BERNOFLOX Film Coated Tablet

Ciprofloxacin 500 mg

Category:

COMPOSITION :

Bernoflox® Film coated tablet 500 mg, each film coated tablet contains : Ciprofloxacin HCl monohydrate equivalent to Ciprofloxacin 500 mg.

 

DESCRIPTIONS :

Bernoflox® with active ingredient Ciprofloxacin HCl monohydrate (equivalent to Ciprofloxacin) available in 500 mg film coated tablet.

 

INDICATIONS :

Infections caused by Ciprofloxacin sensitive bacteria such as :

  • Urinary tract infections, including prostatitis.
  • Urethritis and gonorrheal cervicitis.
  • Gastrointestinal tract infections including typhoid fever caused by thypii. An eradication effect of Ciprofloxacin in chronic typhoid carrier still unknown.
  • Respiratory tract infections except pneumonia caused by streptococcus.
  • Skin and soft tissue infections.
  • Bones and joints infections.

 

DOSAGE AND ADMINISTRATIONS :

Adults :

  • Mild/moderate urinary tract infections : 2 x 250 mg daily.
  • Severe urinary tract infections : 2 x 500 mg daily.
  • Mild/moderate respiratory tract infections, bone and joints, skin and soft tissue infections : 2 x 250 – 500 mg daily.
  • Severe respiratory tract infections, bone and joints, skin and soft tissue infections : 2 x 500 – 750 mg daily.
  • Chronic prostatitis : 2 x 500 mg.
  • Gastrointestinal infections : 2 x 500 mg daily.
  • Acute gonorrhoeae : 250 mg as single dose.
  • To achieve an adequate serum level in acute osteomyelitis, the administration dose should not be less than 2 x 750 mg daily.

Duration of therapy depends on the severity of infection, clinical improvement and bacteriological. In acute infections, the duration of therapy is usually 5 – 10 days. It is recommended to continue the course of treatment for at least 3 days after symptoms have been reduced or have disappeared.

Dosage for renal impairment :

If creatinine clearance < 20 ml/minute, the normal daily recommended dose should be given only once or each dose should be halved if given twice a day.

 

CONTRAINDICATIONS :

Ciprofloxacin is contraindicated for :

  • Patients with hypersensitivity to Ciprofloxacin or other quinolone derivatives.
  • Pregnancy and lactation.
  • Children under 12 years old.

 

WARNINGS AND PRECAUTIONS :

  • Ciprofloxacin should be swallowed whole with adequate amount of plain water to prevent crystalluria.
  • Caution should be exercised in patients with renal impairment (lihat DOSAGE AND ADMINISTRATIONS).
  • The administered dose should not exceed the recommended dose.
  • Ciprofloxacin should be given carefully in elderly patients.
  • In case of epilepsy and in patients with history of CNS disorders (e.g., low-threshold of seizure, history of convulsion, lower blood circulation to brain and stroke), Ciprofloxacin should only be given if the potential benefits exceed potential risks, since these patients are endangered of possible central nervous side effects.
  • Despite usage as prescribed by the physicians, this drug may influence patients response in ability to drive and operate machinery. This condition will be more severe if this drug is used concomitantly with alcohol.
  • Like other antimicrobial agents, prolonged use of Ciprofloxacin may cause overgrowth of non-susceptible microorganisms.
  • Excessive sunlight exposure should be avoided. Treatment should be discontinued if photosensitivity occurs.

 

PRESENTATION :

Bernoflox® Film coated tablet 500 mg                           Box, 2 strips @ 10 film coated tablets

Reg. No. DKL9302317917A1

 

STORAGE :

STORE BELOW 30ºC, PROTECT FROM LIGHT

 

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by :

PT. BERNOFARM

Sidoarjo – Indonesia

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