Forms and presentation

Estecina 500 mg: Coated tablets: Box of 14.

Composition
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Estecina 500 mg: Each tablet contains: Ciprofloxacin (HCI monohydrate): 500 mg.

Properties
Ciprofloxacin is a synthetic broad spectrum antibacterial agent for oral administration.

Pharmacokinetics
Ciprofloxacin is rapidly and well absorbed from the gastrointestinal tract after oral administration. Maximum serum concentrations are attained 1-2 hrs after oral dosing. Mean concentrations 12 hrs after dosing with 250, 500 or 750 mg are 0.1; 0.2 and 0.4 µg/ml respectively. Approximately 40-50% of an orally administered dose is excreted in the urine as unchanged drug. The binding of Ciprofloxacin to serum proteins is 20-40%. After oral administration Ciprofloxacin is widely distributed throughout the body.

Indications
Ciprofloxacin is indicated for the treatment of the following infections:
Lower respiratory tract infections: Acute and chronic bronchitis, cystic fibrosis.
Skin and skin structure infections: Infected ulcers and burns.
Bone and joint infections: Osteomyelitis, arthritis.
Genito-urinary tract infections: Complicated and uncomplicated urethritis, cystitis, pyelonephritis, prostatitis, gonorrhoea.

Contraindications
A history of hypersensitivity to Ciprofloxacin or other quinolones is a contraindication to its use.

Precautions
Patients should be advised that Ciprofloxacin might be associated with hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash or other allergic reaction.

Drug interactions
As with other quinolones, concurrent administration of Ciprofloxacin with theophylline may lead to elevated serum concentrations of theophylline and prolongation of its elimination and its half-life. This may result in increased risk of theophylline-related adverse reactions.

Ability to drive and use machine
Ciprofloxacin may cause dizziness and lightheadedness, therefore patients should know how they react to this drug before they operate an automobile or machinery or engaged in activities requiring mental alertness or coordination.

Pregnancy and lactation
Pregnancy: During pregnancy, especially during the first trimester, Ciprofloxacin should be used only if the potential benefit justifies the potential risk to the foetus.
Lactation: Since the potential effect on nursing infants is not known, Ciprofloxacin should be used with caution in nursing women.

Side effects
Gastrointestinal: The most frequent side effects have been nausea, diarrhea and vomiting.
Hypersensitivity: Allergic reactions in the form of rash, urticaria, pruritus and photosensitivity.

Dosage and administration
Adults:
Urinary tract infections: 250-500 mg every 12 hrs depending of the severity of the infection.
Lower respiratory tract infections, bone and joint infections: 250-500 mg every 12 hrs.
The duration of the treatment depends upon the severity of the infection. Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared. The usual duration is 7-14 days; however, for severe and complicated infections more prolonged therapy may be required.
Children: Safety and security of ciprofloxacin in children and adolescent less than 18 years of age has not been established. However, when the benefit is considered higher to the potential risk (cystic fibrosis) the recommended dosage is 7.5-15 mg/kg/day.

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