C-FLOX 250 TABLETS 250 mg

**Indications:** C-Flox is indicated for the treatment of the following infections due to sensitive bacteria: 1. Respiratory infections: Lobar and bronchopneumonia, acute and chronic bronchitis, acute exacerbation of cystic fibrosis, bronchiectasis, empyema. 2. Ear, nose and throat infection: Otitis media, sinusitis, mastoiditis, especially infections due to Gram-negative bacteria. 3. Intra-abdominal and biliary tract infections: Infective diarrhoea, typhoid fever, cholangitis, cholecystitis. 4. Pelvic infections: Salpingitis, endometritis, pelvic inflammatory disease. 5. Urinary tract infections: Uncomplicated and complicated urethritis, cystitis, pyelonephritis, prostatitis, epididymitis. 6. Gonorrhoea: urethral, rectal and pharyngeal 7. Bone and joint infections: Osteomyelitis, septic. 8. Skin and soft tissue infections: Infected ulcers, wounds, abscesses, cellulitis, erysipelas, infected burns. 9. Systemic infections: Septicemia, peritonitis.

**Contraindications, Warnings, Precautions:** A history of hypersensitivity to any of the quinolones is a contraindication to the use of C-Flox. C-Flox may cause CNS stimulation which may lead to tremor, restlessness or even seizures. So C-Flox should be used with caution in patients of epilepsy. Anaphylactic reactions have also been reported to the first dose of C-Flox. The dose of C-Flox should be approximately adjusted in patients with impaired renal function. When prolonged therapy is given, the renal, hepatic and hemopoietic function must be periodically assessed. _**Peripheral Neuropathy**_ Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including C-Flox. Symptoms may occur soon after initiation of C-Flox and may be irreversible. C-Flox should be discontinued immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense and vibratory sensation. Cardiac disorder: Caution should be taken when using fluoroquinolones, including ciprofloxacin, in patients with known risk factors for prolongation of the QT interval such as, for example: - 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). - Elderly. - Cardiac disease (e.g. heart failure, myocardial infarction, bradycardia). Disabling and potentially irreversible serious adverse reactions Fluoroquinolones, including C-Flox, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). Patients of any age or without pre-existing risk factors have experienced these adverse reactions. Discontinue C-Flox immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including C-Flox, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones. Aortic aneurysm or dissection and heart valve regurgitation / incompetence Epidemiologic studies report an increased risk of aortic aneurysm and dissection, particularly in elderly patients, and of aortic and mitral valve regurgitation after intake of fluoroquinolones. Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal ones), and of regurgitation/incompetence of any of the heart valves have been reported in patients receiving fluoroquinolones. Therefore, fluoroquinolones should only be used after a careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease or congenital heart valve disease, or in patients diagnosed with pre-existing aortic aneurysm and/or dissection or heart valve disease, or in presence of other risk factors or conditions predisposing - for both aortic aneurysm and dissection and heart valve regurgitation/incompetence (e.g. connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Behçet’s disease, hypertension, rheumatoid arthritis) or additionally - for aortic aneurysm and dissection (e.g. vascular disorders such as Takayasu arteritis or giant cell arteritis, or known atherosclerosis, or Sjögren’s syndrome) or additionally - for heart valve regurgitation/incompetence (e.g. infective endocarditis). The risk of aortic aneurysm and dissection, and their rupture may also be increased in patients treated concurrently with systemic corticosteroids. In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department. Patients should be advised to seek immediate medical attention in case of acute dyspnoea, new onset of heart palpitations, or development of oedema of the abdomen or lower extremities. Psychiatric Adverse Reactions Fluoroquinolones, including C-Flox, have been associated with an increased risk of psychiatric adverse reactions, including: toxic psychosis, hallucinations, or paranoia; depression or suicidal thoughts or acts; anxiety, agitation, or nervousness; confusion, delirium, disorientation, or disturbances in attention; insomnia or nightmares; memory impairment. These adverse reactions may occur following the first dose. If these reactions occur in patients receiving C-Flox, discontinue C-Flox immediately and institute appropriate measures. Blood Glucose Disturbances As with all fluoroquinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycaemia have been reported with C-Flox. In C-Floxtreated patients, dysglycaemia occurred predominantly in elderly diabetic patients receiving concomitant treatment with an oral hypoglycaemic agent (for example, sulfonylurea) or with insulin. Severe cases of hypoglycaemia resulting in coma or death have been reported. In diabetic patients, careful monitoring of blood glucose is recommended. If a hypoglycaemic reaction occurs, discontinue C-Flox and initiate appropriate therapy immediately.

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