Artemether + lumefantrine
آرتمتر + لومفانترین
🪱 Antiparasitic Products, Insecticides And RepellentsAntimalarial (artemisinin combination)
Market / country: 🇺🇸 USA
Coartem (US)
🧮 Dose calculator
Malaria (prophylaxis and treatment) · Regimen source: FDA Coartem · 2.2–2.3
- • Shown as the artemether component (20 mg per tablet). First dose, second dose after 8 h, then twice daily for the next 2 days (6 doses total). Take with food; repeat a dose vomited within 1–2 h. FDA Coartem · 2.2–2.3FDA Coartem · 2.1
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to artemether or lumefantrine. FDA Coartem · 4
- ⛔ Coadministration with strong CYP3A4 inducers (rifampin, carbamazepine, phenytoin, St John’s wort). FDA Coartem · 4
Warnings
- • QT prolongation: avoid with known long QT, hypokalaemia or hypomagnesaemia, and with QT-prolonging drugs. FDA Coartem · 5
Important interactions
- • Rifampin, carbamazepine, phenytoin and St John’s wort cause loss of efficacy (contraindicated). FDA Coartem · 4
Formulations
- Artemether 20 mg + lumefantrine 120 mg tablet (scored) — tablet 🇺🇸 USA FDA Coartem · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Coartem · 8.1
“Risk Summary Published data from clinical studies and pharmacovigilance data have not established an association with artemether/lumefantrine use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) .”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Coartem · 8.2
“Risk Summary There are no data on the presence of artemether or lumefantrine in human milk, the effects on the breastfed infant or the effects on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Coartem · 8.4
“The safety and effectiveness of Coartem Tablets have been established in pediatric patients aged 2 months and older with a bodyweight of 5 kg and above for the treatment of acute, uncomplicated malaria [see Clinical Studies (14.1)] .”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Coartem · 8.5
“Clinical studies of Coartem Tablets did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Coartem · 8.3
“Contraception Use of Coartem may reduce the efficacy of hormonal contraceptives.”
🔗 Reference links
- FDA (approval record)NDA022268
- DailyMed (FDA label)FDA Coartem
- MedlinePlus (NIH)❌ None
- WHO ATC/DDDP01BF01
- Darooyab (Iran)Artemether-Lumefantrine
🇮🇷 Not found in Iran list Darooyab · G-5343/Artemether-Lumefantrine
Darooyab lists no registered dosage form or brand for this drug. This does not prove it is unavailable.
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Coartem · 3FDA Coartem · 2.2–2.3FDA Coartem · 2.1FDA Coartem · 4FDA Coartem · 5FDA Coartem · 8.1FDA Coartem · 8.2FDA Coartem · 8.4FDA Coartem · 8.5FDA Coartem · 8.3FDA Coartem · SPL approval / marketing category
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-5343/Artemether-Lumefantrine
- Clinical review⚠ Unverified