39, Oritse Street, Ikeja, Lagos
Akums Drugs & Pharmaceuticals Ltd
2,3,4, & 5. Sector -6B, I.I.E., SIDCUL, Haridwar-249 403. India
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Injection(NRN:): Each mL contains: a-β Arteether 75 m; Arachis Oil B.P q.s
a-B arteether is an ethyl ether derivative of artemisinin which is an efficient schizonticidal drug in p. falciparum malaria.
a-B arteether is a fast acting schizonticidal agent for P. falciparum malaria at the erythrocytic stage. It is concentrated in parasitized erythrocytes.
The functional group responsible for antimalarial activity of a-B arteether is endoperoxide bridge. Iron from the digested haemoglobin of the parasite's victim reduces this bridge, releasing a highly reactive free radical iron species which causes lysis of the parasitic cell.
Lysis of parasitic cell membrane occurs. Damage includes swelling and deformity of food vacuoles membrane, nuclear membrane, endoplasmic reticulum and formation of autophagic vacuoles.
It is also proposed that a-B arteether inhibits the protein synthesis and alters the ribosomal organization and endoplasmic reticulum
ALBETHER is transformed into dihydroartemisinin. It has half-life of 20 hours. It is eliminated by hepatic metabolism. The elimination is much slower compared to other compounds.
⦁ Treatment of uncomplicated plasmodium falciparum malaria in adults. children and infants weighing 5 kg and above.
⦁ Specifically indicated for the treatment of chloroquine resistant P. falciparum malaria and cerebral malaria cases.
⦁ Severe malaria including cerebral malaria and as a second line drug in chloroquine resistant malaria cases
ALBETHER injection is contraindicated in patients hypersensitive to artemisinin derivatives.
Adequate studies regarding safe use of artemisinin derivatives during pregnancy arc not available. Artemisinin derivatives should not be used in pregnancy as primary drugs for uncomplicated malaria cases but these can be used for treatment of severe or complicated P. falciparum malaria infection in patients of multiple drug resistance, if the potential benefit justifies the potential risk to the fetus.
It is not known whether ALBETHER is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised while using ALBETHER
Prolonged QT interval has been reported in some studies with high dosage of artemisinin derivatives. The cardiac effects of Artemisinins are not very important from a clinical point of view. except that caution should be exercised against combination with other drugs that prolong the QT interval, such as quinine and halofantrine.
While neurotoxicity has been reported in experimental animals, there is no evidence of neurotoxicity in human beings with artemisinin derivatives.
ALBETHER is usually well tolerated. However, nausea, dizziness and depressed GIT activity can occur.
Clinical, neurological, electro cardiographic and biochemical monitoring did not reveal significant toxicity. Apart from some increase in eosinophil numbers, no haematological abnormality was seen.
Dosage & Administration
ALBETHER: is for intramuscular use only.
Adult: 150 mg i.e. 1 ampoule of ALBETHER once daily for 3 consecutive days.
Children: 3 mg/kg per day administered by intramuscular injection over a 3-day period.
⦁ The injection must be given under aseptic conditions, deep intramuscularly in the upper lateral quadrant of the buttock. No other drug should be mixed in the same syringe.
Store in a cool place. Protect from light