Febuxostat Tablets 80mg Technical Specification:

Product Name:Febuxostat Tablets 80mg
Brand Name:Generics
Strength:(40mg), (80mg), (120mg)
Dosage Form:Tablet (Film-coated)
Route of Administration:Via oral Route
Packing:30s, 90s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet
Regulatory Documents:COA, MOA, COPP, GMP
Therapeutic use:Antigout Drugs, Anti-hyperuricemia agents.
Indication: Febuxostat is used to lower hyperuricemia (high uric acid in the blood) in patients with gout who have been treated with allopurinol that did not work well or cannot be treated with allopurinol. This medicine is a xanthine oxidase inhibitor. It works by causing less uric acid to be produced by the body.
Storage:Store at a temperature not exceeding 30˚C. Protect from Light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Febuxostat Tablets 40mg
    Each film-coated tablet contains:
    Febuxostat…………………….40mg
    Excipients………………………q.s.
    Colour: Titanium Dioxide IP
  • Febuxostat Tablets 80mg
    Each film-coated tablet contains:
    Febuxostat…………………….80mg
    Excipients………………………q.s.
    Colour: Lake Brilliant Blue Yellow
  • Febuxostat Tablets 120mg
    Each film-coated tablet contains:
    Febuxostat…………………….120mg
    Excipients………………………q.s.
    Colour: Sunset Yellow 6

THERAPEUTIC INDICATIONS:

Febuxostat is used to lower hyperuricemia (high uric acid in the blood) in patients with gout who have been treated with allopurinol that did not work well or cannot be treated with allopurinol. This medicine is a xanthine oxidase inhibitor. It works by causing less uric acid to be produced by the body.

CAUTION & WARNING:

CAUTION:  

Read the enclosed leaflet before use.

Keep the medicine out of reach of children.

SWALLOW WHOLE DO NOT CHEW OR CRUSH

SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage:  Store at a temperature not exceeding 30˚C. Protect from Light and moisture.

Dosage:  As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Febuxostat Tablets 40mg
B. Febuxostat Tablets 80mg
C. Febuxostat Tablets 120mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Febuxostat Tablets 40mg
Each film-coated tablet contains:
Febuxostat…………………….40mg
Excipients………………………q.s.
Colour: Titanium Dioxide IP

b) Febuxostat Tablets 80mg
Each film-coated tablet contains:
Febuxostat…………………….80mg
Excipients………………………q.s.
Colour: Lake Brilliant Blue Yellow


c) Febuxostat Tablets 120mg
Each film-coated tablet contains:
Febuxostat…………………….120mg
Excipients………………………q.s.
Colour: Sunset Yellow 6

THERAPEUTIC INDICATIONS:

Febuxostat is used to lower hyperuricemia (high uric acid in the blood) in patients with gout who have been treated with allopurinol that did not work well or cannot be treated with allopurinol. This medicine is a xanthine oxidase inhibitor. It works by causing less uric acid to be produced by the body.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage: Store at a temperature not exceeding 30˚C. Protect from Light and moisture.

Dosage: As directed by the Physician.