Artesunate & Amodiaquine Tablets 25mg+67.5mg

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Artesunate & Amodiaquine Tablets 25mg+67.5mg
 B) Artesunate & Amodiaquine Tablets 50mg+135mg
C)Artesunate & Amodiaquine Tablets 100mg+270mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Artesunate & Amodiaquine Tablets 25mg+67.5mg
Each uncoated tablet contains:
Artesunate…………………………………………..25mg
Amodiaquine Hydrochloride Equivalent to Amodiaquine Base………….67.5mg
Excipients……………………………………………..q.s
Colour: Ferric oxide Red

 B) Artesunate & Amodiaquine Tablets 50mg +135mg
Each uncoated tablet contains:
Artesunate…………………………………………..50mg
Amodiaquine Hydrochloride Equivalent to Amodiaquine Base………….135mg
Excipients……………………………………………..q.s
Colour: Ferric oxide Yellow

C) Artesunate & Amodiaquine Tablets 100mg+270mg
Each uncoated tablet contains:
Artesunate…………………………………………….100mg
Amodiaquine Hydrochloride Equivalent to Amodiaquine Base……………270mg
Excipients………………………………………………q.s
Colour: Ferric oxide Black

THERAPEUTIC INDICATIONS:

Artesunate & amodiaquine is a medication used for the treatment of malaria. It is a fixed-dose combination of artesunate and amodiaquine. Specifically it recommended for acute uncomplicated Plasmodium falciparum malaria.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician
Attach dispensing label as per end country.

Artesunate & Amodiaquine Tablets 25mg+67.5mg Technical Specification:

Product Name:Artesunate & Amodiaquine Tablets
Brand Name:Generic
Strength:(25mg+67.5mg), (50mg+135mg), (100mg+270mg)
Dosage Form:Tablets (Uncoated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antimalarial
Indication: Artesunate & Amodiaquine is a medication used for the treatment of malaria.
Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Artesunate & Amodiaquine Tablets 25mg+67.5mg
  • Artesunate & Amodiaquine Tablets 50mg+135mg
  • Artesunate & Amodiaquine Tablets 100mg+270mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Artesunate & Amodiaquine Tablets 25mg+67.5mg
    Each uncoated tablet contains:
    Artesunate…………………………………………..25mg
    Amodiaquine Hydrochloride
    Equivalent to Amodiaquine Base…………….…….67.5mg
    Excipients……………………………………………q.s.
    Colour: Ferric oxide Red
  • Artesunate & Amodiaquine Tablets 50mg +135mg
    Each uncoated tablet contains:
    Artesunate…………………………………………..50mg
    Amodiaquine Hydrochloride
    Equivalent to Amodiaquine Base………………..135mg
    Excipients…………………………………….……..q.s.
    Colour: Ferric oxide Yellow
  • Artesunate & Amodiaquine Tablets 100mg+270mg
    Each uncoated tablet contains:
    Artesunate…………………………………………….100mg
    Amodiaquine Hydrochloride
    Equivalent to Amodiaquine Base……………270mg
    Excipients……………………………………………… q.s
    Colour: Ferric oxide Black

THERAPEUTIC INDICATIONS:

Artesunate & amodiaquine is a medication used for the treatment of malaria. It is a fixed-dose combination of artesunate and amodiaquine. Specifically it recommended for acute uncomplicated Plasmodium falciparum malaria.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning:  To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage:  Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dosage:  As directed by the Physician.
Attach dispensing label as per end country.