The following Structured Product Label (SPL) was submitted to the FDA by 60 Degrees Pharmaceuticals, Inc for the product Kodatef (NDC 71475-258). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding warnings and precautions, dear healthcare provider letter, dosage & administration, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Hemolytic Anemia
G6PD Deficiency in Pregnancy and Lactation
Methemoglobinemia
Psychiatric Effects
Hypersensitivity Reactions
Delayed Adverse Reactions, Including Hemolytic Anemia, Methemoglobinemia, Psychiatric Effects, and Hypersensitivity Reactions
Dear Healthcare Provider Letter pages 1-61
Loading Dose: 200 mg (two of the 100 mg filmcoated tablets) once daily for three days.
Maintenance Dose: 200 mg (two of the 100 mg filmcoated tablets) once weekly – start seven days after the last loading dose.
Malaria prophylaxis, consistent with the approved use of ARAKODA
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