General Description
Artesunate 50mg (as sodium salt) uncoated tablets and Sulfadoxine 500mg
+ Pyrimethamine 25mg uncoated tablets, co-packed in blisters/strips of
12+3 / pack of 1
Technical specifications
Each uncoated tablet of Artesunate contains: Artesunate 50mg (as sodium
salt)
Each uncoated FDC tablet contains: Sulfadoxine 500mg + Pyrimethamine
25mg in a ratio of 20:1
Both tablets should be scored with at least one break line to allow for
division of tablets into two parts, each containing the same amount of
active ingredients.
Therapeutic class
Artesunate is a water soluble Sodium salt of the hemisuccinate ester of
dihydroartemesinin.
Sulfadoxine is a slowly eliminated sulphonamide that competitively
inhibits dihydropteroate synthase, the enzyme responsible for the
incorporation of Para amino benzoic acid in the synthesis of folic acid.
Pyrimethamine is a diaminopyrimidine that inhibits plasmodial
dihydrofolate reductase, thus, indirectly blocking the synthesis of
parasite nucleaic acids.
Sulfadoxine and Pyrimethamine as a combination works by sequentially
blocking the two enzymes involved in the biosynthesis of folinic acid in
Plasmodium parasites.
Standard shelf life
2 years (24 months)
Other available formulations
Artesunate 100mg and Sulfadoxine 500mg + Pyrimethamine 25mg co-blistered
tablets, pack of 6+3tablets
Artesunate 50mg and Sulfadoxine 500mg + Pyrimethamine 25mg co-blistered
tablets, Pack of 3+1, 6+2, 12+3 tablets
Indications
Treatment of acute uncomplicated malaria caused by P. falciparum alone
or with other Plasmodium spp. In areas with significant drug resistance.
By Mouth (PO)
Dosage
Suggested dosing is based on the WHO guidelines for the treatment of
Malaria: www.who.int/malaria/publications/atoz/9241546948/en/index.html
Storage
Keep out of the reach and sight of children.
Protect from light.
Protect from moisture.
Temperature considerations
Do not store above 25°C (77°F).
Dispensing instructions
Dispense in original container. Do not repack
Advice patient to take SP tablets after a meal and with plenty of
fluids.
Both Artesunate and Sulfadoxine+ Pyrimethamine must be taken in
combination with each other.
Guidelines for use
For more details, please see
World Health Organisation (WHO), Guidelines for the treatment of
Malaria: (www.who.int/malaria/en/)
WHO, Model Lists of Essential Medicines for adults and/or children
respectively:
(www.who.int/medicines/publications/essentialmedicines/en/index.html)
WHO Model Formulary: (apps.who.int/emlib/Default.aspx?Language=EN)
or your regional and/or national guidelines.
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