Tsiprolet (Pills, coated)

Active material: Ciprofloxacin
When ATH: J01MA02
CCF: Fluoroquinolone antibacterial drug
When CSF: 06.17.02.01
Manufacturer: DR. REDDY`S LABORATORIES LTD. (India)

DOSAGE FORM, COMPOSITION AND PACKAGING

Pills, coated white or nearly white, round, lenticular, with a smooth surface on both sides; of presentations – white with a slightly yellowish tinge mass.

Excipients: corn starch, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, silica colloidal, talc, gipromelloza, sorbic acid, Titanium dioxide, macrogol 6000, polysorbate 80, Dimethicone.

10 PC. – blisters (1) – cardboard boxes.

Pharmacological action

Tsiprolet is a fluoroquinolone antimicrobial drugs.

The mechanism of action involves the action of ciprofloxacin at DNA gyrase (topoisomerase) bacteria, plays an important role in the reproduction of bacterial DNA. Ciprofloxacin has a rapid bactericidal effect on microorganisms, It is in the resting stage, and breeding.

The spectrum of action of ciprofloxacin includes the following Gram(-) and g(+) Microorganisms:

E.coli,Shigella, Salmonella, Citrobacter, Klebsiella, Enterobacter, Serratia, Hafnia, Edwardsiella, Proteus (indolpolozhitelnye and indolotritsatelnye) , Providence, Morganella, Yersinia, Vibrio, Aeromonas, Рlesiomonas, Pasteurella, Haemophilus, Campylobacter, Pseudomonas, Legionella, Neisseria, Moraxella, Branham, Acinetobacter, Brucella, Staphylococcus, Sreptococcus agalactiae, Listeria, Corynebacterium, Chlamydia.

Ciprofloxacin is effective against bacteria, producing beta-lactamase.

Sensitivity varies with ciprofloxacin: Gardnerella, Flavobacterium, Alcaligenes, Streptococcus faecalis, Streptococcus pyogenes, Streptococcus pneumonia, Streptococcus viridans, Mycoplasma hominis, Mycobaсterium tuberculosis, Mycobacterium fortuitum.

Most often resistant: Streptococcus faecium, Ureaplasma urealyticum, Nocardia asteroids.

With a few exceptions anaerobes moderately sensitive (Peptococcus,Peptostreptococcus) or resistant ( Bacteroides). Ciprofloxacin has no effect on Treponema pallidum and fungi.

Resistance to ciprofloxacin is developed slowly and gradually, no resistance plasmid.

Ciprofloxacin is active against pathogens, resistant, eg, a beta-lactam antibiotics, aminoglycosides, or tetracyclines.

Ciprofloxacin does not disturb normal intestinal flora and vaginal.

Pharmacokinetics

Ciprofloxacin is rapidly and well absorbed after ingestion (bioavailability of 70-80%). Maximum plasma concentrations are achieved through 60-90 m. The volume of distribution – 2-3 l / kg. The binding to plasma proteins slightly (20-40%). Ciprofloxacin is well into the organs and tissues. Approximately 2 hours after oral or intravenous administration, it is found in tissues and bodily fluids many times higher concentrations, than serum.

Ciprofloxacin is excreted largely unchanged in mainly through the kidneys. Plasma half-life after the ingestion, and after intravenous administration is 3 to 5 hours.

Significant amounts of the drug are also displayed in the bile and feces, so the only significant renal dysfunction leads to slower elimination.

Testimony

Treatment of uncomplicated and complicated infections, caused by infection,susceptible to malaria:

• respiratory tract infections. When outpatient treatment of pneumococcal pneumonia ciprofloxacin is not the drug of the first stage, but it is shown with pneumonia, for example caused by Klebsiella, Enterobacteriaceae, bacteria of the genus Pseudomonas, Haemophilus influenzae, bacteria of the genus Branhamella, Legionella, staphylococci;
• infections of the middle ear and paranasal sinuses, particularly if they are caused by Gram-negative bacteria, including bacteria of the genus Pseudomonas, or staphylococci;
• eye infection
• infections of the urinary tract
• infections of skin and soft tissue
• bone and joint infections
• pelvic infection (including adnexitis and prostatitis) Gonorrhea infections gastrointestinal tract
• infection of the gallbladder and biliary tract
• peritonitis
• sepsis.

Prevention and treatment of infections in patients with reduced immunity (for example in the treatment of neutropenia and immunosuppressive)

Selective decontamination of the intestine during treatment immunosuppressants.

Dosage regimen

In the absence of specific instructions, the doctor recommends the following indicative dose tsiprolet:

Indications / One-time / daily dose for adults

Uncomplicated infections of the lower and upper urinary tract / 2h125 mg

Complicated urinary tract infections (depending on the severity) / 2h250-500 mg

nfektsii airways / 2h250-500 mg

Other infections / 2x500 mg

When severe infections such as recurrent infections in patients with cystic fibrosis, abdominal infections, bone and joints, caused by Pseudomonas and staphylococci, as well as acute pneumonia, caused by Streptococcus pneumoniae, the daily dose should be increased to 1,5 g (2h750 mg) ingestion, if treatment is not carried out intravenously.

Acute gonorrhea and acute uncomplicated cystitis in women can be treated with a single dose of 250 -500 mg.

If the patient due to the severity of the disease or because of other reasons, is unable to take tablets, coated, it is recommended to start treatment tsiprolet for intravenous infusion.

Patients with impaired renal function: When creatinine clearance less than 20 ml / min ( or serum creatinine above 3 mg / 100ml) appointed : 2 times a day or half the standard dose 1 once daily full standard dose. Patients with impaired hepatic function:

Dose adjustment is not required.

Sick, are on peritoneal dialysis :

When peritonitis ciprofloxacin appointed interior 0,5 g 4 twice daily or drug is added in the form of solution for infusion in a dose of 0,05 g 4 twice a day 1 l dialysis intraperitonealyno.

Duration of use:

The duration of treatment depends on the severity of the disease, the clinical course and the results of bacteriological tests.

Have tsiprolet in two dosage forms allows you to start the treatment of severe infections and intravenous continue his mouth.

It recommended to continue treatment for at least 3 days after the normalization of temperature, or the disappearance of clinical simptomov.Dlitelnost treatment for acute uncomplicated gonorrhea and cystitis is 1 day. With infections of the kidneys, urinary tract and abdomen – to 7 days. When osteomyelitis treatment can be up to 2 months. For other infections treatment – 7-14 days. In patients with reduced immunity treatment is carried out during the entire period of neutropenia.

Mode of application:

Tsiprolet Tablets should be swallowed without chewing, with some liquid. The drug can be taken regardless of meals. Receiving an empty stomach accelerates the absorption of the active substance.

Side effect

Ciprofloxacin is well tolerated.

In the treatment with ciprofloxacin may occur following, usually reversible, side effects:

Cardio-vascular system: In very rare cases – tachycardia, hot flashes, migraine, fainting.

On the part of the digestive tract and liver: nausea, vomiting, diarrhea, stomach ache, flatulence, anorexia.

From the nervous system and psyche: dizziness, headache, fatigue, insomnia, excitation, tremor, In very rare cases: peripheral sensory disturbances, Sweating, unsteady gait, convulsive seizures, fear and confusion, nightmares, depression, hallucinations, disorders of taste and smell, visual disturbances (diplopia, chromatopsia), noise in ears, Temporary hearing loss especially on the high notes. In the case of these reactions should immediately stop the drug and notify your doctor.

From the hematopoietic system: eozinofilija, leukopenia, thrombocytopenia, rarely – leukocytosis, thrombocytosis, gemoliticheskaya anemia.

Allergic and immunopathological reactions: skin rashes, itch, drug fever, and photosensitivity; rarely- angioedema, bronchospasm, artralgii, rarely – anaphylactic shock, mialgii, Stevens-Johnson syndrome, Lyell's syndrome, interstitial nephritis, hepatitis.

Locomotor apparatus: There are few reports, that the use of ciprofloxacin accompanied shoulder tendon rupture, hands and Achilles tendon, require surgery. When the complaints treatment should be discontinued.

Effects on laboratory parameters: especially in patients with impaired liver function may experience a temporary increase in the level of transaminases and alkaline phosphatase; a temporary increase in the concentration of urea, creatinine and serum bilirubin, giperglikemiâ.

Information for road users:

The drug, even when used correctly can change the ability to focus to such an extent, that reduces the ability to drive a vehicle, and serve machinery. This is especially true in cases ONOS interaction with alcohol.

Contraindications

• Hypersensitivity to ciprofloxacin and other quinolone drugs,
• pregnancy,
• lactation,
• childhood and adolescence.

Pregnancy and lactation

The drug is contraindicated.

Cautions

In elderly patients Ciprofloxacin should be used with caution. Patients with epilepsy, convulsive seizures in history, vascular disease and organic brain damage due to the threat of adverse reactions of the nervous system, Ciprofloxacin should be used only for health.

During treatment with ciprofloxacin ensure adequate hydration for the prevention of possible crystalluria.

Overdose

Spetsificheskiy no known antidote. The recommended usual emergency measures, and hemodialysis and peritoneal dialysis.

Drug Interactions

Simultaneous use of ciprofloxacin (inside) and preparations, influencing gastric acidity (Antacids), containing aluminum hydroxide or magnesium, as well as preparations, containing calcium salts, iron and zinc, reduces the absorption of ciprofloxacin. In this regard it should be taken tsiprolet 1-2 hours before or less than 4 hours after administration of said drugs.

With simultaneous application of ciprofloxacin and theophylline should monitor the concentration of theophylline in the blood plasma and adjust the dose, tk. there may be an undesirable increase in the concentration of theophylline in the blood and the development of related side effects.

With simultaneous application of ciprofloxacin and cyclosporine, in some cases, an increase in serum creatinine concentration, therefore such patients requires frequent (2 times a week) Control of this indicator. With simultaneous application of ciprofloxacin and warfarin may increase the action of warfarin.

Animal studies have shown, that very high doses of certain quinolones and nonsteroidal antiinflammatory agents (but not acetylsalicylic acid) can cause seizures. However, in patients with such drug interactions were observed.

Ciprofloxacin can be used in combination with ceftazidime azlocillin and infections, caused by Pseudomonas; with mezlocillin, azlocillin and other effective beta-lactam antibiotics – when streptococcal infections; with izoksazoilpenitsillinami, vancomycin – When staphylococcal infections, metronidazole, klindamiцinom – under anaerobic infections.

Conditions and terms

In dry the dark place at a temperature to 25 ° C.

Shelf life - 3 year.