Bula do remedy Ciflox

the package insert of the medicine Ciflox. Therapeutic class of the Systemic Antibiotics. Active principles Ciprofloxacin.

what For?

DAILY DOSE/INDIVIDUAL ON the ADULT
Cystitis, Infections of the airways and urinary tract, kidney and the gastrointestinal tract (including typhoid fever). Other infections (p. ex.: ent, maxillofacial, dental, eye, genitals, male and female, of the bile ducts, soft tissue, bones and joints, sepsis, peritonitis, the risk of infection in patients with neutropenia, sterilization of the intestinal selective in patients immune-suppressed). 2 x 250 mg 2 x 250 mg 500 mg 2 x 500 mg
In cases of infection severe (p. ex.: infections recidivantes in patients with mucoviscidosis, infections abdominal, serious, osteomyelitis, and infections in the joints) caused by Pseudomonas, Staphylococcus or Streptococcus, the dose may be increased to 2 x 750 mg/day.

The cases of gonorrhea, acute in patients of both sexes and cystitis acute uncomplicated in women, can be treated with a single oral dose of 250 mg.

In elderly patients the dose should be reduced to a minimum, depending on the severity of the infectious condition and the clearance of creatinine.

CIFLOX is not the antibiotic of first choice for the treatment of pneumonia by pneumococcal in patients on an outpatient basis. However, it is indicated in pneumonias caused by Klebsiella, Enterobacter, Proteus, Pseudomonas, Haemophilus, Branhamella, Legionella and Staphylococcus.

In relation to infections, ent, CIFLOX is indicated in otitis media and infections of the paranasal sinuses (sinusitis), when caused by agents for gram-negatives, including Pseudomonas and Staphylococcus.

In urinary tract infection, caused by Chlamydia, the daily dose should be increased to 2 x 750 mg. In urinary tract infections is not complicated or the gastrointestinal tract, you can manage up to 500 mg in single daily dose.

Dosage in renal failure and liver
1. In renal function changed: 1.1. On clearance of creatinine between 31 and 60 ml/min/1,73 m 2, or in the concentration of serum creatinine between 1.4 and 1.9 mg/100 ml: the maximal daily dose, in these cases, you must be 1,000 mg/day by the oral route. 1.2. On clearance of creatinine less than or equal to 30 ml/min/1,73 m 2, or in concentration of creatinine in serum equal to or greater than 2.0 mg/100 ml: the maximal daily dose should be 500 mg/day by the oral route.

2. In changing renal function + haemodialysis: in the days of dialysis, after the same, according to item 1.2.

3. Changing renal function + CAPD: Administer 1 tablet of 500 mg or 2 tablets of 250 mg).

4. In liver function changed: it is Not necessary dose adjustment.

5. In cases of liver and kidney function changed: the dose adjustment must be done in accordance with items 1.1 and 1.2.

Contraindications

When should I not use?

CIFLOX should not be administered to persons with hypersensitivity to the ciprofloxacin or to derivatives quinol├┤nicos.

CIFLOX should not be administered to children, adolescents under 18 years of age, women who are pregnant or breastfeeding, as there is not enough data that ensure the use of the drug in these patient groups.

Dosage

How to use?

The length of treatment depends on the severity of the case, as well as the clinical course and bacteriological of the same, being on average 5-10 days in cases of acute infections. As a rule, the treatment should continue regularly at least during 3 days after the disappearance of fever and of clinical symptoms. In simple infections of the lower airways is enough for a treatment of 3 days. In the case of osteomyelitis it is recommended a maximum of 2 months of treatment. The streptococcal infections should be treated for at least 10 days, due to the risk of complications later on. The same applies to infections by Chlamydia.

Side Effects

What are the evils that can cause me?

The following side effects have been observed:
Effects on the gastrointestinal tract: Vomiting, nausea, diarrhea, dyspepsia, abdominal pain, flatulence and anorexia. Severe diarrhea and continuous, during or after therapy, can be caused by pseudomembranous colitis, which requires immediate medical interference. In this case, therapy with ciprofloxacin should be discontinued, and instituted appropriate medication (p. ex.: vancomycin orally, 4 x 250 mg/day). Drugs inhibiting the peristalsis are contraindicated.

Effects on the central nervous system: Dizziness, headache, tiredness, agitation and tremor.

In very rare cases: insomnia, peripheral paralgesia, state of distress, convulsive crisis, sweating, imbalance, nightmare, mental confusion, depression, hallucinations, increased intracranial pressure and anxiety.

In individual cases: reactions psychotic. In some cases, these reactions occurred after the first administration of ciprofloxacin. In such circumstances, one should immediately suspend the treatment with CIFLOX and inform the doctor.

Reactions relating to organ sensory: Very rarely: alteration of taste and smell, visual disturbances (p. ex.: diplopia, color vision), tinnitus, transient change of the hearing, especially to high frequencies.

hypersensitivity Reactions: In some cases, the following reactions already occurred after the first administration of ciprofloxacin, and treatment must be stopped and the doctor informed immediately.

Reactions of skin such as: skin rash, pruritus, fever medication. Very rarely: bleeding from puncture in the skin (petechiae), the formation bullosa accompanied by bleeding (hemorrhagic blisters) and small nodules (papules) with the formation of crusts, demonstrating commitment to vascular (vasculitis).

Erythema nodosum, erythema multiforme bullous (minor), Stevens-Johnson syndrome, syndrome Lyell. Interstitial nephritis, hepatitis, hepatic necrosis, evolving, very rarely, liver failure life-threatening.

Reactions, anaphylactic/anaphylactoid (p. ex.: edema facial, vascular and laryngeal), dyspnea is progressive, getting to the state of shock (life-threatening) in some cases, after the first administration. In these cases, the administration of CIFLOX should be interrupted and appropriate medical treatment should be instituted.

Effects on the cardiovascular system: Tachycardia. Very rarely: feeling of warmth, migraine, syncope.

Other side effects: Pain and swelling of the joint. Very rarely: feel general weakness, muscle pain, photosensitivity, transient change in renal function, including renal failure transient.

In isolated cases, during the administration of ciprofloxacin, predominantly in elderly patients on systemic treatment earlier with glucocorticoids, aquilotendinite was observed, which may lead to the rupture of the Achilles tendon. Therefore, at the first sign of aquilotendinite (swelling painful) the administration of CIFLOX should be discontinued and the doctor consulted.

The long-term use or administrations repeated CIFLOX can lead to superinfection with resistant bacteria or fungi similar to the yeasts.

Effects on the blood and blood constituents: Eosinophilia, leucocitopenia, granulocytopenia, anemia, thrombocytopenia. Very rarely: leucocytosis, thrombocytosis, haemolytic anaemia, changes in the values of prothrombin.

Influence on laboratory parameters/urinary sediment: there May be temporary increase in transaminases, alkaline phosphatase or cholestatic jaundice, especially in patients with previous liver disease. Temporary increase in urea, creatinine and bilirubin levels. In individual cases: hyperglycaemia, cristal├║ria and hematuria.

local Reactions: Very rarely: phlebitis.

additional information: there May be a delay in the ability to react promptly to situations, compromising the ability to drive or operate machinery, even with the administration being done correctly, according to the prescription. This fact occurs mainly with the concomitant ingestion of alcohol.

Warnings and Precautions

what should I know before using?

In epileptic patients or who have previously presented disturbances of the central nervous system (p. ex.: low seizure threshold, history of convulsive crisis, reduction of cerebral blood flow, structural changes in the brain or a cerebral vascular accident), CIFLOX should only be used after considering carefully the risk-benefit ratio, since these patients are likely to present the side effects the level of the central nervous system.

The patient should avoid sun exposure during treatment with CIFLOX, due to the risk of photosensitization.

This medicine can change the response capacity to drive vehicles or operate machinery. This effect is increased if there is concomitant ingestion of alcohol.

Overdose

what to do if someone use a larger amount than is recommended?

No specific antidote is known. In cases of overdosage acute oral, and it was registered the occurrence of renal toxicity is reversible. Therefore, in addition to the measures of usual emergency, it is recommended to monitor renal function and administer antacids containing magnesium, or calcium, to reduce the absorption of ciprofloxacin.

Only a small amount (< 10%) is removed from the body through hemodialysis theu peritoneal dialysis.

Drug Interactions

concomitant administration of CIFLOX, and iron, sucralfate or antacids and medicines highly buffered (as, p. ex.: anti-retroviral drugs), that contain magnesium, aluminum or calcium reduces the absorption of ciprofloxacin. Therefore, CIFLOX should be administered 1 to 2 hours before or at least 4 hours after these medications. This restriction does not apply to antacids belonging to the class of blockers of the receiver H 2.

Ciprofloxacin when administered concurrently with theophylline can result in an increase in undesirable serum concentration of this, and can give rise to side effects induced by theophylline. In cases in which simultaneous administration is indispensable, it is necessary the monitoring of the concentrations of serum theophylline and reduction convenient dose. This adjustment, which should be done prior to administration of the first dose of ciprofloxacin, is intended to prevent serum concentrations of high theophylline commonly observed that have serious side effects such as ventricular arrhythmias, convulsions or even death, as the first sign of toxicity and without prior notice.

experimental Studies have shown that the association of high doses of quinolones with some nonsteroidal anti-inflammatory drugs (but not aspirin) might cause seizures.

The simultaneous administration of ciprofloxacin and cyclosporine a led to a temporary increase in serum creatinine, making it necessary to control the frequent of the concentration of serum creatinine in these patients.

The use associated with warfarin may enhance the anticoagulant effect of this.

In isolated cases, the simultaneous administration of ciprofloxacin and glibenclamide can intensify the action of glibenclamide (hypoglycaemia).

probenecid interferes in the secretion renal of ciprofloxacin, concomitant administration of probenecid and ciprofloxacin increases serum concentration of ciprofloxacin.

The concomitant use of didanosine and ciprofloxacin can decrease the absorption of this latter.

metoclopramide accelerates the absorption of ciprofloxacin, causing the maximum concentration in plasma is reached in a shorter time period. Not noting the effects on the bioavailability of ciprofloxacin.

Elderly Patients

Studies have not shown problems with regard to the use of ciprofloxacin in elderly patients. However, these patients are more likely to experiencing a renal dysfunction, being in this case required an adjustment in the dose for you.

Compositions

Each film-coated tablet of Ciflox 250 mg and Ciflox 500 mg contains:
Ciprofloxacin (as the hydrochloride monoidratado) 250,0 mg 500,0 mg
Excipient q. s. p. 1 tablet 1 tablet
(lactose, titanium dioxide, microcrystalline cellulose, yellow dye tartrazine, croscarmelose sodium, silicon dioxide colloidal, magnesium stearate, eudragit E 100, polyethylene glycol 6000, polyvidone k 30, talc).

Laboratory

Medley

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