COMPOSITION :
Bernoflox® Infusion 200 mg/100 ml, each 100 ml contains : Ciprofloxacin lactate monohydrate equivalent to Ciprofloxacin 200 mg.
DESCRIPTIONS :
Bernoflox® with active ingredient Ciprofloxacin lactate monohydrate (equivalent to Ciprofloxacin) available in 200 mg/100 ml infusion.
INDICATIONS :
- Lower respiratory tract in the treatment of outpatients with pneumonia due to Pneumococcus Bernoflox® should not be used as a first choice of drug. Bernoflox® can be regarded as an advisable treatment for pneumonias caused by Klebsiella, Enterobacter, Proteus, Pseudomonas, Haemophilus, Branhamella, Legionella and
- Kidney and/or urinary tract.
- Genital organs, including gonorrhoeae and prostatitis.
- Abdominal cavity (e.g., bacterial infections of the gastrointestinal tract, biliary tract, peritonitis).
- Skin and soft tissue.
- Bones and joints.
Infections or imminent risk of infection (prophylaxis), patients whose immune system has been weakened (e.g., patient on immunosuppressants or in states of neutropenia). Selective intestinal decontamination in immunosuppressed patients.
DOSAGE AND ADMINISTRATIONS :
Single/daily doses for adults (mg Ciprofloxacin)
(2 x daily every 12 hours or 3 x daily every 8 hours)
- Dosage for respiratory tract infection (according to severity and organism) : 2 x 200 – 400 mg.
- Dosage for urinary tract infections :
- Acute, uncomplicated : 2 x 100 mg.
- Cystitis in women (before menopause) : Single dose 100 mg.
- Complicated : 2 x 200 mg.
- Dosage for gonorrhoea :
- Extragenital : 2 x 100 mg.
- Acute, uncomplicated : Single dose 100 mg.
- Dosage for other interactions (see indications) : 2 x 200 – 400 mg.
- Particularly severe, life threatening infections e.g., Streptococcal pneumonia, recurrent infections in cystic fibrosis, bone and joint infections, septicemia, peritonitis : 3 x 400 mg.
After intravenous administration the treatment can be continued orally.
- Dosage for impaired kidney and liver function :
- Creatinine clearance < 20 ml/minute – serum creatinine > 3 mg/100 ml : Half the normal dose twice daily or the full normal dose once a day.
- Impaired kidney function + haemodialysis : Half the normal dose twice daily or the full normal dose once a day, on dialysis days after dialysis.
- Impaired liver function : No dosage adjustment required.
- Impaired kidney and liver function : Half the normal dose twice daily or the full normal dose once a day, possible check Bernoflox® serum levels.
Method of administration :
The intravenous infusion is administered over a period of 30 minutes for 100 and 200 mg or 60 minutes for 400 mg.
The infusion solution may be administered simultaneously with or following other infusion solutions. It may also be injected into infusions which are already running. After the bottle has been broached the drug’s stability is limited by microbiological and hygienic factors. The solutions themselves are not sensitive to oxygen and therefore, are still stable after the containers have been opened.
Where their compatibility with other infusion solutions/drugs has not been proven, the infusion solution and diluted infusion solution concentrate should, in principle, be administered separately. Visible sign of incompatibility include precipitation, clouding, discoloration.
Since Bernoflox® Infusion solution is sensitive to light, the bottles should only be taken out of the cardboard packaging immediately before use in daylight, full efficacy is guaranteed for a period of 3 days.
Duration of use :
The duration of treatment depends upon the severity and the clinical course of the illness and on bacteriological results. Treatment should generally be continued for at least 3 days after the temperature has returned to normal and/or the clinical symptoms have disappeared.
Average duration of treatment :
- 1 day for acute gonorrhoea.
- Up to 7 days of infections of the kidneys, urinary tract and abdominal cavity, throughout the entire neutropenic phase in immunocompromised patients.
- A maximum of 2 months for osteomyelitis.
- And 7 – 14 days for all other interactions.
Treatment should be carried out for a minimum of 10 days in Streptococcal infections due to the risk of late complications.
Initial intravenous treatment may be replaced by oral therapy with Bernoflox® after a few days.
OVERDOSAGE :
In the incident of oral overdose, reversible renal toxicity has been reported in some cases. Therefore, apart from routine emergency measures, it is recommended to monitor renal function and to administer Mg- or Ca-containing antacids which reduce the absorption of Ciprofloxacin.
Only a small amount of Ciprofloxacin (< 10 %) is removed from the body after haemodialysis or peritoneal dialysis.
CONTRAINDICATIONS :
- Patients with hypersensitivity to Ciprofloxacin or other Quinolone derivatives antibiotic.
- Ciprofloxacin should not be prescribed to children (under 18 years old), growing adolescents and pregnant or nursing women, as there is no evidence of its safety when used in these groups and on the basis of results from animal experiments, injury to the articular cartilage of an organism which is not fully grown cannot be completely ruled out.
WARNINGS AND PRECAUTIONS :
- Caution administered in patients with renal impairment.
- The administered dose should not exceed the recommended dose.
- Ciprofloxacin should be given carefully in elderly patients.
- Central nervous system : 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 benefits greater than the risks, because these patients may suffered central nervous system side effects. In these cases, Ciprofloxacin has to be discontinued and the physician should be informed immediately.
- Although given according to a doctor prescription, this drug can interfere with the patients response, ability to drive and run the engine. The disorder will be more severe if this drug is taken with alcohol.
- Skin system : Avoid patients in excessive sunlight exposure or UV-light. If phototoxicity (e. sunburn-like skin reactions) occurs, treatment should be discontinued.
- Severe infections and/or infections due to gram positive or anaerobic bacteria : Ciprofloxacin monotherapy is not suited for treatment of severe infections and infections that might be due to Gram-positive or anaerobic pathogens. In such infections Ciprofloxacin must be co-administered with other appropriate antibacterial agents.
- Streptococcus pneumonia infections : Ciprofloxacin is not recommended for treatment of pneumococcal infections due to inadequate efficacy against Streptococcus pneumoniae.
- Genital tract infections : Epididymo-orchitis and pelvic inflammatory diseases may be caused by Fluoroquinolone-resistant Neisseria gonorrhoeae. Ciprofloxacin should be co-administered with another appropriate antibacterial agent, unless Ciprofloxacin-resistant Neisseria gonorrhoeae can be excluded. If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.
- Cardiac disorders : Ciprofloxacin is associated with cases of QT prolongation. In general, elderly patients may be more susceptible to drugs that affect on the QT interval. Precaution should be taken when using Ciprofloxacin with concomitant drugs that can result in prolongation with the QT interval (e.g., class IA or III antiarrhythmics) or in patients with risk factors for torsade de pointes (e.g., patient with QT prolongation, hypokalemia).
- Children and adult : As with medicinal products in its class, Ciprofloxacin has been proven to cause arthropathy in weight-bearing joints of immature animals. The analysis of available safety data from Ciprofloxacin use in patients less than 18 years old, the majority of whom had cystic fibrosis, did not disclose any evidence of drug-related cartilage or articular damage. The use of Ciprofloxacin has not been studied for indications other than the treatment of acute pulmonary exacerbation of cystic fibrosis caused by Pseudomonas aeruginosa infection (children 5 – 17 years old), complicated urinary tract infections and pyelonephritis due to Escherichia coli (children 1 – 17 years old) and for the use in inhalational anthrax (post-exposure).
- Hypersensitivity : Hypersensitivity and allergic reactions may occur in the use of single dose and a physician should be informed immediately. Anaphylactic reactions are very rare and can be life-threatening after the first administration. If this occurs, Ciprofloxacin should be discontinued and medical treatment (e.g., treatment for shock) is required.
- Gastrointestinal system : In the incident of severe and persistent diarrhea during treatment, a physician must be consulted since this symptom can hide a serious intestinal disease that requires immediate treatment (life-threatening pseudomembranous colitis with fatal outcome). In such cases, the use of Ciprofloxacin must be discontinued and appropriate therapy (e.g., oral Vancomycin 4 x 250 mg/day). Drugs that inhibits peristalsis are contraindicated include aminase, alkaline phosphatase or cholestatic jaundice, especially in patients with liver damage.
- Local IV site reactions have been reported with the intravenous administration of Ciprofloxacin. These reactions are more frequent if the infusion time is 30 minutes or less. These may appear as local skin reactions which resolve rapidly upon completion of the infusion. Subsequent intravenous administration is not contraindicated unless the reactions recur or worsen.
- Musculoskeletal system : Ciprofloxacin should not be used in patients with a history of tendon disease/disorder related to Quinolone treatment. Tendinitis and tendon rupture (especially Achilles tendon), sometimes bilateral, may occur within 48 hours after the use of Ciprofloxacin. The risk of tendinopathy may be increased in elderly patients or in patients concomitantly treated with corticosteroid. At any sign of tendinitis (e.g., painful swelling, inflammation), Ciprofloxacin treatment should be discontinued, immediately contact a doctor to consult on a replacement drugs and avoid other activities that use tendons are affected. Ciprofloxacin should be used cautiously in patients with myasthenia gravis.
- In patients for whom Sodium intake is of medical concern (patients with congestive heart failure, renal failure, nephrotic syndrome, etc.) the additional Sodium load should be taken into account.
- Cytochrome P450 : Ciprofloxacin is a moderate inhibitor of the CYP450 1A2 enzymes. Caution when given concomitantly Ciprofloxacin with drugs which are metabolized via the same enzymatic pathway (e.g., Theophylline, Methylxanthines, Caffeine, Duloxetine, Clozapine). Increased plasma concentrations associated with drug-specific side effects may be observed due to inhibition of their metabolic clearance by Ciprofloxacin.
- Laboratory tests : Ciprofloxacin in vitro potency may interfere with Mycobacterium spp. culture test, thus giving a false negative result.
PRESENTATION :
Bernoflox® Infusion 200 mg/100 ml Box, 1 bottle @ 100 ml
Reg. No. DKL1002342149A1
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
