Presentation
Ciprofloxacin 250: Each film-coated tablet contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 250 mg.
Ciprofloxacin 500: Each film-coated tablet contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 500 mg.
Ciprofloxacin 750: Each film-coated tablet contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 750 mg.
Ciprofloxacin 125 Granules for suspension: Each sachet contains Ciprofloxacin USP 125 mg.
Ciprofloxacin 250 Granules for suspension: Each sachet contains Ciprofloxacin USP 250 mg.
Ciprofloxacin IV Infusion: Each 100 ml solution contains Ciprofloxacin Lactate equivalent to Ciprofloxacin BP 200 mg.
Ciprofloxacin IV Infusion: Each 200 ml solution contains Ciprofloxacin Lactate equivalent to Ciprofloxacin BP 400 mg.
Ciprofloxacin sterile eye/ear drops: Each ml contains Ciprofloxacin Hydrochloride USP equivalent to ciprofloxacin 3 mg.

Description
Ciprofloxacin is a synthetic broad-spectrum antimicrobial agent for oral, intravenous and topical (ocular/otic) administration. It is a fluoroquinolone antibacterial agent active against a broad spectrum of gram positive and gram-negative pathogens that exerts its bactericidal effects by inhibiting DNA-gyrase enzyme. It is a faint to light yellow crystalline powder with a molecular weight of 385.8.

Indications and Uses
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
Corneal Ulcers
Conjunctivitis
Otitis externa
acute otitis media
cronic suppurative otitis media
Prophylaxis in otic surgeries such as mastoid surgery

Contraindications
A history of hypersensitivity to Ciprofloxacin or any member of quinolone class of antimicrobial agents.

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
Complicated
Nosocomial Mild/ 400 mg 8 hourly 10-14 days
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

Eye
Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is 2 drops into the affected eye every 15 minutes for the first 6 hours and then 2 drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill 2 drops in the affected eye hourly. On the third through the fourteenth day, place 2 drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.
Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is 1 or 2 drops instilled into the conjunctival sac(s) every 2 hours while awake for 2 days and one or 2 drops every 4 hours while awake for the next 5 days.

Ear
For all infections, 2-3 drops every 2-3 hours initially, reducing the frequency of the instillation with control of infection. Treatment should be continued at least 7 days.


Precautions
Ciprofloxacin 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.

As with other antibacterial preparations, prolonged use of ciprofloxacin may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.
Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction.

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.

The most frequently reported drug related adverse reaction is local burning or discomfort. In corneal ulcer studies with frequent administration of the drug, white crystalline precipitates were seen in approximately 17% of patients. Other reactions occurring in less than 10% of patients included lid margin crusting, crystals/scales, foreign body sensation, itching, conjunctival hyperemia and a bad taste following instillation. Additional events occurring in less than 1% of patients included corneal staining, keratopathy/keratitis, allergic reactions, lid edema, tearing, photophobia, corneal infiltrates, nausea and decreased vision.

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.

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.

Commercial Pack
Ciprofloxacin 250: Box containing 6 blister strips of 3 film coated tablet.
Ciprofloxacin 500: Box containing 2 blister strips of 10 film coated tablet.
Ciprofloxacin 750: Box containing 2 blister strips of 5/6 film coated tablet.
Ciprofloxacin 250 granules for suspension: Each box contains 14 sachets.
Ciprofloxacin 125 granules for suspension: Each box contains 14 sachets.
Ciprofloxacin IV Infusion 100 ml: Each box contains 1 bag of 100 ml solution for injection.
Ciprofloxacin IV Infusion 200 ml: Each box contains 1 bag of 200 ml solution for injection.
Ciprofloxacin sterile eye/ear drops: Plastic dropper bottle containing 5 ml sterile eye/ear drops.

Other
Instructions for the Use of Ciprofloxacin 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 Ciprofloxacin Infusion. 9. Open flow control clamp to expel air from set. Close clamp. 10. Regulate rate of administration with flow control clamp.