

ALBENZA 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.

2. Dosage and Administration

2.1 Dosage

Dosing of ALBENZA will vary depending upon the indication. ALBENZA tablets may be crushed or chewed and swallowed with a drink of water. ALBENZA tablets should be taken with food [see Clinical Pharmacology (12.3)].

Table 1. ALBENZA Dosage:

IndicationPatient WeightDoseDuration
Hydatid Disease 60 kg or greater 400 mg twice daily,
with meals 		28-day cycle followed
by a 14-day
albendazole-free
interval, for a total of
3 cycles
Less than 60 kg 15 mg/kg/day given in
divided doses twice
daily with meals
(maximum total daily
dose 800 mg)
Neurocysticercosis 60 kg or greater 400 mg twice daily,
with meals 		8 to 30 days
Less than 60 kg 15 mg/kg/day given in
divided doses twice
daily with meals
(maximum total daily
dose 800 mg)

2.2 Concomitant Medication to Avoid Adverse Reactions

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 [see Warnings and Precautions (5.3)].

2.3 Monitoring for Safety Before and During Treatment

  • Monitor blood counts at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy with ALBENZA in all patients [see Warnings and Precautions (5.1)].
  • Monitor liver enzymes (transaminases) at the beginning of each 28-day cycle of therapy, and at least every 2 weeks during treatment with ALBENZA in all patients [see Warnings and Precautions (5.5)].
  • Obtain a pregnancy test in women of reproductive potential prior to therapy [see Warnings and Precautions (5.2)].

10. Overdosage

In case of overdosage, symptomatic therapy and general supportive measures are recommended.

16.2. Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

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