NOROX 400

NOROX 400
17 May

NOROX 400

Antibiotics & Antibacterial

- Norfloxacin is a synthetic broad spectrum antibacterial  agent, belongs to 
 the group of the fluoroquinolones.   
-Norfloxacin has antibacterial activity against gram positive& gramnegative 
 aerobic pathogens; it is more active  with broad spectrum of inhibition  than 
 earlier quinolones.
- Norfloxacin  destroys bacteria by inhibition of a substance  which certain 
 bacteria require in order to multiply.
- About 30 to 40% of an oral dose of Norfloxacin is absorbed and the peak 
 plasma concentrations of about 1.5 μg / ml have achieved 1 to 2 hours after 
 the administration of 400 mg dose by mouth.  
- The presence of food can delay absorption.
- The plasma half life is about 4 hours & may be prolonged in renal  
 impairment; a value of 6.5 hours or more has been reported, when 
 creatinine clearance is below 30 ml / minute.
- Norfloxacin has been reported to be 14% bound to plasma  proteins & is 
 widely distributed.
- Norfloxacin  penetrates  well  into tissues of  genito-urinary tract, it crosses 
 the placenta, relatively high concentrations are achieved in bile.
- About 30% of dose is excreted unchanged in the urine within 24 hours 
 producing high urinary concentrations.
- Norfloxacin is bactericide  & active against the following 
 bacteria: 
* Bacteria found in urinary tract infections: entrobacteriaceae, 
  pseudo-monadaceae &  gram positive cocci.
* Bacteria associated with acute gastroenteritis.
* Bacillus cereus, Neisseria gonorrhoeae,  Ureaplasma 
 urealyticum & Haemophilus influenzae

Indecation

 NOROX® is indicated for the treatment of: 
- Upper and lower infections complicated, uncomplicated, acute & chronic 
 urinary tract infections include cystitis, pyelitis, 
 cystopyelitis,pyelonephritis, chronic prostatitis, epididymitis & those 
 urinary infections associated with 
 urologic surgery, neurogenic bladder or nephrolithiasis caused by bacteria 
 susceptible to NOROX®    
- A severe infection of the stomach & small intestines.
- Gonorrheal urethritis, proctitis or cervicitis caused by both penicillinase & 
 non penicillinase producing Neisseria gonorrhea.
- Typhoid fever. 
- The prophylaxis infections in patients with profound neutropenia.
- Peritonitis.
- Infections caused by multiple-resistant organisms. 

Dosage & Administration

 - In urinary tract infections: the usual dosage is 400 mg twice  daily for 
  3 -10 days.  
- For chronic recurrent urinary tract infections: 400 mg twice daily   
  prescribed for up to 12 days.  
  For chronic prostatitis, the recommended dosage is 400 mg twice daily for 
 at least 4 weeks. 

- For stomach & intestinal inflammation, the usual dose is 400  mg twice 
 daily for 5 days.  
- For Acute gonorrhoeal urethritis, proctitis or cervicitis: 800 mg single dose 
 is usually recommended.  
- Typhoid fever: 400 mg three times daily for 14 days. 
 Note: In chronic recurrent urinary tract infections, if adequate suppression is 
 obtained within the first 4 weeks of therapy the dose of NOROX®    may be 
 reduced to 400 mg daily.   

Prophylaxis:-
- Sepsis of profound neutropenia: 400 mg three times daily.
- Renal impairment: the recommended dose is 400 mg once daily for patients 
 with creatinine clearance of 10-30 ml / min / 1.73 m2      
- Bacterial gastroenteritis: 400 mg daily for starting with 24 hrs prior to arrival 
 & continuing 48 hrs after departure form endemic areas. 
- NOROX®  should be taken at least one hour before or 2 hours  after a meal 
 with glass of water. 

* Each film-coated tablet of  NOROX®  400 contains:
   Norfloxacin (USP) 400 mg

- Hypersensitivity to NOROX®  or other members of quinolone group of 
 antibacterial agents.
- In both kidney & liver disease.
- NOROX®  should not be used in children. 

- Norfloxacin may enhance the effects of Theophylline and oral anticoagulant, 
 Warfarin or its derivatives. 
- Norfloxacin should not be taken within two hours of taking Multivitamins, or 
 drugs containing Iron, Zinc, Antacids or Sucralfate.
- Probenecid diminishes  the urinary excretion of Norfloxacin   
 when co-administered with each other.  

- NOROX® should be used during pregnancy only if clearly needed. 
- It is not known whether NOROX® is secreted in breast milk. 
- A decision should be made to discontinue nursing or to discontinue the drug, 
 taking into account the importance of the drug to mother. 

Side effects :-
 The most frequent adverse reaction are gastro–intestinal disturbances include: 
 nausea, vomiting, abdominal pain and dyspepsia.
 Rarely: headache, dizziness, and  restlessness, rash, pruritis ahypersensitivity 
 reactions.

- NOROX®  should be used with caution & doses may need to be reduced in 
 patients with severe renal & hepatic impairment, glucose-  6-phosphate 
 dehyrogenase deficiency, epilepsy or a history of  CNS  disorders.
- Excessive sun light should be avoided while receiving  
 NOROX®  & discontinue therapy if phototoxicity occurs. 

 NOROX® tablet 400 mg (blister of 10 tablets, pack of one blister)

-Store in a dry place at a temperature not exceeding 25oC.