Ciprotab infusion 200mg/100ml

Ciprofloxacin solution for infusion is indicated for the treatment of the following infections:

Adults

• Lower respiratory tract infections due to Gram-negative bacteria

– exacerbation of the chronic obstructive pulmonary disease.

In exacerbation of the 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.

– 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 tract infections

– Acute pyelonephritis

– Complicated pyelonephritis

• Bacterial prostatitis

• Genital tract infections

– epididymal-orchitis including cases due to susceptible Neisseria gonorrhoeae

– pelvic inflammatory disease including cases due to susceptible Neisseria gonorrhoeae

• Infections of the gastrointestinal tract (e.g. travelers` diarrhea)

• Intra-abdominal infections

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

• Malignant external otitis

• 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.

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).

Posology

The dosage is determined by the indication, the severity and the site of the infection, the susceptibility to ciprofloxacin of the causative organism(s), the renal function of the patient, and, in children and adolescents the body weight.

The duration of treatment depends on the severity of the illness and on the clinical and bacteriological course.

After intravenous initiation of treatment, the treatment can be switched to oral treatment with a tablet or suspension if clinically indicated at the discretion of the physician. IV treatment should be followed by the oral route as soon as possible.

In severe cases or if the patient is unable to take tablets (e.g. patients on enteral nutrition), it is recommended to commence therapy with intravenous ciprofloxacin until a switch to oral administration is possible.

Treatment of infections due to certain bacteria (e.g. Pseudomonas aeruginosa, Acinetobacter, or Staphylococci) may require higher ciprofloxacin doses and co-administration with other appropriate antibacterial agents.

Treatment of some infections (e.g. pelvic inflammatory disease, intra-abdominal infections, infections in neutropenic patients, and infections of bones and joints) may require co-administration with other appropriate antibacterial agents depending on the pathogens involved.