Usual Adult Dose for Malaria

300 mg orally once as a single dose

Comments:

• Limitations of Use:
• This drug is not indicated for the treatment of acute Plasmodium vivax malaria.
• Concomitant use of this drug with antimalarials other than chloroquine is not recommended due to the risk of recurrence of P vivax malaria.
• This drug should be coadministered on the first or second day of chloroquine therapy for acute P vivax malaria.
• A repeat dose is recommended if vomiting occurs within 1 hour after dosing; re-dosing should not be attempted more than once.

Use: For the radical cure (prevention of relapse) of P vivax malaria in patients receiving chloroquine therapy for acute P vivax infection

Usual Adult Dose for Malaria Prophylaxis

Loading dose: 200 mg orally once a day for 3 days
Maintenance dose: 200 mg orally once a week
Terminal prophylaxis dose: 200 mg orally once as a single dose

Duration of therapy: Up to 6 months of continuous dosing

Comments:

• The loading dose should be administered for each of the 3 days prior to travel to malarious area.
• The maintenance dose should be started 7 days after the last loading dose and should be continued while in the malarious area.
• The terminal prophylaxis regimen should be administered 7 days after the last maintenance dose in the week after exit from malarious area.
• The full course of therapy should be completed (including the loading dose, maintenance dose, and terminal dose).
• To replace missed dose(s):
• If 1 loading dose is missed: 1 dose of 200 mg so that a total of 3 daily loading doses have been administered; the maintenance dose should be started 1 week after the last loading dose
• If 2 loading doses are missed: 2 doses of 200 mg on 2 consecutive days so that a total of 3 daily loading doses have been administered; the maintenance dose should be started 1 week after the last loading dose
• If 1 maintenance (weekly) dose is missed: 1 dose of 200 mg on any day up to the time of the next scheduled weekly dose
• If 2 maintenance (weekly) doses are missed: 1 dose of 200 mg on any day up to the time of the next scheduled weekly dose
• If at least 3 maintenance (weekly) doses are missed: 2 doses of 200 mg, administered as 200 mg once a day for 2 days up to the time of the next scheduled weekly dose
• If the terminal prophylaxis dose is missed: 1 dose of 200 mg as soon as remembered

Use: For the prophylaxis of malaria

Usual Pediatric Dose for Malaria

16 years or older: 300 mg orally once as a single dose

Comments:

• Limitations of Use:
• This drug is not indicated for the treatment of acute P vivax malaria.
• Concomitant use of this drug with antimalarials other than chloroquine is not recommended due to the risk of recurrence of P vivax malaria.
• This drug should be coadministered on the first or second day of chloroquine therapy for acute P vivax malaria.
• A repeat dose is recommended if vomiting occurs within 1 hour after dosing; re-dosing should not be attempted more than once.

Use: For the radical cure (prevention of relapse) of P vivax malaria in patients receiving chloroquine therapy for acute P vivax infection

Renal Dose Adjustments

Renal dysfunction: Monitoring for drug-related side effects recommended.

Liver Dose Adjustments

Liver dysfunction: Monitoring for drug-related side effects recommended.

Precautions

CONTRAINDICATIONS:

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency or unknown G6PD status (due to risk of hemolytic anemia)
• Breastfeeding when infant is G6PD deficient or if G6PD status of infant is unknown
• Known hypersensitivity to the active component, any of the ingredients, or other 8-aminoquinolines
• For the prophylaxis of malaria: History of psychotic disorders or current psychotic symptoms (i.e., hallucinations, delusions, and/or grossly disorganized behavior)

For the prophylaxis of malaria: Safety and efficacy have not been established in patients younger than 18 years.
For the radical cure of P vivax malaria: Safety and efficacy have not been established in patients younger than 16 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Test all patients for G6PD deficiency before prescribing this drug.
• Test females of reproductive potential for pregnancy before starting this drug.
• Administer with food (to increase systemic absorption).
• Swallow tablets whole; do not break, crush, or chew.
• For the prophylaxis of malaria: Complete the full course of therapy (including the loading dose, maintenance dose, and terminal dose).
• For the radical cure of P vivax malaria: Do not use to treat acute P vivax malaria; coadminister this drug on the 1st or 2nd day of chloroquine therapy for acute P vivax malaria.
• For the radical cure of P vivax malaria: Administer an additional dose if vomiting occurs within 1 hour after dosing; do not attempt to re-dose more than once.

Storage requirements:

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Protect from moisture.
• Blister card (100 mg tablets): Dispense only in original carton.
• Bottle (150 mg tablets): Store in original container with desiccant inside; keep bottle tightly closed.

Monitoring:

• General: Pregnancy testing in females of reproductive potential (before therapy); for drug-related side effects in patients with renal and/or liver dysfunction
• Hematologic: For clinical signs/symptoms of hemolysis
• Metabolic: For G6PD deficiency (before prescribing)

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide [for the prophylaxis of malaria]; Patient Information [for the radical cure of P vivax malaria]).
• Promptly seek medical advice if symptoms of hemolytic anemia or methemoglobinemia occur; contact healthcare provider if dark/darker lips or urine develop.
• Females of reproductive potential: Avoid pregnancy or use effective contraception during therapy and for 3 months after the last dose of this drug.
• For the prophylaxis of malaria: Seek medical attention as soon as possible if hallucinations, delusions, or confused thinking occur during therapy; seek prompt evaluation by medical professional if other psychiatric symptoms (e.g., changes in mood, anxiety, insomnia, nightmares) last more than 3 days or are severe.
• For the radical cure of P vivax malaria: Promptly seek medical advice if new or worsening psychiatric symptoms develop.
• Promptly seek medical advice if symptoms of hypersensitivity reactions develop.
• For the prophylaxis of malaria: Avoid missing doses and complete the entire course of therapy.

Frequently asked questions

• What is the difference between Arakoda and Krintafel?
• How do you take Arakoda for the prevention of malaria?
• How do you take Krintafel?