Usual Adult Dose for Malaria

648 mg orally every 8 hours for 7 days

Comments:

• This drug has been effective in geographical regions with documented chloroquine resistance.

Use: Only for treatment of uncomplicated Plasmodium falciparum malaria

US CDC Recommendations: 542 mg base (650 mg sulfate salt) orally 3 times a day for 3 or 7 days

Comments:

• With doxycycline, tetracycline, or clindamycin, recommended as a preferred regimen for treatment of uncomplicated malaria due to chloroquine-resistant (or unknown resistance) P falciparum (or species not identified); in pregnant women, this drug should be used with clindamycin.
• With (primaquine or tafenoquine [Krintafel]) plus (doxycycline or tetracycline), recommended for treatment of uncomplicated malaria due to chloroquine-resistant P vivax; primaquine and tafenoquine must not be used during pregnancy.
• In pregnant women with uncomplicated malaria due to chloroquine-resistant P falciparum or P vivax, doxycycline or tetracycline may be used with this drug if other treatment options are not tolerated/not available and the benefits are deemed to outweigh the risks.
• If needed, as interim therapy for severe malaria until IV artesunate arrives
• The US manufactured quinine sulfate capsule is available in a 324-mg dosage; therefore, 2 capsules should be sufficient for adult dosing.
• Therapy should be continued for 7 days if infection was acquired in Southeast Asia, or for 3 days if acquired elsewhere.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Malaria

16 years or older: 648 mg orally every 8 hours for 7 days

Comments:

• This drug has been effective in geographical regions with documented chloroquine resistance.

Use: Only for treatment of uncomplicated P falciparum malaria

US CDC Recommendations: 8.3 mg base/kg (10 mg sulfate salt/kg) orally 3 times a day for 3 or 7 days
Maximum dose: 542 mg base (650 mg sulfate salt)/dose

Comments:

• With clindamycin in children younger than 8 years and with doxycycline, tetracycline, or clindamycin in children 8 years or older: Recommended as a preferred regimen for treatment of uncomplicated malaria due to chloroquine-resistant (or unknown resistance) P falciparum (or species not identified)
• With primaquine in children younger than 8 years, with primaquine plus (doxycycline or tetracycline) in children 8 to 15 years, and with (primaquine or tafenoquine [Krintafel]) plus (doxycycline or tetracycline) in children 16 years or older: Recommended for treatment of uncomplicated malaria due to chloroquine-resistant P vivax
• If needed, as interim therapy for severe malaria until IV artesunate arrives
• Pediatric dose should never exceed adult dose.
• The US manufactured quinine sulfate capsule is available in a 324-mg dosage; due to the unavailability of non-capsule forms of this drug, pediatric dosing may be difficult.
• Therapy should be continued for 7 days if infection was acquired in Southeast Asia, or for 3 days if acquired elsewhere.
• Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Mild and moderate renal dysfunction: Data not available
Severe chronic renal dysfunction:

• Loading dose: 648 mg orally once followed 12 hours later by maintenance dose
• Maintenance dose: 324 mg orally every 12 hours

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Not recommended.

Comments:

• Patients with mild or moderate liver dysfunction should be closely monitored for side effects of this drug.
• Alternative therapy recommended for patients with severe liver dysfunction.

Precautions

US BOXED WARNING:

• HEMATOLOGIC REACTIONS: Use of this drug for treatment/prevention of nocturnal leg cramps may lead to serious and life-threatening hematologic reactions (including thrombocytopenia and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura [HUS/TTP]); chronic renal dysfunction associated with TTP development reported. Risk associated with use of this drug (without proof of efficacy for nocturnal leg cramp treatment/prevention) outweighs any potential benefit.

CONTRAINDICATIONS:

• Prolonged QT interval
• Known hypersensitivity reactions to the active component (including, but not limited to, thrombocytopenia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, blackwater fever)
• Known hypersensitivity to mefloquine or quinidine
• Myasthenia gravis
• Optic neuritis

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:

• Do not use to treat severe/complicated P falciparum malaria, to prevent malaria, or to treat/prevent nocturnal leg cramps.
• Administer with food to minimize gastric upset.
• Do not exceed the prescribed amount.
• Consult the manufacturer product information regarding missed doses.

Storage requirements:

• Store at 20C to 25C (68F to 77F).
• Dispense in a tight container.

General:

• Unless otherwise specified, the dose is expressed as quinine sulfate (i.e., as the salt).
• The Medication Guide should be dispensed to each patient.

Monitoring:

• General: For side effects in patients with liver dysfunction; serum digoxin levels (if used concomitantly)
• Metabolic: For signs/symptoms of hypoglycemia

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Do not take more than the prescribed amount.