Medication info
Durok Tablet 400 mg (Hydroxychloroquine Sulfate)

Durok Tablet 400 mg (Hydroxychloroquine Sulfate)

Prescription medicationTabletOral
Ingredient · strength
Hydroxychloroquine Sulfate›400mg / 1 tablet
Manufacturer / importer
Korea PMG Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201402973 · Approved 2014.07.04 · Insurance code 697100550

Summary

Main use
Rheumatic diseases (arthritis and lupus), photosensitive skin disorders, and treatment and prevention of malaria
Who takes it
Adults · Children
Adult dose
1. Rheumatoid arthritis, juvenile rheumatoid arthritis, discoid and systemic lupus erythematosus, photosensitive skin diseases Adults - The initial dose is 200∼400mg daily; if administering 400mg, divide the dose. Once 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 the minimum effective dose and should not exceed 6.5mg/kg/day. * It may take several weeks for this medicine to take effect, whereas adverse effects may occur sooner. * Discontinue treatment for rheumatoid arthritis, juvenile rheumatoid arthritis, discoid and systemic lupus erythematosus if symptoms do not improve after 6 months of treatment. * For photosensitive diseases, administer this medicine only during periods of substantial exposure. 2. Malaria 1) Treatment Adults - For treatment of acute disease, administer 800mg initially, followed by 400mg every 6∼8 hours for 3 additional 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. 2) Prevention Adults - Administer 6mg/kg once weekly (usually 400mg once weekly), starting 2 weeks before exposure.
Child dose
Children - The usual average daily dose is 200∼400mg. The maintenance dose should be the minimum effective dose and should not exceed 6.5mg/kg/day or the adult dose, regardless of body weight. Children - Administer 10mg/kg of chloroquine initially, followed by 5mg/kg every 6∼8 hours for 3 additional doses, for a total of 25mg/kg over 2 days. However, the adult dose must not be exceeded. Children - Administer 6mg/kg once weekly, starting 2 weeks before exposure. Therefore, for children weighing less than 30∼40kg, even 1 tablet (200mg) exceeds the appropriate dose, so administration is not recommended.

Ingredients

Manufacturer
Korea PMG Pharmaceutical Co., Ltd.

Efficacy & effects

Rheumatic diseases (arthritis and lupus), photosensitive skin disorders, and treatment and prevention of malaria

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

1. This medication is used in the treatment of autoimmune diseases such as rheumatoid arthritis, juvenile rheumatoid arthritis, discoid and systemic lupus erythematosus, and photosensitive skin diseases. 2. It is also effective in the treatment and prevention of malaria, assisting in the prevention and treatment of infections caused by various malaria parasites.

How to take

Adult dose

1. Rheumatoid arthritis, juvenile rheumatoid arthritis, discoid and systemic lupus erythematosus, photosensitive skin diseases Adults - The initial dose is 200∼400mg daily; if administering 400mg, divide the dose. Once 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 the minimum effective dose and should not exceed 6.5mg/kg/day. * It may take several weeks for this medicine to take effect, whereas adverse effects may occur sooner. * Discontinue treatment for rheumatoid arthritis, juvenile rheumatoid arthritis, discoid and systemic lupus erythematosus if symptoms do not improve after 6 months of treatment. * For photosensitive diseases, administer this medicine only during periods of substantial exposure. 2. Malaria 1) Treatment Adults - For treatment of acute disease, administer 800mg initially, followed by 400mg every 6∼8 hours for 3 additional 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. 2) Prevention Adults - Administer 6mg/kg once weekly (usually 400mg once weekly), starting 2 weeks before exposure.

Child dose

Children - The usual average daily dose is 200∼400mg. The maintenance dose should be the minimum effective dose and should not exceed 6.5mg/kg/day or the adult dose, regardless of body weight. Children - Administer 10mg/kg of chloroquine initially, followed by 5mg/kg every 6∼8 hours for 3 additional doses, for a total of 25mg/kg over 2 days. However, the adult dose must not be exceeded. Children - Administer 6mg/kg once weekly, starting 2 weeks before exposure. Therefore, for children weighing less than 30∼40kg, even 1 tablet (200mg) exceeds the appropriate dose, so administration is not recommended.

Precautions

This medication should not be used by certain patients. For example, those allergic to this medication or similar ingredients, patients with maculopathy, those taking other medications that may cause visual impairment, children requiring long-term treatment, women who are pregnant or nursing should avoid using this medication. Moreover, patients with genetic disorders such as galactose intolerance or lactase deficiency should also avoid taking this medication as it contains lactose. Some patients need to use this medication cautiously. For instance, those allergic to quinine, patients with psoriasis, liver disease, kidney disease, severe gastrointestinal disorders, neurological disorders, blood disorders, and porphyria should exercise caution. This medication can cause various side effects. It may affect the eyes, leading to visual disturbances, retinal abnormalities, corneal opacities, etc. Initially, stopping the medication can lead to recovery, but neglect may result in severe damage. Skin may experience rashes, hives, hair loss, pigmentation changes, and serious skin reactions have been reported rarely. Gastrointestinal side effects can include nausea, diarrhea, and loss of appetite, while the central nervous system may experience headaches, drowsiness, hallucinations, anxiety, and seizures. Muscles and nerves may be affected, leading to muscle weakness or nerve function impairment. Hematological effects may include anemia or leukopenia. Cardiovascular side effects have included arrhythmias and cardiomyopathy, and liver function abnormalities or acute liver failure may also occur. Mental health may be impacted, resulting in depression, hallucinations, anxiety, and confusion. Regular ophthalmological examinations are required during the use of this medication, and if any visual or sight disturbances occur, the medication should be discontinued immediately. Elderly patients or those with impaired kidney function require even more caution. Also, patients with severely impaired liver and kidney function should have their drug levels monitored and dosages adjusted accordingly. This medication may interact with other drugs, so it is essential to consult a physician or pharmacist about any co-administered medications. The blood concentration of certain medications may increase or decrease when taken together. Pregnant or nursing women should avoid this medication as it may be harmful to the fetus or newborn. Overdose can be very dangerous, so if an overdose is suspected, immediate emergency measures should be taken, and measures should be taken to prevent drug absorption such as vomiting or gastric lavage. This medication should be stored out of the reach of children, and transferring it to another container is discouraged as it may not preserve the quality.

Side effects

Visual disturbances, retinal abnormalities, decreased sensitivity of the cornea, corneal opacity, retinopathy, visual impairment, scotoma, halos, photophobia, skin rash, urticaria, changes in pigmentation of the skin and mucous membranes, hair discoloration, alopecia, vesicular rash, erythema multiforme, Stevens-Johnson syndrome, photosensitivity reaction, exfoliative dermatitis, Sweet's syndrome, severe cutaneous adverse reactions, acute generalized exanthematous pustulosis, DRESS syndrome, nausea, diarrhea, loss of appetite, abdominal pain, upper abdominal cramping, vomiting, weakness, fatigue, sensorineural hearing loss, hallucinations, headache, drowsiness, restrictive neuro-excitability reaction, mood changes, nightmares, tinnitus, dizziness, hearing loss, unstable mood changes, psychosis, seizures, skeletal muscle myopathy, neuromuscular disease, perceptual changes, decreased deep tendon reflexes, abnormal nerve conduction studies, aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia, bone marrow suppression, QT prolongation, torsades de pointes, ventricular tachycardia, ventricular tachycardia, cardiomyopathy, left ventricular hypertrophy, conduction disorders, abnormal liver function test results, acute liver failure, hepatocellular injury, cholestatic liver injury, acute hepatitis, mixed hepatocellular/cholestatic liver injury, 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 closed container to prevent air and moisture from entering. It is best to keep storage temperatures between 1°C and 30°C at room temperature.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/bottle

Same-ingredient medicines

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.