PRESCRIBING INFORMATION
Presentation
Geflox 250: Each film coated tablet contains Ciprofloxacin 250 mg (as Ciprofloxacin Hydrochloride USP).
Geflox 500: Each film coated tablet contains Ciprofloxacin 500 mg (as Ciprofloxacin Hydrochloride USP).
Geflox XR: Each XR-tablet contains Ciprofloxacin 500 mg (as Ciprofloxacin Hydrochloride BP).
Geflox Pellets for Suspension 60 ml: After reconstitution each 5 ml suspension contains Ciprofloxacin 250 mg (as Ciprofloxacin Hydrochloride BP).

Pharmacodynamics
Ciprofloxacin inhibits the bacterial DNA gyrase or the topoisomerase IV enzyme, thereby inhibiting DNA replication and transcription. Quinolones can enter cells easily via porins and therefore are often used to treat intracellular pathogens such as Legionella pneumophila and Mycoplasma pneumoniae. For many gram-negative bacteria DNA gyrase is the target, whereas topoisomerase IV is the target for many gram-positive bacteria.

Pharmacokinetics
Ciprofloxacin given orally is rapidly and well absorbed from the gastrointestinal tract & widely distributed throughout the body. The binding of Ciprofloxacin to serum proteins is 20 to 40%. Tissue concentration often exceed serum concentration in both men and women. The serum elimination half-life in subjects with normal renal function is approximately 4 hours. Approximately 40 to 50% of an oral dose of Ciprofloxacin is excreted in the urine within 24 hours as unchanged drug and biologically active metabolites.

Indications
* Respiratory tract infections
* Ear, nose, and throat infections
* Eye infections
* Urinary tract infections
* Skin and soft tissue infections
* Bone and joint infections
* Intra-abdominal infections
* Infections of the biliary tract
* Gastrointestinal infections
* Severe systemic infections
* Gonorrhea
* Inhalational anthrax

Dosage & Administration
Adults
General dosage recommendations

Dosage of Geflox-XR                                                                                                           * Used in conjunction with metronidazol

Infections	Type or severity	Unit dose	Frequency	Usual duration
Urinary tract infections (Acute cystitis)	Uncomplicated	500 mg	Once daily	3 days
	Complicated	1000 mg	Once daily	7 to 14 days
Pyelonephritis	Acute uncomplicated	1000 mg	Once daily	7 to 14 days

Pediatric dosage guideline (1 year & above)

Infections	Type or severity	Unit dose	Frequency	Usual duration
Urinary tract or Pyelonephritis	Complicated	10-20 mg/kg (max 750 mg/dose)	12 hourly	10-21 days
Typhoid fever	Mild/Moderate	10-20 mg/kg	12 hourly	7-14 days
Shigellosis		10-20 mg/kg	12 hourly	5 days
Acute Invasive diarrhea		10-30 mg/kg	12 hourly	3 days
Inhalational anthrax (Post Exposure)		15 mg/kg (max 500 mg/dose)	12 hourly	60 days

In acute uncomplicated pyelonephritis where 1000 mg is the appropritate dose, the dosage of Ciprofloxacin-XR should be reduced to 500 mg-XR tablet daily in patients with creatinine clearance below 30 ml/min.

Missed Dose
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule.

Contraindications
Ciprofloxacin is contraindicated in patients who have shown hypersensitivity to Ciprofloxacin.

Side Effects
Ciprofloxacin is generally well tolerated. The most frequently reported adverse reactions are nausea, diarrhea, vomiting, abdominal pain, discomfort, headache, restlessness and rash.

Precautions
Ciprofloxacin should be used with caution in epileptics and patients with a history of CNS disorders and only if the benefits of the treatment are considered to outweigh the risk of possible CNS side effects. Alteration of the dosage regimen is necessary for patients with impaired renal function.

Drug Interactions
When Ciprofloxacin tablet is given concomitantly with food, there is a delay in the absorption of the drug whereas there is no delay observed when Ciprofloxacin suspension is given with food. Concurrent administration of antacids containing magnesium hydroxide or aluminum hydroxide may reduce the bioavailability of Ciprofloxacin by as much as 90%. Ciprofloxacin may increase the effects of theophylline and caffeine.

Use in Pregnancy and Lactation
Not recommended.

Storage Condition
Store in a cool and dry place, protect from light and out of children's reach. Discard the reconstituted suspension of unused portion after 14 days.

Direction for Reconstitution
Pour the diluent of small bottle into large bottle. No need to add extra water. Now shake the bottle well until the pellets are fully dispersed.

Commercial Pack
Geflox 250: Each box contains 3 blister packs of 10 tablets.
Geflox 500: Each box contains 3 Alu-Alu blister packs of 10 tablets.
Geflox XR: Each box contains 2 blister packs of 10 tablets.
Geflox Pellets for Suspension 60 ml : Each pack contains 1 bottle Ciprofloxacin pellets accompanied by 1 bottle of diluent for
60 ml suspension.