TOCEF 100mg Film Coated Tablet

Cefixime trihydrate equivalent to Cefixime 100 mg.

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COMPOSITIONS :

Tocef® Film Coated Tablet 100 mg, each film coated tablet contains : Cefixime trihydrate equivalent to Cefixime 100 mg.

 

INDICATIONS :

Cefixime is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms :

  • Uncomplicated urinary tract infections caused by Escherichia coliand Proteus mirabillis.
  • Otitis media caused byHaemophilus influenzae (β-lactamase positive and negative strains), Moraxella (Branhamella) catarrhalis (most of which are β-lactamase positive strains) and Streptococcus pyogenes.
  • Pharyngitis and tonsilitis caused by Streptococcus pyogenes.
  • Acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae (β-lactamase positive and negative strains).
  • Treatment of typhoid fever in children, with multi-resistant to the standard drug regiments.
  • Uncomplicated gonorrhea (cervical/urethral) which caused by Neisseria gonorrhoeae (penicillinase and non penicillinase producing strains).

 

DOSAGE AND ADMINISTRATIONS :

  • Tocef®Film coated tablet 100 mg and Film coated caplet 200 mg : For adults and children weighing > 30 kg, the usual recommended daily dose is 50 – 100 mg (potency) of Cefixime given orally twice daily. Dosage should be adjusted according to the age, body weight and condition of the patient. For more severe or intractable infection, the dosage may be increased up to 200 mg (potency) given twice daily.

 

CONTRAINDICATIONS :

Patients with a history of shock or hypersensitivity caused by any ingredients of this product.

 

WARNINGS AND PRECAUTIONS :

  • General precaution : Careful inquiry about any form of hypersensitivity should be made, since reactions such as shock may occur.
  • This product should not be administered to the following patients as a general rule. Patients with a past history of hypersensitivity to other cephem antibiotics. If necessary, however it can be administered with care.
  • Careful administration :
  1. Patients with a history of hypersensitivity to Penicilins.
  2. Patients with a personal or familial history of some form of allergy such as bronchial asthma, rash, urticaria.
  3. Patients with serious renal function disorder.
  4. Patients with poor oral nutrion, patient receiving parenteral nutrition, elderly patients or patients in a debilitated state. Careful observation is essential in these patients as vitamin K deficiency symptoms may develop.
  • Using during pregnancy : Safety during pregnancy has not been established. This product should be administered to pregnant patients or woman suspected of being pregnant, only if the expected therapeutic benefit is thought to outweigh any possible risk.
  • Use in nursing mother : It is not known whether Cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporary during treatment with this drug.
  • Use in newborns or prematures : Efficacy and safety in children aged less than 6 months have not been established (including in newborn and prematures).

 

 

PRESENTATIONS :

Tocef® 100 mg is available in the form of white film-coated tablets with the marking b breakline f on one side and plain on the other, packaged in :

Box, 3 blisters @ 10 film-coated tablets Reg. No. : DKL2202366117A1

 

STORAGE :

STORE BELOW 25ºC

After reconstitution, the suspension may be kept for 7 days either at room temperature or under refrigeration, without significant loss of potency. Keep tightly closed. Discard unused portion after 7 days.

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by :
BERNOFARM

Sidoarjo – Indonesia

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