dihydroartemisinin+piperaquine phosphate tablet 40＋320mg, 9×1Tablets
Indications
Dihydroartemisinin+Piperaquine Phosphate Tablet is indicated for the treatment of uncomplicated malaria. Dihydroartemisinin+Piperaquine Phosphate Tablet is active against all Plasmodium parasites that cause malaria in humans.
Dosage and Administration
Usage: Oral
Dihydroartemisinin+Piperaquine Phosphate Tablet should be administered over 3 consecutive days for a total of 3 doses taken at the same time each day.
Dosing should be based on body weight as shown in the following table:
Body weight( kg) | Number of tablets | Daily dose | |
Dihydroartemisinin | Piperaquine phosphate | ||
1 tablet per day for 3 days | 40 mg | 320 mg | |
17 to＜25 | 11/2 tablets per day for 3 days | 60 mg | 480 mg |
25 to＜36 | 2 tablets per day for 3 days | 80 mg | 640 mg |
36 to＜60 | 3 tablets per day for 3 days | 120 mg | 960 mg |
60 to＜80 | 4 tablets per day for 3 days | 160 mg | 1280 mg |
80 kg or more | 5 tablets per day for 3 days | 200 mg | 1600 mg |
For patients weighing less than 11 kg, alternative formulations supplying lower amounts of active substance should be preferred.
Precautions & Warning:
1. Effects on cardiac repolarization:There has been no evidence of piperaquine-related cardiotoxicity in large randomized trials or in extensive deployment in the field.
2. Delayed haemolytic anaemia: Delayed haemolytic anaemia has been observed up to 1 month following use of intravenous artesunate and oral artemisinin-based combination treatment (ACT) including reports involving dihydroartemisinin + piperaquine. Risk factors may include young age (children under 5 years old) and previous treatment with IV artesunate.
3. Paediatric population Special precaution is advised in young children when vomiting, as they are likely to develop electrolyte disturbances.
Contraindications:
1.Hypersensitivity to the active substances or to any of the excipients.
2.Severe malaria.
3.Inherited long QT syndrome (congenital prolongation of the QTc interval) or a family history of this condition or of sudden death.
4. Any other clinical condition known to prolong the QTc interval.
5.History of symptomatic cardiac arrhythmias or with clinically relevant bradycardia. 6.Any predisposing cardiac conditions for arrhythmia.Electrolyte disturbances, particularly hypokalaemia, hypocalcaemia or hypomagnesaemia.
7.Taking medicinal products that are known to prolong the QTc interval.
8.Recent treatment with medicinal products known to prolong the QTc interval that may still be circulating at the time that dihydroartemisinin + piperaquine phosphate tablet is started, taking into account their elimination halflife .
Adverse Reactions:
1. Infections and infestations: P. falciparum infection
2. Blood and lymphatic disorders: anaemia
3. Nervous system disorders: headache
4. Cardiac disorders: QTc interval prolongation; tachycardia; cardiac conduction disorders; sinus arrhythmia; bradycardia
5. Respiratory disorders: cough
6. Gastrointestinal disorders: vomiting; diarrhoea; nausea; abdominal pain
7. Hepatobiliary disorders: hepatitis; hepatomegaly; abnormal liver function tests
Storage instructions:
Do not store above 25℃. Store in the original pack in a place protected from light and humidity.