OFLOXIN Plus

OFLOXIN Plus
17 May

OFLOXIN Plus

Antibiotics & Antibacterial

- OFLOXIN® plus is a fixed dose combination of ofloxacin, a second 
  generation quinolone antibiotic, and ornidazole, a 5-nitroimidazole derivative. 
- Ofloxacin is a broad spectrum antibiotic, exert a bactericidal effect on
  susceptible microorganisms by inhibiting DNA gyrase, an essential enzyme
  that is a critical catalyst in the duplication, transcription, and repair of bacterial 
  DNA.
- Ofloxacin has been shown both in vitro and in specific clinical infections to
  be active against most strains of the following organisms:
  Aerobic gram-positive bacteria: Staphylococcus aureus, Staphylococcus
  epidermidis, Streptococcus pneumoniae.
  Aerobic gram-negative bacteria: Enterobacter cloacae, Haemophilus 
  influenzae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia marcescens.
  Anaerobic bacteria: Propionibacterium acnes.
- Ofloxacin is rapidly and well absorbed from the gastrointestinal tract. 
  Absorption may be delayed by the presence of food, but the extent of 
  absorption is not substantially affected. About 25% is bound to plasma
  proteins. Ofloxacin is widely distributed in body fluids, including the CSF, and 
  tissue penetration is good. It crosses the placenta and is distributed into breast 
  milk. It also appears in the bile. The elimination of ofloxacin is biphasic; 
  half-lives of about 4 to 5 and 20 to 25 hours have been reported for the 2 
  phases, respectively. Ofloxacin is eliminated mainly by the kidneys. Between 
  65 to 80% of a dose is excreted unchanged in the urine over 24 to 48 hours, 
  resulting in high urinary concentrations. Less than 5% is excreted in the urine
  as metabolites. From 4 to 8% of a dose may be excreted in the faeces. Only 
  small amounts of ofloxacin are removed by haemodialysis or peritoneal
  dialysis.
- Ornidazole, like other nitroimidazoles, kills the susceptible organisms by 
  targeting the DNA synthesis and inhibits the nucleic acid formation.
- Ornidazole is active against several protozoa including Balantidium coli, 
  Entamoeba histolytica, Giardia intestinalis and Trichomonas vaginalis.
  Most obligate anaerobic bacteria including bacteroides and clostridium spp.
  are sensitive in vitro to ornidazole. It is bactericidal. It also has activity against 
  the facultative anaerobes Gardnerela vaginalis and Helicobacter pylori and 
  against some sphirochaetes. 
- It shows superior efficacy as compared to other nitroimidazole and is thus 
  preferred in treatment of protozoal infections. 
- Ornidazole is rapidly absorbed from the gastrointestinal tract. Peak plasma 
  concentration is achieved within 3 hours. The plasma elimination half-life of 
  ornidazole is 12 to 14 hours. Less than 15% is bound to plasma proteins. It is
  widely distributed in body tissues and fluids including the cerebrospinal fluid.  
   Ornidazole is metabolized in the liver and
  is excreted in the urine, mainly as conjugates and metabolites, and to a lesser 
  

  extent in faeces. Biliary excretion may be important in the elimination of 
  ornidazole and its metabolites.

Indecation

  OFLOXIN® plus is indicated for the treatment of:
- Diarrhoea and dysentery of bacterial or protozoal infections (amoebiasis and 
  giardiasis) origin or mixed infections. 
- Pelvic inflammatory disease.
- Post surgical care: including prophylaxis in elective surgery, post appendectomy, 
  intra-abdominal infections or Hernia repair.
- Dental infections: including root canal infections, peripheral abscess, 
  periodontal abscess, and pre and post-operative care.
- Ear, Nose and Throat infections.
- Skin and soft tissue infections.

Dosage & Administration

- For adults: The usual dose of OFLOXIN® plus is one tablet twice daily or as
   directed by the physcian.
- In pediatric patients: Ofloxacin 7 - 10 mg/kg/day and Ornidazole 25 - 40  
  mg/kg/day. 
  Adults and Adolescents (Age 13 years and older):
- Amoebiasis: one tablet twice daily for 5 - 10 days.
- Amoebic dysentery: 3 tablets as a single dose.
- Trichomoniasis: 3 tablets as a single dose or one tablet twice daily for 5 days.
- Giardiasis: 2 - 3 tablets as a single daily dose for 1 or 2 days. 
- Anaerobic bacterial infections: one tablet twice daily or 2 tablets as a single
  daily dose for 5 - 10 days.

Overdosage:-
- For acute overdosage induce vomiting or give gastric lavage to empty the 
  stomach. Symptomatic supportive therapy is instituted with monitoring of all 
  vital functions.

- Each film-coated tablet of OFLOXIN® plus contains: 
       Ofloxacin                                200 mg 
       Ornidazole                              500 mg

- Hypersensitivity.
- Pregnancy.
- Anuric patients. 

- Fluoroquinolones are known to inhibit hepatic drug metabolism and may
  interfere with the clearance of drugs metabolized by the liver such as 
  cyclosporine, theophylline/ methylxanthines, warfarin, etc.. On the other 
  hand, cations like aluminum, magnesium, or iron reduce the absorption of 
  ofloxacin when given concomitantly. 
- Non-steroidal anti-inflammatory drugs: The concomitant administration of
  ofloxacin may increase the risk of CNS stimulation and convulsive seizures. 

- Antidiabetic agents:
- The concomitant administration of antidiabetic agents with 
  OFLOXIN® plus may disturbe blood glucose, thereby, careful monitoring of 
  blood glucose is recommended.
- Ornidazole when given in conjunction with alcohol, ornidazole may provoke a 
  disulfiram-like reaction in some individuals. Acute psychoses or confusion has 
  been associated with the concomitant use of ornidazole and disulfiram. 
- Ornidazole is reported to impair the metabolism or excretion of several drugs
  including warfarin, phenytoin, lithium, and fluorouracil, with the consequent 
  potential for an increased incidence of adverse effects. Plasma concentrations of 
  ornidazole are decreased by the concomitant administration of phenobarbitone or 
  phenytoin. 
- Cimetidine has increased plasma concentrations of ornidazole and might 
  increase the risk of neurological side effects.

- OFLOXIN® plus is well tolerated, rarely shows following side effects: 
  Allergic reactions: cough, rhinorrhea, and urticaria. In addition, it shows 
  dyspepsia, dysmenorrhea, menorrhagia, seizures, anxiety, cognitive change, 
  depression, dream abnormality, euphoria, hallucinations, syncope, vertigo, 
  tremor and/or confusion.

- General: Adequate hydration of patients receiving OFLOXIN® plus should be 
  maintained to prevent the formation of a highly concentrated urine. 
- Administer OFLOXIN® plus with caution in patients with known or suspected
  renal or hepatic insufficiency/impairment, careful clinical observation and 
  appropriate laboratory studies should be performed prior to and during therapy 
  since elimination of ofloxacin may be reduced. In patients with impaired renal 
  function (creatinine clearance < 50 mg/ml), alteration of the dosage regimen is
   necessary. 
- Patients receiving haemodialysis should be given a supplemental dose 
  equivalent to one-half of the usual dose of ornidazole before dialysis. 
- Phototoxicity reactions may be observed in patients exposed to direct sunlight 
  with ofloxacin. Therapy should be discontinued if phototoxicity (e.g., skin 
  eruption, etc.) occurs. 
- Ofloxacin and other fluoroquinolones can cause degenerative changes in weight 
  bearing joints of young animals, they should only be used in children and 
  adolescents where their use may be justified if the benefits outweigh the risks.

- Blister of 10 tablets, pack of 1 blisters.

- Store at a temperature not exceeding 30°C in a dry place.