Aurother (artemether 20mg & lumefatrine 120mg)

AUROTHER

COMPOSITION

Each uncoated tablet contains

Artemether………………20mg

Lumefantrin…………….120mg

Excipients…………………..q.s

 

INDICATIONS: Artemether and Lumefantrin tablets are indicated for the treatment of acute, uncomplicated malaria infections due to plasmodium falciparum in patients of 5kg bodyweight and above. Artemether and Lumefantrin tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported.

 

DOSAGE AND ADMINISTRATION: Adults: A 3-day treatment schedule with a total of 6 doses is recommended:

For adult patients with a body weight of 35kg and above:

PO 4 tablets as a single dose, 4 tablets again after 8hr, then 4 tablets twice daily(morning and evening) for the following 2 days (total course of 24 tablets).

For children 16 years or younger or weighing less than 35kg

3 tablets as an initial dose, 3 tablets again after 8hr and then 3 tablets twice daily for the following 2 days (total course of 18 tablets). .

15kg to less than 25kg body weight:

2 tablets as initial dose, 2 tablets again after 8 hr., and then 2 tablets twice daily for the following 2 days (total course of 12 tablets).

5kg to less than15kg:

1 tablet as initial dose, 1 tablet again after 8hr, then 1 tablet twice daily(morning and night) for the following 2 days(total course of 6 tablets).

 

CONTRAINDICATIONS: Hypersensitivity to artemether, lumefantrin, or any of the excipients of tablet.

PREGNANCY: There is insufficient data for the use of Artemether and Lumefantrin in pregnant women. Based on animal data, Artemether and Lumefantrin tablets are suspected to cause serious birth defects when administered during the first trimester of pregnancy.

NURSING MOTHERS: Animal data suggest excretion into breast milk but no data are available in humans. Women taking Artemether and Lumefantrin tablets should not breast feed during their treatment. Due to the long elimination half-life of lumefantrin (4-6 days), it is recommended that breast-feeding should not resume until at least one week after the last dose of Artemether and Lumefantrin tablets.

SIDE EFFECTS: The common side effects include: cough, diarrhea, dizziness, fatigue, headache, joint and muscle pain and stiffness, loss of appetite, nausea, stomach pain, tiredness, sleeping problems, vomiting and weakness.

Seek medical attention right away if any of these severe side effects occur: severe allergic reactions (rash, hives, itching, difficulty in swallowing or breathing, tightness in the chest, swelling of the mouth, face, lips or tongue, unusual hoarseness); fainting, fast or irregular heartbeat, fever, chills, or persistent sore throat, pale color, severe or persistent headache, muscle pain, or weakness, speech problems.

 

DRUG INTERACTIONS:

Antiretrovirals, quinidine, procainamide, disopyramide, amiodarone, sotalol, ziprasidone, antidepressants halofantrin, pimozide, terbinafine, astemizole, cisapride, quinine, CYP2D6 substrates, CYP3A4 inhibitors. Fluoroquinolone may further prolong QT interval.

Hormonal contraceptives: may reduce contraceptive effect. Recommend alternative or additional contraception.

Mefloquine: may decrease drug’s effectiveness. Administer drug with food to increase absorption.

Drug-food: Grapefruit juice may increase drug level. Avoid.

 

OVERDOSAGE: There is no information on overdoses of Artemether & lumefantrin Tablets, higher than the doses recommended for treatment. In cases of suspected over dosage, symptomatic and supportive therapy, which would include ECG and blood electrolyte monitoring, should be given as appropriate.

 

STORAGE: Store in a cool, dry place and protect from light. Keep out of children.

PRESENTATION: Blister of 8 tablets. 3 blisters per pack.