Osen 500

Osen 500
17 May

Osen 500

Antibiotics & Antibacterial

- Phenoxymethylpenicillin, an antimicrobial acid, is a highly potent 
  antibacterial oral penicillin. It exerts its killing action on growing 
  and dividing bacteria by inhibiting bacterial cell-wall synthesis. 
  The spectrum of action is virtually identical to that of 
  benzylpenicillin. Phenoxymethylpenicillin has bactericidal action 
  against Gram-positive bacteria and may be less active against some 
  susceptible organisms particularly Gram-negative bacteria. It 
  covers group A,C, G,H,L, and M Streptococci, Streptococcus
   pneumonia, non-penicillinase-producing Staphylococci, 
   Neisseriae, Erysipelothrix rhusiopathiae, Bacillus anthracis and 
  spirochetal species as well as numerous anaerobic agents are
   also sensitive. 
- Phenoxymethylpenicillin potassium is not effected by gastric acid. 
  Absorption is usually rapid and the potassium salt is better 
  absorbed than the free acid. About 80% is reported to be protein 
   bound. 
- Phenoxymethylpenicillin is widely distributed at varying
  concentrations in body and fluids. It is metabolized in the liver.
- Most of the applied dose is eliminated along renal pathways in an 
  unchanged form. Biliary elimination of the active drug is confined
  to a minor fraction of the dose.

Indecation

- OSEN® used for treatment of angina tonsillans, bacterial 
  pneumonia, bronchitis, otitis media, scarlet fever, furuncles,
  abscesses, infection or danger of infection due  haemolytic 
  streptococci, prophylaxis before and after tonsillectomy,
  prophylaxis of recurrences in rheumatic polyarthritis, bacterial 
  endocarditis, glomerulonephritis.
- It is also used to prevent pneumococcal infection in children with 
   sickle cell anemia. 

Dosage & Administration

- It is preferably to be taken at least 30 minutes before or 2 hours      
  after food. 
 Tablets :  For Adults and children :
  OSEN® 500 : 1 tablet 3- 4 times daily. 
  OSEN® 1000: 1/ 2 - 1 tablet 3- 4 times daily.
  During acute stage of severe infections: 1 tablet every 4 hours. 
  As rule, treatment should be continued for further 2 - 5 days 
  following regression of symptoms.
  for prophylaxis of long-term recurrences:
  OSEN® 500: 1 tablet 1 - 2 times daily.
  OSEN® 1000: 1/ 2 - 1 tablet 1- 2 times daily.
  Dry syrup :
- Children may be given the following doses :-  
-  less than 3 years : 5 ml OSEN® 125   3 - 4  times daily
-  3 - 6 years : 5 ml OSEN® 250  3 - 4 times daily
-  over 6 years :  5 - 10 ml OSEN® 250   3 - 4 times daily
- Treatment should be continued for 2 - 5 days after the symptoms 
   have subsided. 
-  For Prevent recurrence of rheumatic fever: 250 mg twice daily. 

- Each film-coated  tablet of OSEN® 1000 contains: 
   Phenoxymethylpenicillin  as potassium      1.000.000 i.u
- Each film-coated  tablet of OSEN® 500 contains: 
   Phenoxymethylpenicillin  as  potassium    500.000 i.u
- Each 5ml of OSEN® 250 oral solution contains: 
   Phenoxymethylpenicillin  as potassium     400.000 i.u
- Each 5ml of OSEN® 125 oral solution contains: 
   Phenoxymethylpenicillin as potassium      200.000 i.u

- History of penicillin or cephalosporins hypersensitivity.
- Manifest gastrointestinal disturbance (diarrhea,vomiting).  

- OSEN® should not be combined with bacteriostatic antibiotics. 
- Competitive inhibition of OSEN® elimination should be 
   remembered, whenever NSAIDs (indomethacin, phenylbutazone 
   and salicylate in high doses) or probenecid are used comcomitantly.
- Ingestion of  OSEN® with meals reduces the absorption of the drug.

- There is no evidence suggesting that OSEN® has embryotoxic, 
   teratogenic or mutagenic effects. 
- OSEN® may be present in breast milk.

- OSEN® is usually well tolerated but may occasionally cause 
   transient nausea and diarrhoea. 
- The most common adverse effects are hypersensitivity reactions 
  especially skin rash.   

- Patients known to be hypersensitive to penicillins should be given an 
  antibacterial of another class. 
- Dosage may need to be modified in severe renal impairment. 
- During long-term treatment attention should be paid to the potential   
  overgrowth of resistant micro-organisms and fungi. 
- Particular caution should be exercised in patients with an allergic 
  diathesisor with bronchial asthma.

- OSEN® 1000 tablet :(Blister of 10 tablets , pack of 2 blisters)
- OSEN® 500 tablet :(Blister of 10 tablets , pack of 2 blisters)
- OSEN® 250 Oral solutions (bottle of 100 ml after reconstitution)
- OSEN® 125 Oral solutions (bottle of 100 ml after reconstitution)

- Store  in dry place, at a temperature below 250C
- After reconstitution store in a refrigerator and use within one week.