Medication info
Oxychlorine 400 mg (Hydroxychloroquine Sulfate)

Oxychlorine 400 mg (Hydroxychloroquine Sulfate)

Prescription medicationTabletOral
Ingredient · strength
Hydroxychloroquine Sulfate›400mg / 1 tablet
Manufacturer / importer
Erison Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201600454 · Approved 2016.01.25 · Insurance code 620500270

Summary

Main use
Autoimmune diseases (arthritis, lupus, etc.), photosensitive skin disorders, treatment and prevention of malaria
Who takes it
Adults · Children
Adult dose
Rheumatoid arthritis, juvenile rheumatoid arthritis, discoid and systemic lupus erythematosus, photosensitive skin diseases Adults - The initial dose is 200~400mg daily; if 400mg is administered, divide the dose. If an effect is observed after administration, reduce the dose to 200mg daily; if the effect is inadequate, increase it to 400mg daily. The maintenance dose should be set at the minimum effective dose and must not exceed 6.5mg/kg/day. For rheumatoid arthritis, juvenile rheumatoid arthritis, discoid and systemic lupus erythematosus, discontinue treatment if symptoms do not improve after 6 months of use. When used for photosensitive diseases, administer only during periods of substantial exposure. Treatment of malaria Adults - For treatment of acute disease, administer 800mg initially, followed by 400mg at 6∼8-hour intervals for 3 more doses, for a total of 2g over 2 days. For treatment of acute disease caused by Plasmodium falciparum or Plasmodium vivax, a single dose of 800mg may also be administered. Malaria prophylaxis Adults - Starting 2 weeks before exposure, administer 6mg/kg once weekly (usually 400mg once weekly).
Child dose
Rheumatoid arthritis, juvenile rheumatoid arthritis, discoid and systemic lupus erythematosus, photosensitive skin diseases Children - The usual average daily dose is 200∼400mg. The maintenance dose should be set at the minimum effective dose and must not exceed 6.5mg/kg/day or the adult dose, regardless of body weight. Treatment of malaria Children - Administer 10mg/kg of chloroquine initially, followed by 5mg/kg at 6-8-hour intervals for 3 more doses, for a total of 25mg/kg over 2 days. However, the adult dose must not be exceeded. Malaria prophylaxis Children - Starting 2 weeks before exposure, administer 6mg/kg once weekly. For children weighing 30∼40kg or less, one tablet (200mg) would exceed the appropriate dose; therefore, administration is not recommended.

Ingredients

Manufacturer
Erison Pharmaceutical Co., Ltd.

Efficacy & effects

Autoimmune diseases (arthritis, lupus, etc.), photosensitive skin disorders, treatment and prevention of malaria

  • Rheumatoid arthritis
  • juvenile idiopathic arthritis
  • discoid lupus erythematosus
  • systemic lupus erythematosus
  • photosensitive skin diseases
  • malaria
View approved original text

Used for rheumatoid arthritis and juvenile idiopathic arthritis, discoid and systemic lupus erythematosus, and photosensitive skin diseases. It is also used for the treatment and prevention of malaria (P. vivax, P. malariae, P. ovale, and sensitive P. falciparum).

How to take

Adult dose

Rheumatoid arthritis, juvenile rheumatoid arthritis, discoid and systemic lupus erythematosus, photosensitive skin diseases Adults - The initial dose is 200~400mg daily; if 400mg is administered, divide the dose. If an effect is observed after administration, reduce the dose to 200mg daily; if the effect is inadequate, increase it to 400mg daily. The maintenance dose should be set at the minimum effective dose and must not exceed 6.5mg/kg/day. For rheumatoid arthritis, juvenile rheumatoid arthritis, discoid and systemic lupus erythematosus, discontinue treatment if symptoms do not improve after 6 months of use. When used for photosensitive diseases, administer only during periods of substantial exposure. Treatment of malaria Adults - For treatment of acute disease, administer 800mg initially, followed by 400mg at 6∼8-hour intervals for 3 more doses, for a total of 2g over 2 days. For treatment of acute disease caused by Plasmodium falciparum or Plasmodium vivax, a single dose of 800mg may also be administered. Malaria prophylaxis Adults - Starting 2 weeks before exposure, administer 6mg/kg once weekly (usually 400mg once weekly).

Child dose

Rheumatoid arthritis, juvenile rheumatoid arthritis, discoid and systemic lupus erythematosus, photosensitive skin diseases Children - The usual average daily dose is 200∼400mg. The maintenance dose should be set at the minimum effective dose and must not exceed 6.5mg/kg/day or the adult dose, regardless of body weight. Treatment of malaria Children - Administer 10mg/kg of chloroquine initially, followed by 5mg/kg at 6-8-hour intervals for 3 more doses, for a total of 25mg/kg over 2 days. However, the adult dose must not be exceeded. Malaria prophylaxis Children - Starting 2 weeks before exposure, administer 6mg/kg once weekly. For children weighing 30∼40kg or less, one tablet (200mg) would exceed the appropriate dose; therefore, administration is not recommended.

Precautions

This medication should not be used in certain patients. For example, individuals allergic to this drug or similar components, those with central eye problems, those taking other medications that may cause vision impairment, children, women who are pregnant or breastfeeding should avoid this medication. Additionally, this medication should be used cautiously in patients with kidney or liver issues, certain skin diseases, blood disorders, or neurological diseases. Such patients should consult a doctor before taking the medication and monitor their condition carefully during use. Taking this medication can cause eye abnormalities. Symptoms such as blurred vision or impaired eyesight may occur, and in rare cases, damage to the retina can result, thus regular ophthalmic examinations are necessary. Initial discontinuation can lead to recovery, but if neglected, permanent damage may occur. Skin rashes, discoloration, and hair loss may appear, and in severe cases, life-threatening skin reactions may occur; if unusual symptoms arise, the medication should be discontinued immediately. Gastrointestinal symptoms such as nausea, diarrhea, and abdominal pain may occur, usually resolving upon reducing or discontinuing the medication. The central nervous system and muscles may also be affected, leading to fatigue, headaches, hallucinations, and muscle weakness, necessitating caution. This medication can decrease blood cell counts, so regular blood tests are necessary, and it may affect the heart, leading to arrhythmias or cardiac dysfunction. Liver function may also be impaired; therefore, periodic liver function tests should be conducted, and any signs of liver damage during use should be reported to healthcare professionals immediately. It may also impact mental health, leading to symptoms like depression, anxiety, and hallucinations; monitoring of mental state is important. During treatment, regular ophthalmic exams, blood tests, and muscle function tests should be conducted, and if any unusual symptoms occur, immediate consultation with healthcare professionals is required. Also, this medication can interact with others, so if taking other medications, inform the doctor or pharmacist. Special caution is needed when taken with medications that may cause cardiac arrhythmias or affect liver function. Pregnant or breastfeeding women are safest avoiding this medication, as it may harm the fetus or neonate. In case of overdose, serious side effects may occur; thus, adherence to prescribed dosages is critical, and immediate emergency intervention is needed if overdose is suspected. This medication must be stored out of reach of children and should not be transferred to another container for safety.

Side effects

Visual disturbances, retinal abnormalities, decreased sensitivity of the cornea, corneal opacity, retinopathy, visual impairment, scotoma, color halos, glare, skin rash, urticaria, pigment changes in the skin and mucous membranes, hair bleaching, alopecia, vesicular rash, erythema multiforme, Stevens-Johnson syndrome, phototoxic reactions, exfoliative dermatitis, Sweet's syndrome, severe skin reactions, psoriasis flare, acute generalized exanthematous pustulosis, DRESS syndrome, nausea, diarrhea, anorexia, abdominal pain, upper abdominal cramps, vomiting, myasthenia, fatigue, sensorineural hearing loss, hallucinations, headache, drowsiness, restrictive neuropsychiatric reactions, mood swings, nightmares, tinnitus, dizziness, hearing loss, unstable emotional changes, mental illness, seizures, skeletal muscle disease, neuromuscular disease, perceptual changes, decreased tendon reflexes, abnormal nerve conduction, aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia, bone marrow suppression, QT prolongation, torsades de pointes, ventricular tachycardia, ventricular tachycardia, cardiomyopathy, left ventricular hypertrophy, conduction abnormalities, abnormal liver function test results, fulminant liver failure, hepatocyte damage, cholestatic liver injury, acute hepatitis, mixed hepatocellular/cholestatic liver damage, fulminant hepatic failure, depression, anxiety, agitation, confusion, delusions, mania, sleep disorders, weight loss, lethargy

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to protect it from air or moisture. It is best to maintain storage temperatures between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle

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Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.