Ciprofloxacin Solution

Composition

Each 100 ml contains: ciprofloxacin USP – 200 mg, sodium chloride USP – 0.9% w/v, water for Injection USP q.s.’

Indications for use

The Сiprofloxacin is indicated for the treatment of the following infections. Special attention should be paid to available information on resistance to ciprofloxacin before commencing therapy.

Adults:
Lower respiratory tract infections due to Gram-negative bacteria:

• Exacerbations of chronic obstructive pulmonary disease
• Broncho-pulmonary infections in cystic fibrosis or in bronchiectasis, pneumonia
• Chronic suppurative otitis media;

Acute exacerbation of chronic sinusitis especially if these are caused by Gram-negative bacteria:

• Urinary and genital tract infections
• Gonococcal uretritis and cervicitis due to susceptible Neisseria gonorrhoeae
• Epididymo-orchitis including cases due to susceptible Neisseria gonorrhoeae
• Pelvic inflammatory disease including cases due to susceptible Neisseria gonorrhoeae
• Infections of the gastro-intestinal tract (e.g. travellers’ diarrhoea)
• Intra-abdominal infections
• Infections of the skin and soft tissue caused by Gram-negative bacteria
• Malignant external otitis
• Infections of the bones and joints
• Prophylaxis of invasive infections due to Neisseria meningitidis
• Inhalation anthrax (post-exposure prophylaxis and curative treatment)
• Ciprofloxacin may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.

Children and adolescents:

• Broncho-pulmonary infections in cystic fibrosis caused by Pseudomonas aeruginosa
• Complicated urinary tract infections and pyelonephritis
• Inhalation anthrax (post-exposure prophylaxis and curative treatment)
• Сiprofloxacin may also be used to treat severe infections in children and adolescents when this is considered to be necessary.

Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents.
Сiprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls, including events related to joints and/or
surrounding tissues.

Mode of application

Adults:
Infections of the lower respiratory tract: 400 mg twice daily to 400 mg three times a day. Total duration of treatment – 7 to 14 days.
Infections of the upper respiratory tract:
Acute exacerbation of chronic sinusitis – 400 mg twice daily to 400 mg three times a day. Total duration of treatment – 7 to 14 days.
Chronic suppurative otitis media – 400 mg twice daily to 400 mg three times a day. Total duration of treatment – 7 to 14 days.
Malignant external otitis – 400 mg three times a day. Total duration of treatment – 28 days up to 3 months.
Urinary tract infections:
Complicated and uncomplicated pyelonephritis – 400 mg twice daily to 400 mg three times a day. Total duration of treatment – 7 to 21 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses).
Prostatitis – 400 mg twice daily to 400 mg three times a day. Total duration of treatment – 2 to 4 weeks (acute).
Genital tract infections:
Epididymo-orchitis and pelvic inflammatory diseases – 400 mg twice daily to 400 mg three times a day. Total duration of treatment – at least 14 days.
Infections of the gastro-intestinal tract and intra-abdominal infections:
Diarrhoea caused by bacterial pathogens including Shigella spp. other than Shigella dysenteriae type 1 and empirical treatment of severe travellers’ diarrhea – 400 mg twice daily. Total duration of treatment – 1 day.
Diarrhoea caused by Shigella dysenteriae type 1 – 400 mg twice daily. Total duration of treatment – 5 days.
Diarrhoea caused by Vibrio cholera – 400 mg twice daily. Total duration of treatment – 3 days.
Typhoid fever – 400 mg twice daily. Total duration of treatment – 7 days.
Intra-abdominal infections due to Gram-negative bacteria – 400 mg twice daily to 400 mg three times a day. Total duration of treatment – 5 to 14 days.
Infections of the skin and soft tissue: 400 mg twice daily to 400 mg three times a day. Total duration of treatment – 7 to 14 days.
Bone and joint infections: 400 mg twice daily to 400 mg three times a day. Total duration of treatment – max. of 3 months.
Neutropenic patients with fever that is suspected to be due to a bacterial infection: 400 mg twice daily to 400 mg three times a day. Total duration of treatment -Therapy should be continued over the entire period of neutropenia.
Ciprofloxacin should be co-administered with appropriate antibacterial agent(s) in accordance to official guidance.
Inhalation anthrax post-exposure prophylaxis and curative treatment for persons requiring parenteral treatment: 400 mg twice daily. Total duration of treatment – 60 days from the