Coartem^® /Riamet^®

Prescribing Coartem^®

Before prescribing, please read full local prescribing information

Coartem^® is indicated for the treatment, including standby emergency treatment, of adults, children and infants with acute, uncomplicated infections due to P. falciparum or mixed infections including P. falciparum. Because Coartem^® is effective against both drug-sensitive and drug-resistant P. falciparum it is also recommended for malaria infections acquired in areas where the parasites may be resistant to other antimalarials.

Coartem^® is contraindicated in those with hypersensitivity to the active substances or any of the excipients; in cases of severe malaria and in the first trimester of pregnancy. During the second and third trimester, treatment should only be considered if the expected benefit to the mother outweighs the risk to the foetus. Coartem^® is also contraindicated in patients with a history of symptomatic cardiac arrhythmias, clinical relevant bradycardia or severe heart disease. Also in patients with a family history of congential prolongation of the QTc interval or sudden death, disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia. Drugs that are known to be metabolised by cytochrome enzyme CYP2D6 or drugs that are known to prolong the QTc interval should not be used concomitantly with Coartem^®.

Coartem^® is not indicated for prophylaxis, or for treating severe malaria, including cerebral malaria, or malaria with pulmonary oedema or renal failure. Coartem^® is not indicated for and has not been evaluated in, the treatment of malaria due to P. vivax, P. malariae or P. ovale. Coartem^® is active against the blood stages of P. vivax, but is not active against hypnozoites. Therefore, an 8-amino-quinoline derivative such as primaquine should be given sequentially after Coartem^® in cases of mixed infections of P. falciparum and P. vivax to achieve hypnozoites eradication.

Other precautions

Use with caution in patients with severe hepatic or renal insufficiency and patients refusing food intake. No specific studies have been carried out in these patients, therefore no specific dose adjustment recommendation can be made. Driving and use of machinery is not recommended due to risk of dizziness and fatigue. Special care should be taken with patients previously treated with halofantrine, mefloquine or quinine.

Dosage

For adults and children weighing 35 kg and above a standard three days treatment schedule with a total of 6 doses is recommended as follows: four tablets as a single dose at the time of initial diagnosis, again four tablets after eight hours and then four tablets twice daily (morning and evening) on each of the following two days (total comprises 24 tablets). For infants and children weighing 5 to less than 35 kg, a six-dose regimen is recommended with 1 to 3 tablets per dose, depending on bodyweight. With very small children the tablet should be crushed before giving it to the child.

Coartem^® dosage schedule

Standby emergency treatment

The same six-dose regimen should be instituted at the onset of symptoms, with 1-4 tablets per dose, depending on bodyweight, being administered over the course of three days. See also Riamet^® . Most tourists and business travellers, considered to be non-immune, will be able to obtain prompt medical attention if malaria is suspected. However, a minority at risk of infection may be unable to obtain such care within 24 hours of the onset of symptoms, particularly if they are in an isolated location far from medical services. In such cases, prescribers are advised to issue Coartem^® /Riamet^® to be carried by the traveller for self-administration (‘standby emergency treatment’).
Consideration should be given to official guidance regarding the appropriate dosage and use of antimalarial agents.

Dosage and method of administration

The dose should be taken with high fat food or drinks such as milk. Patients should be encouraged to resume normal eating as soon as food can be tolerated since this improves absorption of artemether and lumefantrine. In the event of vomiting within 1 hour of administration a repeat dose should be taken. Note that patients with acute malaria are frequently averse to food.

Special populations

Dosage in elderly patients

Although no studies have been carried out in the elderly, no special precautions or dosage adjustments are considered necessary in such patients.

Dosage in patients with renal or hepatic impairment

No specific studies have been carried out in these groups of patients and no specific dose adjustment recommendations can be made for these patients. Most patients with acute malaria present with some degree of related hepatic impairment. The adverse event profile did not differ in patients with and those without hepatic impairment. Moreover, baseline abnormalities in liver function tests improved in nearly all patients after treatment with Coartem^®.

New and recrudescent infections in adults, children and infants

Data for a limited number of patients show that new and recrudescent infections can be treated with a second course of Coartem^®.

Drug interactions

Should not be given concurrently with other antimalarials unless there is no other treatment option.

Pregnancy and breast-feeding

Coartem^® treatment is contraindicated during the first trimester of pregnancy. During the second and third trimester, treatment should only be considered if the expected benefit to the mother outweighs the risk to the foetus.

As Coartem^®/Riamet^® is contraindicated during the first trimester of pregnancy, women of child-bearing potential should not conceive while on Coartem^® treatment for malaria. This includes women prescribed Coartem^® for standby emergency treatment of malaria during their travel, in case they may require treatment for malaria.

Women of child-bearing potential should be advised to practice contraception during travel with standby emergency treatment, while on Coartem^® and until the start of next menstruation after the treatment.

Breast-feeding women should not take Coartem^®. Due to the long elimination half-life of lumefantrine (4 to 6 days), it is recommended that breast-feeding should not resume before day 28 unless potential benefits to mother and child outweigh the risk of Coartem^® treatment.

Coartem® is contraindicated in:

• Patients with hypersensitivity to the active substances or to any of the excipients
• Patients with severe malaria
• First trimester of pregnancy (see ‘pregnancy and breast-feeding’)
• Patients with a family history of congenital prolongation of the qtc interval or sudden death or with any other clinical condition known to prolong the qtc interval such as patients with a history of symptomatic cardiac arrhythmias, patients with clinically relevant bradycardia or with severe cardiac disease
• Patients with known disturbances of electrolyte balance, e.g. Hypokalaemia or hypomagnesaemia
• Patients taking any drug that is metabolised by the cytochrome enzyme cyp2d6 (e.g. Flecainide, metoprolol, imipramine, amitriptyline, clomipramine)
• Patients taking drugs that are known to prolong the qtc interval such as antiarrhythmics of classes ia and iii, neuroleptics, antidepressant agents, certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones, imidazole, and triazole antifungal agents, certain non-sedating antihistaminics (terfenadine, astemizole), cisapride.