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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)

Malaria drug resistance in Southeast Asia caused by a single mutated gene in the disease-causing parasite
Source: Genetics News From Medical News Today [2014.12.18]
Growing resistance to malaria drugs in Southeast Asia is caused by a single mutated gene inside the disease-causing Plasmodium falciparum parasite, according to a study led by David Fidock, PhD...

Research uncovers reasons for malaria's drug resistance
Source: MRSA / Drug Resistance News From Medical News Today [2014.12.17]
Scientists from Nanyang Technological University (NTU) have discovered exactly how the malaria parasite is developing resistance towards the most important front-line drugs used to treat the disease.

Analogues of a natural product are drug candidates against malaria
Source: Tropical Diseases News From Medical News Today [2014.12.12]
Malaria is one of the most serious health problems worldwide, registering 200 million clinical cases and more than 600,000 attributable deaths per year, according to information from the World...

Nanotechnology against malaria parasites
Source: Tropical Diseases News From Medical News Today [2014.12.10]
Malaria parasites invade human red blood cells, they then disrupt them and infect others.

WHO: malaria gains 'at risk' in Ebola-affected countries
Source: Tropical Diseases News From Medical News Today [2014.12.09]
WHO say malaria deaths have fallen dramatically worldwide - with more countries moving towards elimination. However, nations affected by the Ebola virus risk losing their gains.

more news >>

Published Studies Related to Coartem (Artemether / Lumefantrine)

Comparative evaluation of efficacy and safety of artesunate-lumefantrine vs. artemether-lumefantrine fixed-dose combination in the treatment of uncomplicated Plasmodium falciparum malaria. [2013]
uncomplicated Plasmodium falciparum malaria... CONCLUSION: Artesunate (100 mg)/lumefantrine (480 mg) fixed-dose combination

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.

more studies >>

Clinical Trials Related to Coartem (Artemether / Lumefantrine)

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 Coartem® are substrates for the 3A4 isoform of cytochrome P450. Despite the lack of data, antiretroviral drugs and/or antituberculous drugs in addition to Coartem® 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 Coartem® and commonly co-prescribed inducers of 3A4 i. e. nevirapine, efavirenz and rifampicin.

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

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

3. Comparison of steady state pharmacokinetics of Coartem® 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.

Artemether-lumefantrine (AL) Versus Artesunate + Amodiaquine (ASAQ) for the Treatment of Uncomplicated Falciparum Malaria in Burkina Faso [Recruiting]
Several countries in Africa have changed their first-line treatment for uncomplicated malaria to an ACT. Burkina Faso has changed its policy to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS). However, such choice has been done without knowing the local effectiveness of these drugs when they are given to patients in real life conditions, without direct observation of the drug administration. Thus, this study aims at investigating the effectiveness of AQ+AS and AL, when given to children with uncomplicated malaria in Burkina Faso.

Amodiaquine-Artesunate & Artemether-Lumefantrine Efficacy in Burkina Faso [Recruiting]
This is a two-arm study aiming at recruiting 150 patients to assess the efficacy of Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) in patients with a microscopy positive diagnosis of malaria in Nanoro, Burkina Faso and assess the performance of the Rapid Diagnosis Tests (RDTs) compared to the microscopy.

Efficacy of Artemether-lumefantrine, Artesunate-amodiaquine and Dihydroartemisinin-piperaquine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Malawi [Recruiting]
Background: Malaria is a cause of substantial morbidity and mortality in Malawi. Prompt and effective treatment of uncomplicated malaria remains a key strategy to reduce the public health burden of malaria. Due to the rising resistance to and falling efficacy of sulfadoxine-pyrimethamine, the first-line treatment of uncomplicated malaria from 1993 to 2007, the National Malaria Control Program (NMCP) revised the national treatment guidelines in 2007. The revised treatment guidelines recommend artemether-lumefantrine as the first-line treatment for uncomplicated malaria and artesunate-amodiaquine as a second-line treatment for uncomplicated malaria. The change in policy was based primarily on efficacy data from other countries in sub-Saharan Africa. However, although both artemether-lumefantrine and artesunate-amodiaquine have been in use in Malawi since 2007, there are relatively few studies assessing their efficacy. In a study conducted in 2004-2006 in Blantyre, artemether-lumefantrine was found to be efficacious. 1 In addition, a more recent assessment of artemether-lumefantrine in vivo efficacy conducted in six sites in Malawi in 2009 also suggests that the standard formulation artemether-lumefantrine remains highly efficacious (Kamija Phiri, personal communication).

Although, some Malawi-specific data on the in vivo efficacy of the standard formulation of artemether-lumefantrine exists, there are additional data that is needed to support the current policy and inform future policy decisions. In 2010 the NMCP has introduced the dispersible formulation of artemether-lumefantrine (Coartem-D™) for use as a first-line antimalarial in Malawi, due to the global unavailability of the standard formulation of artemether-lumefantrine from Novartis, the key supplier of the standard formulation of artemether-lumefantrine (Coartem™) in Malawi. In light of these developments, an assessment of the efficacy, safety and tolerability of the dispersible formulation of artemether-lumefantrine is warranted. In addition, the efficacy, safety and tolerability of co-formulated artesunate-amodiaquine, the current secondline treatment for uncomplicated malaria, has never been assessed in Malawi and should be evaluated. Lastly, dihydroartemisinin-piperaquine has recently been added to the new World Health Organization (WHO) guidelines for the treatment of uncomplicated malaria. This promising new antimalarial might have a role as a first-line or second-line antimalarial for the treatment of uncomplicated malaria, but there are no efficacy and safety data from Malawi. This knowledge gap needs to be addressed to help inform policy makers about the potential role of dihydroartemisinin-piperaquine for the treatment of uncomplicated malaria in Malawi.

Objective: Efficacy and safety of the dispersible formulation of artemether-lumefantrine, co-formulated artesunate-amodiaquine and co-formulated dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria at Machinga District Hospital- Malawi

Methods: An antimalarial drug efficacy trial will be conducted in Malawi. The participants will be febrile people 6-59 months old with confirmed uncomplicated P. falciparum infection. Patients will be sequentially allocated to receive treatment with either the dispersible formulation of artemether-lumefantrine at a dose of 2/12 mg/kg body weight of artemether and lumefantrine, respectively, per dose, given twice a day for 3 days; or co-formulated artesunate-amodiaquine at a dose of 4 mg/kg/day artesunate and 10 mg/kg/day amodiaquine once a day for 3 days; or co-formulated dihydroartemisinin-piperaquine at a dose of 4 mg/kg/day dihydroartemisinin and 18 mg/kg/day piperaquine once a day for 3 days. Clinical and parasitological parameters will be monitored over a 42-day follow-up period to evaluate drug effi¬cacy. The study will be conducted from January to December, 2011. The results of this study will be used to assist the Ministry of Health in Malawi in assessing the current national treatment guidelines for uncomplicated P. falciparum malaria.

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: 2014-12-18

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