ARALEN?
(chloroquine phosphate, USP)
For Malaria and Extraintestinal Amebiasis
DRUG DESCRIPTION
ARALEN, chloroquine phosphate, USP, is a 4-aminoquinoline compound for oral administration. It is a white, odorless, bitter tasting, crystalline substance, freely soluble in water.
ARALEN is an antimalarial and amebicidal drug.
Each tablet contains 500 mg of chloroquine phosphate USP, equivalent to 300 mg chloroquine base.
Inactive Ingredients: Carnauba Wax, Colloidal Silicon Dioxide, Dibasic Calcium Phosphate, Hydroxypropyl Methylcellulose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid, Titanium Dioxide.
INDICATIONS
ARALEN is indicated for the suppressive treatment and for acute attacks of malaria due to P. vivax, P.malariae, P. ovale, and susceptible strains of P. falciparum. The drug is also indicated for the treatment of extraintestinal amebiasis.
ARALEN does not prevent relapses in patients with vivax or malariae malaria because it is not effective against exoerythrocytic forms of the parasite, nor will it prevent vivax or malariae infection when administered as a prophylactic. It is highly effective as a suppressive agent in patients with vivax or malariae malaria, in terminating acute attacks, and significantly lengthening the interval between treatment and relapse. In patients with falciparum malaria it abolishes the acute attack and effects complete cure of the infection, unless due to a resistant strain of P. falciparum.
SIDE EFFECTS
Special Senses: Ocular: Irreversible retinal damage in patients receiving long-term or high-dosage 4-aminoquinoline therapy visual disturbances (blurring of vision and difficulty of focusing or accommodation) nyctalopia scotomatous vision with field defects of paracentral, pericentral ring types, and typically temporal scotomas, e.g., difficulty in reading with words tending to disappear, seeing half an object, misty vision, and fog before the eyes.
Auditory: Nerve type deafness tinnitus, reduced hearing in patients with preexisting auditory damage.
Musculoskeletal system: Skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups, which may be associated with mild sensory changes, depression of tendon reflexes and abnormal nerve conduction, have been noted.
Gastrointestinal system: Anorexia, nausea, vomiting, diarrhea, abdominal cramps.
Skin and appendages: Pleomorphic skin eruptions, skin and mucosal pigmentary changes lichen planus-like eruptions, pruritus, photosensitivity and hair loss and bleaching of hair pigment.
Hematologic system: Rarely, aplastic anemia, reversible agranulocytosis, thrombocytopenia and neutropenia.
Central Nervous system: Convulsive seizures. Mild and transient headache. Neuropsychiatric changes including psychosis, delirium, personality changes and depression.
Cardiovascular system: Rarely, hypotension, electrocardiographic change (particularly, inversion or depression of the T-wave with widening of the QRS complex), and cardiomyopathy.