Beuflox IV Infusion Ciprofloxacin BP 0.2% solution for Intravenous infusion Presentation Beuflox IV Infusion 100 ml: Each 100 ml solution contains Ciprofloxacin Lactate equivalent to Ciprofloxacin BP 200 mg. Beuflox IV Infusion 200 ml: Each 200 ml solution contains Ciprofloxacin Lactate equivalent to Ciprofloxacin BP 400 mg. Descriptions Ciprofloxacin is a synthetic broad-spectrum antimicrobial agent for intravenous (IV) administration. Ciprofloxacin is a faint to light yellow crystalline powder. The solution is provided in plastic bag that is latex-free and is fabricated from a specially formulated polyvinyl chloride. Indications Urinary Tract Infection Lower Respiratory Tract Infection Nosocomial pneumonia Skin and Skin Structure Infections Bone and Joint Infection Complicated Intra-Abdominal Infections Acute sinusitis Chronic bacterial prostatitis Infectious diarrhea Inhalational anthrax Dosage and Administration Indication Severity Dose Days Urinary Tract Mild to Moderate 200 mg 12 hourly 7-14 days infection Severe or 400 mg 12 hourly 7-14 days Complicated Lower Respiratory Mild to Moderate 400 mg 12 hourly 7-14 days Tract infection Severe or 400 mg 8 hourly 7-14 days 400 mg 8 hourly 10-14 days Complicated Nosocomial Mild/ Pneumonia Moderate/Severe Skin and Skin Mild to Moderate 400 mg 12 hourly 7-14 days Structure Severe or Complicated 400 mg 8 hourly 7-14 days Bone and Joint Mild to Moderate 400 mg 12 hourly >4-6 weeks Infection Severe/Comlicated 400 mg 8 hourly >4-6 weeks Intra abdominal Complicated 400 mg 12 hourly 7-14 days (Acute abdomen) Acute Sinusitis Mild/Moderate 400 mg 12 hourly 10 days Chronic Bacterial Mild/Moderate 400 mg 12 hourly 28 Days Prostatitis In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. Contraindications A history of hypersensitivity to Ciprofloxacin or any member of quinolone class of antimicrobial agents. Precautions Beuflox Injection should only be administered by slow intravenous infusion over a period of 60 minutes. Local IV site reactions have been reported with the intravenous administration of Ciprofloxacin. These reactions are more frequent if infusion time is 30 minutes or less or if small vein of the hand are used. Side-effects The following events were reported, regardless of drug relation, in greater than 1.0% of patients treated with intravenous Ciprofloxacin: nausea, diarrhea, central nervous system disturbance, local IV site reactions, liver function tests abnormal, eosinophilia, headache, restlessness, and rash. Many of these events were described as only mild or moderate in severity, abated soon after the drug was discontinued, and required no treatment. Use in pregnancy & lactation The safety of Ciprofloxacin in pregnancy has not yet been established. Ciprofloxacin should not be used in pregnant women unless the likely benefits outweigh the possible risk to the fetus. Ciprofloxacin has been shown to be nonembryotoxic and nonteratogenic in animal studies. Ciprofloxacin is excreted in human milk. A decision should be made to discontinue nursing or to discontinue the administration of Ciprofloxacin, taking into account the importance of the drug to the mother and the possible risk to the infant. Drug Interactions Concurrent administration of Ciprofloxacin with Theophylline may lead to elevated plasma concentrations of Theophylline and prolongation of its elimination half-life. This may result in increased risk of Theophylline related adverse reactions. If concomitant use cannot be avoided plasma level of Theophylline should be monitored and dosage adjustments made as appropriate. Antacid containing Magnesium hydroxide or Aluminium hydroxide may interfere with the absorption of Ciprofloxacin resulting in serum and urine levels lower than desired, concurrent administration of these agents with Ciprofloxacin should be avoided. Probenecid interferes with renal tubular secretion of Ciprofloxacin and produces an increase in the level of Ciprofloxacin in the serum. This should be considered if patients are receiving both drugs concomitantly. As with other broad spectrum antibiotics prolonged use of Ciprofloxacin may result in over growth of non-susceptible organisms. Repeated evaluation of patient's conditions and microbial susceptibility testing is essential. If superinfections occur during therapy, appropriate measure should be taken. Overdosage In case of acute overdose, the patient should be carefully observed and given supporative treatment, including monitoring of renal function. Adequate hydration must be maintained. Instructions for the Use of Beuflox Injection 1. Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution. 2. Do not use if the solution is cloudy or a precipitate is present. 3. Do not use flexible bags in series connections. 4. Close flow control clamp of administration set. 5. Remove cover from port at bottom of bag. 6. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. 7. Suspend bag from hanger. 8. Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Beuflox Infusion. 9. Open flow control clamp to expel air from set. Close clamp. 10. Regulate rate of administration with flow control clamp. Commercial pack Beuflox IV Infusion 100 ml: Each box contains 1 bag of 100 ml solution for injection. Beuflox IV Infusion 200 ml: Each box contains 1 bag of 200 ml solution for injection. Manufactured by Incepta Pharmaceuticals Ltd Dhaka, Bangladesh Registered Trademark PTG : 221/170407/30000 PTM I BFV