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U.S. Department of Health and Human Services

Safety

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Aralen (chloroquine phosphate, USP) 500 mg tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2009

 

Summary View

 

PRECAUTIONS

Drug Interactions
  • Mefloquine: Co-Administration of chloroquine and mefloquine may increase the risk of convulsions
  • The blood concentrations of chloroquine and desethylchloroquine (the major metabolite of chloroquine, which also has antimalarial properties) were negatively associated with log antibody titers.  Chloroquine taken in the dose recommended for malaria prophylaxis can reduce the antibofy response to primary immunization with intradermal human diploid-cell rabied vaccine.
Nursing Mothers
  • The excretion of chloroquine and the major metabolite, desethylchloroquine, in breast milk was investigated in eleven lactating mothers following a single oral dose of chloroquine (600 mg base).  The maximum daily dose of the drug that th einfant can receive from breastfeeding was about 0.7% of the maternal start dose of the drug in malaria chemotherapy.  Separate chemoprophylaxis for the infant is required.

ADVERSE REACTIONS

Special Senses: Ocular
  • Reversible corneal opacities have also been reported
Gastrointestinal system
  • hepatitis, increased liver enzymes
Skin and appendages
  • Rare reports of erythema multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and similar desquamation-type events.
  • urticaria, anaphylactic/anaphylactoid reacction including angioedema
Hematologic system
  • pancytopenia
Nervous system
  • polyneuritis, anxiety, agitation, insomnia, confusion, hallucinations