Pregnancy and lactation. Avoid concomitant use of drugs known to prolong QT interval or monitor such patients.
Lactation: not known if either component enters breast milk, use caution
FDA has not yet classified the drug into a specified pregnancy category.
Mode of Action
Artemether is a potent and rapidly acting blood schizontocide. Artemether and active metabolite (DHA): via endoperoxide.
Lumefantrine: unknown; possibly inhibits beta-hematin formation
Both artemether and lumentantrine inhibit nucleic acid and protein synthesis
Interaction
Artemether causes QT prolongation in some patients. Thus concomitant use of erythromycin, terfenadine, procainamide, quinidine, disopyramide, amiodarone, bretylium, bepridil, sotalol, astemizole, probucol, tricyclic antidepressants, phenothiazines may be avoided.
Pregnancy Category Note
Pregnancy
Published data from clinical studies and pharmacovigilance data have not established an association between drug use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes
Malaria during and after pregnancy increases risk for adverse pregnancy and neonatal outcomes, including maternal anemia, severe malaria, spontaneous abortion, stillbirths, preterm delivery, low birth weight, intrauterine growth restriction, congenital malaria, and maternal and neonatal mortality
Contraception
May reduce efficacy of hormonal contraceptives; advise patients using hormonal contraceptives to use an alternative non-hormonal contraceptive method or add a barrier method of contraception during treatment
Infertility
In animal fertility studies, administration of repeated doses to female rats (for 2 to 4 weeks) resulted in pregnancy rates that were reduced by one half
Male rats dosed for approximately 3 months, abnormal sperm cells, showed decreased sperm motility, and increased testes weight
Lactation
There are no data on presence of drug in human milk, effects on breastfed infant or on milk production; drug components are transferred into rat milk; when a drug is transferred into animal milk, it is likely that the drug will also be transferred into human milk
The developmental and health benefits of breastfeeding should be considered along with the mother?s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
Adult Dose
Oral
Adults (weighing 35 kg and above): Administer 24 tablets over 3 days; use a 3-day treatment schedule with total of 6 doses.
Day 1: 4 tablets initially and 4 tablets again after 8 hours.
Days 2 & 3: 4 tablets BID (morning & evening).
Child Dose
Oral
Children (weighing 35 kg and above or more than 12 years of age): Administer 24 tablets over 3 days; use a 3-day treatment schedule with total of 6 doses.
Day 1: 4 tablets initially and 4 tablets again after 8 hours.
Days 2 & 3: 4 tablets BID (morning & evening).
Children: < 12 years
5 to <15 kg: Administer 6 tablets over 3 days; 1 tablet initially and again after 8 hours on first day; follow by 1 tablet BID (morning & evening) for the next 2 days.
15 to <25 kg: Administer 12 tablets over 3 days; 2 tablets initially and again after 8 hours on first day; follow by 2 tablets BID (morning & evening) for the next 2 days.
25 to <35 kg: Administer 18 tablets over 3 days; 3 tablets initially and again after 8 hr on 1st day; follow by 3 tablets BID (morning & evening) for the next 2 days.
Renal Dose
N/A
Administration
Should be taken with food.
Disclaimer
The information provided herein are for informational purposes only and not intended to be a substitute for professional medical advice, diagnosis, or treatment. Please note that this information should not be treated as a replacement for physical medical consultation or advice. Great effort has been placed to provide accurate and comprehensive data. However, Medicart along with its authors and editors make no representations or warranties and specifically disclaim all liability for any medical information provided on the site. The absence of any information and/or warning to any drug shall not be considered and assumed as an implied assurance of the Company.