| |
| Gvither Oral Suspension |
| Presentation |
| Givither Oral
Suspension
(Artemether 300 mg in
100 ml bottle) |
| Pharmaceutical
Precautions |
| The suspension should
be stored at a room temperature in their original containers and
protected from light
& moisture. Under this conditions the oral suspension have a self
life of 2 years. |
| Pharmacodynamics |
| 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. |
| Pharmacokinetics |
| Oral Artemether is
rapidly absorbed reaching Cmax within 2-3 hours. It is metabolized in the liver to the
demethylated derivative Dihydroartemisinin. The elimination is rapid, with a T 1/2 of 4 hours.
Dihydroaiiemisimn has T 1/2 of more than 10 hours. |
| Indications |
For the treatment of
malaria caused by all types of plasmodium including multiple drug resistant
strains, for the
treatment of severe P. falciparum malaria |
| Side Effects |
| There are virtually no
side effects. At high doses, transient abdominal pain, diarrhoea
and tinnitus can occur. |
| Dosage and Adminstration |
| |
Day
(ML) |
| Weight of children (Age) |
DAY 1 |
DAY 2 |
DAY 3 |
DAY
4 |
DAY 5 |
| 5
kg - 7.5 kg (1 Month - 6 Months) |
0 ml |
5
ml |
5
ml |
5
ml |
5
ml |
| 8 kg - 15 kg (7 Months - 3 yrs) |
20 ml |
10
ml |
10
ml |
10 ml |
10 ml |
| 15.5 kg -
22 5 kg (4 yrs - 8 yrs) |
30 ml |
15 ml |
15 ml |
15 ml |
15
ml |
| 23 kg - 30 kg (9 yrs- 12 yrs) |
40 ml |
20 ml |
20 ml |
20 ml |
20 ml |
|
| Iomportant Considerations |
- 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.
- Specific
age group of children - none.
|
| Note |
-The container
bottle is provided with a measuring cap which is calibrated in division of 5
ml.
-Each 5 ml of suspension contains 15 mg of Artemether |
| Directions for Constitution |
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-constitued, the suspension must be used within 7 days. The
re-constittited mixture should be stored at a temperature not exceeding 25"c. |