Hydroxychloroquine Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Malaria

Treatment of the acute attack: 800 mg (620 mg base) followed in 6 to 8 hours by 400 mg (310 mg base), then 400 mg (310 mg base) once a day for 2 consecutive days; alternatively, a single dose of 800 mg (620 mg base) has also been effective

Dosage on the basis of body weight:
First dose: 10 mg base/kg (not to exceed 620 mg base)
Second dose: 5 mg base/kg (not to exceed 310 mg base) 6 hours after first dose
Third dose: 5 mg base/kg 18 hours after second dose
Fourth dose: 5 mg base/kg 24 hours after third dose

Each dose should be taken with a meal or a glass of milk.

Concomitant therapy with an 8-aminoquinoline drug is necessary for the radical cure of vivax and malariae malaria.

Usual Adult Dose for Malaria Prophylaxis

Suppression: 400 mg (310 mg base) orally on the same day every week

Suppressive therapy should begin 2 weeks prior to exposure; however, failing this, an initial dose of 800 mg (620 mg base) may be taken in 2 divided doses (6 hours apart). Suppressive therapy should continue for 8 weeks after leaving the endemic area.

Each dose should be taken with a meal or a glass of milk.

Usual Adult Dose for Rheumatoid Arthritis

Initial dose: 400 to 600 mg (310 to 465 mg base) orally once a day
Maintenance dose: 200 to 400 mg (155 to 310 mg base) orally once a day

Each dose should be taken with a meal or a glass of milk.

Usual Adult Dose for Systemic Lupus Erythematosus

Discoid and systemic lupus erythematosus:
Initial dose: 400 mg (310 mg base) orally once or twice a day for several weeks or months, depending on patient response
Maintenance dose: 200 to 400 mg (155 to 310 mg base) orally once a day

Each dose should be taken with a meal or a glass of milk.

Usual Pediatric Dose for Malaria

Treatment of the acute attack:
1 year or older:
First dose: 10 mg base/kg (not to exceed 620 mg base)
Second dose: 5 mg base/kg (not to exceed 310 mg base) 6 hours after first dose
Third dose: 5 mg base/kg 18 hours after second dose
Fourth dose: 5 mg base/kg 24 hours after third dose

Each dose should be taken with a meal or a glass of milk.

Concomitant therapy with an 8-aminoquinoline drug is necessary for the radical cure of vivax and malariae malaria.

Usual Pediatric Dose for Malaria Prophylaxis

Suppression:
1 year or older: 5 mg base/kg of body weight (not to exceed 310 mg base) orally on the same day every week

Suppressive therapy should begin 2 weeks prior to exposure; however, failing this, an initial dose of 10 mg base/kg (not to exceed 620 mg base) may be taken in 2 divided doses (6 hours apart). Suppressive therapy should continue for 8 weeks after leaving the endemic area.

Each dose should be taken with a meal or a glass of milk.

Usual Pediatric Dose for Dermatomyositis

Case Review (n=25)
Juvenile Dermatomyositis (JDMS):
1.5 to 15 years: 7 mg/kg orally per day (added to first course treatment for JDMS if the patient presented with extensive skin rash and needed steroids in high doses)

Each dose should be taken with a meal or a glass of milk.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

Temporary reduction of initial dosage may be necessary in rheumatoid arthritis patients with troublesome side effects. A gradual dose increase to the optimum response level may be initiated later (usually 5 to 10 days).

After a good response is obtained in rheumatoid arthritis with the initial recommended dosage (usually in 4 to 12 weeks), the dosage is reduced by 50% (maintenance dose).

Precautions

Physicians should completely familiarize themselves with the prescribing information of hydroxychloroquine before its administration.

Hydroxychloroquine is contraindicated in the presence of retinal or visual field changes attributable to any 4-aminoquinoline compound and for long-term therapy in children.

If prolonged therapy with an antimalarial compound is considered, baseline ophthalmologic examinations (including visual acuity, expert slitlamp, funduscopic, and visual field tests) are recommended. While the manufacturer recommends repeating the examination at 3 month intervals, many clinicians recommend repeating the examination at 6 month intervals. Discontinuation of therapy followed by close observation is recommended if there is any indication of abnormality in visual acuity, visual field, retinal macular areas, or any visual symptoms which are not fully explainable by difficulties of accommodation or corneal opacities.

Irreversible retinal damage has been observed in patients receiving long-term or high dosage 4-aminoquinoline therapy. Retinopathy has been reported to be dose-related. The methods advised for early diagnosis of "chloroquine retinopathy" consist of funduscopic examination of the macula for fine pigmentary disturbances or loss of foveal reflex and examination of the central visual field with a small red test object for pericentral or paracentral scotoma or determination of retinal thresholds to red. Any unexplained visual symptoms, such as light flashes or streaks should also be regarded with suspicion as possible manifestations of retinopathy. Retinal damage may be avoided if vision is monitored (visual fields, color vision), dosage is kept below 6.5 mg/kg/day, the drug is discontinued at the first sign of retinal toxicity, and it is not administered to patients with significant renal dysfunction. A complete ophthalmologic examination is recommended prior to therapy, annually for high risk patients (60 years of age or older, liver disease, retinal disease), and every 5 years for low risk patients.

A higher incidence of retinopathy has been reported when the maintenance dose for rheumatoid arthritis and lupus erythematosus is exceeded.

Hydroxychloroquine is not effective against chloroquine-resistant strains of Plasmodium falciparum.

Administration of hydroxychloroquine in patients with psoriasis may precipitate a severe attack of psoriasis. When used in patients with porphyria, exacerbation of the condition may occur. The preparation should not be used in these conditions unless in the judgment of the prescriber the benefit to the patient outweighs the possible hazard.

Caution is recommended if the drug is used in an alcoholic patient, a patient with liver dysfunction, or in conjunction with known hepatotoxic drugs.

Periodic blood cell counts are recommended for patients on prolonged therapy. Discontinuation of therapy is recommended if any severe blood disorder occurs which is not attributable to the patient's disease state. Caution is recommended if hydroxychloroquine is given to patients with glucose-6-phosphate dehydrogenase deficiency as hemolysis may occur.

Periodic examination including testing knee and ankle reflexes to detect evidence of muscular weakness is recommended for patients receiving long-term therapy. Discontinuation of therapy is recommended if weakness occurs.

If the drug is being used for the treatment of rheumatoid arthritis, discontinuation of therapy is recommended if improvement is not seen within 6 months.

Dermatologic reactions may occur and, therefore, proper care should be exercised when it is administered to any patient receiving a drug with a significant tendency to produce dermatitis.

If serious toxic symptoms are observed from overdosage or sensitivity, it has been suggested that ammonium chloride (8 g daily in divided doses for adults) be administered orally 3 or 4 days a week for several months after therapy has been stopped, as acidification of the urine increases renal excretion of the 4-aminoquinoline compounds by 20% to 90%. However, caution is advised in patients with impaired renal function and/or metabolic acidosis.

Patients should be strongly warned to keep this drugs away from children since there have been fatalities reported in this group after accidental ingestion of small doses.

Safety and effectiveness of hydroxychloroquine for the treatment or suppression of malaria have not been established in pediatric patients less than 1 year of age. Safety and effectiveness for the treatment of juvenile arthritis, lupus erythematosus, or rheumatoid arthritis have not been established in pediatric patients less than 18 years of age.

Dialysis

Data not available

Other Comments

One 200 mg tablet of hydroxychloroquine sulfate is equivalent to 155 mg base.

Acidification of the urine increases renal excretion of the 4-aminoquinoline compounds.

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