Artemether 80 mg Injection
- Product Name: Artemether 80 mg Injection
- Available Strength: 80 mg per 1 mL (typical); clear, oily solution in glass ampoule
- Packing: 10x1ml Amp
- Pack Insert/Leaflet: Yes
- Dosage Form: 80 mg per 1 mL (typical); clear, oily solution in glass ampoule
- Excipients (Typical): 80 mg per 1 mL (typical); clear, oily solution in glass ampoule
- Packaging: Cartons of 5 or 10 ampoules; disposable syringes/needles per market pack
- Self Life Storage: Store below 30 °C, protect from light, do not freeze
- Therapeutic Category: Parenteral antimalarial (artemisinin derivative) for severe malaria when IV access/IV artesunate is not immediately available
Artemether 80 mg Injection is a higher-strength IM presentation used for emergency treatment of severe or complicated malaria (primarily P. falciparum). The 80 mg strength reduces the number of ampoules per dose compared with 40 mg, aiding faster preparation in urgent care. Where available, IV artesunate remains preferred; artemether IM is an effective alternative or bridge until IV therapy or oral ACT can be given.
Active Ingredient: Artemether
Class: Artemisinin derivative (prodrug)
Mechanism of Action: Rapid conversion to dihydroartemisinin (DHA); activation of the endoperoxide bridge generates reactive species that alkylate essential parasite proteins, rapidly killing blood-stage parasites (including early ring stages).
Onset of Action: Rapid clinical and parasitological response (often within hours)
Half-life: Artemether ~1–3 h; DHA slightly longer
Resistance Considerations: Active against multidrug-resistant P. falciparum; always complete therapy with oral ACT to prevent recrudescence
Class: Artemisinin derivative (prodrug)
Mechanism of Action: Rapid conversion to dihydroartemisinin (DHA); activation of the endoperoxide bridge generates reactive species that alkylate essential parasite proteins, rapidly killing blood-stage parasites (including early ring stages).
Onset of Action: Rapid clinical and parasitological response (often within hours)
Half-life: Artemether ~1–3 h; DHA slightly longer
Resistance Considerations: Active against multidrug-resistant P. falciparum; always complete therapy with oral ACT to prevent recrudescence
Severe/complicated malaria (e.g., cerebral malaria, shock, acidosis, organ dysfunction) when IV therapy is unavailable or delayed
Initial parenteral management in field/transport settings without reliable IV access, followed by step-down to oral ACT when stable
Initial parenteral management in field/transport settings without reliable IV access, followed by step-down to oral ACT when stable
Standard IM Artemether Regimen (severe malaria):
Loading: 3.2 mg/kg IM at 0 hour
Maintenance: 1.6 mg/kg IM once daily at 24, 48, and 72 hours (total 5 doses over 4 days)
Transition: As soon as the patient can take oral medicines and is clinically stable, switch to a full course of oral ACT (e.g., artemether–lumefantrine) to complete treatment.
Administration Notes
Inject deep IM (anterolateral thigh for small children; ventrogluteal/gluteal for older children/adults).
Do not administer IV.
Use aseptic technique; warm ampoule in hand if solution is very viscous.
Avoid dividing a single calculated dose into many small injections unless necessary for volume tolerance.
Loading: 3.2 mg/kg IM at 0 hour
Maintenance: 1.6 mg/kg IM once daily at 24, 48, and 72 hours (total 5 doses over 4 days)
Transition: As soon as the patient can take oral medicines and is clinically stable, switch to a full course of oral ACT (e.g., artemether–lumefantrine) to complete treatment.
Administration Notes
Inject deep IM (anterolateral thigh for small children; ventrogluteal/gluteal for older children/adults).
Do not administer IV.
Use aseptic technique; warm ampoule in hand if solution is very viscous.
Avoid dividing a single calculated dose into many small injections unless necessary for volume tolerance.
Preferred therapy: Use IV artesunate where available; IM artemether is an alternative/bridge.
Oil vehicle sensitivity: Review history of sesame/peanut/soy allergy depending on vehicle.
Hepatic/Renal impairment: Use with caution; monitor clinically and with labs as feasible.
Hemolysis monitoring: Consider post-treatment hemoglobin checks if symptomatic (fatigue, jaundice, dark urine).
Pregnancy: Parenteral artemisinin derivatives are indicated for severe malaria; follow national/WHO guidance.
Drug interactions: Few clinically significant parenteral interactions; reassess concomitant meds when stepping down to oral combinations.
Oil vehicle sensitivity: Review history of sesame/peanut/soy allergy depending on vehicle.
Hepatic/Renal impairment: Use with caution; monitor clinically and with labs as feasible.
Hemolysis monitoring: Consider post-treatment hemoglobin checks if symptomatic (fatigue, jaundice, dark urine).
Pregnancy: Parenteral artemisinin derivatives are indicated for severe malaria; follow national/WHO guidance.
Drug interactions: Few clinically significant parenteral interactions; reassess concomitant meds when stepping down to oral combinations.
Artemether Injection 80 mg/mL
Common: Injection-site pain/tenderness, headache, dizziness, nausea/vomiting, transient fever
Less common: Mild, transient liver enzyme elevations
Rare/serious: Hypersensitivity (including to oil vehicle), neurotoxicity (very rare at therapeutic doses), severe hemolysis (rare)
Less common: Mild, transient liver enzyme elevations
Rare/serious: Hypersensitivity (including to oil vehicle), neurotoxicity (very rare at therapeutic doses), severe hemolysis (rare)
Specifications: Meets pharmacopeial/market authorization requirements (assay, related substances, sterility, endotoxin, particulate matter, fill volume, container integrity).
Stability: Protect from light; maintain labeled storage to preserve potency.
Stability: Protect from light; maintain labeled storage to preserve potency.
Rapid-acting IM antimalarial useful when IV access or IV artesunate isn’t immediately available.
Higher strength (80 mg) reduces ampoule count per dose vs. 40 mg, expediting preparation.
Standard regimen: 3.2 mg/kg once, then 1.6 mg/kg daily × 4; always complete with oral ACT once feasible.
Screen for oil-vehicle allergies; administer deep IM only.
Higher strength (80 mg) reduces ampoule count per dose vs. 40 mg, expediting preparation.
Standard regimen: 3.2 mg/kg once, then 1.6 mg/kg daily × 4; always complete with oral ACT once feasible.
Screen for oil-vehicle allergies; administer deep IM only.