Sovuna Dosage

Important Administration Instructions

Administer SOVUNA orally with food or milk. Do not crush the tablets.

Dosage for Malaria in Adult and Pediatric Patients

SOVUNA is not recommended in pediatric patients less than 23 kg because the lowest possible dose of 150 mg (half of the scored 300 mg tablet) exceeds the recommended dose for these patients.

Prophylaxis

Treatment must start 2 weeks before travel to an endemic area. Advise the patient to take the prophylaxis dosage once a week, staring 2 weeks prior to travel to the endemic area, on the same day every week, continuing the same weekly dose while in the endemic area, and for 4 weeks after leaving the endemic area. The recommended prophylaxis dosage is:

• Adult patients: 400 mg once a week
• Pediatric patients ≥ 23 kg: 6.5 mg/kg actual body weight (up to 400 mg) once a week

Treatment of Uncomplicated Malaria

The dosages for the treatment of uncomplicated malaria are:

• Adult patients: Administer 800 mg initially; subsequently administer 400 mg at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 2000 mg).
• Pediatric patients ≥ 23 kg: Administer 13 mg/kg (up to 800 mg) initially; subsequently administer 6.5 mg/kg (up to 400 mg) at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 31 mg/kg - up to 2000 mg).

For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8­aminoquinoline drug is necessary [see Microbiology (12.4)].

Dosage for Rheumatoid Arthritis in Adults

The recommended dosage is:

• Initial dosage: 400 mg to 600 mg daily as a single daily dose or two divided doses. The action of hydroxychloroquine is cumulative and may require weeks to months for maximum therapeutic effect. Daily doses exceeding 5 mg/kg (actual weight) of hydroxychloroquine sulfate increase the incidence of retinopathy [see Warnings and Precautions (5.2)].
• Chronic dosage: 200 mg, 300 mg or 400 mg daily, as a single dose or two divided doses.

Corticosteroids, salicylates, and other antirheumatic agents may be used concomitantly with SOVUNA.

Dosage for Systemic Lupus Erythematosus in Adults

The recommended dosage is 200 mg, 300 mg or 400 mg daily, as a single dose or two divided doses

Dosage for Chronic Discoid Lupus Erythematosus in Adults

The recommended dosage is 200 mg or 400 mg daily, as a single dose or two divided doses.