Johns Hopkins POC-IT: Point of Care Information Technology [Home]
HIV Guide
 Zambia HIV National Guidelines
 


Introduction  

HIV Counseling and Testing  

Sexually Transmitted Infections (STIs)  

General Principles of Antiretroviral Therapy for Chronic HIV Infection in Adults and Adolescents  

When to Start ARV Therapy for Chronic HIV Infection in Adults and Adolescents  

Initial Regimen for ARV Therapy  

Adherence  

Baseline evaluation and Monitoring  

Calculations: Ideal Body Weight, Body Mass Index and Creatinine Clearance  

ARV Therapy for Individuals with Tuberculosis Co-Infection  

Adverse Effects and Toxicity  

Immune Reconstitution Inflammatory Syndrome (IRIS)  

Changing or Stopping ART  

Treatment Failure  

Stopping ARV Therapy  

Post Exposure Prophylaxis  

Cotrimoxazole Prophylaxis  

WHO Staging in Adults and Adolescents  

Nutrition Care and Support  

Palliative Care in HIV and AIDS  

 Guide Editors
 Editor In Chief
    Joel E. Gallant, MD, MPH

Pharmacology Editor
    Paul Pham, PharmD, BCPS

Zambia Guideline Team
   Peter Mwaba MMed PhD FRCP
   Alywn Mwinga MMed
   Isaac Zulu MMed MPH
   Velepie Mtonga MMed
   Albert Mwango MBChB
   Jabbin Mulwanda MMed FCS
 

 

 

Drugs>Antimicrobial Agents>
HIV Guide Home PageEmail this module to a friend

Artemether/Lumefantrine

Alice M. Jenh, Pharm.D. and Paul A. Pham Pharm.D.
05-18-2011

Zambia Specific Information

  • Available formulations in Zambia: oral tablet: 20 mg artemether/120 mg lumefantrine (adult formulation); 10 mg artemether/60 mg lumefantrine(pediatric formulation)
  • Preferred treatment for uncomplicated P. falciparum malaria.
  • LPV/r increased lumefantrine AUC by 193%, but co-administration was well tolerated.
  • Artemether serum concentrations may also be increased with PI co-administration.
  • Rifampicin, EFV, and NVP may decrease artemether and lumefantrine serum concentrations. Monitor closely for anti-malarial activity with co-administration. Artemether with lumefantrine may need to be increased.
  • Should be administered with food containing at least 1.3 g of fat.
Zambia Information Author: Alice M. Jenh, Pharm.D. and Paul A. Pham Pharm.D.

INDICATIONS

FDA

  • Falciparum malaria, uncomplicated disease in geographic areas of known chloroquine resistance.
  • Not approved for patients with severe or complicated P. falciparum malaria.
  • Not approved for the prevention of malaria.
NON-FDA APPROVED USES

  • No data in complicated falciparum malaria
  • Vivax malaria: Limited efficacy observed in one Thai study: rapid parasite clearance observed with 4-dose regimen, relapse was common, suggesting minimal activity against the hypnozoite stage of P. vivax (Karbwang et al, 2000).

FORMS

brand 
name
 
generic 
Mfg 
brand 
forms
 
cost* 
Coartem artemether / lumefantrine Novartis Pharmaceuticals Corp. Oral
tab
20 mg (artemether)/120 mg (lumefantrine)
$3.63

*Prices represent cost per unit specified and are representative of "Average Wholesale Price" (AWP). AWP Prices were obtained and gathered by Lakshmi Vasist Pharm D using the Red Book, manufacturer's information, and the McKesson database.

^Dosage is indicated in mg unless otherwise noted.

USUAL ADULT DOSING

  • Fixed-dose 20mg artemether/120mg lumefantrine tablet formulation: 4-dose regimen over 48 hours is now considered inferior; 6-dose regimen over 3 or 5 days is superior and recommended (van Vugt et al, 1999).
  • Uncomplicated Falciparum malaria; adults (>35 kg): 6-dose regimen over 3 days (4 tablets/dose at 0, 8, 24, 36, 48, and 60 hours)
  • Weight-based dosing: artemether-lumefantrine 1 tab stat, then 8 hours later, followed by 1 tab bid x 2 days (total course=6 tabs for 5kg to <15kg); Artemether-lumefantrine 2 tab stat, then 8 hours later, followed by 2 tab bid x 2 days (total course=12 tabs for 15 kg to <25kg); Artemether-lumefantrine 3 tab stat, then 8 hours later, followed by 3 tab bid x 2 days (total course=18 tabs for 25 kg to <35kg); Artemether-lumefantrine 4 tab stat, then 8 hours later, followed by 4 tab bid x 2 days (total course=24 tabs for 35kg to <65kg); >65kg limited experience, but consider Artemether-lumefantrine 4 tab stat, then 8 hours later, followed by 4 tab bid x 2 days with close monitoring
  • Should be administered with food containing at least 1.3 g of fat.
  • Tablet may be crushed and disolved in 5-10ml of water.

RENAL DOSING

DOSING FOR GLOMERULAR FILTRATION OF 50-80

Usual dose

DOSING FOR GLOMERULAR FILTRATION OF 10-50

Limited data. Usual dose likely.

DOSING FOR GLOMERULAR FILTRATION OF <10 ML/MIN

Limited data . Usual dose likely.

DOSING IN HEMODIALYSIS

No data. On days of dialysis, dose post-HD.

DOSING IN PERITONEAL DIALYSIS

No data.

DOSING IN HEMOFILTRATION

No data. Not recommended in the treatment of severe malaria.

ADVERSE DRUG REACTIONS

GENERAL

  • Generally well tolerated with only 1.1% discontinuation ratedue to adverse drug reactions.
OCCASIONAL

  • Rash, pruritis
  • Nausea and vomiting (generally within 1 hour of 1st dose), abdominal pain, anorexia, and diarrhea
  • Anemia
  • Myalgias
  • Dizziness, headache, asthenia, insomnia
  • Cough
RARE

  • Hemolytic anemia
  • Increased QTc interval (maximum mean change 7.5 msec), modest ST-elevations. Avoid in patients with baseline QTc prolongation.
  • Nystagmus, abnormal gait, paresthesias, tremor

DRUG INTERACTIONS

Both artemether and lumefantrine are CYP450 3A4 substrates. Inhibitors and inducers of CYP3A4 may affect artemether's and lumefantrine's serum concentrations. Artemether may induce CYP3A4/5. CYP2D6 may be inhibited.

  • Aurothioglucose: Increased risk of blood dyscrasias. Avoid aurothioglucose co-administration.
  • Halofantrine: may increase risk of QTc prolongation. Avoid halofantrine co-administration.
  • Manufacturer recommends against the co-administration of artemether/lumefantrine with the following drugs that may prolong QTc: antiarrhythmics, such as amiodarone, disopyramide, flecainide, procainamide, sotalol, and quinidine; antibacterials, such as macrolides and quinolones; antidepressants (imipramine, amitriptyline, clomipramine); antifungals such as imidazoles and triazoles; terfenadine; other antimalarials; antipsychotic drugs (droperidol, pimozide and ziprasidone); . However, there is no evidence that co-administration with these drugs would be harmful. (WHO guidelines for the treatment of malaria. 2006.)
  • Rifampicin, efavirenz,,nevirapine, phenobarbital, phenytoin, and carbamazepine, may decrease artemether and lumefantrine serum concentrations. Monitor closely for anti-malarial activity with co-administration.
  • HIV-protease inhibitors may increase artemether and lumefantrine serum concentrations. Consider EKG monitoring for QTc prolongation.
  • Grapefruit juice: may increase artemether and lumefantrine serum concentrations. Avoid
  • Oral contraceptive: may reduce the effectiveness of hormonal contraceptives. Use an additional barrier form of contraception.

SPECTRUM

  • Plasmodium falciparum (Chloroquine-resistant)
  • Plasmodium vivax (requires additional treatment with other antimalarial agents to eradicate hypnozoites forms that may remain dormant in the liver)

PHARMACOLOGY

Pharmacology

COMMENTS

  • Artemisinin-based combination therapy (ACT) is currently the WHO recommended treatment of choice for the treatment of uncomplicated falciparum malaria: based on the level of resistance, in Africa, artemether-lumefantrine and artesunate + amodiaquine are the ACTs of choice; Amodiaquine + sulfadoxine-pyrimethamine may be considered as an interim option in situations where ACTs cannot be made available. Fixed artemether/lumefantrine is not indicated in the treatment of complicated falciparum malaria or Plasmodium vivax malaria.

REFERENCES


 
Diagnosis
 


Complications of Therapy


Malignancies


Miscellaneous


Opportunistic Infections


Organ System

Drugs
 


Antimicrobial Agents


Antiretrovirals


Miscellaneous

Guidelines
 


Zambia HIV National Guidelines

Management
 


Antiretroviral Therapy


Laboratory Testing


Miscellaneous

Pathogens
 


Bacteria


Fungi


Parasites


Viruses

View All Modules
 
Index
 
 
Contacts    Help    Copyright    Acknowledgments    Abbreviations