Artesunate - Antimalarial- (FDC-List)- (Aug 1996)
Drug Name:Artesunate - Antimalarial- (FDC-List)- (Aug 1996)
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Interaction with Food
Pregnancy and lactation
Drug Interaction:
Antimalarial potentiating action seen with mefloquin, primaquine and tetracycline.
Additive effect seen with chloroquine.
Antagonistic effect seen with pyrimethamine and sulfonamides.
Indication:
Artesunate injection - Each pack combipack contains-
Artesunate for injection 120mg ( Each vial contains Artesunate IP 120mg,)
sodium bicarbonate injection IP 5% w/v
Each 2ml ampoule contains-
Sodium Bicarbonate IP 5%w/v) sodium Chloride injection IP 0.9%w/v)
Each 10ml ampoule contains-
Sodium chloride IP 0.9% w/v
Indication-
Promoted for use in severe malaria including cerebral malaria as a
second line in chloroquine resistent malaria cases only.
Approved by FDA on 13-11-2013 (Ref- FDA approved List- 2014)
Artesunate powder for injection 60mg/ml along with 6ml ampoule
of phosphate buffer solution (pH 8. 0,0.0 M)
Indication-
For the treatment of severe Falciparium malaria in areas where there
is evidence if quinine resistence
Approved by FDA on 2-07-2014 (Ref- FDA approved List- 2014)
LIST OF DRUGS DURING 2007
Sr.No- 123
Name of the Drug- Combipack of
Artesunate 50mg each +
3 tablet of each containing
Sulfodoxine 500mg +
Pyrmethamine 25mg tablet
(addl,stgh)
Pharmacological Classification- As approved
Date of Approval- 01-08-07
Approved by U.S.FDA on 30-12-2007 (Ref- FDA approved List- 2007)
LIST OF DRUGS DURING 2007
Sr.No- 181
Name of the Drug- Combipack of
12 Artesunate 50mg tablets+
6 Mefloquin 250mg tablets
Pharmacological classification- For drug resistent P.Falciparum malaria infection
,
Date of Approval- 06-12-07
Approved by US FDA on 30-12-2007 (Ref- FDA approved List- 2007)
Falciparium malaria
Approved by (DCI) Drug Controller GENERAL - India For Marketting
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Artesunate Malaria 02-08-1996
2.Artesunate 2 tablets of Artesunate 100mg+ 25-05-2010
3 tablets of artesunate 50mg and
2 tablets of FDC of pyrimethamine 25mg +
sulphadoxime 500mg combipack
(Addl.strgth.)
3.Artesunate powder for injection 60mg/vial 02-07-2014
along with 6ml ampoule of phosphate
buffer solution( ph 8.0; 0.30M)
For the treatment of severe falciparium malaria in areas
where there is evidence if quinine resistence
4.Artesunate (25/50/100mg) + 01-09-2009
Amodiaquine 967.5mg/135/270mg)
bilayerd tablets
For the treatment of uncomplicated malaria due to plasmodium
falciparum strain in various age groups
5. Artesunate injection - each combipack contains 13-11-2013
Artesunate for injection 120mg
(each vial contains artesunate IP 120mg)
Sodium bicarbonate injection IP 5% w/v
( each 2ml ampoule contains - sodium
bicarbonate IP 5% w/v)
Sodium chloride injection IP 0.9% w/v
( each 10ml ampoule contains sodium
chloride IP 0.9%w/v)
Promoted for use in severe malaria including cerebral malaria
as a second line in chloroquine resistent malaria cases only
6. Artesunate injection -each combipack contains 13-11-2013
artesunate for injection 120mg
(each vial contains artesunate IP 120mg)
Sodium bicarbonate injection IP 5%w/v
(each 2ml vial ampoule contains sodium
bicarbonate IP 5%w/v)
Sodium chloride IP 0.9% w/v
( Addl. strgth.)
Promoted for use in severe malaria including cerebral malaria and
as second line in chloroquine resistent malaria cases only
7. Combipack of 12 Artesunate 50mg tablets 12-06-2007
+ 6 Mefloquin 250mg tablets
For drug resistent Falciparium Malaria Infection
8. Combipack of 12 Tablet of Artesunate 50mg each + 01-08-2007
3 tablet each containing Sulfodoxine 500mg +
Pyremethamine 25mg ( Addl stgth)
As approved
9.Combipack of Artesunate Tablet and 15-07-2009
FDC Tablet of Sulphadoxime +
Pyrimethhamine composition -
A- combipack of 1 strip of 3 tablets of
Artesunate 25mg and 1 strip of
1 Tablet of Sulphadoxime 125mg +
Pyremethamine 6.25mg+
B. Combipack pack of 1 strip of 3 tablets
of Artesunate 50mg and 1 strip of
1 tablet of Sulphadixime 500mg +
Pyrimethamine 25mg
C. Combipack of 1 strip of 3 tablets
of Artesunate 100mg and 1 strip of
1 Tablet of Sulphadoxime 500mg +
Pyremethamine 25mg
D. Combipack of 1 strip of 3 Tablets
of Artesunate 200mg and 1strip of
1 Tablet of Sulphadoxime 500mg+
Pyremethamine 25mg
For the treatment of P.Falciparium resistent malaria patients
10.One strip of 3 unocated tablets 05-04-2010
of Arteunate 150mg &
One Strip of 2 uncoated Tablets of
FDC of Sulphodoxime IP 500mg
+ Pyrimethamine IP 25mg
Addl.Stgth
As approved
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
3 tablets of artesunate 100mg+ 28-05-2010
3 tablets of Artesunate 50mg and &
2 tablets of FDC of pyrimethine 25mg +
Sulphadoxime 500mg combipack
For the treatment of P.falciparum resistent malaria patients
2.Artesunate 25/50/100mg+ 01-09-2009
Amodiaquine 67.5mg/135mg/270mg
Bilayered Tablets
For the treatment of uncomplicated malaria due to plasmodium
falciparum strain in various age groups
3.Artesunate 150mg/200mg+ 25-07-2006
Sulphadoxime 500mg/750mg+
Pyrimethamine 25/37.5mg Combipack
For the treatment of P.Falciparum resistent malaria
(age 9-14 yrs and above)
4.Combipack of 12 artesunate -50mg tabletsents & 12-06-2007
6 Mefloquin 250mg tablets
For drug resistent P.falciparum malaria infection
5.Combipack of 12 tablet of Artesunate 50mg each + 01-08-2007
3 tablets each containing Sulfodoxine 500mg +
Pyremethamine 25mg tablet
Addl.Stgth
For the treatment of P.falciparum resistent malaria
patients
6.Combipack of artesunate tablet and FDC of 15-07-2009
Sulphadoxime + Pyrimethamine Composition
A. Combipack of 1 strip of 3 tablets of Artesunate 25mg and
1 strip of 1 tablet of Sullphadoxine 125mg +
Pyremethamine 6.25mg
B. Combipack of 1 strip of 3 tablets of Artesunate 50mg and
1 strip of 1 tablet of Sulphadoxime 500mg+
Pyrimethamine 25mg
C. Combipack of 1 strip of 3 tablets of Artesunate 100mg and
1 strip of 2 tablets of sulphadoxime 500mg +
Pyremethamine 25mg
D. Combipack of 1 strip 3 tablets of Artesunate 200mg and
1 strip of 3 tablets of Sulphadoxime 500mg +
Pyremethamine 25mg
For the treatment of P.Falciparum resistent malaria
patients
Adverse Reaction:
Transcient and reversible reticulocytopenia, dry fever, rash, bradycardia,
transcient first degree heart block, and reversible elevation of serum transaminases.
Contra-Indications:
Hypersensitivity
Special precautions:
Pregnancy.
Hepatic/renal insufficiency states.
Dosages/ Overdosage Etc:
Interaction with Food:
None reported.
Pregnancy and lactation:
Observe caution if required to be administered
