Usual Adult Dose for Malaria Prophylaxis

400 mg salt (310 mg base) orally once a week

Weight-based dosing: 6.5 mg/kg salt (5 mg/kg base) orally once a week

• Maximum dose: 400 mg salt (310 mg base)/dose

Comments:

• This drug should be administered on the same day of each week.
• Suppressive therapy should begin 2 weeks prior to exposure and should continue for 4 weeks after leaving the endemic area.

Use: For the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported

US CDC Recommendations: 310 mg base (400 mg salt) orally once a week

Comments:

• An alternative to chloroquine for prophylaxis only in areas with chloroquine-sensitive malaria
• Prophylaxis should start 1 to 2 weeks before travel to malarious areas; should continue weekly (same day each week) while in malarious areas and for 4 weeks after leaving such areas
• If malaria develops while using this drug for chemoprophylaxis, it should not be used as part of the treatment regimen.
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Malaria

800 mg salt (620 mg base) orally as an initial dose, followed by 400 mg salt (310 mg base) at 6, 24, and 48 hours after the initial dose
Total dose: 2000 mg salt (1550 mg base)

Weight-based dosing:

• First dose: 13 mg/kg salt (10 mg/kg base) orally
• Second dose (6 hours after first dose): 6.5 mg/kg salt (5 mg/kg base) orally
• Third dose (24 hours after first dose): 6.5 mg/kg salt (5 mg/kg base) orally
• Fourth dose (48 hours after first dose): 6.5 mg/kg salt (5 mg/kg base) orally

Maximum Dose:

• First dose: 800 mg salt (620 mg base)/dose
• Second, third, and fourth dose: 400 mg salt (310 mg base)/dose

Comments:

• Concomitant therapy with an 8-aminoquinoline compound is necessary for radical cure of Plasmodium vivax and P ovale infections.

Use: For the treatment of uncomplicated malaria due to P falciparum, P malariae, P ovale, and P vivax

US CDC Recommendations: 620 mg base (800 mg salt) orally at once, followed by 310 mg base (400 mg salt) orally at 6, 24, and 48 hours
Total dose: 1550 mg base (2000 mg salt)

Comments:

• Recommended for uncomplicated malaria (P falciparum or species not identified) in regions with chloroquine sensitivity
• Recommended for uncomplicated malaria (P malariae, P knowlesi, P vivax [unless chloroquine-resistant P vivax suspected], or P ovale) in all regions; if treating P vivax or P ovale infections, concomitant treatment with primaquine (after quantitative testing to rule out glucose-6-phosphate dehydrogenase [G6PD] deficiency) is recommended.
• Recommended for uncomplicated malaria treatment for pregnant women in regions with chloroquine sensitivity
• Current guidelines should be consulted for additional information.

Usual Adult Dose for Systemic Lupus Erythematosus

200 to 400 mg salt (155 to 310 mg base)/day orally divided in 1 or 2 doses

Comments:

• Doses above 400 mg/day are not recommended.
• Higher incidence of retinopathy reported when this maintenance dose is exceeded.

Uses: For the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus

Usual Adult Dose for Rheumatoid Arthritis

Initial dose: 400 to 600 mg salt (310 to 465 mg base)/day orally divided in 1 or 2 doses
Maintenance dose: 200 to 400 mg salt (155 to 310 mg base)/day orally divided in 1 or 2 doses
Maximum dose: 600 mg salt (465 mg base)/day or 6.5 mg/kg salt (5 mg/kg base)/day, whichever is lower

Comments:

• The action of this drug is cumulative and may require weeks to months to achieve the maximum therapeutic effect.
• When a good response is obtained, the initial dose may be reduced by 50% and continued at a maintenance dose.
• Higher incidence of retinopathy reported when this maintenance dose is exceeded; 600 mg salt (465 mg base) or 6.5 mg/kg salt (5 mg/kg base), whichever is lower, should not be exceed per day.
• Corticosteroids and salicylates may be used with this drug, and they can generally be decreased gradually in dosage or eliminated after a maintenance dose of this drug has been achieved.

Use: For the treatment of acute and chronic rheumatoid arthritis

Usual Pediatric Dose for Malaria Prophylaxis

6.5 mg/kg salt (5 mg/kg base) orally once a week
Maximum dose: 400 mg salt (310 mg base)/dose

Comments:

• This drug should be administered on the same day of each week.
• Suppressive therapy should begin 2 weeks prior to exposure and should continue for 4 weeks after leaving the endemic area.

Use: For the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported

US CDC Recommendations: 5 mg/kg base (6.5 mg/kg salt) orally once a week
Maximum dose: 310 mg base (400 mg salt)/dose

Comments:

• An alternative to chloroquine for prophylaxis only in areas with chloroquine-sensitive malaria
• Prophylaxis should start 1 to 2 weeks before travel to malarious areas; should continue weekly (same day each week) while in malarious areas and for 4 weeks after leaving such areas
• If malaria develops while using this drug for chemoprophylaxis, it should not be used as part of the treatment regimen.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Malaria

First dose: 13 mg/kg salt (10 mg/kg base) orally
Second dose (6 hours after first dose): 6.5 mg/kg salt (5 mg/kg base) orally
Third dose (24 hours after first dose): 6.5 mg/kg salt (5 mg/kg base) orally
Fourth dose (48 hours after first dose): 6.5 mg/kg salt (5 mg/kg base) orally

Maximum Dose:

• First dose: 800 mg salt (620 mg base)/dose
• Second, third, and fourth dose: 400 mg salt (310 mg base)/dose

Comments:

• Concomitant therapy with an 8-aminoquinoline compound is necessary for radical cure of P vivax and P ovale infections.

Use: For the treatment of uncomplicated malaria due to P falciparum, P malariae, P ovale, and P vivax

US CDC Recommendations: 10 mg/kg base orally at once, followed by 5 mg/kg base orally at 6, 24, and 48 hours
Total dose: 25 mg/kg base

Comments:

• Pediatric dose should never exceed adult dose.
• Recommended for uncomplicated malaria (P falciparum or species not identified) in regions with chloroquine sensitivity
• Recommended for uncomplicated malaria (P malariae, P knowlesi, P vivax [unless chloroquine-resistant P vivax suspected], or P ovale) in all regions; if treating P vivax or P ovale infections, concomitant treatment with primaquine (after quantitative testing to rule out G6PD deficiency) is recommended.
• Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Renal dysfunction: No adjustment recommended.

Liver Dose Adjustments

Data not available

Comments:

• Antimalarial compounds should be used with caution in patients with liver disease or alcoholism, or in conjunction with known hepatotoxic agents.

Precautions

CONTRAINDICATIONS:
Known hypersensitivity to 4-aminoquinoline compounds

Safety and efficacy have not been established for the chronic use of this drug for systemic lupus erythematosus and juvenile idiopathic arthritis in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer with a meal or a glass of milk.
• Do not crush or divide the tablets.

General:

• Each 200 mg tablet of hydroxychloroquine sulfate is equivalent to 155 mg hydroxychloroquine base.
• The pediatric dose should never exceed the adult dose.
• Since the tablets cannot be divided, this drug should not be used to treat patients weighing less than 31 kg.
• Limitations of Use in Malaria:
• This drug is not recommended for the treatment of complicated malaria.
• This drug is not effective against chloroquine-resistant or hydroxychloroquine-resistant strains of Plasmodium species; it is not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified.
• This drug is not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs.
• This drug does not prevent relapses of P vivax or P ovale; it is not active against the hypnozoite forms of these parasites. Concomitant therapy with an 8-aminoquinoline compound is necessary for radical cure of P vivax and P ovale infections.

Monitoring:

• Cardiovascular: For signs/symptoms of cardiomyopathy, including appropriate diagnostic tools such as ECG (during therapy)
• Hematologic: Blood cell counts (periodically during prolonged therapy)
• Musculoskeletal: Muscle strength and deep tendon reflexes (periodically during long-term therapy)
• Ocular: Ophthalmological examination, including best corrected distance visual acuity, automated threshold visual field of the central 10 or 24 degrees (the manufacturer product information should be consulted), and spectral domain optical coherence tomography (at baseline [within first year of starting therapy] then annually with significant risk factors or deferred until 5 years of therapy without significant risk factors)
• Renal: Renal function in elderly patients

Patient advice:

• Consult physician at once if signs/symptoms of toxicity (e.g., rash, visual changes) or any unusual effects develop.
• Watch for clinical signs/symptoms of hypoglycemia.
• It is very important to keep this drug out of the reach of children.

Frequently asked questions

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