In the pharmaceutical industry, Artemether is a lipid-soluble methyl ether derivative of Artemisinin. As a pharmacist and manufacturer, I classify this as a medication that is generally considered compatible with breastfeeding, particularly because it is the frontline treatment for life-threatening malaria where the benefit to the mother significantly outweighs the theoretical risk to the infant.
At your WHO-GMP facility in Mumbai, you likely manufacture this in combination with Lumefantrine, which is the global gold standard for Artemisinin-based Combination Therapy (ACT).
Safety Profile & Clinical Evidence
| Factor | Clinical Data | Safety Impact |
| Transfer to Milk | Very Low: Only minute amounts are excreted into breast milk due to its rapid metabolism. | The amount the infant receives is far below a therapeutic dose. |
| Infant Absorption | Limited: Artemether has low oral bioavailability in infants when consumed via milk. | Minimal risk of systemic toxicity in the nursing baby. |
| Infant Side Effects | None Reported: No adverse events have been documented in infants whose mothers were treated with ACTs. | High clinical safety margin. |
Mechanism: Why It Is Considered Safe
Artemether’s pharmacokinetics and molecular behavior explain its safety profile during lactation:
Short Half-Life: Artemether and its active metabolite, Dihydroartemisinin (DHA), have very short half-lives (approximately 2–3 hours). This means the drug is cleared from the mother’s system rapidly, leaving little time for significant accumulation in breast milk.
Lipophilic Nature: While its lipophilicity might suggest milk transfer, its rapid conversion into more polar metabolites and high plasma clearance minimize the total “drug load” available to the mammary glands.
The WHO Position: The World Health Organization (WHO) states that breastfeeding should not be discontinued during ACT treatment because the risk of malaria to the mother is a greater threat to the infant’s well-being than the trace amounts of drug in the milk.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai, here is how to position this for your digital platforms and marketplace:
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The FDC Advantage: On your marketplace, emphasize the Artemether 80 mg + Lumefantrine 480 mg combination. Highlighting that your facility follows WHO-PQ (Prequalification) standards is a major USP for international NGO buyers (like the Global Fund).
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Stability in Tropical Zones: Artemether is sensitive to heat and moisture. At our facility, we utilize Alu-Alu blister packaging to ensure a 24 to 36-month shelf life, which is essential for export to Zone IVb (Sub-Saharan Africa and SE Asia).
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Clinical Transparency: In your Product Information Leaflet (PIL), advise that while safe, the infant should be monitored for rare signs like jaundice or diarrhea. This professional caution builds immense trust with Ministry of Health buyers.
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Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in malaria-endemic regions, ensuring your export business remains regulatory-compliant.