CIPROFLOXACIN Available composition V-CIP 250 Each Film Coated Tablets Contains Ciprofloxacin Hydrochloride Bp Eq to Ciprofloxacin 250mg V-CIP 500 Each Film Coated Tablets Contains Ciprofloxacin Hydrochloride Bp Eq to Ciprofloxacin 500mg CIPROFLOXACIN Available composition V-CIP 250 Each Film Coated Tablets Contains Ciprofloxacin Hydrochloride Bp Eq to Ciprofloxacin 250mg V-CIP 500 Each Film Coated Tablets Contains Ciprofloxacin Hydrochloride Bp Eq to Ciprofloxacin 500mg PHARMACOLOGICAL CLASSIFICATION Antibiotic (Antibacterial) MECHANISM OF ACTION The primary mechanism of action of ciprofloxacin is inhibition of the activity of the A subunit of DNA gyrase. Inhibition of bacterial gyrase causes relaxation of the supercoiled DNA. These changes lead to termination of chromosomal replication and to interference with cell division and gene expression. A secondary mechanism, inhibition of the activity of topoisomerase IV, leads to separation of 2 united DNA molecules and subsequent interference with cellular replication. Ciprofloxacin has been shown to kill bacteria in both growth and stationary phases. This may provide an advantage over other classes of antibiotics such as b-lactams, which are not bactericidal when bacteria are in the stationary phase of growth or growing slowly. PHARMACOKINETICSCiprofloxacin is rapidly and well absorbed from the gastrointestinal tract. Oral bioavailability is approximately 70% and a peak plasma concentration of about 2.5 micrograms/ml is achieved 1 to 2 hours after a dose of 500 mg by mouth. Absorption may be delayed by the presence of food, but is not substantially affected overall. The plasma half-life is about 3.5 to 4.5 hours and there is evidence of modest accumulation. Half-life may be prolonged in renal impairment—a value of 8 hours has been reported in end-stage renal disease—and to some extent in the elderly. Plasma protein binding ranges from 20 to 40%. Ciprofloxacin is widely distributed in the body and tissue penetration is generally good. It appears in the CSF, but concentrations are only about 10% of those in plasma when the meninges are not inflamed. Ciprofloxacin crosses the placenta and is also distributed into breast milk. High concentrations are achieved in bile. Ciprofloxacin is eliminated principally by urinary excretion, but non-renal clearance may account for about a third of elimination and includes hepatic metabolism, biliary excretion, and possibly transluminal secretion across the intestinal mucosa. At least 4 active metabolites have been identified. Oxociprofloxacin appears to be the major urinary Urinary excretion is by active tubular secretion as well as glomerular filtration and is reduced by probenecid; it is virtually complete within 24 hours. About 40 to 50% of an oral dose is excreted unchanged in the urine and about 15% as metabolites. Only small amounts of ciprofloxacin are removed by haemodialysis or peritoneal dialysis. INDICATIONS V-CIP is indicated:To treat gram-negative infections, sexually transmitted diseases, mycobacterial infections, corneal ulcers, and bacterial conjunctivitis. For the treatment of Bacterial infection of Respiratory tract, UTI, Uncomplicated Cystitis in females, GI, Chronic Bacterial Prostatitis, CNS, Immuno compromised patients, Skin, Bone and Joint Infections, Uncomplicated cervical and urethral gonorrhea. Patient information: BEFORE YOU TAKE V-CIPBefore taking ciprofloxacin make sure your doctor or pharmacist knows If you:- are pregnant, trying for a baby or breast-feeding. - are under 18 years of age. - suffer from liver or kidney problems (other than a kidney infection). - have diabetes. - have a history of tendon problems such as tendinitis. suffer with epilepsy or any other condition that causes convulsions (fits). - suffer from myasthenia gravis (muscle weakening disease). - have glucose 6-phosphate dehydrogenase (G6PD) deficiency or if you have a family history of this condition. - are taking non-steroidal anti-inflammatory medication (NSAIDs) such as aspirin, ibuprofen or diclofenac. - are taking corticosteroids. - have ever had an allergic reaction after taking antibiotics. HOW TO TAKE V-CIPTake your medication exactly as directed by your doctor. The dosage of V-CIP required and the duration of treatment depends upon the severity and type of your infection. The usual dosage is 250mg to 750 mg twice daily. For the treatment of a lung infection in cystic fibrosis patients (aged 5 – 17 years), a dose of 20mg/kg orally twice daily. (The maximum daily dose is 1500 mg.) For the treatment of anthrax in children, a dose of 15mg/kg twice daily (the maximum daily dose is 1000mg). V-CIP may also be used in adolescents and children for the treatment of other infections if the doctor considers it essential. The usual dose in these cases is 4 – 8mg/kg iv twice daily or 5 – 15 mg/kg orally twice daily. The exact dosage depends on the severity of the infection. Take the tablets as prescribed by your doctor. The tablet(s) should be swallowed whole with a glass of water. Drink several more glasses of water during every day of your treatment, unless told otherwise by your doctor. Take the tablets for as long as directed by your doctor. The usual duration of treatment is between 3 and 10 days, but it may be longer if your infection is more persistent or severe. It is important that you complete the course of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return. The duration of treatment for lung infection in children or adolescents with cystic fibrosis is 10 – 14 days. IF YOU MISS A DOSETake your normal dose as soon as possible and then continue as prescribed. However, if it is almost time for your next dose, do not take the missed dose and continue as usual, making sure that you complete your course of treatment. WHAT TO DO IF AN OVERDOSE IS TAKENIf you take more than the prescribed dose, or in the event of an overdose, seek medical advice immediately and, if possible, take your tablets or the box with you to show the doctor. TAKING OTHER MEDICINETell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. V-CIP and certain other medicines can affect each other. You may have to adjust the times you takecertain other medicines, vitamins, and herbal supplements. Especially, tell your doctor if you take: theophylline, didanosine chewable buffered tablets or pediatric powder; warfarin; glyburide, phenytoin; sucralfate; or antacids or vitamins that contain magnesium, calcium, aluminum, iron, or zinc. SIDE EFFECTSV-CIP is generally well tolerated. The most common side effects with V-CIP include vaginal yeast infection and headache. Less common side effects include nausea, diarrhea, dizziness, and abdominal pain. You should be careful about driving or operating machinery until you are sure the V-CIP is not causing dizziness or lightheadedness.Rare cases of allergic reactions have been reported in patients receiving quinolones, including ciprofloxacin, even after just one dose. Stop taking V-CIP and call your doctor or get emergency medical attention right away if you develop a rash, hives, swelling of your face or throat, or have trouble breathing. Pain, swelling, and tears of Achilles, shoulder, or hand tendons have been reported in patients receiving fluoroquinolones, including V-CIP. The risk for tendon effects is higher if you are over 65 years of age, and especially if you are taking corticosteroids. If you develop pain, swelling, or rupture of a tendon you should stop taking V-CIP,refrain from exercise and strenuous use of the affected area, and contact your health care provider.Convulsions have been reported in patients receiving quinolone antibiotics including V-CIP. Tell your doctor if you have experienced convulsions in the past. Quinolones, including ciprofloxacin, have been rarely associated with other centralnervous system events including confusion, tremors, hallucinations, and depression. Stop taking V-CIP and call your doctor right away if you get any of these symptoms. Diarrhea that usually ends after treatment is a common problem caused by antibiotics. A more serious form of diarrhea can occur during or up to 2 months after the use of antibiotics. This has been reported with all antibiotics including with V-CIP. If you develop a watery and bloody stool with or without stomach cramps and fever, contact your physician as soon as possible. STORING Keep all medicines out of the reach of children. Store in a cool, dry place, away from direct heat and light. |
