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ARMETH

ARTEMETHER AND LUMEFANTRINE · by MEDERA

ANTIMALARIALS Artemisinin derivative/Synthetic racemic fluorene mixture MEDERA

Composition

Cap/Tab 20/120 mg: Artemether 20 mg, Lumefantrine 120 mg. Cap/Tab 40/240 mg: Artemether 40 mg, Lumefantrine 240 mg. Cap/Tab 80 mg/480 mg: Artemether 80 mg, Lumefantrine 480 mg. Susp 15 mg/90 mg: Artemether 15 mg, Lumefantrine 90 mg

Indications & 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

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.

Interactions

Inhibitors of CYP3A4, substrates of CYP2D6, grapefruit juice, class la and III antiarrhythmics, drugs prolonging QT interval, fluoroquinolones, azole antifungals, cisapride.

Pregnancy

Avoid unless benefits outweigh risk

Lactation

Contraindicated

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