Ciprofloxacine

Visa No.: 893115177625

Product: Ciprofloxacin EG 500 mg

API: Ciprofloxacine

Product Category: Antibiotics

Version approved leaflet: 181/QĐ-QLD_27/03/2018_161

INDICATIONS

Ciprofloxacin is indicated for the treatment of severe infections where commonly used antibiotics are no longer effective, in order to prevent the development of ciprofloxacin-resistant bacteria. Ciprofloxacin is used for the treatment of infections caused by susceptible organisms, including:

Adults:

• Lower respiratory tract infections (including pneumonia, acute exacerbations of chronic obstructive pulmonary disease, and lower respiratory tract infections in patients with cystic fibrosis or bronchiectasis).
• Ear, nose and throat infections (including otitis externa and otitis media).
• Genital tract infections (including pelvic inflammatory disease, cervicitis, orchitis, including infections caused by susceptible Neisseria gonorrhoeae; chronic bacterial prostatitis; chancroid).
• Complicated urinary tract infections (upper and lower urinary tract infections, including gonococcal urethritis).
• Gastrointestinal infections (such as infectious diarrhea) and typhoid fever caused by Salmonella typhi.
• Intra-abdominal infections and biliary tract infections..
• Skin and soft tissue infections, including infected bites or insect stings.
• Bone and joint infections.
• Anthrax (treatment or post-exposure prophylaxis).
• Prevention of invasive infections caused by Neisseria meningitidis.
• Ciprofloxacin may be used for the treatment of febrile neutropenia when a bacterial infection is suspected.

Infections requiring special consideration before use of ciprofloxacin:

• Uncomplicated urinary tract infections: Because fluoroquinolones, including ciprofloxacin, are associated with serious adverse reactions (see Warnings and Precautions), and because uncomplicated urinary tract infections may resolve spontaneously in some patients, ciprofloxacin should only be used when no alternative treatment options are available.
• Acute exacerbations of chronic bronchitis: Due to the risk of serious adverse reactions associated with fluoroquinolones, including ciprofloxacin (see Warnings and Precautions), and because acute exacerbations of chronic bronchitis may resolve spontaneously in some patients, ciprofloxacin should be used only when no alternative treatment options are available.
• Acute exacerbation of chronic bronchitis: Because fluoroquinolone antibiotics, including ciprofloxacin, are associated with serious adverse reactions (see Warnings and Precautions), and because acute exacerbations of chronic bronchitis may resolve spontaneously in some patients, ciprofloxacin should be used only in patients for whom no alternative treatment options are available.
• Acute bacterial sinusitis: Because fluoroquinolone antibiotics, including ciprofloxacin, are associated with serious adverse reactions (see Warnings and Precautions), and because acute bacterial sinusitis may resolve spontaneously in some patients, ciprofloxacin should be used only in patients for whom no alternative treatment options are available.

Children and adolescents: 

In general, ciprofloxacin is not recommended for use in children and adolescents under 18 years of age. However, its use may be permitted in severe cases such as: 

• Lower respiratory tract infections caused by Pseudomonas aeruginosa in children with cystic fibrosis.
• Complicated urinary tract infections (including pyelonephritis).
• Inhalational anthrax (treatment or post-exposure prophylaxis).
   

DOSAGE AND ADMINISTRATION

Method of administration:
Do not take the medicine together with milk, yogurt, or calcium-fortified products. Administer the medicine at least 2 hours before or after consumption of calcium supplements or products containing high amounts of calcium (more than 800 mg). Drink plenty of fluids and do not take antacids within 2 hours after taking the medicine.
Dosage: 
Adults
General dosage: 250–750 mg every 12 hours. 
Recommended dosages for specific indications:
Anthrax:

• Inhalational anthrax (post-exposure prophylaxis): 500 mg every 12 hours for 60 days.
• Cutaneous anthrax (treatment): 500 mg every 12 hours for 60 days. In cases with systemic involvement, marked edema, or lesions of the head or neck, switch to intravenous administration: 400 mg every 12 hours for 60 days, followed by oral therapy when clinically appropriate.

Bone and joint infections 500–750 mg twice daily for 4–6 weeks..
Chancroid: 500 mg twice daily for 3 days. 
Uncomplicated gonorrhea: A single dose of 250–500 mg (may be administered concomitantly with doxycycline or azithromycin when Chlamydia co-infection is suspected).
Disseminated gonococcal infection: 500 mg twice daily for 7 days (initial treatment with ceftriaxone 1 g/day for 24–48 hours). Fluoroquinolones should not be used for complicated or severe gonorrhea unless no alternative treatment is available or bacterial culture confirms susceptibility.

Infectious diarrhea:

• Salmonella infection: 500 mg twice daily for 5–7 days.
• Shigella infection: 500 mg twice daily for 3 days.
• Traveler’s diarrhea: Mild disease: single dose of 750 mg. Severe disease: 500 mg twice daily for 3 days.
• Vibrio cholerae infection: single dose of 1 g.

Intra-abdominal infections: 500 mg every 12 hours for 7–14 days.
Lower respiratory tract infections: 500–750 mg every 12 hours for 7–14 days.
Skin and soft tissue infections: 500–750 mg every 12 hours for 7–14 days.
Prostatitis (chronic bacterial): 500 mg every 12 hours for 28 days.
Typhoid fever: 500–750 mg every 12 hours for 7–14 days.
Severe or complicated cases: intravenous administration of 400 mg every 12 hours for 10–14 days.
Urinary tract infections: 
Complicated infections (including pyelonephritis): 500 mg every 12 hours for 7–14 days.

* Infections requiring special consideration before use:

• Uncomplicated urinary tract infections: 250–500 mg every 12 hours for 3 days.
• Acute exacerbations of chronic bronchitis: 500–750 mg every 12 hours for 7–14 days.
• Acute bacterial sinusitis: 500–750 mg every 12 hours for 7–14 days.

Children: 
Use in children and adolescents under 18 years of age is generally not recommended unless clearly necessary. 
General dose: 20 mg/kg (maximum 750 mg per dose), administered twice daily.

Recommended doses for specific indications in children:
Inhalational anthrax:

• Post-exposure prophylaxis: 15 mg/kg per dose every 12 hours for 60 days (maximum 500 mg per dose).
• Cutaneous anthrax (treatment): 10–15 mg/kg per dose every 12 hours for 60 days (maximum 1 g/day). In cases of extensive edema or lesions of the head or neck, switch to intravenous administration and resume oral therapy when clinically appropriate.

Cystic fibrosis: Lower respiratory tract infection caused by Pseudomonas aeruginosa:
40 mg/kg/day, pided into two doses every 12 hours, following one week of intravenous therapy. Total treatment duration is 10–21 days.
Complicated urinary tract infections or pyelonephritis: 20–30 mg/kg/day, pided into two doses every 12 hours, for 10–21 days. Maximum dose: 1.5 g/day.

Dose adjustment in patients with renal impairment:
Adult: 

Children and adolescents (under 18 years of age): For now, no dosage recommendations are available for children with creatinine clearance below 50 ml/min.
Patients undergoing dialysis: Administer 250–500 mg per dose every 24 hours after dialysis.

CONTRAINDICATIONS

• History of hypersensitivity to ciprofloxacin, any excipient of the product, or other quinolones.
• Concomitant treatment with tizanidine.
• Not to be used during pregnancy and breastfeeding, unless clearly necessary.
   

WARNINGS AND PRECAUTIONS

Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children