Albendazole

ALBENDAZOLE- albendazole tablet, film coated
Northstar Rx LLC.

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage

Dosing of albendazole 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) ].

Table 1 AlbendazoleDosage
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)

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 albendazole 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 albendazole in all patients [see Warnings and Precautions (5.5) ]
  • Obtain a pregnancy test in females of reproductive potential prior to therapy [see Warnings and Precautions (5.2) ].

3 DOSAGE FORMS AND STRENGTHS

Albendazole tablets USP, 200 mg are white to off-white, round, film coated tablets debossed ’1021′ on one side and plain on the other side.

4 CONTRAINDICATIONS

Albendazole tablets are contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of albendazole tablets.

5 WARNINGS AND PRECAUTIONS

5.1 Bone Marrow Suppression

Fatalities associated with the use of albendazole have been reported due to granulocytopenia or pancytopenia. Albendazole may cause bone marrow suppression, aplastic anemia, and agranulocytosis. Monitor blood counts at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy with albendazole in all patients. Patients with liver disease and patients with hepatic echinococcosis are at increased risk for bone marrow suppression and warrant more frequent monitoring of blood counts. Discontinue albendazole if clinically significant decreases in blood cell counts occur.

5.2 Embryo-Fetal Toxicity

Based on findings from animal reproduction studies, albendazole may cause fetal harm when administered to a pregnant woman. Embryotoxicity and skeletal malformations were reported in rats and rabbits when treated during the period of organogenesis (at oral doses approximately 0.1 to 0.6 times the recommended human dose normalized for total body surface area). Advise pregnant women of the potential risk to a fetus. Pregnancy testing is recommended for females of reproductive potential prior to initiating albendazole [see Dosage and Administration (2.3)]. Advise females of reproductive potential to use an effective method of contraception during treatment with albendazole and for 3 days after the final dose [see Use in Specific Populations (8.1, 8.3) and Clinical Pharmacology (12.3)].

5.3 Risk of Neurologic Symptoms in Neurocysticercosis

Patients being treated for neurocysticercosis should receive steroid and anticonvulsant therapy to prevent neurological symptoms (e.g., seizures, increased intracranial pressure and focal signs) as a result of an inflammatory reaction caused by death of the parasite within the brain.

5.4 Risk of Retinal Damage in Patients with Retinal Neurocysticercosis

Cysticercosis may involve the retina. Before initiating therapy for neurocysticercosis, examine the patient for the presence of retinal lesions. If such lesions are visualized, weigh the need for anticysticeral therapy against the possibility of retinal damage resulting from inflammatory damage caused by albendazole-induced death of the parasite.

5.5 Hepatic Effects

In clinical trials, treatment with albendazole has been associated with mild to moderate elevations of hepatic enzymes in approximately 16% of patients. These elevations have generally returned to normal upon discontinuation of therapy. There have also been case reports of acute liver failure of uncertain causality and hepatitis [see Adverse Reactions (6) ].

Monitor liver enzymes (transaminases) before the start of each treatment cycle and at least every 2 weeks during treatment. If hepatic enzymes exceed twice the upper limit of normal, consideration should be given to discontinuing albendazole therapy based on individual patient circumstances. Restarting albendazole treatment in patients whose hepatic enzymes have normalized off treatment is an individual decision that should take into account the risk/benefit of further albendazole usage. Perform laboratory tests frequently if albendazole treatment is restarted.

Patients with elevated liver enzyme test results are at increased risk for hepatotoxicity and bone marrow suppression [see Warnings and Precautions (5.1) ]. Discontinue therapy if liver enzymes are significantly increased or if clinically significant decreases in blood cell counts occur.

5.6 Unmasking of Neurocysticercosis in Hydatid Patients

Undiagnosed neurocysticercosis may be uncovered in patients treated with albendazole for other conditions. Patients with epidemiologic factors who are at risk for neurocysticercosis should be evaluated prior to initiation of therapy.

6 ADVERSE REACTIONS

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.

The adverse reaction profile of albendazole differs between hydatid disease and neurocysticercosis. Adverse reactions occurring with a frequency of 1% or greater in either disease are described in Table 2 below.

These symptoms were usually mild and resolved without treatment. Treatment discontinuations were predominantly due to leukopenia (0.7%) or hepatic abnormalities (3.8% in hydatid disease). The following incidence reflects adverse reactions that were reported to be at least possibly or probably related to albendazole.

Table 2: Adverse Reaction Incidence 1% or Greater in Hydatid Disease andNeurocysticercosis
Adverse Reaction Hydatid Disease Neurocysticercosis
Gastrointestinal
Abdominal Pain 6 0
Nausea 4 6
Vomiting 4 6
General disorders and administration site conditions
Fever 1 0
Investigations
Elevated Hepatic Enzymes 16 less than 1
Nervous system disorders
Dizziness 1 less than 1
Headache 1 11
Meningeal Signs 0 1
Raised Intracranial Pressure 0 2
Vertigo 1 less than 1
Skin and subcutaneous tissue disorders
Reversible Alopecia 2 less than 1

The following adverse events were observed at an incidence of less than 1%:

Blood and Lymphatic System Disorders

There have been reports of leukopenia, granulocytopenia, pancytopenia, agranulocytosis, or thrombocytopenia [see Warnings and Precautions (5.1) ].

Immune System Disorders

Hypersensitivity reactions, including rash and urticaria.

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