YOUR HEALTH FIRST
YOUR HEALTH FIRST
BEETHER (a-b ARTEETHER INJECTION)
DESCRIPTION:
BEETHER (a-b Arteether) is a synthetic derivative of artemisinin, a product of Chinese plant Artemisia annua.
BEETHER (a-b Arteether) is fast acting blood schizonticide specifically indicated for the treatment of chloroquine resistant P. falciparum malaria and cerebral malaria cases
COMPOSITION :
Each 2 ml. contains
a-b Arteether..............................150 mg.
Arachis oil B.P. ............................q.s.
PHARMACOLOGY :
a-b Arteether is fast acting blood schizonticidal agent for P. falciparam Malaria at the erythrocytic stage.
Arteether is concentrated in parasitized erythroctytes. The functional group responsible for antimalarial activity of a-b Arteether is “endoperoxide bridge”.
The researchers believe that iron from the digested haemoglobin of the parasite’s victim reduces this bridge releasing a highly reactive free radical iron (IV) oxo species which rips apart the parasitic cells.
It is proposed that a-b Arteether inhibits the protein synthesis and alter the ribosomal organization and endoplasmic reticulum.
a-b Arteether also acts on the membranes of the parasites through lipid peroxidation.
PHARMACOKINETICS :
Main metabolite of a-b Arteether is Dihydroartemisinin. The half life of Dihydroartemisinin is more than 20 hours. The elimination of the drug is through hepatic metabolism and gets eliminated at a low rate as compared to other artemisinin derivatives
CLINICAL DATA :
In multicentric clinical evaluation of a-b Arteether in complicated and uncomplicated P. falciparum malaria,
A total of 267 patients of uncomplicated P. falciparum malaria, having fever with chill/rigor and 211 patients of complicated P. falciparum malaria having fever, headache, vomiting, diarrhoea, convulsions, renal impairment, severe anaemia, spleenomegaly, hypotension and coma were treated with a-b Arteether.
Most of the cases became afebrile within 36 hours without the use of antipyretic drugs and
parasite free within 72 hours. The cure rate in uncomplicated malaria was nearly 100% and in complicated P. falciparum malaria about 90%.
Recrudescence was less than 7%.
a-b Arteether is more lipophillic and has the advantage of greater accumulation in brain tissue, hence a potential drug for the treatment of cerebal malaria
a-b Arteether, also exhibits gametocytocidal action on P. falciparum which wll be an added advantage in cutting down the transmission of P. falciparum malaria.
a-b Arteether is well tolerated and compliance is very good with virtually no drug related side effects
INDICATION :
BEETHER (a-b Arteether) is indicated for use in sever P. falciparum malaria including cerebral malaria and as a second line treatment in chloroquine resistant malaria. No cross resistance detected with Chloroquine
CONTRAINDICATION :
BEETHER (a-b Arteether) is contraindicated in patients hypersensitive to artemisinin derivatives.
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DOSAGE AND ADMINISTRATION :
BEETHER (a-b Arteether) Injection is for INTRAMUSCULAR USE ONLY.
Adult : 150 mg i.e. 1 ampoule of BEETHER(a-b Arteether) once daily for 3 consecutive days or as directed by the physician.
Children : 3 mg/kg per day administered by intramuscular injection over a 3 day period or as directed by the physician.
The injection must be given in aseptic conditions, deep intramuscularly in the upper-external quadrant of the buttock.
No other drug should be mixed in the same syringe.
OVERDOSE :
The pre-clinical studies of a-b Arteether have shown that LD50 value is more than 1000 mg/kg, whereas the maximum dose injected in adult is about 2.5 mg/kg. per day. This confirms that the safety window for the dose administered is very wide. Hence this study conludes that a-b Arteether is well tolerated even when overdose is administered.
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PRECAUTIONS :
Pregnancy :
Since no clinical data is available for the use of a-b Arteether during pregnancy, it should be used with caution in pregnant women, if the potential benefits justify the potential risk to the foetus.
Nursing Mother :
It is not known whether a-b Arteether is excreted in human milk, because many drugs are excreted in human milk, a caution should be exercised while using a-b Arteether
DRUG INTERACTIONS :
BEETHER (a-b Arteether) does not interfere with the action of other commonly used drugs for treatment of P. falciparum malaria, eg., Quinine and can be administered along with these drugs for the treatment of severe form of malaria.
(Except for other Artemisinin Derative like Artesunate and Artemether)
ADVERSE EFFECTS
Neurotoxicity is the common side effect associated with all artemisinin compounds in high doses.
Neurotoxicity in manifests as gait disturbances, loss of spinal cord pain responses, incoordination, respiratory depression, convulsions and cardio respiratory arrest.
Other side effects are nausea, dizziness and depressed GIT activity. Clinical, neurological, electrocardiographic and biochemical abnormality were seen.
In the multi centric trails of a-b Arteether involving 478 patients suffering from P.falciparum malaria, no significant side effects were observed.
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STORAGE:
Store below 25 C. Protect From Light.
PRESENTATION: 3 X 2 ml. ampoules.
Manufactured By :
Makcur Laboratories Limited
46/4-7, Village : Zak, Tal : Dehgam
Dist : Gandhinager – 30
GUJARAT. INDIA
Manufactured for :
(A Division of Schwitz Biotech)
C/101, Satya Appartments, Near Sai Baba Temple, Ghatlodia,
AHMEDABAD - 61, GUJARAT, INDIA.
Marketed by :
142 Okporo Road, Port Harcourt,
Rivers State, NIGERIA
KINGZY PHARMACEUTICALS LTD.