Atovaquone and Proguanil Hydrochloride Tablet (250mg+100mg) Technical Specification:

Product Name:Atovaquone and Proguanil Hydrochloride Tablet (250mg+100mg)
Brand Name:Generics
Strength:Pediatric: 62.5mg+25mg
Adult: 250mg+100mg
Dosage Form:Film-coated Oral Tablets
Route of Administration:Via Oral Route
Packing:12s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antimalarials
Indication: Atovaquone/Proguanil Hydrochloride is a fixed dose combination of atovaquone and proguanil hydrochloride which acts as a blood schizonticide and also has activity against hepatic schizonts of Plasmodium falciparum. It is indicated for: Prophylaxis of Plasmodium falciparum malaria.
Storage:Store in in cool & Dry place. Do not store in bathroom.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Atovaquone and Proguanil Hydrochloride Tablet (250mg+100mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Atovaquone and Proguanil Hydrochloride Tablet (250mg+100mg)
    Each film-coated tablet contains:
    Atovaquone …………………250mg
    Proguanil Hydrochloride ………100mg
    Excipients……………………………. q.s.
    Colour: Titanium Dioxide

THERAPEUTIC INDICATIONS:

Atovaquone/Proguanil Hydrochloride is a fixed dose combination of atovaquone and proguanil hydrochloride which acts as a blood schizonticide and also has activity against hepatic schizonts of Plasmodium falciparum. It is indicated for: Prophylaxis of Plasmodium falciparum malaria.

CAUTION & WARNING:

CAUTION:  TABLET SHOULD BE SWALLOWED WHOLE & DO NOT CHEWED OR CRUSHED.

WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

Keep medicine out of reach of children.

*Not suitable for children under 5 years.

STORAGE & DOSAGE:

STORAGE: Store in in cool & Dry place. Do not store in bathroom.

Read enclosed leaflet before use.

Dosage: As Directed by the Physician.

Note: One tablet is taken 1-2 days before entering the endemic area (area affected with malaria). Then continued as a ONCE DAILY dose which in that area. Once you leave the area with malaria you must continue the ONCE DAILY regime for a further 7 days.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Atovaquone and Proguanil Hydrochloride Tablet (250mg+100mg)
B. Atovaquone and Proguanil Hydrochloride Tablet (62.5mg+25mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Atovaquone and Proguanil Hydrochloride Tablet (250mg+100mg)
Each film-coated tablet contains:
Atovaquone …………………250mg
Proguanil Hydrochloride ………100mg
Excipients……………………………. q.s.
Colour: Titanium Dioxide


B. Atovaquone and Proguanil Hydrochloride Tablet (62.5mg+25mg)
Each film-coated tablet contains:
Atovaquone …………………62.5mg
Proguanil Hydrochloride ………25mg
Excipients……………………………. q.s.
Colour: Lake Indigo Carmine

THERAPEUTIC INDICATIONS:

Atovaquone/Proguanil Hydrochloride is a fixed dose combination of atovaquone and proguanil hydrochloride which acts as a blood schizonticide and also has activity against hepatic schizonts of Plasmodium falciparum. It is indicated for: Prophylaxis of Plasmodium falciparum malaria.

CAUTION & WARNING:

CAUTION: TABLET SHOULD BE SWALLOWED WHOLE & DO NOT CHEWED OR CRUSHED.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN
*Not suitable for children under 5 years.

STORAGE & DOSAGE:

STORAGE: Store in in cool & Dry place.
Do not store in bathroom.
Read enclosed leaflet before use.
DOSAGE: AS Directed by The Physician.
Note: One tablet is taken 1-2 days before entering the endemic area (area affected with malaria). Then continued as a ONCE DAILY dose which in that area. Once you leave the area with malaria you must continue the ONCE DAILY regime for a further 7 days.