Durok Tablets 300 Milligrams (Hydroxychloroquine Sulfate)

Adult dose

1. Rheumatoid arthritis, juvenile rheumatoid arthritis, discoid and systemic lupus erythematosus, photosensitive skin diseases 1) Adults - The initial dose is 200～400mg daily; if 400mg is administered, divide the dose. Once an effect is observed, reduce the dose to 200mg daily; if the effect is inadequate, increase the dose to 400mg daily. The maintenance dose should be set at the minimum effective dose and must not exceed 6.5mg/kg/day. * It may take several weeks for this medicine to take effect, whereas adverse effects may occur sooner. * If there is no improvement in symptoms after taking this medicine for 6 months for rheumatoid arthritis, juvenile rheumatoid arthritis, discoid and systemic lupus erythematosus, discontinue its use. * When used for photosensitive diseases, administer only during periods of substantial exposure. 2. Malaria 1) Treatment (1) Adults - For treatment of an acute attack, 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 an acute attack caused by Plasmodium falciparum or P. vivax, a single dose of 800mg may also be administered. 2) Prevention (1) Adults - Starting 2 weeks before exposure, administer 6mg/kg once weekly (usually 400mg once weekly).

Child dose

1. Rheumatoid arthritis, juvenile rheumatoid arthritis, discoid and systemic lupus erythematosus, photosensitive skin diseases 2) 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. 2. Malaria 1) Treatment (2) Children - Administer chloroquine 10mg/kg 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. 2) Prevention (2) Children - Starting 2 weeks before exposure, administer 6mg/kg once weekly. For children weighing 30∼40kg or less, 1 tablet (200mg) would exceed an appropriate dose; therefore, administration is preferably avoided.

This medication should not be used in certain patients. For example, people who are allergic to this drug or similar medications, those with eye problems or taking medications that may cause visual impairment, children who require long-term treatment, women who are pregnant or breastfeeding, and patients with genetic issues such as lactose intolerance should not take this medication. Additionally, there are patients who require caution when using this medication. For example, individuals with specific allergies, psoriasis, blood disorders, liver or kidney diseases, or severe neurological disorders should use this medication cautiously. This medication can affect the eyes and may cause visual disturbances such as blurred vision, retinal abnormalities, corneal problems, etc. If these symptoms occur, consult a doctor immediately, and discontinue use if symptoms worsen. Skin reactions such as rashes, hair loss, and hives may also occur, so be cautious. Gastrointestinal symptoms may present as nausea, diarrhea, appetite loss, and abdominal pain, while the central nervous system and muscles may be affected leading to fatigue, headaches, muscle weakness, etc. Serious side effects such as blood disorders, cardiac arrhythmias, and liver dysfunction have also been reported, thus regular check-ups are necessary. While taking this medication, eye examinations are needed every 3 to 6 months, and particularly those on high doses, elderly patients, or those with reduced kidney function should undergo examinations more frequently. If any abnormal vision occurs, medication should be stopped immediately, and caution should be exercised when driving or operating machinery. Patients with liver or kidney diseases may need to measure the concentration of this medication and adjust the dosage accordingly. Moreover, regular blood tests should be performed, and if any issues arise, the medication should be discontinued. This medication can interact with other drugs, hence it is essential to discuss any concurrent medications with a doctor or pharmacist. Caution is needed when used alongside drugs that may cause cardiac arrhythmias or those that inhibit or induce liver metabolism. Pregnant or breastfeeding women are advised not to take this medication; if breastfeeding, it is recommended to stop nursing while on this medication. In case of overdose, serious side effects may occur, requiring immediate emergency treatment, including possible gastric lavage or preventive measures against drug absorption. Lastly, this medication should be kept out of reach of children and should not be transferred to other containers for safety.

Visual distortion, retinal abnormalities, decreased sensitivity of the cornea, corneal opacity, retinopathy, visual impairment, scotoma, color halo, glare, skin rash, urticaria, pigment changes in the skin and mucous membranes, hair discoloration, alopecia, vesicular rash, erythema multiforme, Stevens-Johnson syndrome, phototoxic reactions, exfoliative dermatitis, Sweet's syndrome, severe cutaneous adverse reactions, acute generalized exanthematous pustulosis, DRESS syndrome, nausea, diarrhea, appetite loss, abdominal pain, upper abdominal cramps, vomiting, weakness, fatigue, neurogenic hearing loss, hallucinations, headaches, drowsiness, restrictive neuroexcitability reactions, mood changes, nightmares, tinnitus, dizziness, auditory loss, unstable mood changes, psychosis, convulsions, myopathy, neuromuscular disorders, perceptual changes, decreased reflexes, abnormal nerve conduction, aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia, bone marrow suppression, QT prolongation, torsades de pointes, ventricular tachycardia, ventricular tachycardia, cardiomyopathy, biventricular hypertrophy, conduction disturbances, abnormal liver function test results, fulminant hepatic failure, hepatocyte damage, cholestatic liver injury, acute hepatitis, mixed hepatocellular/cholestatic liver damage, fulminant liver failure, depression, anxiety, agitation, confusion, delusions, mania, sleep disorders, weight loss, lethargy

This medication should be stored in a tightly sealed container to prevent air or moisture intrusion. It is also safest to store the medication at room temperature, between 1 degree and 30 degrees Celsius.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 300 tablets/bottle