WARNINGS: Cases of an encephalopathy-like syndrome associated with demyelination have been reported in patients treated with levamisole hydrochloride. combination therapy of Levamisole and fluorouracil has also included reports of peripheral neuropathy and multifocal inflammatory leukoencephalopathy. Symptoms may include coma, confusion, lethargy, memory loss, muscle weakness, paresthesia, seizures, and speech disturbances. This condition has been associated with MRI and CT scan findings of demyelinating lesions in the white matter. Levamisole has been associated with agranulocytosis, sometimes fatal.

Higher than recommended doses of Levamisole may be associated with an increased incidence of agranulocytosis, so the recommended dose should not be exceeded.

Patients with hepatic impairment should be monitored for adverse events, including encephalopathy.

PRECAUTIONS:

Information for Patients: The patient should be informed that if flu-like symptoms or malaise occurs, the physician should be notified immediately.

Pregnancy: Pregnancy Category C

Nursing Mothers: Because of the potential for serious adverse reactions in nursing infants from Levamisole, a decision should be made whether to discontinue nursing or to discontinue the drug.

Pediatric Use: Safety and effectiveness of Levamisole in children have not been established.

SIDE EFFECTS:

Adverse experience % in 440 patients who consumed Levamisole

Gastrointestinal: Nausea %22, Diarrhea %13, Stomatitis %3, Vomiting %6, Anorexia %2, Abdominal pain %2, Constipation %2.

Hematological: Leukopenia   >/=2000 to <4000/mm 3   %4, Thrombocytopenia

  >/=50,000 to <130,000/mm 3 %1.

Skin and Appendages: Dermatitis %8, Alopecia %3.

Body as a Whole: Fatigue %6, Fever %3, Rigors %3.

Resistance Mechanisms: Infection %5.

Special Senses: Taste Perversion %8.

Musculoskeletal System: Arthralgia %5, Myalgia %3.

Central and peripheral nervous system: Dizziness %3, Headache %3, Paresthesia %2.

Psychiatric: Somnolence %3.

DOSAGE AND ADMINISTRATION:

Ascariasis: 150 mg single dose, in child 3 mg/kg single dose.

Hookworm: 2.5 mg/kg as a single dose in adult and child repeat one week later in severe cases.

Initial Therapy: 50 mg p.o. q8h for 3 days (starting 7-30 days post-surgery)

Maintenance: 50 mg p.o. q8h for 3 days every 2 weeks.

How Supplied: Pack of 100 tablets in 10 Blisters.

storage: Store at controlled room temperature, (15°-25°C). Protect from moisture.

For more information please refer to:

USPDI for Professional Health Care, 2004, Page 1774-6

Martindale 2005, Page 107-8