Tsiprolet

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

Solution for infusion in the form of a transparent, a colorless or pale yellow liquid.

Excipients: sodium chloride, lactic acid, disodium эdetat, citric acid monohydrate, Sodium hydroxide, hydrochloric acid, water d / and.

100 ml – bottles (1) complete with a loop for attaching – packs cardboard.

Pharmacological action

Ciprofloxacin 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. The drug 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, Moprganella, 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.

Pharmacokinetics

After intravenous administration of ciprofloxacin high concentration in the blood plasma (to 4 ug / ml) achieved through 20-30 minutes. The binding to plasma proteins slightly (20-40%). The volume of distribution – 2-3 l / kg.

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; GI infections;
• 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:

Indications / One-time / daily dose for adults

Uncomplicated infections of the lower and upper urinary tract / 2 x 100 mg

Complicated urinary tract infections (depending on the severity) / 2 x 200 mg

Respiratory Tract Infections / 2 x 200-400 mg

Other infections / 2 x 200-400 mg

Acute gonorrhea and acute uncomplicated cystitis in women can be treated with a single dose of 200 mg (intravenously).

With infections of the urinary tract, including for acute uncomplicated gonorrhea, Ciprofloxacin can be administered intravenously in a dose of 100 mg 2 once a day.

With infections of the respiratory tract, depending on the severity and the causative agent administered at a dose ciprofloxacin 200-400 mg 2 once a day, ceteris infections – by 200-400 mg 2 once a day. With the improvement of the patient go to the reception of the drug inside.

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 normalization of temperature or the disappearance of clinical symptoms. The duration of 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:

The duration of infusion should be 30 min at a dose 200 mg 60 min at a dose 400 mg. The solution preparation can be administered undiluted or after the addition of the other infusion solutions.

The solution contains ciprofloxacin 0,9% sodium chloride and is suitable for infusion solutions: 0,9% sodium chloride, Ringer, and Ringer laktatnыm rastvorom Hartmanna, 5% and 10% glucose solutions, 10% fructose solution, and 5% glucose solution, contains 0,225% or 0,45% sodium chloride.

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, digestive disorders, 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.

Local reactions: phlebitis

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, as well as cholestatic jaundice: a temporary increase in the concentration of urea, creatinine and serum bilirubin, giperglikemiâ.

Contraindications

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

Pregnancy and lactation

The drug is contraindicated.

Cautions

Not disclosed.

Overdose

These are not represented.

Drug Interactions

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 serum 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 a dry, dark place at a temperature of up to 25C.

Do not freeze.

Shelf life – Set on the label.