REDIRECTION PAGE
COMPOSITOIN
Active component:
Ciprofloxacin hydrochloride equivalent to 250 mg and 500 mg Ciprofloxacin in one filmtablet and auxiliary substances.
EFFECT: ANTI-INFLAMATORY
The Ciprofloxacin is a synthetic wide spectrum antibacterial preparation of the group of the fluorinated 4-hinolons. It has a strong microbicidal (germicidal) effect and high activity towards a great deal of gram negative and gram positive microorganisms. It is used for treatment of bacterial infections in different parts of the body. The tablets are resorbed quickly into the gastro-intestinal tract.
The Ciprofloxacin is a synthetic chemotherapeutic preparation of the group of 4-chinolones with a wide anti-bacterial spectrum of the effect. It oppresses the replication of bacterial deoxyribonucleic acid and the protein synthesis, by means of which the generative ability of the microorganisms is interrupted. It has a bactericide effect to gram-positive and gram-negative microorganisms, including the resistant ones to other antibacterial means: E.coli, Proteus (indolpositive and indolnegative), Providentia, Klebsiella, Enterobacteur, Cirtobacteur, Pseudomonas, Hafnia, Edwardsiella, Shigella, Salmonella, Vibro cholearae, Pasteurella, Listeria, Acinectobacteur, Haemophilis, Neisseria, Corinebacterium, Ataphylococcus, Streptococcus, Chlamidia, etc. Changeable is its effect towards Serratia, Streptococcus faecalis, Str. faecium, Str. pneumoniae, Mycoplasma hominis, Mycobacterium, anaerobe microorganisms – Peptococcus, Peptostreptococcus, Veillonella, Fusobacterium, Clostridium, Bacteriodes, etc.
The Ciprofloxacin is characterized with very good pharmacokinetic parameters. After one fold peroral application of 500 mg the maximal serum concentrations (from 1,5 to 2 mkg/ml) are reached within the 60th and 90th minutes, remaining as therapeutic serum levels toward the most of the pathogenous microorganisms up to the 12th hour.
The absolute bioavailability is approximately 70 to 80%. High concentrations in the nasal and bronchial secretes, in the prevral liquid, the urogenial organs (including the prostate gland), the bile, the bone and muscle tissue and considerably lower in the fluids has been found. It is excreted mainly through glomerular filtration and tubular excretion in biologically active form.
INDICAITONS
To be used according to physician’s prescription.
Ciprofloxacin is applied for infections provoked by sensitive to it microorganisms of: the lower respiratory tract, the genito-urinary system, the skin, the soft tissues, the bones and joints. It has a good medical effect in gastrointestinal infections, in infections of diseased with decreased immune protection.
CONTRAINDICATIONS
The patient has to warn the treating physician if you have been hypersensitive to this preparation or to other similar preparations; you have had a cerebral irritation, cerebral trauma, you have disturbed circulation of the blood, disturbed cerebral irrigation and you have passed a cerebral insult; you have damaged kidneys.
Super sensitivity to Ciprofloxacin and other chemotherapeutics of the group of chinolones, pregnancy and lactation; children with not finished growth; with attention has to be applied in diseases in advanced years or with damaged central nervous system (epilepsy, eccentric convulsions in the anamnesis, violation in the encephalic irritation and apoplexy.)
SIDE EFFECTS
Ciprofloxacin is endured very well. Seldom are observed the following side effects: gastro-intestinal disorders (nausea, emesis, diarrhea, pains and hooves, lack of appetite); manifestations of neurotoxicity (vertigo, cephalalgia (headache), excitation, fright condition, violation of the periphere sensibility and very rarely double vision, changes in the color reception, convulsions; allergy reactions (irritation, exanthema, erythema, medicine fever, edema of the face; cardiovascular disorders (hypotension, tachycardia; pains in the joint; fleeting changes of the laboratory indices – increase of the transminases, the alkaline phosphates, the bilirubin, urea, creatinine, cristalluria (if no sufficient quantity of liquids are taken). In individual cases some other phenomena are possible, described in the application of the preparation of the chinolone group: changes in blood condition, tongue edema, swallowing embarrassment, asthma, fulminating shock, papulas, hemorrhagic bullos, vasculitis, intensified heat (erubescense of the skin) after durable isolating, etc.
UNDUE MEDICAL REACTIONS
If during the treatment appear complaints not connected with the basic disease, please consult your physician.
During the treatment with Ciprofloxacin may appear diarrhea, nausea, emesis, cephalalgia (headache), drowsiness, depression; in some cases imbalance, myalgia, articulation (joint) pain and tendon pains; tendon inflammatory and rupture of the Achilles; nasal blood.
Some diseased develop seldom hypersensitive reaction of the skin (eruptions, edema) or of the respiratory organs (edema of the larynx, of the lung).
Very seldom – pains of the bulb of the eyes, disturbed circulation, cerebral thrombosis; thrombophlebitis, vena inflammation; anemia, hyperorthocytosis, blood coagulation violation.
OVERDOSAGE
In case of overdose immediately consult a physician!
Gastric lavage is immediately made, more liquids are to be taken and symptomatic treatment to the medication. No specific antitoxin is available.
PREVENTIVE MEASURES AND WARNING
It is not to be used for children under 18 years, because it provokes and enhances the joint diseases.
Patients hypersensitive to other representatives of the group fluorochololones may be hypersensitive to Ciprofloxacin as well.
If you suffer epilepsy, you have had convulsions, muscle cramps let the physician know! Ciprofloxacin is not applied in these cases, because it can provoke convulsions, increased cerebral pressure, psychisis.
Warn during the treatment if you have liver examinations, because the preparation changes the results of some tests.
The preparation creates photosensibilization (increased sensitivity to light) and during treatment the patient has to avoid direct sun light.
In middle doses the Ciprofloxacin may considerably destroy the reflexes, which has to be taken into consideration when prescribing it to vehicle or machine operators.
MEDICAL AND OTHER INTERACTIONS
The preparation interacts with other medicines and its combined reception is to be determined by a physician!
The antiacid medicaments (against increased stomach acidity) containing aluminum and magnesium decrease the effect of the Ciprofloxacin because they decrease its resorption by the gatro-intestinal tract. They have to be taken with an interval of 4 hours before or after the acceptance of Ciprofloxacin.
Alkalizing agents such as the carbonanhydrate inhibitors natrium bicarbonate reduce the solubility of the preparation and the patients have to control for cristallury and neurotoxicity.
In simultaneous treatment with Teophilin a danger for increase of its toxicity is available. A big dose of Ciprofloxacin (1500 mg) the Theophilin may cause undesired increase of the concentration of the Theophilin in the plasma. Physician’s control is necessary and if needed a change in the dosage to b made.
The Ciprofloxacin increase the toxicity of the Probencide and hence the undesired reactions.
Because of disorderly action of the hearth it has not to be applied together with intravenously applied barbiturates.
The joint acceptance of Ciprofloxacin C increases the damaging effect on the kidneys.
Ciprofloxacin prolongs the effects of peroral anticoagulants.
PREGNANCY AND LACTATION
Ciprofloxacin should not be applied to pregnant or lactating women.
EFFECTS ON THE ABILITY FOR DRIVING AND MACHINE OPERATION
Ciprofloxacin is not recommended for vehicle and machine operators.
APPLICATION AND DOSAGE
The preparation is applied as a medication under physician’s control!
The preparation is to be taken on an empty stomach with more fluids or during meals.
For infections of the lower respiratory tracts, the skin, the bones and joints, the gastro-intestinal tract – 500 mg every 12 hours. In case of heavy forms of the shown infections the dose may be increased to 750 mg every 12 hours.
In cases of heavy infections of the ear, nose, throat, the genitals, the biliary ducts, the skin and soft tissues, sepsis, peritonitis and in fulminating infections of people with decreased protective potency 500 mg every 12 hours.
At especially heavy infections – frequent ebullitions of the mucoviscidosis, heavy infections of the abdominal cavity, of the marrow, infected artificial joints, very heavy infection of the ear 750 mg every 12 hours.
The treatment duration depend on the gravity of the infection and is determined by the physician. Usually the treatment with Ciprofloxacin endures 2 days after disappearing of the symptoms of the infection. The treatment is most often continued for 14 days and for infections of the bones and joints the product may be taken form 4 to 6 weeks.
For conditions with damaged kidney function the dosage is to be corrected, as well the interval for acceptance, depending on the creating clearance being determined by the physician.
The treatment is not to be interrupted if a dose is missed. The omitted dose should be taken as soon as possible.
The treatment is suspended in lack of improvement and availability of undesired medical reactions; it is to be carried out with other medications as determined by the physician.
MEDICINE FORMS
Film tablets of 500 mg each in blister sheets of 10 tablets
Filmtablets of 250 mg each in packs of 20.
STORAGE
In the original packaging in dry and protected from light place at temperatures 15 -25ºC.
KEEP OUT OF REACH OF CHILDREN!
DO NOT STORE IT IN DAMP ROOMS, BATHROOMS, ETC.
STABILITY TERM
Three (3) years from the date of manufacture
PRODUCER
Balkanpharma Dupnitsa PLC
Pharmacia AD
3 Samokovsko Shosee
Dupnitsa, Bulgaria 2600
