Roxilab PFS

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Generic : Cefuroxime Axetil
Therapeutic : Cefuroxime Axetil

Composition :

Roxilab 250 Tablet: Each film coated tablet contains Cefuroxime 250 mg as Cefuroxime Axetil BP.

Roxilab 500 Tablet: Each film coated tablet contains Cefuroxime 500 mg as Cefuroxime Axetil BP.

Roxilab Powder for Suspension: Each 5 ml reconstituted suspension contains 125 mg Cefuroxime as Cefuroxime Axetil BP.

Description :

Cefuroxime  is  one  of  the  bactericidal  second  generation  cephalosporin antibiotics which is active against a wide range of Gram-positive and Gram-negative  susceptible  organisms  including  many  beta-lactamase  producing strains.

Indications :

Cefuroxime is indicated in the treatment of:

Pharyngitis/Tonsillitis caused by Streptococcus pyogenes. Acute  bacterial  otitis  media  caused  by  Streptococcus  pneumoniae, Haemophilus influenzae (including beta-lactamase producing strains), Moraxella catarrhalis  (including  beta-lactamase  producing  strains)  or  Streptococcus

pyogenes.

Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae (non-beta-lactamase producing strains only).

Acute bacterial exacerbations of chronic bronchitis and secondary bacterial infections  of  acute  bronchitis  caused  by  Streptococcus  pneumoniae, Haemophilus  influenzae  (beta-lactamase  negative  strains),  or  Haemophilus parainfluenzae (beta-lactamase negative strains).

Uncomplicated skin and skin-structure infections caused by Staphylococcus aureus (including beta-lactamase producing strains) or Streptococcus pyogenes. Uncomplicated urinary tract infections caused by Escherichia coli or Klebsiella pneumoniae.

Uncomplicated gonorrhoea (urethral and endocervical) caused by penicillinase-producing and non-penicillinase producing strains of Neisseria gonorrhoeae and uncomplicated gonorrhoea, rectal, in females, caused by non-penicillinase producing strains of Neisseria gonorrhoeae. Impetigo  caused  by  Staphylococcus  aureus  (including  beta-lactamase producing strains) or Streptococcus pyogenes.

Dosage and Administration :

Cefuroxime Tablets:

Cefuroxime Suspension:

Side effects :

Cefuroxime has been associated with nausea, vomiting, headache, rashes, dizziness in a small number of patients.

Use in special group :

Pregnancy: There is no experimental evidence of embryopathic or teratogenic effect  attributable  to  Cefuroxime  but  as  with  all  medicines,  it  should  be administered with caution during the early months of pregnancy.

Nursing mother: Cefuroxime is excreted in human milk and consequently, caution should be exercised when Cefuroxime Axetil is administered to a nursing mother.

Pediatric  use:  The  safety  and  effectiveness  of  Cefuroxime  have  been established for pediatric patient aged 3 months to 12 years for acute bacterial maxillary sinusitis based upon its approval in adults.

Contraindications :

Cefuroxime is contraindicated in patients with known allergy to cephalosporins.

Precautions :

Prolonged use of Cefuroxime may result in the over growth of non-susceptible organisms (e.g. Candida, Enterococci, Clostridium difficile), which may result interruption of treatment.

Drug Interaction :

No potentially hazardous interaction have been reported. In common with other antibiotics, Cefuroxime Axetil may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral contraceptives.

Storage :

Store in a cool and dry place, away from light. Keep out of the reach of children.

Commercial Pack :

Roxilab 250 Tablet: Each box contains 2 x 7 tablets in Alu-Alu blister pack.

Roxilab 500 Tablet: Each box contains 1 x 7 tablets in Alu-Alu blister pack.

Roxilab Powder for Suspension: Each bottle contains Cefuroxime powder for

preparation of 70 ml suspension.



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