Emal Injection: Uses, Indication, Dosage, Composition, Side Effects & Price. .Alpha beta injection: uses, mechanism of action, side effects.
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E MAL
a-B Arteether Injection 150mg/2ml
DESCRIPTION:
E MAL (a-B Arteether) is a synthetic derivative of artemisinin, a product of Chinese plant ARTEMISIA ANNUA.
E MAL (a-B Arteether) is a fast acting blood schizonticide specifically indicated for the treatment of chloroquine resistant p.falciparum malaria and cerebral malaria cases.
E MAL (a-B Arteether) is developed by Central Drug Research Institute (C.D.R.I), Lucknow, and Themis Medicare Limited after extensive preclinical, clinical and toxicological studies.
COMPOSITION:
Each 2ml contains:
a-B Arteether….. 150mg
PHARMACOLOGY:
a-B Arteether is a fast acting blood schizonticidal agent for p.falciparum Malaria at the erythrocytic stage. Arteether is concentrated in parasitized erthrocytes. The functional group responsible for antimalarial activity of a-B Arteether is “endoperoxide bridge”. The researchers believe that iron from the digested heamoglobin of the parasite’s victim reduces this bridge releasing a highly reactive free radical iron (IV) oxo species which rips apart the parasitic cells.
Credit: Marvicani
It is proposed that a-B Arteether inhibits the protein synthesis and alter the ribosomal organisation and endoplasmic reticulum. Alpha-Beta 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 with complicated p.falciparum malaria having fever, headache, vomiting, diarrhoea, convulsions, renal impairment, severe anaemia, splenomegaly, 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 lipophilic and has the advantage of greater accumulation in brain tissue, hence a potential drug for the treatment of cerebral malaria.
a-B Arteether, also exhibit gametocytocidal action on p.falciparum malaria.
a-B Arteether is well tolerated and compliance is very good with virtually no drug related side effects.
INDICATIONS:
E MAL (a-B Arteether) is indicated for use in severe p.falciparum malaria including cerebral malaria and as a second line treatment in chloroquine resistant malaria. No cross resistance detected with chloroquine.
CONTRA-INDICATION:
E MAL (a-B Arteether) is contraindicated in patients hypersensitive to artemisinin derivatives. They manifest as wheals, urticaria or difficulty with breathing from laryngeal oedema
DOSAGE AND ADMINISTRATION:
E MAL (a-B Arteether) injection is for INTRAMUSCULAR USE ONLY.
Adult: Emal Injection dosage for adults
150mg i.e. 1 ampoule of EMAL (a-B Arteether) once daily for 3 consecutive days or as directed by the physician.
Children:Emal Injection dosage for pediatrics
3mg/kg per day administrated by intramuscular injection over a 3 day period or as directed by the physician..
E Mal Injection IV or IM
NOT IV. The injection must be given in aseptic conditions, deep intramuscularly (IM) 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 1000mg/kg, whereas the maximum dose injected in adult is about 2.5mg/kg.per day. This confirms that the safety window for the dose administrated is very wide. Hence this study concludes that a-B Arteether is well tolerated even when overdose is administrated.
PRECAUTIONS:
Emal injection in 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 outweighs the potential risk to the foetus. It is safe in pregnancy.
Nursing Mother:
It is not known whether a-B Arteether is excreted in human milk, because many drugs are excreted in human milk, caution should be exercised while using a-B Arteether.
DRUG INTERACTIONS
E MAL (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 administrated along with these drugs for the treatment of severe form of malaria. (Except for other Artemisinin Derative like Artesunate and Arteether)
ADVERSE EFFECTS:
Neurotoxicity is the common side effect associated with all Artemisinin compounds in high does.
Neurotoxicity 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, electro-cardiographic and biochemical abnormality were seen.
In the multi centric trials of E MAL (a-B Arteether) involving 478 patients suffering from p.falciparum malaria, no significant side effects were observed.
STORAGE:
Store below 30°C. Protect from light.
Keep all medicines out of the reach of children.
PRESENTATION:
3x2ml ampoules.
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