📋 Indications & Clinical Dosage
*Treatment of acute uncomplicated falciparum malaria, Treatment of chloroquine-resistant non-falciparum malaria:*
Adults: Cap/Tab 20/120 mg: 4 tab as single first dose followed by 4 tabs after 8 hr of the 1st dose, 4 tab after 24 hr of the 1st dose and then 48 hr after the 1st dose. (Total course is 16 tabs).
Cap/Tab 40/240 mg: 2 tab as single first dose followed by 2 tabs after 8 hr of the 1st dose, 2 tabs after 24 hr of the 1st dose and then 48 hr after the 1st dose. (Total course is 8 tabs).
Cap/Tab 80/480 mg: 1 tab as single first dose followed by 1 tab after 8 hr of the 1st dose, 1 tab after 24 hr of the 1st dose and then 48 hr after the 1st dose. (Total course is 4 tabs).
Children: Cap/Tab 20/120 mg: 5-15 kg body weight: Total course of 4 tab: 1 tab initially followed by 1 tab after 8 hr, after 24 hr and after 48 hr of the 1st dose; 15-25 kg body weight: Total course is 8 tab 2 tab as a single dose initially followed by dose of 2 tab after 8 hr, after 24 hr and after 48 fir of the 1st dose; 25-35 kg body weight: Total course of 12 tab 3 tabs as a single dose initially followed by dose of 3 tabs after 8 hr, after 24 hr and after 48 hr of the 1st dose.
Children: Susp: 5-15 kg body wt: Total course of 80 mg (Artemether) & 480 mg (Lumefantrine): 20 mg & 120 mg initially followed by 20 mg & 120 mg after 8 hr, after 24 hr and after 48 hr of the 1st dose. 15-25 kg body wt: Total course of 160 mg & 960 mg: 40 mg & 240 mg as a single dose initially followed by dose of 40 mg & 240 mg after 8 hr, after 24 hr and after 48 hr of the 1st dose. 25-35 kg body wt: Total course of 240 mg & 1440 mg: 60 mg & 360 mg as a single dose initially followed by dose of 60 mg & 360 mg after 8 hr, after 24 hr and after 48 hr of the 1st dose.
⛔ Contraindications
History of arrhythmias, clinical relevant bradycardia, congestive heart failure accompanied by reduced ventricular ejection fraction; family history of sudden death or of congenital QT interval prolongation.
⚠️ Precautions & Warnings
Electrolyte disturbances, concomitant use with other drugs known to cause QT-interval prolongation, monitor patients unable to take food (greater risk of recrudescence). Dizziness may affect performance.
🔄 Drug Interactions
Inhibitors of CYP3A4, substrates of CYP2D6, grapefruit juice, class la and III antiarrhythmics, drugs prolonging QT interval, fluoroquinolones, azole antifungals, cisapride.
⚠️ Adverse Reactions / Side Effects
Abdominal pain, ataxia,anorexia, arthralgia, asthenia, cough, diarrhoea, muscle weakness, dizziness, headache, myalgia, nausea, palpitation, paraesthesia, prolonged QT interval, pruritus, rash, sleep disturbances, vomiting
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Avoid unless benefits outweigh risk
Lactation / Breastfeeding:
Contraindicated
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.