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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