Artesunate Suppositories

Artesunate Suppositories 100 mg are indicated for use as pre-referral treatment for suspected or proven severe malaria in children aged between 2 months and 6 years who are unable to take oral medication or to obtain injectable antimalarial treatment. The patient should be immediately referred to a facility where accurate diagnosis and complete treatment with effective antimalarials can be instituted [1]. The product should not be used to prevent malaria, must not be used for uncomplicated malaria, and must not be used in patients aged 7 years and over [1].

Artesunate Suppositories 100 mg are for rectal use only. The suppository should be inserted into the rectum with the rounded end first [1]. 1. Administration should be started as soon as a presumptive diagnosis of severe malaria is made and the patient is judged unable to take oral medication, and it is likely to be several hours before the patient can be treated at a health care facility. 2. Care should be taken to ensure that the suppository is retained after insertion. Especially in young children, the buttocks should be held together for about 10 minutes to prevent expulsion of the suppository. 3. If the dose is expelled from the rectum within 30 minutes of insertion, a repeat dose should be inserted. 4. Artesunate suppositories should not be given concomitantly with other rectal medications. 5. Treatment should be followed as soon as possible by transfer to a hospital or health care facility for confirmation of diagnosis and complete treatment, including curative antimalarial therapy. Patients and their guardians should be informed that this medicine does not cure malaria and that urgent further management of the patient will be necessary [1].

For community health workers and in places with limited diagnostic capacity for severe malaria, the WHO algorithm for giving rectal artesunate for pre-referral treatment of severe febrile illness in children under 6 years should be followed: give one 100 mg suppository for fever AND (convulsions, or unusually sleepy or unconscious, or not able to drink or feed anything, or vomiting everything) in children aged 2 months up to 3 years; give two 100 mg suppositories for children aged 3 years up to 6 years [1]. Artesunate Suppositories 100 mg must not be used in patients aged 7 years and over [1].

● Contraindicated in patients with known hypersensitivity to artesunate, to related artemisinin derivatives, or to any of the excipients [1]. ● Referral is essential: the product is intended as stand-by emergency treatment to enable the patient to reach a health care facility without complications; referral is important both to complete malaria treatment and to diagnose any other underlying life-threatening infection [1]. ● Absorption may be reduced in patients with diarrhoea; such patients should be closely monitored, and an additional dose should be given per rectum if the initial suppository is expelled within 30 minutes [1]. ● In children treated in hospital with the 10 mg/kg single-dose regimen, the most frequently reported adverse reactions were vomiting (4.2%), headache (3.5%) and convulsions (2.1%) [1]. ● The product must not be used to prevent malaria and must not be used for uncomplicated malaria; it is for severe malaria only [1]. ● Overdose can be life-threatening (a fatal case was reported after repeated high doses); there is no known antidote. Medical attention must be sought immediately in case of suspected overdose [1]. ● Store at 25 °C (77 °F); excursions between 15 °C and 30 °C are permitted. Avoid excursions above 30 °C. Do not freeze [1]. ● Keep out of the reach of children. Dispose of any unused product in accordance with local requirements [1]. This document is a customer information summary. The complete prescribing information, including composition, indications, contraindications, posology and undesirable effects, is provided in the approved package insert (Summary of Product Characteristics) of the product concerned.