| |
| Gvither® 80 KIT Injection |
| Presentation |
Gvither® 80 mg/ml, ampoule Clear glass ampoules containing Artermether 80 rag in 1 ml
solution The
solution is colourless or pale yellow & sterile. |
| Pharmacokinetics |
Arteraether,
when injected through in route is rapidly absorbed reaching Cmax withing 2-3
hours. It
is metabolised in the liver to the demethylated derivative Dihydroartemisinin.
The elimination is rapid, with a T 1/2 of 4 hours. Dihydroartemisinin
has T 1/2 of more than 10 hours |
| Indications |
Gvither®
is indicated for the treatment of malaria caused by all forms of plasmodium
including severe
malaria caused by multiple drug resistant strains of P. falcipamm. |
| Side Effects |
At the therapeutic
dose (700 rag) there are virtually no side effects. There are reports on
laboratory abnormalities i.e., a decrease in reticulocytes count, an increase
in transaminase and ECG changes (Sinus Bradycardia). However, these are transient. At
high doses, transient abdominal pain, diarrhoea and tinnitus can occur. |
| Contra-Indication |
| Pregnancy,
unless the doctor considers it essential as in the case of Cerebral malaria |
| Dosage and Adminstration |
|
Day- 1 |
Day - 2 |
Day - 3 |
Day - 4 |
Day - 5 |
Adults |
160 mg
(2 Amps)
|
80 mg
(1 Amp) |
80mg
(1 Amp)
|
80 mg
(1 Amp) |
80 mg
(1 Amp) |
| Children |
4.0 mg/kg
body wt. |
2.0 mg/kg
body wt. |
2.0 mg/kg
body wt. |
2.0 mg/kg
body wt. |
2.0 mg/kg
body wt. |
|
| Precautions |
| In
Cerebral malaria and complicated malaria, general supporting therapy may be
required |
| Pharmacodynamics |
Artemether,
and its derivatives act essentially as blood schizonticides. The presence of
the endoperoxide
bridge appears to be essential for anti-malaria 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 |
| Conservation |
Gvither® 80mg. injection should be protected from light and stored at room temperature,
If stored for
long periods in the cold, precipitation may occur which may clear on storage at
room temperature. If not, the contents of the ampoule should be discarded. Do
not store below room temperature. |
| Presentation |
Gvither
80mg.Kit pack : Contains 1 sterile Artemelher Injection Ampoule with
Sterilised
disposable 2 ml Syringe and sterile needle.
BRISTAL PACK 2 X 5 X
1 ml Ampoule blisters are packed in a carton |
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