Levofloxacin Tablet USP 750mg Technical Specification:

Product Name:Levofloxacin Tablet USP
Brand Name:Levotaj
Strength:250mg, 500mg, 750mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via Oral Route
Packing:10s, 20s, 30s, 50s, 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:Anti-biotics (Quinolone)
Indication: Levofloxacin is used to treat bacterial infections in many different parts of the body. This is an antibiotic used to treat various bacterial infections, such as those in the lungs, urinary tract, kidneys, sinuses, and skin.
Storage:Store at 20° to 25°C (68° to 77°F).

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Levofloxacin Tablet USP 700mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  •  Levofloxacin Tablet USP 750mg
    Each Film-coated tablet contains:
    Levofloxacin Hemihydrate USP
    Eq. to Levofloxacin USP…………………….…..750mg
    Excipients …………………………………..…….……q.s
    Colour:Ferric Oxide of Iron Yellow USP

THERAPEUTIC INDICATIONS:

  • Levofloxacin is used to treat bacterial infections in many different parts of the body. It is also used to treat anthrax infection after inhalational exposure. Levofloxacin is also used to treat and prevent plague (including pneumonic and septicemic plague) This is an antibiotic used to treat various bacterial infections, such as those in the lungs, urinary tract, kidneys, sinuses, and skin.

CAUTION & WARNING:

  • CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
  • 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).
  • Dosage: As directed by the Physician.

Attach dispensing label as per end county.

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Levofloxacin Tablet USP 250mg
B) Levofloxacin Tablet USP 500mg
C) Levofloxacin Tablet USP 700mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Levofloxacin Tablet USP 250mg
Each Film-coated tablet contains:
Levofloxacin Hemihydrate USP
Eq. to Levofloxacin USP…………………….…..250mg
Excipients …………………………………..…….……q.s
Colour: Red Oxide of Iron and Titanium Dioxide USP

B) Levofloxacin Tablet USP 500mg
Each Film-coated tablet contains:
Levofloxacin Hemihydrate USP
Eq. to Levofloxacin USP…………………….…..500mg
Excipients …………………………………..…….……q.s
Colour: Red Oxide of Iron and Titanium Dioxide USP

C) Levofloxacin Tablet USP 750mg
Each Film-coated tablet contains:
Levofloxacin Hemihydrate USP
Eq. to Levofloxacin USP…………………….…..750mg
Excipients …………………………………..…….……q.s
Colour: Red Oxide of Iron and Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

Levofloxacin is used to treat bacterial infections in many different parts of the body. It is also used to treat anthrax infection after inhalational exposure. Levofloxacin is also used to treat and prevent plague (including pneumonic and septicemic plague) This is an antibiotic used to treat various bacterial infections, such as those in the lungs, urinary tract, kidneys, sinuses, and skin.

CAUTION & WARNING:

CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN. 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).
Dosage: As directed by the Physician.
Attach dispensing label as per end county.