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LUMIGARD:

 
 
 
   
   
   
 
    
 
 
   Abridged Prescribing Information
     
     
 
  Composition
   
  Each tablet of LUMIGARD contains:
  Ofloxacin…200 mg
  Ornidazole…500 mg
   
   
  Therapeutic Indications & Usage
   
 
LUMIGARD is indicated for:
   
 
Mixed diarrheas Postoperative infections

Respiratory tract infections

» Lower respiratory tract
 
  • Lung abscess/empyema
  • Bronchiectasis
» Upper respiratory tract
 
  • Chronic sinusitis
  • Purulent sinusitis
  • Peritonsillar abscess
Appendicitis
All abscesses
Biliary infections
Osteomyelitis
Wound infections
  » Postoperative
  » Infected decubitus ulcer
Immunocompromised patients
  » Infections in cancer patients
 
  • Wounds
  • Tumor infection
Gynecological infections    
Dental infections    
Diabetic foot infections    
   
  LUMIGARD is advocated as prophylaxis for:
   
 
Postoperative infections Wound infections
» Gynecological surgeries » Post-operative
» Medical termination of pregnancy Immunocompromised patients
» Abdominal surgeries » Wounds in cancer patients
» Oral surgery » Wounds in AIDS patients
   
   
  Contraindications
   
 

LUMIGARD is contraindicated in patients with known hypersensitivity to this product or any of its ingredients, or to nitroimidazoles. It is not advocated during the first trimester of pregnancy and in those with history of tendinitis or tendon rupture following use of quinolones. Because of the potential for serious adverse reactions in the nursing infant, LUMIGARD must be either stopped during lactation or nursing discontinued (at least for 3 days after last dose) depending on the importance of the drug to the lactating mother.

   
  GYNOTRIM is not advocated during pregnancy, lactation and in children.
   
   
  Precautions & Warnings
   
 
LUMIGARD must be used with caution in those with known or suspected central nervous system (CNS) disorders such as severe cerebral arteriosclerosis, epilepsy, multiple sclerosis and other factors known or suspected which predispose to seizures. In renal dysfunction, and in those hypersensitive to quinolones, LUMIGARD must be advocated with caution. LUMIGARD must also be advocated with caution in hepatic dysfunction.
   
 
Ofloxacin (in LUMIGARD) must also be avoided in those taking class non-steroidal anti-inflammatory drugs, antacids, hematinics and anticoagulants. Ornidazole also has potential to interact with anticoagulants and muscle relaxants, and hence LUMIGARD must be coadministered along with these agents with due caution.
   
 
Ofloxacin (in LUMIGARD) must also be avoided in those taking class non-steroidal anti-inflammatory drugs, antacids, hematinics and anticoagulants. Ornidazole also has potential to interact with anticoagulants and muscle relaxants, and hence LUMIGARD must be coadministered along these agents with due caution.
   
 
LUMIGARD needs to be discontinued if symptoms of neuropathy occur. It must be stopped if tendon rupture occurs, or if photosensitivity is seen, due to ofloxacin.
   
 
In view of possibility of ofloxacin intake resulting in dizziness and lightheadedness, and ornidazole's potential to cause somnolence, dizziness, tremor, rigidity, poor coordination, seizures, vertigo or temporary loss of consciousness, those taking LUMIGARD must avoid operating an automobile or machinery, or engaging in activities requiring mental alertness and coordination.
   
 
LUMIGARD is to be taken in pregnancy only if strictly necessary. Alcohol beverages must be avoided whilst taking LUMIGARD, and for three days thereafter since simultaneous intake of nitroimidazoles like ornidazole could result in abdominal cramps, flushing, nausea, vomiting, headaches and even psychotic reactions.
   
   
  Adverse Reactions
   
 
Ofloxacin (in LUMIGARD) can cause gastrointestinal intolerance, psychoneurologic symptoms and allergic reactions. It can rarely cause malaise, fever, palpitations, taste abnormality, convulsions, acute renal failure, jaundice, hematologic abnormalities, rhabdomyolysis, hypoglycemia in susceptible diabetics, tendon disorders and psychiatric symptoms such as confusion.
   
 
Mild side effects of ornidazole (in LUMIGARD) include somnolence, headache and gastrointestinal disturbances like nausea and vomiting. Disturbances of the CNS such as dizziness, tremor, rigidity, poor coordination, seizures, tiredness, vertigo, temporary loss of consciousness and signs of sensory or mixed peripheral neuropathy are know to occur with ornidazole (in LUMIGAR). peripheral neuropathy are known to occur with ornidazole (in LUMIGARD). Taste disturbances, abnormal liver function tests and skin reactions can also occur.
   
   
  Drug Interactions:
   
 
Ofloxacin (in LUMIGARD) can interact with nonsteroidal anti-inflammatory drugs, antacids, hematinics and anticoagulants. Ornidazole (in LUMIGARD) can potentiate the action of anticoagulants, and prolong the action of certain muscle relaxants.
   
   
  Recommended Dosage & Administration
   
 
ADULTS: 1 LUMIGARD Tab bid for 3-5 days after food, or as prescribed.
  ELDERLY CHILDREN: ½-1 LUMIGARD Tab bid for 3-5 days after food, or as prescribed.
   
   
  Presentations
   
  LUMIGARD Tablets: Blister strips of 10s.
   
 
 
 
   
 
         
 
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