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Ципролет®

Препарат Ципролет®. Dr. Reddys Laboratories Ltd.  (Д-р Реддис Лабораторис Лтд.) Индия


Producer: Dr. Reddys Laboratories Ltd. (Dr. of Reddis Laboratoris Ltd.) India

Code of automatic telephone exchange: J01MA06

Release form: Firm dosage forms. Tablets.

Indications to use: Digestive tract infections. Sepsis. Pneumonia. Staphylococcal infections. Adnexitis. Prostatitis. Peritonitis. Gonorrhea. Neutropenia.


General characteristics. Structure:

Tsiprolet - 250: 1 tablet, coated, contains Ciprofloxacin of 250.0 mg, Corn starch of 57.87 mg, mikroktistallichesky cellulose of 7.5 mg, a kroskarameloz of sodium of 10.0 mg, colloid ангидрат silicon of 5.0 mg, talc of 7.0 mg, magnesium stearate of 3.510 mg, a gipromelloza of 6.0 mg, sorbic acid of 0.1 mg, titanium dioxide of 2.5 mg, a macrogoal of 1.7 mg, polysorbate of 0.1 mg, диметикон 0.1 mg

Tsiprolet - 500: 1 tablet, coated, contains monohydrate hydrochloride ciprofloxacin in the dose equivalent to 500 mg of ciprofloxacin and excipients - microcrystallic cellulose of 5.0 mg, a kroskarameloza of sodium of 20 mg, corn starch of 37.25 mg, magnesium stearate of 4.5 mg, silicon dioxide of colloid 5.0 mg, talc of 8.5 mg, a gipromelloza of 7.0 mg, sorbic acid of 0.1 mg, titanium dioxide of 2.5 mg, a macrogoal of 1.7 mg, polysorbate of 0.1 mg, диметикон 0.1 mg.




Pharmacological properties:

Pharmacodynamics. The mechanism of effect of ciprofloxacin is connected with influence on DNK-girazu (topoisomerase) of bacteria, the playing important role and reproductions of bacterial DNA. Ciprofloxacin has bystry bactericidal effect on the microorganisms which are as in a rest stage, and reproduction.
The range of effects of ciprofloxacin includes the following types of gram(s) and grams (-+-) of microorganisms:
E. coli, Shigella, Salmonella, Citrobacler, Klebsiella, Enterobacter, Serratia, Hafnia, Edwardsiella Proteus (indolpolozhitepny and indolnegative), Providencia, Morganella, Yersinia, Vibrio. Aeromonas, Plesiomonas, Pasteurella, Haemophilus, Campylobacter, Pseudomonas, Legionella, Neisseria, Moraxella, Branhamella, Acinetobacter, Brucella, Staphylococcus, Sreptococcus agalactiae, Listeria, Corynebacterium, Chiamydia.
Ciprofloxacin is effective concerning the bacteria producing beta lactamelements.
Sensitivity to ciprofloxacin varies at: Gardnerella, Flavobaclerium, Alcaligenes, Streptococcus faecalis, Streptococcus pyogenes, Streptococcus pneumonia, Streptococcus viridans, Mycoplasma hominis, Mycobacterium tuberculosis, Mycobacterium fortuitum.
Most often rezistentna of Streptococcus faecium, Ureaplasma urealyticum, Nocardia asteroides.
Anaerobe bacterias behind some exception are moderately sensitive (Peptococcus, Peptostreptococcus) or are steady (Bacteroides).
Ciprofloxacin does not work Treponema pallidum and mushrooms.
The Rezistemtnost to ciprofloxacin is developed slowly and gradually, plasmid resistance is absent. Tsiprofloksztsin is active concerning activators, resistant,
for example, to betalaktamny antibiotics, aminoglikoeida or tetracyclines.
Ciprofloxacin does not break normal intestinal and vaginal microflora.

Pharmacokinetics. Tsilrofloksatsin is quickly and well soaked up after administration of drug (bioavailability makes 70-80%). The maximum concentration in a blood plasma are reached in 60-90 min. Distribution volume - 2-3 l/kg. Linkng with proteins of a blood plasma is insignificant (20-40%). Ciprofloxacin well gets into bodies and fabrics. Approximately in 2 hours after intake or intravenous administration it is found in fabrics and liquids of an organism many times over big concentration, than in blood serum.
Ciprofloxacin is removed from an organism generally not changed look mainly through kidneys.
Plasma elimination half-life both after intake, and after intravenous administration makes from 3 to 5 hours.
Significant amounts of drug are removed also with bile and a stake therefore only considerable renal failures lead to removal delay.


Indications to use:

Treatment of the uncomplicated and complicated infections caused by the activators sensitive to drug
- respiratory infections. At out-patient treatment of pneumococcal pneumonia ciprofloxacin is not drug of the first stage, but it is shown at the pneumonia caused for example by klebsiyella, an enterobakter, sort Pseudomonas bacteria, hemophilic sticks, bacteria of the sort Branhamella, legionellama, stafilokokkama;
- infections of a middle ear and adnexal bosoms of a nose, especially if they are caused by gram-negative bacteria, including sort Pseudomonas bacteria, or stafilokokkam;
- infections of eyes
- infections of kidneys and urinary tract
- infections of skin and soft tissues
- infections of bones and joints
- infections of bodies of a small pelvis (including an adnexitis and prostatitis)
- gonorrhea
- GIT infections
- infections of a gall bladder and biliary tract
- peritonitis
- sepsis;
- Prevention and baking of infections at patients with reduced immunity (for example, at treatment by immunodepressants and at a neutropenia)
- Selective decontamination of intestines against the background of treatment by immunodepressants.


Route of administration and doses:

Indications to use                            Single/daily doses for adults
 
Uncomplicated infections of lower
and upper uric ways                                      of 2x125 mg
 
The complicated infections of uric
ways (depending on severity)          2x250-500 mg
 
Respiratory infections                             of 2x250-500 mg
 
Other infections                                                  of 2x500 mg

At infections of a heavy current, for example at recurrent infections at patients with a mucoviscidosis, the infections of an abdominal cavity, bones and joints caused by Pseudomonas or stafilokokka and also at the acute pneumonias caused by Streptococcus pneumoniae, it is necessary to increase a daily dose to 1,5 g (2x750 mg) die intake if treatment is not carried out intravenously.
Acute gonorrhea and acute uncomplicated cystitis at women it is possible to treat a single dose in 250 - 500 mg. If the patient in the gravity of a disease or owing to other reasons is not able to take a pill, coated, it is recommended to begin treatment tsiprolety for intravenous infusion

Patients with a renal failure:
At clearance of creatinine less than 20 ml/min. (or the level of serumal creatinine it is higher than 3 mg / 100 of ml) are appointed: 2 times a day a half standard dose or once a day a full standard dose.
Patients with abnormal liver functions:
Selection of a dose is not required.

The patients who are on peritoneal dialysis:
At peritonitis ciprofloxacin is appointed inside on 0,5 g by 4 times a day or add drug in the form of solution for infusion in a dose of 0,05 g 4 times a day on 1 п dialyzate intraperitoneally.

Use duration
Duration of treatment depends on disease severity, a clinical current and results of a bacteriological research.
Existence of a tsiprolet in two dosage forms pozvopyat to begin treatment of heavy infections intravenously and to continue it orally.
It is recommended to continue treatment within not less than 3 days after normalization of temperature or disappearance of clinical symptoms. Treatment duration at acute uncomplicated gonorrhea and cystitis makes 1 day. At infections of kidneys, urinary tract and an abdominal cavity - up to 7 days. At osteomyelitis the course of baking can make up to 2 months. At other infections a course of treatment - 7-14 days. At patients with reduced immunity treatment is carried out during the entire period of a neutropenia.
Route of administration
Tablets should be swallowed without chewing, washing down with liquid. Drug can be accepted irrespective of meal. Reception on an empty stomach accelerates digestion of active ingredient.


Features of use:

At patients elderly to increase ciprofloxacin should be applied with care. The patient with epilepsy, attacks of spasms in the anamnesis, vascular diseases and organic lesions of a brain in connection with threat of development of side reactions from TsNS, it is necessary to appoint ciprofloxacin only according to vital indications.
During treatment by ciprofloxacin adequate hydration is necessary for prevention of a possible crystalluria.

The instruction for participants of traffic
This medicine even at appropriate use can change ability to concentration of attention in such degree that ability to manage the vehicle, and also to service machines and mechanisms decreases. Especially it belongs to cases of interactions with alcohol.


Side effects:

Ciprofloxacin is well transferred by patients.
At treatment by-effects can arise ciprofloxacin following, usually reversible:
From cardiovascular system, seldom or never - tachycardia, heat inflows, migraine, a faint
From a GIT and a liver: nausea, vomiting, diarrhea, abdominal pains, meteorism, lack of appetite.
From a nervous system and mentality: dizziness, a headache, fatigue, sleeplessness, excitement, a tremor, seldom or never, peripheral disturbances of sensitivity, perspiration, instability of gait, attacks of spasms, sensation of fear and confusions, nightmares, depressions, hallucinations, disturbances of taste and sense of smell, a visual disturbance (a diplopia, a chromatopsia), a sonitus, temporary relative deafness especially on high-pitched sounds. In case of these reactions it is necessary to cancel immediately drug and to notify the attending physician.
From system of a hemopoiesis: an eosinophilia, a leukopenia, thrombocytopenia, it is very rare - a leukocytosis, a thrombocytosis, hemolitic anemia.
Allergic and immunopathological reactions: skin rashes, itch, medicamentous fever, and also photosensitization; seldom - a Quincke's edema, a bronchospasm, arthralgias, it is very rare - an acute anaphylaxis, mialgiya, Stephens-Johnson's syndrome, a Lyell's disease, intersticial nephrite, hepatitis.
Musculoskeletal system: there are single messages that use of ciprofloxacin was followed by the ruptures of sinews of a shoulder, hands and the Achilles tendon demanding surgical intervention. At emergence of complaints treatment should be stopped.
Influence on laboratory indicators: especially at patients with abnormal liver functions temporary increase in level of transaminases and an alkaline phosphatase can be noted; temporary increase in concentration of urea, creatinine and bilirubin in blood serum, a hyperglycemia.


Interaction with other medicines:

Simultaneous use of ciprofloxacin (inside) and the drugs influencing acidity of a gastric juice (antiacid means), containing a hydroxide of aluminum or magnesium, and also the drugs containing salts calcine, gland and zinc reduces ciprofloxacin absorption. In this regard Tsiprolet should take for 1-2 h to or not less than in 4 h after reception of the specified drugs. At simultaneous use of ciprofloxacin and theophylline it is necessary to control concentration of theophylline in a blood plasma and to adjust its dose since, undesirable increase in concentration of theophylline in blood and development of the corresponding side effects can be observed.
At simultaneous use of ciprofloxacin and cyclosporine increase in concentration of serumal creatinine therefore at such patients control of this indicator is necessary frequent (2 times a week) was in some cases observed.
At simultaneous use of ciprofloxacin and warfarin strengthening of effect of warfarin is possible. Animal experiments showed that very high doses of hinolon and some non-steroidal anti-inflammatory drugs (but not acetylsalicylic acid) can cause spasms. However at sick such medicinal interactions it was not observed.
Ciprofloxacin can be applied in combinations with azlotsilliny and a ceftazidime at the infections caused by Pseudomonas; with mezlotsilliny, azlotsilliny and others effective beta лактамными antibiotics - at streptococcal infections; with izoksazoilpenitsillina, Vancomycinum - at staphylococcal infections, with metronidazole, clindamycin - at mephitic gangrenes.


Contraindications:

Hypersensitivity to ciprofloxacin and other drugs of group of hinolon
pregnancy
lactation
children's and teenage age.


Overdose:

The specific antidote is not known. Usual measures of acute management, and also a hemodialysis and peritoneal dialysis are recommended.


Storage conditions:

In the dry dark place at a temperature up to 25 °C. Period of validity 3 years. Tsiprolet is not allowed to be applied after expiry date.


Issue conditions:

According to the recipe


Packaging:

The blister containing 10 tablets (250 mg or 500 mg), coated.



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