Artesunate Atlantic

Artesunate Atlantic

artesunate

Manufacturer:

Atlantic Lab

Distributor:

Atlantic Pharma
Full Prescribing Info
Contents
Artesunate.
Description
Tab: Each tablet contains 50 mg of Dihydroartemisinine-12α-succinate (artesunate).
Molecular Formula: C19H28O8.
Inj: Artesunate for injection is a sterile pyrogen-free powder of artesunate for injection 60 mg per vial.
Indications/Uses
Tab: Artesunate is the preparation for killing the erythrocytic stage of plasmodium asexual form.
It is effective to malaria caused by chloroquine-resistant strain of Plasmodium falciparum, can quickly and reliably control the acute attack of malaria. It is suitable to salvage the patients with critical malaria, and treat P. falciparum malaria and P. vivax malaria.
Artesunate should be used as combination with other antimalarial drugs which have long half life such as mefloquine, amodiaquine, sulfadoxine-pyrimethamine.
Combinations of antimalarials are now recommended by WHO for the treatment of falciparum malaria.
Inj: Artesunate for injection is an antimalarial drug. It acts on the asexual forms of malaria parasites with high, quick-efficiency to bring about control of an acute attack but no effect on the gametocytes of Plasmodium falciparum. It has advantages of no cross resistance to chloroquine. It is used to treat cerebral malaria and serious malaria patients in emergency.
Dosage/Direction for Use
Tab: For treatment: Combination therapy dosage: Orally.
200 mg of Artesunate and 750 mg of Mefloquine initially.
200 mg of Artesunate and 500 mg of Mefloquine on the second day.
200 mg of Artesunate and 30 mg of Primaquine on the third day.
Inj: Before use, dissolve the artesunate for injection 60 mg (1 vial) with 1 amp. (1 ml) of 5% sodium bicarbonate injection and add 5% glucose injection or glucose and normal saline injection 5 ml to make each ml contains artesunate 10 mg, then I.V. slowly (3-4 ml/minute). Dose 1.2 mg/kg of body-weight for adult or 1.5 mg/kg body-weight for children under 7 years of age, I.V. or I.M. To inject repeatedly every 4, 24, and 48 hours after the first dose.
Contraindications
Do not use this drug in pregnant women and children (tab only).
Special Precautions
Artesunate should be used with caution in patients with cardiac, hepatic, renal and gastrointestinal disease.
Inj: It should be injected immediately after dissolving the powder of artesunate for injection. If the solution appears cloudy or sediment occurs, it should not be used.
The first dose may be doubled if the malaria patients condition is very serious.
It is necessary to treat radically with other antimalarial drug after the malaria symptoms were controlled by artesunate.
Caution: Artesunate injection should be used with caution in patients with cardiac, hepatic, renal and gastrointestinal disease.
Use In Pregnancy & Lactation
Artesunate is contraindicated in pregnant women.
Side Effects
Tab: Artesunate Tablets may depress bone marrow and cause reticulocytopenia.
Inj: In the mice, decreased reticulocyte and increased alkaline phosphatase in plasma.
Influence on central nervous system. In mice when give Artesunate at high dose cause decreased activity, retardation of reaction, and increase in pain threshold and caused transient lowering of body temperature.
Parenchymal damage in the mucosa of stomach and intestines.
In mice, have liver and kidney intoxication.
Damage red blood cell in bone marrow in mice.
In mice, made embryotoxicity at the mid and late stages in organogenetic period of fetal rats.
Storage
Tab: Store below 30°C in airtight containers and protected from light.
Inj: It should be stored in dark, protected from light, and in cool place (below 25°C).
Shelf-Life: 2 years.
MIMS Class
ATC Classification
P01BE03 - artesunate ; Belongs to the class of artemisinin and derivative antimalarials.
Presentation/Packing
Tab (white) 50 mg x 12's. Inj (vial) 60 mg x 1's.
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