Cefuroxime Axetil Tablets USP 250mg

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Cefuroxime Axetil Tablets USP 500mg
b) Cefuroxime Axetil Tablets USP 250mg
c) Cefuroxime Axetil Tablets USP 125mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Cefuroxime Axetil Tablets USP 500mg
Each film coated tablet contains:
Cefuroxime Axetil USP
Equivalent to Cefuroxime…………..500mg
Excipients………………………………….q.s.
Color: Red oxide of iron

b) Cefuroxime Axetil Tablets USP 250mg
Each film coated tablet contains:
Cefuroxime Axetil USP
Equivalent to Cefuroxime ………..250mg
Excipients………………………………….q.s.
Color: Tartrazine

c) Cefuroxime Axetil Tablets USP 125mg
Each film coated tablet contains:
Cefuroxime Axetil USP
Equivalent to Cefuroxime ………..125mg
Excipients………………………………….q.s.
Color: Sunset yellow FCF

THERAPEUTIC INDICATIONS:

Cefuroxime is used to treat certain infections caused by bacteria, such as bronchitis (infection of the airway tubes leading to the lungs); gonorrhea (a sexually transmitted disease); Lyme disease (an infection that may develop after a person is bitten by a tick); and infections of the skin, ears, sinuses, throat, tonsils, and urinary tract.

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.

Cefuroxime Axetil Tablets USP 250mg Technical Specification:

Product Name:Cefuroxime Axetil Tablets USP
Brand Name:Generic
Strength:500mg, 250mg, 125mg
Dosage Form:Tablets
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:β-lactam Antibiotic, Anti-bacterial & Cephalosporins.
Indication: Cefuroxime is used to treat certain infections caused by bacteria, such as bronchitis (infection of the airway tubes leading to the lungs); gonorrhea (a sexually transmitted disease); Lyme disease (an infection that may develop after a person is bitten by a tick); and infections of the skin, ears, sinuses, throat, tonsils, and urinary tract.
Storage:Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Cefuroxime Axetil Tablets USP 250mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Cefuroxime Axetil Tablets USP 250mg
    Each film-coated tablet contains:
    Cefuroxime Axetil USP
    Equivalent to Cefuroxime…………..250mg
    Excipients………………………………….q.s.
    Color: Tartrazine

THERAPEUTIC INDICATIONS:

Cefuroxime is used to treat certain infections caused by bacteria, such as bronchitis (infection of the airway tubes leading to the lungs); gonorrhea (a sexually transmitted disease); Lyme disease (an infection that may develop after a person is bitten by a tick); and infections of the skin, ears, sinuses, throat, tonsils, and urinary tract.

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

Attach dispensing label as per end country.