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Dosage Form, Composition & NAFDAC Registration Number (NRN)
Suppository (NRN:04-6439): Dihydroartemisinin 40 mg.
Pack size: 8 suppositories in plastic wrapping
Description: White or pale yellow suppositories made by incorporation of Dihydroartemisinin in soluble base.
A powerful plasmodicide, which controls symptoms rapidly. It is highly effective against all types of malaria including multi-drug resistant malaria. It has a high safety profile and low toxicity. In reproduction toxicology, there was an increased fetal absorption during pregnancy in mice. No mutation effects were observed.
After rectal administration, Dihydroartemisinin absorption is rapid and complete, and the active agent takes effect promptly. Pharmacokinetic parameters by rectal route are: Tmax = 1.68 + 0.33 hr; Cmax = 0.42 µg/mL; T½ = 1.57 + 0.46 hr.
Special features include rapid absorption, extensive distribution, metabolism and quick excretion.
For the treatment of malaria due to Plasmodium falciparum, Plasmodium vivax and Plasmodium malariae, as well as in complicated malaria especially for those who cannot take oral medication. The efficiency of Dihydroartemisinin suppository is obviously superior to that of IV quinine and other non-artemisinin oral antimalarials.
Diarrhoea may lead to poor absorption of the drug.
The drug may be used in the second and third trimester. However, there are no reports of teratogenicity with its use in the first trimester of pregnancy.
No significant adverse effect observed. Occassionally, there is transient reduction in reticulocyte count. In rare cases, there may transient increase in transaminases (SGOT, SGPT).
Dosage & Administration
Dosage recommendation for multi-drug resistant P. falciparum malaria and non complicated malaria is by rectally, 80 mg twice daily (2 suppositories) on the first day followed by 80 mg once daily for the next six days. This dosage scheme consisting of 640 mg total dose of Dihydroartemisinin has been found to prevent recrudescence.
The recommended dosage using the 40 mg suppository is 4 mg/kg body weight twice daily (2 suppositories) on the first day followed by 4 mg/kg daily for the next six days. This is suitable for children between the ages of 1-7 years.
How to use the Suppositories:
The suppositories should be inserted deeply into the anus, if possible after having bowel movement.
Clean the area around the rectum with mild soap and warm water, and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth.
Detach one suppository from the strip. Remove wrapper before inserting suppository by holding suppository upright and carefully peeling wrapper evenly down both sides of the suppository. Avoid excessive handling as the suppository is designed to melt at body temperatures.There is no need to refrigerate this product if stored below 80oF (27oC).
Position the patient flat on back or on one side, with anal opening exposed. Gently insert the suppository well into the rectum. Use fingertip to complete insertion. If necessary, hold buttocks together for 30-60 second to keep suppository in place.
Preserve in well closed, light-resistant containers. Store in a cool place.