pharmacopeia
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/api/v1/drug/chloroquine

Mechanism of action

Sourced from openFDA

Chloroquine, a 4-aminoquinoline, is an anti-protozoal agent. The precise mechanism by which chloroquine exhibits activity is not known.

Nucleic Acid Synthesis

Indications

Sourced from openFDA
  • Chloroquine phosphate tablets are indicated for the: Treatment of uncomplicated malaria due to susceptible strains of P. falciparum, P.malariae, P.ICD-10: B54

Contraindications

Sourced from openFDA
  • Use of chloroquine phosphate tablets for indications other than acute malaria is contraindicated in the presence of retinal or visual field changes of any etiology. Use of chloroquine phosphate tablets is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.contraindicated

Dosage & administration

Sourced from openFDA

The dosage of chloroquine phosphate is often expressed in terms of equivalent chloroquine base. Each 500 mg tablet of Chloroquine phosphate contains the equivalent of 300 mg chloroquine base. In infants and children the dosage is preferably calculated by body weight. Prophylaxis against chloroquine-sensitive Plasmodium species Adult Dose: The dosage for prophylaxis is 500 mg (= 300 mg base) administered once per week on exactly the same day of each week. Pediatric Dose : The dosage for prophylaxis is 5 mg calculated as base, per kg of body weight, administered once per week on exactly the same day of each week. The pediatric dose should never exceed the adult dose regardless of weight. If circumstances permit, suppressive therapy should begin two weeks prior to exposure. However, failing this in adults, an initial double (loading) dose of 1 g (= 600 mg base), or in children 10 mg base/kg may be taken in two divided doses, six hours apart. The suppressive therapy should be continued for eight weeks after leaving the endemic area. Treatment of uncomplicated malaria due to chloroquine-sensitive Plasmodium species Adults : An initial dose of 1 g salt (= 600 mg base) followed by an additional 500 mg (= 300 mg base) after six to eight hours and a single dose of 500 mg (= 300 mg base) on each of two consecutive days. This represents a total dose of 2.5 g chloroquine phosphate or 1.5 g base in three days. Infants and Children: In infants and children, the recommended dose is 10 mg base/kg followed by 5 mg based/kg at 6, 24 and 36 hours (total dose 25 mg based/kg).

Warnings & precautions

Sourced from openFDA

Chloroquine-Resistant Malaria Chloroquine phosphate tablets are not effective against chloroquine-or hydroxychloroquine-resistant strains of Plasmodium species (see CLINICAL PHARMACOLOGY , Microbiology ). Chloroquine resistance is widespread in P. falciparum and is reported in P. vivax . Before using chloroquine for prophylaxis, it should be ascertained whether chloroquine is appropriate for use in the region to be visited by the traveler. Information regarding the geographic areas where resistance to chloroquine occurs, is available at the Centers for Disease Control and Prevention (www.cdc.gov\malaria). Patients infected with a resistant strain of plasmodia as shown by the fact that normally adequate doses have failed to prevent or cure clinical malaria or parasitemia should be treated with another form of antimalarial therapy. Treatment of Exo-Erythocytic Forms of Malaria Chloroquine does not treat the hypnozoite liver stage forms of Plasmodium and will therefore not prevent relapses of malaria due to P. vivax or P. ovale . Additional treatment with an anti-malarial agent active against these forms, such as an 8-aminoquinoline, is required for the treatment of infections with P. vivax and P. ovale . Cardiac Effects including Cardiomyopathy and QT prolongation Fatal and life-threatening cardiotoxicity, including cardiomyopathy and arrhythmias, have been reported with the use of chloroquine (see ADVERSE REACTIONS and OVERDOSAGE ).

Adverse reactions

Sourced from openFDA

The following adverse reactions have been identified during post-approval use of chloroquine or other 4-aminoqunoline compounds. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Ocular disorders: Maculopathy and macular degeneration have been reported and may be irreversible. Irreversible retinopathy with retinal pigmentation changes (bull’s eye appearance) and visual field defects (paracentral scotomas) in patients receiving long-term or high-dosage 4-aminoquinoline therapy have been reported (see WARNINGS ). 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) have been reported. Reversible corneal opacities have also been reported. Immune system disorders: Urticaria, anaphylactic reaction including angioedema. Ear and labyrinth disorders: Nerve type deafness; tinnitus, reduced hearing in patients with preexisting auditory damage. Musculoskeletal and connective tissue-disorders : Sensorimotor disorders, skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups, depression of tendon reflexes and abnormal nerve conduction.

Overdosage

Sourced from openFDA

Signs and Symptoms: Chloroquine is very rapidly and completely absorbed after ingestion. Toxic doses of chloroquine can be fatal. As little as 1 g may be fatal in children. Toxic symptoms can occur within minutes. The symptoms of overdosage may include nausea, vomiting, headache, drowsiness, visual disturbances, cardiovascular collapse, convulsions, hypokalemia, rhythm and conduction disorders including QT prolongation, torsades de pointes, ventricular tachycardia and ventricular fibrillation, followed by sudden potentially fatal respiratory and cardiac arrest. Immediate medical attention is required, as these effects may appear shortly after the overdose. Cases of extrapyramidal disorders have also been reported in the context of chloroquine overdose (see WARNINGS and ADVERSE REACTIONS ). Treatment: Treatment is symptomatic and must be prompt with immediate evacuation of the stomach by emesis or gastric lavage followed by treatment with activated charcoal. Chloroquine overdose is a life-threatening emergency and should be managed with cardio-respiratory and hemodynamic support, monitoring of potassium along with management of arrhythmias and convulsions, as necessary.

Approval history

Sourced from openFDA
  • Dec 11, 1974ANDAANDA080880Impax Labs
  • Aug 29, 2003ANDAANDA040516Impax Labs
  • Jan 21, 2011ANDAANDA090612Natco Pharma Ltd
  • Jan 21, 2011ANDAANDA091621Natco Pharma Ltd
  • Sep 3, 2021ANDAANDA214756Suven Pharms

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
652 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use639.7%
  2. 2Vomiting497.5%
  3. 3Nausea487.4%
  4. 4Hypertension426.4%
  5. 5Headache416.3%
  6. 6Pneumonia406.1%
  7. 7Pyrexia406.1%
  8. 8Fatigue385.8%
  9. 9Pain375.7%
  10. 10Toxicity To Various Agents365.5%
  11. 11Hypoxia324.9%
  12. 12Drug Ineffective314.8%
  13. 13Intentional Overdose314.8%
  14. 14Abdominal Pain304.6%
  15. 15Dyspnoea294.4%

Literature

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Recent PubMed references pinned to Chloroquine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 671 ClinicalTrials.gov registrations naming Chloroquine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Chloroquine. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • G6PDCPIC CClinPGx 4FDA label: Actionable PGx
    G6PD

Frequently asked questions

How does Chloroquine work?
Chloroquine, a 4-aminoquinoline, is an anti-protozoal agent. The precise mechanism by which chloroquine exhibits activity is not known.
What is Chloroquine used for?
According to FDA labeling, Chloroquine carries indications including: Chloroquine phosphate tablets are indicated for the: Treatment of uncomplicated malaria due to susceptible strains of P. falciparum, P.malariae, P.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Chloroquine?
Chloroquine is classified as Aminoquinolines, Antimalarial, Nucleic Acid Synthesis Inhibitors, Decreased Metabolic Rate, Decreased Prostaglandin Activity, Nucleic Acid Replication Alteration.
What are the contraindications for Chloroquine?
Chloroquine labeling lists contraindications including: Use of chloroquine phosphate tablets for indications other than acute malaria is contraindicated in the presence of retinal or visual field changes of any etiology. Use of chloroquine phosphate tablets is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.. Always consult the full prescribing information and a clinician.
Note. Data for chloroquine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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