Ciprofloxacin

This product must only be prescribed when other antibiotics that are commonly recommended for the infection are inappropriate. This applies to all indications listed below. Situations where other antibiotics are considered to be inappropriate are where:

• there is resistance to other first-line antibiotics recommended for the infection;

• other first-line antibiotics are contraindicated in an individual patient;

• other first-line antibiotics have caused side effects requiring treatment to be stopped;

• treatment with other first-line antibiotics has failed.

Ciprofloxacin film-coated tablets are indicated for the treatment of the following infections (see sections 4.4 and 5.1). 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

- pneumonia

- broncho-pulmonary infections in cystic fibrosis or in bronchiectasis

• Chronic suppurative otitis media

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

• Acute pyelonephritis

• Complicated urinary tract infections

• Bacterial prostatitis

• Genital tract infections

• Intra-abdominal infections

• Infections of the skin and soft tissue caused by Gram-negative bacteria

• Infections of the bones and joints

• 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.

In exacerbations of chronic obstructive pulmonary disease Ciprofloxacin should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.

In uncomplicated acute cystitis Ciprofloxacin should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.

Children and adolescents

• Broncho-pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis

• Complicated urinary tract infections and acute pyelonephritis

• Inhalation anthrax (post-exposure prophylaxis and curative treatment)

Ciprofloxacin 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 (see sections 4.4 and 5.1).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Ref: http://www.medicines.org.uk/emc/product/7257

Available on request.

Available on request.