CIPROM 500

DOSAGE

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, in children and adolescents, the body weight. Treatment of some infections may require co-administration with other appropriate antibacterial agents depending on the pathogens involved.

Adults:

Children:

Elderly

The elderly should receive a dose selected according to the severity of the infection and the patient's creatinine clearance.

Patients with renal and hepatic impairment

Recommended starting and maintenance doses for patients with impaired renal function:

In patients with impaired liver function, no dose adjustment is required.

Dosing in children with impaired renal and/or hepatic function has not been studied.

ADMINISTRATION 

Tablets are to be swallowed unchewed with fluid. They can be taken independent of mealtimes. Ciprofloxacin tablets should not be taken with dairy products (e.g. milk, yoghurt) or mineral-fortified fruit -juice (e.g. calcium-fortified orange juice).

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.

CONTRAINDICATIONS

Hypersensitivity to the active substance, to other quinolones or to any of the excipients.

Concomitant administration of ciprofloxacin and tizanidine.

WARNINGS AND PRECAUTIONS

Paediatric population: The use of ciprofloxacin in children and adolescents should follow available official guidance. Ciprofloxacin treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents. Ciprofloxacin has been show to cause arthropathy in weight-bearing joint of immature animals. Safe on children is not clear, thus treatment should be initiated only after a careful benefit/risk evaluation, due to possible adverse events related to joints and/or surrounding tissue. 

Musculoskeletal system: Ciprofloxacin should generally not be used in patients with a history of tendon disease/disorder related to quinolone treatment. Nevertheless, in very rare instances, after evaluation of the risk/benefit balance, ciprofloxacin may be prescribed to these patients for the treatment of certain severe infections, particularly in the event of failure of the standard therapy or bacterial resistance, where microbiological data may justify the use of ciprofloxacin. Tendinitis and tendon rupture (especially Achilles tendon), sometimes bilateral, may occur with ciprofloxacin, even within the first 48 hours of treatment and up to several months after discontinuation of ciprofloxacin therapy. The risk of tendinopathy may be increased in elderly patients or in patients concomitantly treated with corticosteroids. At any sign of tendinitis (e.g. painful swelling, inflammation), ciprofloxacin treatment should be discontinued. Care should be taken to keep the affected limb at rest.

Hypersensitivity: Hypersensitivity and allergic reactions, including anaphylaxis and anaphylactoid reactions, may occur following a single dose and may be life-threatening. If such reaction occurs, ciprofloxacin should be discontinued and an adequate medical treatment is required.

Photosensitivity: Ciprofloxacin has been shown to cause photosensitivity reactions. Patients taking ciprofloxacin should be advised to avoid direct exposure to either extensive sunlight or UV irradiation during treatment.

Central nervous system: Quinolones are known to trigger seizures or lower the seizure threshold. Ciprofloxacin should be used with caution in patients with CNS disorders which may be predisposed to seizure. Psychiatric reactions may occur even after the first administration of ciprofloxacin. In rare cases, depression or psychosis can progress to suicidal ideations/throughts culminating in attempted suicide or completed suicide. In these cases, ciprofloxacin should be discontinued.

Cardiac disorders: Caution should be taken when using fluoroquinolones, including ciprofloxacin, in patients with known risk factor for prolongation of the QT interval especially elderly patients and women such as: congenital long QT syndrome, concomitant use of drugs that are known to prolong the QT interval (e.g. Class IA and III anti-arrhythmics, tricyclic antidepressants, macrolides, antipsychotics), uncorrected electrolyte imbalance (e.g. hypokalaemia, hypomagnesaemia), cardiac disease (e.g. heart failure, myocardial infarction, bradycardia).

Gastrointestinal System: The occurrence of severe and persistent diarrhoea during or after treatment (including several weeks after treatment) may indicate an antibiotic-associated colitis (life-threatening with possible fatal outcome), requiring immediate treatment.

Glucose-6-phosphate dehydrogenase deficiency: Haemolytic reactions have been reported with ciprofloxacin in patients with glucose-6-phosphate dehydrogenase deficiency. Ciprofloxacin should be avoided in these patients unless the potential benefit is considered to outweigh the possible risk. In this case, potential occurrence of haemolysis should be monitored.

Resistance: During or following a course of treatment with ciprofloxacin bacteria that demonstrate resistance to ciprofloxacin may be isolated, with or without a clinically apparent superinfection. There may be a particular risk of selecting for ciprofloxacin-resistant bacteria during extended durations of treatment and when treating nosocomial infections and/or infections caused by Staphylococcus and Pseudomonas species.

PREGNANCY AND LACTATION

Pregnancy 

The data that are available on administration of ciprofloxacin to pregnant women indicates no malformative or feto/neonatal toxicity of ciprofloxacin. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. In juvenile and prenatal animals exposed to quinolones, effects on immature cartilage have been observed, thus, it cannot be excluded that the drug could cause damage to articular cartilage in the human immature organism/foetus. As a precautionary measure, it is preferable to avoid the use of ciprofloxacin during pregnancy.

Lactation

Ciprofloxacin is excreted in breast milk. Due to the potential risk of articular damage, ciprofloxacin should not be used during breast-feeding.

SHELF-LIFE

36 months from the manufacturing date. Do not use after the expiry date.