OFLOBAC® 400
OFLOBAC® 400
Broad Spectrum antimicrobial

Indication

OFLOBAC® is used in the treatment of a wide range of infections including: 

  • Biliary tract infections. 
  • Bones and joint infections. 
  • Gastro-enteritis (including diarrhoea and campylobacter enteritis, cholera, shigellosis and salmonella enteritis.)
  • Meningitis, otitis media and Q-fever.
  • Lower respiratory tract infections. 
  • Skin infections, septicemia and leprosy. 
  • Typhoid and paratyphoid fever. 
  • Urinary tract infections and exacerbation of cystic fibrosis.

Composition

Each film-coated tablet of  OFLOBAC® 400 contains:

  • Ofloxacin      400 mg  

Each film-coated tablet of  OFLOBAC® 200 contains: 

  • Ofloxacin      200 mg 

Dosage

  • The usual adult oral dose of OFLOBAC® ranges from 200 mg to 400 mg twice daily depending on the severity and the nature of the infection.
  • Oral doses of OFLOBAC® up to 400 mg may be given as a single dose, preferably in the morning.

¤ OFLOBAC® must be taken on the empty stomach at least 1 hour before or 2 hours after meals with a full glass of water.

  • Ofloxacin is a fluoroquinolone, synthetic broad spectrum antimicrobial agent for oral administration. 
  • Ofloxacin is rapidly well absorbed from the gastro-intestinal tract. Oral bioavailability is almost 100% and a peak plasma concentration of 3 to 5 μg/ml is achieved 1 to 2 hours after a dose of 400 mg by mouth. 
  • Absorption may be delayed by the presence of food, but the extent of absorption is not substantially affected. The plasma half-life ranges from 4 to7 hours.
  • Ofloxacin is widely distributed in body fluids, including the CSF, It crosses the placenta and distributed into breast milk. It  also appears in the bile. 
  • Ofloxacin has a  limited metabolism to desmethyl and N-oxide metabolites, desmethylofloxacin has moderate antibacterial activity. 
  • Ofloxacin is eliminated mainly by the kidneys and 65 to 80% of a dose is excreted unchanged in the urine, over 24 to 48 hours. 

Each film-coated tablet of  OFLOBAC® 400 contains:

  • Ofloxacin      400 mg  

Each film-coated tablet of  OFLOBAC® 200 contains: 

  • Ofloxacin      200 mg 

OFLOBAC® is used in the treatment of a wide range of infections including: 

  • Biliary tract infections. 
  • Bones and joint infections. 
  • Gastro-enteritis (including diarrhoea and campylobacter enteritis, cholera, shigellosis and salmonella enteritis.)
  • Meningitis, otitis media and Q-fever.
  • Lower respiratory tract infections. 
  • Skin infections, septicemia and leprosy. 
  • Typhoid and paratyphoid fever. 
  • Urinary tract infections and exacerbation of cystic fibrosis.

OFLOBAC® is contraindicated in

  • patients with a history of hypersensitivity to Ofloxacin or other quinolone derivatives. 
  • Epileptics and patients with pre-existing CNS lesions. 
  • Children, adolescent, pregnant or breast-feeding mothers.
  • Fluoroquinolones are known to inhibit hepatic drug metabolism and may interfere with the clearance of drugs metabolized by the liver such as theophylline.
  • On the other hand, Cations like aluminium, magnesium, or iron reduce the absorption of ofloxacin and related drugs when given concomitantly.
  • OFLOBAC® should be used during pregnancy only if clearly needed
  • OFLOBAC® should be used with caution in lactating mothers.

As with other quinolones, side effects are usually:

  • Gastrointestinal disturbances including: nausea, vomiting, diarrhoea, abdominal pain and dyspepsia.
  • Headache, dizziness and restlessness are among the commonest effects on the CNS.
  • Hypersensitivity type reactions affecting the skin, in addition to rash and pruritus. 
  • The usual adult oral dose of OFLOBAC® ranges from 200 mg to 400 mg twice daily depending on the severity and the nature of the infection.
  • Oral doses of OFLOBAC® up to 400 mg may be given as a single dose, preferably in the morning.

¤ OFLOBAC® must be taken on the empty stomach at least 1 hour before or 2 hours after meals with a full glass of water.

  • OFLOBAC® should be used with caution in psychiatric disorders, renal and hepatic impairment, glucose-6-phosphate dehydrogenase deficiency and diabetes.
  • During treatment, patients should not expose themselves to sunlight, UV rays or sunray lamp (due to photosensitivity reactions.)
  •  Avoid driving or other activities requiring alertness. 
  • Antacid or iron should not be taken within 2 hours of taking OFLOBAC®.   
  • OFLOBAC® tablet 400 mg (Blisters of 10 Tablets, Pack of one blister).
  • OFLOBAC® tablet 200 mg (Blisters of 10 Tablets, Pack of one blister).

Hospital packs of different sizes

  • Store in a dry place at a temperature  not exceeding 25°C.