Axcel Ciprofloxacin Special Precautions

Hypersensitivity: In some instances, the hypersensitivity and allergic reactions already occurred after the first administration and the doctor should be informed immediately. Anaphylactic/anaphylactoid reactions in very rare instances can progress to a life threatening shock, in some instances after the first administration. In these cases Ciprofloxacin has to be discontinued, medical treatment (e.g. treatment for shock) is required.
Cytochrome P450: Ciprofloxacin is known to be moderate inhibitor of the CYP 450 1A2 enzymes. Care should be taken when other drugs are administered concomitantly which are metabolized via the same enzymatic pathway (e.g theophylline, methylxantines, caffeins, duloxetine, clozapine). Increased plasma concentrations associated with drug specific side effects may be observed due to inhibitions of their metabolic clearance by ciprofloxacin.
Gastrointestinal system: In the event of severe and persistent diarrhoea during or after treatment a doctor must be consulted, since this symptom can hide a serious intestinal disease (life threatening pseudomembranous colitis with possible fatal outcome), requiring immediate treatment. In such cases Ciprofloxacin must be discontinued and appropriate therapy initiated (e.g. vancomycin, orally, 4 x 250mg / day). Drugs that inhibit peristalsis are contraindicated. There can be a temporary increases in transaminases, alkaline phosphatase or cholestatic jaundice, especially in patients with previous liver damage.
Nervous system: In epileptics and in patients who have suffered from previous CNS-disorders (e.g lowered convulsion threshold, previous history of convulsion, reduced cerebral blood flow, altered brain structure/stroke), ciprofloxacin should only be used where the benefits of treatment exceed the risks, since these patients are endangered because of possible central-nervous side effects. In some instances the CNS reactions occurred after the first administration of Ciprofloxacin already. In rare cases depression or psychosis can progress to self-endangering behavior. In these cases Ciprofloxacin has to be discontinued and the doctor should be informed immediately.
Musculo-skeletal system: The risk of developing fluroquinolone-associated tendonitis and tendon rupture is further increased in people older than 60, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients. Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication (to specify the active ingredient) and to contact their health care professional promptly about changing their antimicrobial therapy. Patients should also avoid exercise and using the affected area at the first sign of tendon pain, swelling or inflammation.
Skin and appendages: Ciprofloxacin has been shown to produce photosensitivity reactions. Patients taking Ciprofloxacin should avoid direct exposure to excessive sunlight or UV-light. Therapy should be discontinued if photosensitation (i.e. sunburn-like skin reactions) occurs.
Exacerbation of myasthenia gravis: Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in person with myasthenia gravis. Post marketing serious adverse events, including deaths and requirement for ventilator support have been associated with fluoraquinolones use in persons with myasthenia gravis. Avoid fluoroquinolones in patients with known history of myasthenia gravis.
Effects on ability to drive and use machines: Even when the drug is taken exactly as prescribed, it can affect the speed of reaction to such as extent that the ability to drive or to operate machinery is impaired. This applies particularly in combination with alcohol.
Use in Pregnancy and Lactation: Ciprofloxacin must not be prescribed for pregnant women or nursing mothers, since there is no experience on the drug's safety in these patient groups and since, on the basis of animal studies, it is not entirely improbable that the drug could cause damage to articular cartilage in the immature organism. Animal studies have not shown any evidence of teratogenic effects (malformations).
Use in Children: As with drugs in its class, ciprofloxacin has been shown to cause arthropathy in weight-bearing joints of immature animals. The analysis of available safety data from ciprofloxacin use in patients less than 18 years of age, the majority of whom had cystic fibrosis, did not disclose any evidence of drug related cartilage or articular damage. The use of ciprofloxacin for indications other than for the use in inhalational anthrax (post-exposure) is not recommended. For other indications clinical experience is limited. For the indication of inhalational anthrax (post-exposure), the risk-benefit assessment indicates that administration of ciprofloxacin to pediatric patients is appropriate.