| Composition : |
Each un-coated tablet contains Artemether 20 mg & Lumefantrine 120 mg. |
| Indications : |
For the treatment of acute uncomplicated Plasmodium falciparum malaria in adults, children and infants of 5 kg and above.
|
| Contraindications : |
It is contraindicated in:
• Patients with known hypersensitivity to the active substances or to any of the excipients.
• Patients with severe malaria according to WHO definition.
• Metoprolol, imipramine, amitryptyline, clomipramine.
• Patients with a family history of sudden death or of congenital prolongation of the QTc interval on electrocardiograms, or with any other clinical condition known to prolong the QTc interval.
• Antiarrhythmics of classes IA and III,
- Neuroleptics, antidepressive agents,
- Macrolides, fluoroquinolones, imidazole and triazole antifungal agents,
- terfenadine, astemizole,cisapride, flecainide
|
| Adverse Effects : |
Hypersensitivity, Decreased appetite, Sleep disorders, Insomnia, Headache, Dizziness, Paraesthesia, Ataxia, hypoaesthesia, Somnolence, Palpitations, Vomiting, Abdominal pain, Nausea, Diarrhoea |
| Dosage : |
Adults and children weighing 35 kg and above
For patients 12 years of age and above and 35 kg body weight and above, a course of treatment comprises six doses of four tablets i.e. total of 24 tablets, given over a period of 60 hours as follows: the first dose of four tablets, given at the time of initial diagnosis, should be followed by five further doses of four tablets given at 8, 24, 36, 48 and 60 hours thereafter.
Children and infants weighing 5 kg to less than 35 kg
A six-dose regimen is recommended with 1 to 3 tablets per dose, depending on bodyweight:
5 to less than 15 kg bodyweight: the first dose of one tablet, given at the time of initial diagnosis, should be followed by five further doses of one tablet given at 8, 24, 36, 48 and 60 hours thereafter.
15 to less than 25 kg bodyweight: the first dose of two tablets, given at the time of initial diagnosis, should be followed by five further doses of two tablets given at 8, 24, 36, 48 and 60 hours thereafter.
25 to less than 35 kg bodyweight: the first dose of three tablets, given at the time of initial diagnosis, should be followed by five further doses of three tablets given at 8, 24, 36, 48 and 60 hours thereafter.
|
