Gvither Oral Suspension
2, Bank Lane, Off Town Planning Way, Ilupeju, Lagos State, Nigeria
Email: email@example.com, firstname.lastname@example.org
Tel: 01-737-8991; 01-871-3181; 0803-343-1338; 0803-569-9324
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Suspension (NRN: 04-3266): Each 5 mL of suspension contains: Artemether 15 mg.
Pack size: 100 mL (in a bottle with measuring cap which is calibrated in divisions of 5 mL).
Artemether and its derivatives act essentially as blood schizonticides. The presence of the endoperoxide bridge appears to be essential for
antimalarial activity, generation of singlet oxygen and formation of free radicals. Inhibition of protein synthesis as the basic mechanism of action
is suggested in studies which showed morphological changes in ribosomes as well as in the endoplasmic reticulum.
Oral Artemether is rapidly absorbed reaching Cmax within 2-3 hours. It is metabolized in the liver to the demethylated derivatives dihydroartemisinin.
The elimination is rapid, with a T½ of 4 hours. Dihydroartemisinin has T½ of more than 10 hours.
For the treatment of malaria caused by all types of Plasmodium including multiple drug resistant strains; for the treatment of severe P. falciparum malaria.
There are virtually no side effects. At high doses, transient abdominal pain, diarrhoea and tinnitus can occur.
Dosage & Administration
|Weight of Children (Age)||Dose (mL)|
|Day 1||Day 2||Day 3||Day 4||Day 5|
|5 - 7.5 kg (1 - 6 months)||10||5||5||5||5|
|8 - 15 kg (7 months - 3 years)||20||10||10||10||10|
|15.5 - 22.5 kg (4 - 8 years)||30||15||15||15||15|
|23 - 30 kg (9 - 12 years)||40||20||20||20||20|
Directions for reconstitution:
To make 100 mL suspension, add a little water, invert bottle and shake until all powder is dispersed, then slowly add more water upto the level mark (®) on the bottle. Use only boiled and cooled water. Once re-constituted, the suspension must be used within 7 days. The re-constituted mixture should be stored at temperature not exceeding 25oC.
It is essential for the patient to complete the course of treatment to avoid recrudescence. In severe malaria it may be necessary to prolong treatment for 7 days.
The suspension should be stored at a room temperature in their original containers and protected from light & moisture. Under this condition the oral suspension has a shelf life of 2 years.