描述

ARTEMETHER+LUMEFANTRINE TABLET 20+120MG, 18’S/BOX

Indicatios:

Compound Artemether Tablets is indicated for the treatment of acute uncomplicated Plasmodium falciparum malaria in adults, children and infants of 5 kg and above.

Dosage and administration：

Compound Artemether Tablets should be taken with food.

Tablets may be crushed and mixed with water immediately prior to administration to patients, including children.

Compound Artemether Tablets should be administered over 3 days for a total of 6 doses: an initial dose, second dose after 8 hours, and then twice-daily (morning and evening) for the following 2 days.

The adult dosage for patients with bodyweight of 35 kg and above is 4 tablets per dose for a total of 6 doses. The number of tablets per dose for children is determined by bodyweight.

Contraindications:

Known hypersensitivity to artemether, lumefantrine, or to any of the excipients.

Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine,

phenytoin, and Perforate St John’s-wort with Compound Artemether Tablets.

Precautions:

l Compound Artemether Tablets is not recommended during the first trimester of pregnancy in situations where other suitable and effective antimalarials are available.

l Compound Artemether Tablets has not been evaluated for the treatment of severe malaria, including cases of cerebral malaria or other severe manifestations such as pulmonary oedema or renal failure.

l Due to limited data on safety and efficacy, Compound Artemether Tablets should not be given concurrently with any other antimalarial agent unless there is no other treatment option.

l If a patient deteriorates whilst taking Compound Artemether Tablets, alternative treatment for malaria should be started without delay.  In such cases, monitoring of the ECG is recommended and steps should be taken to correct any electrolyte disturbances.

l Caution is recommended when combining Compound Artemether Tablets with drugs exhibiting variable patterns of inhibition, moderate induction or competition for CYP3A4 as the therapeutic effects of some drugs could be altered.

l Caution is recommended when combining Compound Artemether Tablets with hormonal contraceptives.  Compound Artemether Tablets may reduce the effectiveness of hormonal contraceptives.

l Patients who remain averse to food during treatment should be closely monitored as the risk of recrudescence may be greater.

l Renal impairment

l Hepatic impairment

l New infections

Drug interactions:

CYP3A4 Inducers: Potential for loss of antimalarial efficacy.

CYP3A4 Inhibitors: Use cautiously due to potential for QT prolongation.

Antiretrovirals: Use cautiously due to potential for QT prolongation, loss of antiviral efficacy, or loss of antimalarial efficacy of Compound Artemether Tablets.

Mefloquine: If used immediately before treatment, monitor for decreased efficacy of Compound Artemether Tablets and encourage food consumption.

Hormonal Contraceptives: Effectiveness may be reduced; use an additional method of birth control.

CYP2D6 Substrates: Monitor for adverse reactions and potential QT prolongation.

Storage:

Do not store above 30°C.