Waipa Compound Dihydroartemisinin Tablets

WAIPA

Compound Dihydroartemisinin Tablets

 

COMPOSITION

(3R-5aS, 6R, 8aS, 9R, 12S, 12Ar) – Eight hydro-3,6,9-trimethyl-3, 12-epoxy-12H-prano-[4,3-J] -1,2-benzodioxopine – 10(3H)-oI. (Dihydroartemisinin, DHA) AND 1,3 di[4-(7-chlorine-quinoIine-4-methyl-) piperazine-[-methyl] propone and tetradic phosphate (Piperaquine phosphate, PQP) combination.

 

DESCRIPTION

Each tablet contains Dihydroartemisinin 30mg and Piperaquine Phosphate 225mg.

 

PHARMACOLOGY

WAIPA is a novel excellent antimalarial drug with rapid action, high efficacy, low toxicity, high safety, strong inhibitory, gametocidal effect and short course for treatment of all forms of malaria, particularly for multi-drug resistant falciparum malaria.

 

RAPID ACTION

Clinical trials showed that WAIPA has excellent efficacy to relieve clinical symptoms of malaria patients. Respectively, the average fever clearance time and parasite-clearance time is 16-20 hours and 24-50 hours. 98% of parasites are cleared within 24 hours, and 100% within 48 hours in the blood. The third day treatment is to clear the parasites from the liver. So, WAIPA prevents the re-occurrence of malaria for a long time and reduces the morbidity and mortality rates of malaria notably.

 

HIGH EFFICACY

Recent clinical trials showed that 99.1% of malaria cases are cured and only 0.9% are recrudesced (re-occurred) after treatment with WAIPA during 28 days follow-up observations.

 

SHORT COURSE

A 3-day treatment course reached very high cure rate.

 

LOW TOXICITY

Experiments on mice showed that there is no parameter changes on central nervous system, cardiovascular system, respiratory system and haematology, blood biochemistry after administration of WAIPA.

 

GAMETOCIDAL EFFECT

Experiments on mice showed that there is no parameter changes on central nervous system, cardiovascular system, respiratory system and haematology, blood biochemistry after administration of WAIPA.

WAIPA is very effective for Vivax malaria. It also has quick and high efficacy in killing vivax parasites and only 1.7% recrudesced as showed in clinical trials after 28 days.

 

PHARMACOKINETICS

Dihydroartemisinin (DHA): DHA is absorbed rapidly and completely, and distributed via circulation widely in kidney, lung, liver, spleen, bone, heart, muscle and brain, etc. 1 hour after oral administration.

Human pharmacokinetic parameters: Oral dosage 2mg/Kg, Tmax = 1 .33h, Cmax = 0.71 mg/ml, T ½ = 1.57h, 82.7% are excreted by urine and faeces and no primary combination was observed in 24 hours.

Piperaquine Phosphate (POP): 80-90% are absorbed in gastro-intestinal system and accumulated in liver, kidney, lung and spleen, etc. ¼ of the drug are accumulated in liver in 8 hours T ½ = 9 hours, T ½ 9hrs, Faeces and bile are the main excretion routes.

 

INTERACTION

Researches showed the two components of WAIPA had synergism with potentiation of antimalarial effects and prevention of resistance to either Dihydroartemisinin and Piperaquine Phosphate.

 

ADMINISTRATION AND DOSAGE

Orally, take as shown below:

Adult (15 years and above): 4 tablets once daily for 3 days.

Children (8-14 years): 3 tablets once daily for 3 days.

Children (3-7 years): 2 tablets once daily for 3 days.

Children (0-2 years): ½ -1 Tablets once daily for 3 days.

 

SIDE EFFECTS

Few cases of side effects occurred after administration of WAIPA, mainly caused by Piperaquine Phosphate, i.e. nausea 5.5%, vomiting 2.8%, inappetence 2.0%, belly ache 1.5%, diarrhoea 1.0%, dizziness 1.2%, itching 0.5% and rashes 0.1%.

 

CONTRA INDICATIONS

This drug should be used carefully in pregnant women particularly in the first trimester and patients with liver diseases. This drug should not be taken repeatedly in four weeks after first treatment course.

 

PRESENTATION

12 tablets, each containing Dihydroartemisinin 30mg and Piperaquine Phosphate 225mg, packed in blisters.

 

STORAGE

Store in a cool, dry place and away from children.

 

Manufactured by

KUNIMED PHARMACEUTICAL LTD.

1, Adelanwa Street, Valley Estate,

Dopemu, Ikeja, Lagos, Nigeria,

www.kunimed.com