Ciprolet 500Mg

COMPOSITION CIPROLET 500 Each film coated tablet contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 500mg. CIPROLET 250 Each film coated tablet contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 250mg. Excipients Maize starch, Microcrystalline Cellulose, Croscarmellose sodium, Colloidal Anhydrous silica, Purified talc, Magnesium stearate, Hypromellose (Hydroxypropyl methyl cellulose 6cps), Sorbic acid, Titanium dioxide, Macrogol (Polyethylene Glycol 6000), Polysorbate 80, Dimethicone, Purified water. 

CLINICAL INFORMATION: Indications: Ciprofloxacin is indicated for the treatment of the following infections caused by susceptible bacteria. Respiratory tract infections: Acute bronchitis, exacerbation of chronic obstructive airways disease, empyema, lung abscess, infected bronchiectasis, cystic fibrosis and pneumonia. Urinary tract infections: Acute and chronic pyelonephritis, prostatitis, cystitis, epididymitis and chronic complicated or recurrent UTI caused by multi-resistant organism and or pseudomonas aeruginosa. Skin and soft tissue infections: In surgical and post-operative wound infections due to gram-negative organism such as Enterobacteriaceae and pseudomonas aeruginosa. Also useful in infections caused by resistant staphylococci. Surgical infections: Peritonitis, intra-abdominal abscess, cholangitis, cholecystitis, empyema of gall bladder. Bone and joint infections: Since ciprofloxacin achieves adequate tissue concentration in bone, it is useful in the management acute and chronic osteomyelitis. Gynecological infections: Severe pelvic infections caused by susceptible bacteria. Sexually transmitted diseases: Gonorrhea including that caused by beta-lactamase producing strains. Gastrointestinal infections: Effective in the treatment of typhoid and may also eradicate carrier stage. Useful resistant salmonella typhi infections. Severe systemic infections: Septicemia, Bacteremia, Infections in immunosuppressed patients. Contraindications: History of hypersensitivity to ciprofloxacin or to any member of the quinolone class of antimicrobial agents to any of the components of the formulation. Pregnancy and lactation. 

WARNING AND PRECEAUTION: Ciprofloxacin should be used with caution in epileptics and patients with a history of CNS disorders and only if the benefits of treatment are considered to outweigh the risk of possible CNS side effects. Crystalluria related to the use of ciprofloxacin has been reported. Patients receiving ciprofloxacin should be well hydrated and excessive alkalinity of the urine should be avoided. Patients with a family history of actual defects in glucose 6 phosphate dehydrogenase activity are prone to hemolytic reactions with quinolones, and so ciprofloxacin should be used with caution in these patients. Tendon inflammation and rupture may occur with quinolone antibiotics. Such reactions have been observed particularly in older patients and those treated concurrently with corticosteroids. At the first sign of pain or inflammation, patients should discontinue ciprofloxacin and rest the affected limbs. Serious and occasionally fatal anaphylactic reactions have been reported in patients receiving quinolones. Treatment with ciprofloxacin should be discontinued if patients develop skin rash or any other symptoms of hypersensitivity. Ciprofloxacin should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. Pseudomembranous colitis has been reported with nearly all antibacterial agents including ciprofloxacin and may range in severity from mild to life threating. Moderate to severe phototoxicity manifested as an exaggerated sunburn reaction has been reported in patients who are exposed to direct sunlight while receiving some members of the quinolone class of drugs. Excessive sunlight should be avoided.  

ADVERSE REACTIONS: Ciprofloxacin is generally well tolerated. The most frequently reported adverse reactions wherein the causal relationship with ciprofloxacin could not be established include nausea, diarrhea, vomiting, abdominal pain, headache, restlessness and rash. Other adverse reactions that have been reported in <1 % of patients include Gastrointestinal: Oral ulceration, oral candidiasis, dysphagia, intestinal perforation, gastrointestinal bleeding and cholestatic jaundice. CNS: Lightheadedness, depression, dizziness, insomnia, irritability, ataxia, tremor, convulsions, weakness, hallucinations, malaise, anorexia and paresthesia. Hypersensitivity: Rash, pruritus, urticaria, photosensitivity, flushing, fever, chills, anaphylactic/anaphylactoid reactions including angioedema, edema of face, neck, lips, hands, cutaneous candidiasis, hyperpigmentation and rarely, erythema nodosum. Renal/Urogenital: Renal failure, polyuria, interstitial nephritis, acidosis, urethral bleeding, urinary retention, and vaginitis. Musculoskeletal: Arthralgia or back pain, joint stiffness, achiness neck or chest pain and flare up of gout. Respiratory: Dyspnea, pulmonary embolism, bronchospasm, laryngeal or pulmonary oedema, hemoptysis, epistaxis, and hic-coughs. Cardiovascular: Cardiopulmonary arrest, myocardial infarction, cerebral thrombosis, syncope, hypertension, angina pectoris, atrial flutter, ventricular ectopy. Adverse Laboratory Changes: Hepatic: Elevations of AST, ALT alkaline phosphate, LDH, and serum bilirubin. Hematologic: Elevated eosinophil and platelet counts, decreased platelet counts, leucopenia, granulocytopenia, hemoglobin and/or hematocrit; altered prothrombin levels and very rarely, hemolytic anemia or agranulocytosis. Renal: Elevations of serum creatinine, BUN, crystalluria and hematuria.  

OVERDOSAGE AND TREATMENT: In the event of acute overdosage, the treatment should be symptomatic and supportive and may include, emptying the stomach by induction of emesis or by gastric lavage and maintenance of adequate hydration. Only a small amount of ciprofloxacin (<10%) is removed from the body after hemodialysis or peritoneal dialysis.  

Dr. Reddy’s Laboratories Ltd