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Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet (NRN:04-8386): Each pack of Amdin-600/750 is composed of: 3 Lactab containing each 200 mg Artesunate and 3 lactab containing each 250 mg Mefloquine base (in the form of 275mg Mefloquine HCl).
Pack size: 6's (3 Artesunate lactabs + 3 Mefloquine lactabs).
Amdin-600/750 is indicated for the oral treatment of non-complicated P. falciparum malaria in high transmission endemic areas (e.g. Africa). It can also be used for treating multi drug resistant strains of P. falciparum, as well as malaria caused by mixed Plasmodium pathogens.
So far, there have been no reports of negative drug interactions with artesunate. Concomitant administration of mefloquine and related substance (e.g. quinine, quinidine and chloroquine) may produce electrocardiographic abnormalities and increase the risk of convulsions.
Therefore, halofantrine, which is known to cause QT interval prolongation, must not be administered concomitantly with or after Amdin-600/750 for at least 3 weeks. In patients undergoing treatment with anticonvulsants such as valproic acid, carbamazepin, phenobarbital or phenytoin, mefloquine contained in Amdin-600/750 may lower the plasma concentration of the anticonvulsive, resulting in seizures.
In such cases, it may be required to adjust the dosage of the anticonvulsive.
Adverse events experienced by patients taking antimalarial drugs after mirror the symptoms of an acute malaria infection. It may therefore not be possible to distinguish undesirable effects of Amdin-600/750 from the symptoms of the disease.
The most common adverse experiences reported in clinical studies on patients treated with Amdin-600/750 were:
Gastrointestinal disorders: Common: abdominal pain, nausea, vomiting and diarrhoea.
Nervous system disorders: Very common: dizziness. Common: insomnia.
General disorders: Common: asthenia, anorexia. Common: 1 to 10%, very common, 10% or more.
Most of these adverse events were of mild to moderate severity and occurred with a similar frequency, when historically compared to the incidence rate of adverse events observed in patients receiving either drug as monotherapy. No other significant adverse effects have been observed in patients treated with Amdin-600/750.
Nevertheless, any other side effects that have been reported with either artesunate or mefloquine used as monotherapy could also occur with Amdin-600/750.
In addition, the following most common adverse events have been reported in the literature with the combination of artesunate and mefloquine: headache and allergic reactions including rash and pruritus. In rare cases mild and transient reduction in reticulocytes and neutrophil granulocytes, as well as transient increase in transaminases and total bilirubin have been described.
Dosage & Administration
Partially immune adults and children with a bodyweight between 30 and 55 kg. A treatment course course comprises 3 daily doses of two tablets, i.e. one artesunate 200mg tablet and one mefloquine 250mg tablet, given simultaneously, once daily for 3 consecutive days.
The first dose of two tablets is given at the time of initial diagnosis, followed by a second dose of 2 tablets 24 hours thereafter and a third (last) dose of 2 tablets 48 hours after the initial dose. If any Amdin-600/750 daily dose (2 tablets) is missed, the patient should be advised to take the missed dose (2 tablets) as soon as it is realised that it has been forgotten. Then the next dose (2 tablets) should be taken after a further 24 hour interval.
Patients who vomit within less than 30 minutes after administration of any Amdin-600/750 daily dose (2 tablets) should be given a replacement (full) dose of 2 tablets. In this case, the prescription of another Amdin-600/750 pack should be considered. Parts of this new pack may be used to ensure that the patient will complete a 3 day full treatment course with Amdin-600/750.
Following treatment with Amdin-600/750 of malaria caused by a mixed infection with P. vivax, relapse prophylaxis with an 8-amino quinoline derivative (e.g. primaquine) should be considered to eliminate hepatic forms of the parasite.
Non-immune patients and patients with a body weight of more than 55 kg. For these patients, higher Amdin doses might be more appropriate.
Children with less than 30 kg body weight. Due to limited clinical experience, Amdin-600/750 is currently not recommended for use in patients who have less than 30 kg body weight. Different Amdin dosage regimens are still under evaluation in children.
Mode of administration:The 2 tablets constituting an Amdin-600/750 daily dose must be taken simultaneously without chewing them, with a large amount of liquid and if possible with a meal.
For patients having difficulties with swallowing, the tablets can be crushed and dissolve