Coartem

COARTEM com posologia, indicações, efeitos colaterais, interações e outras informações. Todas as informações contidas na bula de COARTEM têm a intenção de informar e educar, não pretendendo, de forma alguma, substituir as orientações de um profissional médico ou servir como recomendação para qualquer tipo de tratamento. Decisões relacionadas a tratamento de pacientes com COARTEM devem ser tomadas por profissionais autorizados, considerando as características de cada paciente.



Laboratório

novartis

Apresentação COARTEM

Informação não disponível para esta bula.

COARTEM – Indicações

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.

Contra indicações de COARTEM

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. Coartem is contraindicated in those with hypersensitivity to the active substances or any of the excipients, in cases of severe malaria, in the first trimester of pregnancy (see precautions), cardiac arrhythmia, bradycardia, severe cardiac diseases, QTc prolongation, family history of sudden death, disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia. Concomitant use of drugs that are known to be metabolised by cytochrome enzyme CYP2D6 or drugs that are known to prolong the QTc interval. 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.

Advertências

Informação não disponível para esta bula.

Interações medicamentosas de COARTEM

Informação não disponível para esta bula.

Reações adversas / efeitos colaterais de COARTEM

A causal relationship with the use of coartemether could not be excluded for the following adverse events (ranked in descending order of frequency): Source: BPI, September 2005 QTc vs lumefantrine concentration: > 5 years 2-5 years Median QTc (418 ms) 500 475 450 425 400 375 350 QTc (ms) Conc. (ng/ml) 0 5000 10000 15000 20000 25000 30000 35000 Immune system disorders Very rare Hypersensitivity Nervous system disorders Very common Headache, dizziness Common Sleep disorder Uncommon Somnolence, involuntary muscle contractions, paraesthesia, hypoaesthesia, abnormal gait, ataxia Cardiac disorders Common Palpitation Respiratory, thoracic and mediastinal disorders Common Cough Gastrointestinal disorders Very common Abdominal pain, anorexia Common Diarrhoea, vomiting, nausea Skin and subcutaneous tissue disorders Common Pruritus, rash Musculoskeletal and connective tissue disorders Common Arthralgia, myalgia General disorders and administration site conditions Common Asthenia, fatigue

COARTEM – Posologia

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.

Super dosagem

Informação não disponível para esta bula.

Caracteristicas farmalogicas

Informação não disponível para esta bula.

Resultados de eficacia

Informação não disponível para esta bula.

Usos em idosos, crianças e em outros grupos de risco

Informação não disponível para esta bula.

Armazenagem

Informação não disponível para esta bula.

Dizeres legais

Informação não disponível para esta bula.

COARTEM – Bula para o paciente

Informação não disponível para esta bula.

Data da bula

Informação não disponível para esta bula.