Bula do medicamento Coartem

Coartem – Bula do remédio

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

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.

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.

Coartem – Informações

Certifique-se de que fez o tratamento COMPLETO
durante 3 dias, nos horários recomendados.
? Tome a primeira dose imediatamente e a segunda dose 8 horas depois. Tome as doses restantes de manhã e à noite no segundo e terceiro dias, até acabar o pacote.
Comece imediatamente o tratamento.
? Tome cada comprimido acompanhado de comida ou bebida com um elevado teor
de gordura (por exemplo, leite).
? Para crianças pequenas, esmague o comprimido antes de administrar a dose.
? Se vomitar no intervalo de uma hora após a ingestão do medicamento Coartem,
repita a dose. Obtenha mais comprimidos em uma farmácia.