Febuxostat Tablets 40mg
Categories: , , ,
Date:

Febuxostat Tablets 40mg Technical Specification:

Product Name:Febuxostat Tablet 40mg
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), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
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 25°C (77°F), excursions permitted to 15°C to 30°C (59°F and 86°F) (See USP Controlled room temperature). Protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Febuxostat Tablet 40mg
    Each film-coated tablet contains:
    Febuxostat…………………….40mg
    Excipients………………………q.s.
    Colour: Ponceau 4R
  • Febuxostat Tablet 80mg
    Each film-coated tablet contains:
    Febuxostat…………………….80mg
    Excipients………………………q.s.
    Colour: Quinoline Yellow
  • Febuxostat Tablet 120mg
    Each film-coated tablet contains:
    Febuxostat…………………….120mg
    Excipients………………………q.s.
    Colour: FD&C 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

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

STORAGE & DOSAGE:

Storage:  Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F and 86°F) (See USP Controlled room temperature). Protect from moisture.

Dosage:  As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Febuxostat Tablet 40mg
Each film-coated tablet contains:
Febuxostat…………………….40mg
Excipients………………………q.s.
Colour: Ponceau 4R

B. Febuxostat Tablet 80mg
Each film-coated tablet contains:
Febuxostat…………………….80mg
Excipients………………………q.s.
Colour: Quinoline Yellow

C. Febuxostat Tablet 120mg
Each film-coated tablet contains:
Febuxostat…………………….120mg
Excipients………………………q.s.
Colour: FD&C 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

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

STORAGE & DOSAGE:

Storage: Store at 25°C (77°F),, excursions permitted to 15°C to 30°C (59°F and 86°F) (See USP Controlled room temperature). Protect from moisture.

Dosage: As directed by the Physician.