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Coartem (Artemether / Lumefantrine) - Summary

 
 



COARTEM SUMMARY

Coartem Tablets contain a fixed combination of two antimalarial active ingredients, artemether, an artemisinin derivative, and lumefantrine. Both components are blood schizontocides.

COARTEM (ARTEMETHER/LUMEFANTRINE) is indicated for the following:

  • Coartem (artemether and lumefantrine) Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum in patients of 5 kg bodyweight and above.
  • Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported.
  • Coartem Tablets should not be used to treat severe malaria or to prevent malaria.

  • See all Coartem indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Coartem (Artemether / Lumefantrine)

Discovery of a weakness in malaria parasite fats could lead to new treatments
Source: Tropical Diseases News From Medical News Today [2014.09.12]
A new study has revealed a weak spot in the complex life cycle of malaria, which could be exploited to prevent the spread of the deadly disease.

DNA region controlling red blood cell invasion holds genetic key to malaria in chimpanzees
Source: Genetics News From Medical News Today [2014.09.11]
A genetic region responsible for red blood cell invasion was among a small number of areas found to differ between the genomes of malaria parasites that affect chimpanzees and Plasmodium falciparum...

Malaria parasites sense and react to mosquito presence to increase transmission
Source: Infectious Diseases / Bacteria / Viruses News From Medical News Today [2014.09.11]
Many pathogens are transmitted by insect bites. The abundance of vectors (as the transmitting insects are called) depends on seasonal and other environmental fluctuations.

When distributing bed nets from clinics in malaria endemic regions, pregnant women should be prioritized
Source: Pregnancy / Obstetrics News From Medical News Today [2014.09.11]
Donors, Ministries of Health, implementing agencies, and other partners should prioritise providing pregnant women in malaria endemic regions with long-lasting insecticide treated nets (LLINs)...

Why humans don't suffer from chimpanzee malaria: DNA region controlling red blood cell invasion holds genetic key to infection
Source: Genetics News From Medical News Today [2014.09.09]
The DNA region controlling red-blood-cell invasion holds the genetic key to human malaria infection, according to new research.

more news >>

Published Studies Related to Coartem (Artemether / Lumefantrine)

Intermittent preventive therapy for malaria with monthly artemether-lumefantrine for the post-discharge management of severe anaemia in children aged 4-59 months in southern Malawi: a multicentre, randomised, placebo-controlled trial. [2012]
reduced this risk... INTERPRETATION: In areas with intense malaria transmission, chemoprevention with

The impact of retail-sector delivery of artemether-lumefantrine on malaria treatment of children under five in Kenya: a cluster randomized controlled trial. [2011.05]
CONCLUSIONS: Subsidizing ACT in the retail sector can significantly increase ACT coverage for reported fevers in rural areas. Further research is needed on the impact and cost-effectiveness of such subsidy programmes at a national scale. TRIAL REGISTRATION: Current Controlled Trials ISRCTN59275137 and Kenya Pharmacy and Poisons Board Ethical Committee for Clinical Trials PPB/ECCT/08/07.

Therapeutic efficacy and effects of artemether-lumefantrine and artesunate-amodiaquine coformulated or copackaged on malaria-associated anemia in children with uncomplicated Plasmodium falciparum malaria in Southwest Nigeria. [2011.05]
The therapeutic efficacy and effects of artemether-lumefantrine (AL) and artesunate-amodiaquine co-formulated (AAcf) or co-packaged (AAcp) on malaria-associated anemia (MAA) were evaluated in 285 children < 12 years of age with uncomplicated Plasmodium falciparum malaria randomized to receive one of the three drug combinations...

Efficacy and effectiveness of artemether-lumefantrine after initial and repeated treatment in children <5 years of age with acute uncomplicated Plasmodium falciparum malaria in rural Tanzania: a randomized trial. [2011.04.01]
BACKGROUND: We assessed the efficacy, effectiveness and safety of artemether-lumefantrine, which is the most widely used artemisinin-based combination therapy in Africa, against Plasmodium falciparum malaria during an extended follow-up period after initial and repeated treatment... CONCLUSIONS: Artemether-lumefantrine was highly efficacious even after unsupervised administration, despite significantly lower lumefantrine concentrations, compared with concentration achieved with supervised intake, and was well-tolerated and safe after initial and repeated treatment. CLINICAL TRIAL REGISTRATION: ISRCTN69189899. (c) The Author 2011. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved.

Artesunate/mefloquine paediatric formulation vs. artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum in Anonkoua koute, Cote d'Ivoire. [2011.03]
OBJECTIVES: To test the hypothesis that Artesunate-mefloquine paediatric (AS+MEF) is as effective as Artemether-lumefantrine (AL) in treating acute uncomplicated malaria in children... CONCLUSION: AS+MEF is as effective as AL, and both combinations were efficacious and safe. (c) 2011 Blackwell Publishing Ltd.

more studies >>

Clinical Trials Related to Coartem (Artemether / Lumefantrine)

Surveillance of Effectiveness/Safety of Artemether-lumefantrine in Patients With Malaria [Recruiting]
The purpose of this study is to describe the pediatric and adult patients (U. S. and foreign residents) diagnosed with malaria and treated with artemether-lumefantrine with regard to their demographics, including evaluation of their malaria immune status, treatment effectiveness, prior and concomitant medication use, and the occurrence of adverse events in association with artemether-lumefantrine treatment, based on the information collected in the CDC Malaria Case Surveillance Report Form.

Drug Interaction Between Coartem® and Nevirapine, Efavirenz or Rifampicin in HIV Positive Ugandan Patients [Recruiting]
There are increasing numbers of HIV-infected patients in sub-Saharan Africa receiving antiretroviral drugs and/or rifampicin based antituberculous therapy. HIV infected patients are at an increased risk of contracting malaria. Increasing resistance to anti-malarials such as chloroquine, amodiaquine, fansidar, sulphadoxine-pyrimethamine in East and West Africa has led the WHO to recommend artemether-lumefantrine (Coartem®- Novartis) as first line therapy for malaria for adults and children. As early as 2004, fourteen countries in sub-Saharan Africa had adopted this guideline as national policy.

There are no data on the interaction between Coartem® and any of the antiretroviral agents. Both components of CoartemĀ® are substrates for the 3A4 isoform of cytochrome P450. Despite the lack of data, antiretroviral drugs and/or antituberculous drugs in addition to CoartemĀ® are of necessity co-prescribed daily in the African setting. Nevirapine, efavirenz and rifampicin are known inducers of cytochrome P450 3A4. A technical consultation convened by WHO in June, 2004 concluded that additional research on interactions between antiretroviral and antimalarial drugs is urgently needed.

We propose to perform a suite of pharmacokinetic studies to evaluate these interactions in HIV infected Ugandan patients. The aim of these studies is to evaluate the pharmacokinetic interaction between CoartemĀ® and commonly co-prescribed inducers of 3A4 i. e. nevirapine, efavirenz and rifampicin.

1. Comparison of steady state pharmacokinetics of CoartemĀ® in HIV-infected patients prior to commencement of nevirapine and at nevirapine steady state

2. Comparison of steady state pharmacokinetics of CoartemĀ® in HIV-infected patients prior to commencement of efavirenz and at efavirenz steady state

3. Comparison of steady state pharmacokinetics of CoartemĀ® in Ugandan patients at rifampicin steady state and without rifampicin

Trial of Artemether-Lumefantrine Alone and in Combination With Ivermectin to Reduce Post-Treatment Malaria Transmission [Recruiting]
The purpose of this study is to determine the safety and impact of ivermectin, administered as single or repeated dose, in combination with artemether-lumefantrine in reducing the proportion of mosquitoes that survive and become infected after feeding on a blood meal from a malaria-infected individual.

Studies of a Candidate Aminoquinoline Antimalarial (AQ-13) [Not yet recruiting]
This is an initial efficacy study of a candidate antimalarial in human subjects with uncomplicated malaria caused by the most common and most important parasite in Africa (Plasmodium falciparum). This study will enroll 66 adult Malian males with uncomplicated P. falciparum malaria and randomize them to treatment with 1750 mg of the investigational drug (AQ-13) by mouth over 3 days or the current standard treatment, which is 4 tablets of Coartem twice daily for 3 days. The hypothesis underlying this study is that AQ-13 will be similarly effective to Coartem for the treatment of uncomplicated P. falciparum malaria due to both chloroquine-susceptible and chloroquine-resistant parasites.

more trials >>

Reports of Suspected Coartem (Artemether / Lumefantrine) Side Effects

Wrong Drug Administered (5)Acute Respiratory Distress Syndrome (5)Acidosis (3)Malaria (3)Drug Ineffective (2)Thrombocytopenia (2)Condition Aggravated (2)Blood Bilirubin Increased (1)Abortion Spontaneous (1)Protein Total Increased (1)more >>


Page last updated: 2014-09-12

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