Artesunate injection 60mg
1. Product name: Artesunate injection
2. Specification: 60mg+1ml solution
3. Package: 1 ampoule+1vial/box
4. Shelf life: 36 months
5. Registration dossiers are available.
If you are interested in our products, please feel free to contact us.
Artesunate injection 60mg
1. Product name: Artesunate injection
2. Specification: 60mg+1ml solution
3. Package: 1 ampoule+1vial/box
4. Shelf life: 36 months
5. Registration dossiers are available.
If you are interested in our products, please feel free to contact us.
1. What ARTESUNATE-REX is and what it is used for
Artesunate is a water-soluble hemisuccinate derivative of artemisinin. It is unstable in neutral solution and theinjectable formulation must be prepared immediately before use in 5% (w/v) sodium bicarbonate solution to
produce the salt sodium artesunate.
Indications
Artesunate is developed for killing the erythrocytic stage of plasmodium asexual form. It is effective to malaria
caused by chloroquine resistant stain of plasmodium falciparum. It can quickly and reliably control the acute
attack of malaria. It is suitable to salvage the patients with pernicious malaria and treat P. falciparum malaria
and P. vivax malaria. Artesunate Injection is indicated for the treatment of serious malaria infections and the
patients with cerebral malaria.
Pharmacologic Effects
Artesunate has an excellent anti-malarial activity on the asexual forms of malaria parasites with high, quick
efficiency to bring about rapid control of an acute attack. It has advantages of no cross resistance to
Chloroquine.
Absorption, Distribution and Excretion
The concentration in plasma decreases rapidly after administered intravenously. The plasma half-life time is
about 30 minutes. It distributes widely throughout the body and with high concentration in intestines, liver and
kidneys. Only a small quantity excretes in urine and stools.
It is mainly eliminated by metabolic bio-transformation.
2. Before you use ARTESUNATE-REX
PrecautionsParenteral artesunate should be used for the treatment of severe falciparum malaria only where there is
evidence that the antimalarial efficacy of quinine is declining.
The powder for injection is difficult to dissolve and care should be taken to ensure that it is completely dissolved
before parenteral administration. It should always be used immediately following reconstitution. If the solution
is cloudy or a precipitate is present, the parenteral preparation should be discarded.
Notes:
(a) The solution should be used immediately after the powder is dissolved. It should not be used for intravenous
infusion if the solution appears cloudy or sediment occurs.
(b) The speed for intravenous infusion is 3-4 ml per minute.
(c) A dose of 60 mg Artesunate Injection should be given 4-6 hour following the first dose of 120 mg in the
patients infected with high parasitemia (Over 10% of RBC infection rate).
(d) The recrudescence rate is less than 10% of cases with Chloroquine resistance if the patient is treated using
Artesunate Injection for 5 days. A 7-day treatment is recommended for patients with serious infection and
non-immune. It will be helpful taking Artesunate Tablets for another 7 days after malaria symptoms are
controlled by the injection.
(e) Embryo-toxic effects were observed in some animal studies. Use Artesunate carefully in pregnant women
during the first three months.
3. How to use ARTESUNATE-REX
Administration and DosageIt should be administered in a dose of 60 mg via intramuscular or intravenous infusion, once daily for 5-7 days
for a course. Double the first dose! Total doses are 360-480 mg for adults.
The vial of Artesunate powder should be mixed with 1 ml of 5% sodium bicarbonate solution (provided) and
shaken 2-3 minutes for better dissolution.
Add 5 ml of 5% glucose or normal saline to make the concentration of Artesunate in 10 mg/ml for slow
intravenous infusion.
Add 2 ml of 5% glucose or normal saline to make the concentration of Artesunate in 20 mg/ml for intramuscular
injection.
Doses for Children: 1.2mg/kg for children.
4. Possible side effects
No adverse reactions were observed with recommended dose up to now.Transient reticulocytopenia may occurwhen overdose of Artesunate Injection (more than 3.75 mg/kg) is given.
5. Storing ARTESUNATE-REX
Store at room temperature, 15-30 (59-86), protected from light.6. Shelf life: 3 years
