FDA Label for Kodatef
View Indications, Usage & Precautions
Kodatef Product Label
The following document was submitted to the FDA by the labeler of this product 60 Degrees Pharmaceuticals, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Warnings And Precautions
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
Dear Healthcare Provider Letter pages 1-61
Dosage & Administration
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.
Indications & Usage
Malaria prophylaxis, consistent with the approved use of ARAKODA
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