August 1, 2015
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Albenza

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Albenza




Indications
Dosage
How Supplied

INDICATIONS

Neurocysticercosis

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

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.

DOSAGE AND ADMINISTRATION

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 chewable tablets are also available for children and patients who may experience swallowing difficulties. ALBENZA tablets and ALBENZA chewable tablets should be taken with food [see CLINICAL PHARMACOLOGY].

Table 1: ALBENZA Dosage

Indication Patient Weight Dose Duration
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)

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].

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].
  • 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].
  • Obtain a pregnancy test in women of reproductive potential prior to therapy [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

  • Tablet: 200 mg
  • Chewable Tablet: 200 mg
Tablets

Each white to off-white, circular, biconvex, bevel-edged film coated, TILTAB tablet is debossed with “ap” and “550” and contains 200 mg of albendazole.

Bottles of 2 Tablets NDC 52054-550-22
Bottles of 28 Tablets NDC 52054-550-28

Chewable Tablets

Each round, mottled pink, concave chewable tablet is debossed with “ap” above “551” and contains 200 mg of albendazole.

2 Tablets in 1 Blister Pack (configured as a Wallet Card)
NDC
52054-551-22
6 Tablets in 1 Blister Pack; 2 Blister Packs in 1 Carton
NDC
52054-551-12

Storage And Handling

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

Distributed by: Amedra Pharmaceuticals LLC Horsham, PA 19044. Revised: June 2015

Last reviewed on RxList: 6/29/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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