Medication info
Durok Tablet 200 mg (Hydroxychloroquine Sulfate)

Durok Tablet 200 mg (Hydroxychloroquine Sulfate)

Prescription medicationTabletOral
Ingredient · strength
Hydroxychloroquine Sulfate›200mg / 1 tablet
Manufacturer / importer
Korea PMG Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 200101190 · Notified 2001.09.28 · Insurance code 697100380

Summary

Main use
Rheumatic diseases (arthritis, lupus), photosensitive skin disorders, 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; when administering 400mg, divide the dose. After a response is achieved, reduce the dose to 200mg daily; if the response is inadequate, increase it to 400mg daily. The maintenance dose should be the minimum effective dose and must not exceed 6.5mg/kg/day. * It may take several weeks for this medicine to produce an effect, whereas adverse effects may occur sooner. * For photosensitive diseases, use only during periods of high exposure. 2. Malaria 1) Treatment Adults: For treatment of acute disease, administer 800mg initially, followed by three additional doses of 400mg at 6∼8-hour intervals, 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 be administered. 2) Prevention Adults: Administer 6mg/kg (usually 400mg) once weekly, starting 2 weeks before exposure.
Child dose
1. 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 the minimum effective dose and must not exceed 6.5mg/kg/day or the adult dose, regardless of body weight. * If there is no improvement in symptoms after 6 months of treatment for rheumatoid arthritis, juvenile rheumatoid arthritis, discoid or systemic lupus erythematosus, discontinue treatment. 2. Malaria 1) Treatment Children: Administer 10mg/kg of chloroquine initially, followed by three additional doses of 5mg/kg at 6-8-hour intervals, for a total of 25mg/kg over 2 days. However, do not exceed the adult dose. 2) Prevention Children: Administer 6mg/kg once weekly, starting 2 weeks before exposure. For children weighing 30∼40kg, one tablet (200mg) would exceed the appropriate dose; therefore, administration is not recommended.

Ingredients

Manufacturer
Korea PMG Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

Used for rheumatoid arthritis and juvenile rheumatoid arthritis, discoid lupus erythematosus, systemic lupus erythematosus, and photosensitive skin disorders. It is also used for the treatment and prevention of malaria.

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; when administering 400mg, divide the dose. After a response is achieved, reduce the dose to 200mg daily; if the response is inadequate, increase it to 400mg daily. The maintenance dose should be the minimum effective dose and must not exceed 6.5mg/kg/day. * It may take several weeks for this medicine to produce an effect, whereas adverse effects may occur sooner. * For photosensitive diseases, use only during periods of high exposure. 2. Malaria 1) Treatment Adults: For treatment of acute disease, administer 800mg initially, followed by three additional doses of 400mg at 6∼8-hour intervals, 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 be administered. 2) Prevention Adults: Administer 6mg/kg (usually 400mg) once weekly, starting 2 weeks before exposure.

Child dose

1. 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 the minimum effective dose and must not exceed 6.5mg/kg/day or the adult dose, regardless of body weight. * If there is no improvement in symptoms after 6 months of treatment for rheumatoid arthritis, juvenile rheumatoid arthritis, discoid or systemic lupus erythematosus, discontinue treatment. 2. Malaria 1) Treatment Children: Administer 10mg/kg of chloroquine initially, followed by three additional doses of 5mg/kg at 6-8-hour intervals, for a total of 25mg/kg over 2 days. However, do not exceed the adult dose. 2) Prevention Children: Administer 6mg/kg once weekly, starting 2 weeks before exposure. For children weighing 30∼40kg, one tablet (200mg) would exceed the appropriate dose; therefore, administration is not recommended.

Precautions

This medication should not be administered to certain patients under any circumstances. For example, patients who are allergic to this drug or similar drugs, those with issues in the central part of the eye, patients taking medications that may cause visual impairment, as well as children who require long-term treatment and pregnant or nursing women should not take this medication. This medication contains lactose, so patients with a genetic disorder that prevents lactose digestion should not take it. Some patients need to use this medication cautiously. For example, patients allergic to quinine or with liver, kidney, nerve, and blood disorders, or those with specific skin diseases such as psoriasis or porphyria should exercise caution. This medication can cause various adverse reactions in the eyes. Symptoms may include visual disturbances, abnormalities in the retina, corneal edema or opacity leading to blurred vision. If these symptoms are noticed, discontinuing the medication promptly can lead to recovery, but negligence may result in permanent damage. Skin reactions such as rashes, urticaria, hair loss, and discoloration may occur, and rarely severe skin reactions have been reported. Gastrointestinal symptoms may include nausea, diarrhea, appetite loss, and abdominal pain, while central nervous system effects can include headache, drowsiness, hallucinations, anxiety, and seizures. Muscle weakness or nerve function impairment may occur, and laboratory tests may show anemia or leukopenia. Patients with cardiac issues should be particularly cautious, as arrhythmias or cardiomyopathy may arise. Liver function abnormalities or liver damage can occur rarely, so patients with liver disease need regular check-ups. Regular eye examinations should be conducted every 3 to 6 months while on this medication, and those on high doses or the elderly with impaired vision or kidney dysfunction should be examined more frequently. If symptoms of visual impairment occur, the medication should be discontinued immediately and a doctor should be consulted. Patients with severe liver or kidney damage require careful monitoring of drug concentration and dosage adjustment. Regular blood tests are necessary to reduce the risk of blood disorders, and if any abnormal findings arise, the medication should be stopped. This medication may interact with certain drugs, so if you are taking other medications, you must inform your doctor or pharmacist, especially avoiding combinations with medications that can induce cardiac arrhythmias. Pregnant or nursing women should not take this medication as it may harm the fetus or newborn.

Side effects

Visual disturbances, retinal disorders, decreased corneal sensitivity, corneal opacities, changes in pigmentation, visual impairment, halos, glare, skin rash, urticaria, changes in pigmentation of skin and mucous membranes, hair discoloration, alopecia, vesicular rash, erythema multiforme, mucocutaneous syndrome, phototoxic reactions, exfoliative dermatitis, Sweet's syndrome, severe cutaneous adverse reactions, acute generalized exanthematous pustulosis, DRESS syndrome, nausea, diarrhea, loss of appetite, abdominal pain, upper abdominal cramps, vomiting, muscle weakness, fatigue, sensorineural hearing loss, hallucinations, headache, drowsiness, restrictive neurotoxic reaction, mood changes, nightmares, tinnitus, dizziness, auditory loss, unstable emotional changes, psychosis, seizures, skeletal muscle disease, neuromuscular disease, perceptual changes, diminished reflex response, abnormal nerve conduction, aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia, bone marrow suppression, QT prolongation, torsades de pointes, ventricular tachycardia, cardiomyopathy, left ventricular hypertrophy, conduction disorders, abnormal liver function test results, fulminant hepatic failure, hepatocyte damage, cholestatic liver injury, acute hepatitis, mixed hepatocyte/cholestatic liver injury, fulminant liver failure, depression, hallucinations, 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 prevent air and moisture from entering. It is best to keep it at room temperature between 1 to 30 degrees Celsius. This will help to maintain the drug's effectiveness and safety for a long time.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 500 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.