Primaquine Phosphate Tablets USP 7.5mg Technical Specification:

Product Name:Primaquine Phosphate Tablets USP 7.5mg
Brand Name:Generic
Strength:7.5mg, 15mg
Dosage Form:Tablets (Film-coated)
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: Primaquine is a medication used to treat and prevent malaria and to treat Pneumocystis pneumonia.
Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  •  Primaquine Phosphate Tablet USP 7.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Primaquine Phosphate Tablet USP 7.5mg
    Each film-coated tablet contains:
    Primaquine Phosphate USP
    Equivalent to Primaquine………………..7.5mg
    Excipients…………………………………………q.s.
    Colour: Ponceau 4 R

THERAPEUTIC INDICATIONS:

Primaquine is a medication used to treat and prevent malaria and to treat Pneumocystis pneumonia. Specifically, it is used for malaria due to Plasmodium vivax and Plasmodium ovale along with other medications and for prevention if other options cannot be used.

CAUTION & WARNING:

CAUTION: Read the enclosed leaflet before use.

Keep the 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

Adult dosage should not exceed 1 tablet daily for 14 days.

Discontinue promptly if signs suggestive of haemolytic anaemia occur (i.e., darkening of urine, marked fall of haemoglobin, of erythrocyte count).

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Primaquine Phosphate Tablet USP 7.5mg
b) Primaquine Phosphate Tablet USP 15mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Primaquine Phosphate Tablet USP 7.5mg
Each film coated tablet contains:
Primaquine Phosphate USP
Equivalent to Primaquine………………..7.5mg
Excipients…………………………………………q.s.
Colour: Ponceau 4 R


b) Primaquine Phosphate Tablet USP 15mg
Each film coated tablet contains:
Primaquine Phosphate USP
Equivalent to Primaquine…………..15mg
Excipients…………………………………..q.s.
Colour: Fast green FCF

THERAPEUTIC INDICATIONS:

Primaquine is a medication used to treat and prevent malaria and to treat Pneumocystis pneumonia. Specifically, it is used for malaria due to Plasmodium vivax and Plasmodium ovale along with other medications and for prevention if other options cannot be used.

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
Adult dosage should not exceed 1 tablet daily for 14 days.
Discontinue promptly if signs suggestive of haemolytic anaemia occur (i.e., darkening of urine, marked fall of haemoglobin, of erythrocyte count).
Attach dispensing label as per end country.