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ARALEN
Malaria
Protozoal infections
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Drug Name:

ARALEN Rx

Generic Name and Formulations:
Chloroquine phosphate 500mg (equivalent to 300mg chloroquine base); tabs.

Company:
Sanofi Aventis

Therapeutic Use:

Indications for ARALEN:

Treatment of uncomplicated malaria due to susceptible strains of P. falciparum, P. malariae, P. ovale, and P. vivax. Prophylaxis of malaria in geographic areas without resistance to chloroquine.

Adult:

Prophylaxis: 500mg once every 7 days. Treatment: 1g once, then 500mg 6–8hrs later; then 500mg once daily for next 2 days. Low body wt: use children's dose. P. vivax and P. ovale (hypnozoite liver stage): give with concomitant 8-aminoquinoline.

Children:

Prophylaxis: 8.33mg/kg (max 500mg) once every 7 days. Treatment: 16.7mg/kg (max 1g) once, then 8.33mg/kg (max 500mg) 6, 24 and 36hrs after 1st dose. P. vivax and P. ovale (hypnozoite liver stage): give with concomitant 8-aminoquinoline.

Contraindications:

Retinal or visual field changes in indications other than acute malaria.

Warnings/Precautions:

Prophylaxis: start 2 weeks before and continue for 8 weeks after trip. Monitor for cardiomyopathy esp. at high doses; discontinue if occurs. Cardiac disease. History of ventricular arrhythmias. Uncorrected hypokalemia and/or hypomagnesemia. Bradycardia. Monitor for hypoglycemia. Macular disease. Perform baseline eye exam within the first year of initiation, then annually. Avoid in psoriasis, porphyria. Discontinue if muscular weakness, ocular toxicity, or hearing defects occur. Hepatic, renal, or auditory dysfunction. Alcoholism. Seizure disorders. G6PD deficiency. Monitor CBC, reflexes in long-term use. Elderly. Children. Pregnancy (use adequate contraception in endemic areas). Nursing mothers: not recommended.

Interactions:

Avoid cimetidine. Retinal toxicity with concomitant tamoxifen: not recommended. May potentiate insulin and other antidiabetic drugs: decrease doses of these. Separate ampicillin dose by 2hrs; dosing of antacids or kaolin by 4hrs. Caution with concomitant QT interval prolonging agents, arrhythmogenic, or hepatotoxic drugs. Increased risk of convulsions with concomitant mefloquine. Potentiates cyclosporine (monitor). May antagonize praziquantel.

Pharmacological Class:

Aminoquinoline.

Adverse Reactions:

Retinopathy, maculopathy, macular degeneration, cardiomyopathy, hearing defects, hypoglycemia, acute extrapyramidal disorders, blood dyscrasias, muscular weakness, GI upset, skin reactions, neuropsychiatric disorders.

How Supplied:

Tabs—25

Indications for ARALEN:

Extraintestinal amebiasis (use with intestinal amebicide).

Adult:

1g daily for 2 days, then 500mg daily for at least 2–3 weeks.

Children:

See full labeling.

Contraindications:

Retinal or visual field changes in indications other than acute malaria.

Warnings/Precautions:

Prophylaxis: start 2 weeks before and continue for 8 weeks after trip. Monitor for cardiomyopathy esp. at high doses; discontinue if occurs. Cardiac disease. History of ventricular arrhythmias. Uncorrected hypokalemia and/or hypomagnesemia. Bradycardia. Monitor for hypoglycemia. Macular disease. Perform baseline eye exam within the first year of initiation, then annually. Avoid in psoriasis, porphyria. Discontinue if muscular weakness, ocular toxicity, or hearing defects occur. Hepatic, renal, or auditory dysfunction. Alcoholism. Seizure disorders. G6PD deficiency. Monitor CBC, reflexes in long-term use. Elderly. Children. Pregnancy (use adequate contraception in endemic areas). Nursing mothers: not recommended.

Interactions:

Avoid cimetidine. Retinal toxicity with concomitant tamoxifen: not recommended. May potentiate insulin and other antidiabetic drugs: decrease doses of these. Separate ampicillin dose by 2hrs; dosing of antacids or kaolin by 4hrs. Caution with concomitant QT interval prolonging agents, arrhythmogenic, or hepatotoxic drugs. Increased risk of convulsions with concomitant mefloquine. Potentiates cyclosporine (monitor). May antagonize praziquantel.

Pharmacological Class:

Aminoquinoline.

Adverse Reactions:

Retinopathy, maculopathy, macular degeneration, cardiomyopathy, hearing defects, hypoglycemia, acute extrapyramidal disorders, blood dyscrasias, muscular weakness, GI upset, skin reactions, neuropsychiatric disorders.

How Supplied:

Tabs—25

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