1300105  Amod 153mg+Arte 50mg FDC tab/3/PAC-20

02 PHARMACEUTICALS
06 Anti-infective drugs
70 Antimalarial drugs

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General Description:
Amodiaquine hydrochloride 200mg equivalent to Amodiaquine 153mg base
plus Artesunate 50mg fixed dose combination, bi-layered tablets, blister
of 3/PAC-20.

Technical specifications
Each fixed dose combination bilayered tablet contains Amodiaquine
Hydrochloride 200mg, USP equivalent to Amodiaquine base 153mg +
Artesunate 50mg.
The tablet should be scored with at least one break line to allow for
division of tablets into two parts, each containing the same amount of
active ingredients.

Therapeutic class
Amodiaquine is a 4-Aminoquinolone
Artesunate is an Artemesinin derivative

Standard shelf life
2 years (24 months)

Other available formulations
AQ 153mg& AS 50mg Co-blister 3+3, 6+6, 12+12
AQ 75mg & AS 25mg Co-blister 6+6 ? NA from UNICEF
AQ 150mg & AS 50mg Co-blister 3+3, 6+6
AQ 153mg+AS 50mg Fixed dose combination bilayered tablets, 3s, 6s, 12s
AQ 67.5mg+AS 25mg Fixed dose combination bilayered tablets, 3s
AQ 135mg+AS 50mg Fixed dose combination bilayered tablets, 3s
AQ 270mg+AS 100mg Fixed dose combination bilayered tablets, 3s, 6s
AQ 306.2mg+ AS 100mg Fixed dose combination tablets 3s, 6s - NA from
UNICEF

Indications
Treatment of uncomplicated malaria, by mouth (oral)

Storage
Do not store above 30 °C (86 °F).
Keep out of the reach of children

Dispensing instructions
Dispense in original container. Do not repack.

Guidelines for useFor more details, please see
World Health Organisation (WHO), Guidelines for the treatment of
Malaria: (www.who.int/malaria/en/)
WHO, Model Lists of Essential Medicines for adults and/or children
respectively:
(www.who.int/medicines/publications/essentialmedicines/en/index.html)
WHO Model Formulary: (apps.who.int/emlib/Default.aspx?Language=EN)
or your regional and/or national guidelines.




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