Protsipro - instructions for use, doses, side effects, contraindications

Active substance: ciprofloxacin lactate 265 mg (equivalent to 200 mg ciprofloxacin); Excipients: sodium chloride 900 mg, water for injection up to 100 ml.

Description:

Transparent, colorless or light yellow solution.

Pharmacotherapeutic group:Antimicrobial agent, fluoroquinolone.

ATX: & nbsp

J.01.M.A.02 Ciprofloxacin

Pharmacodynamics:

Ciprofloxacin is a synthetic antimicrobial agent of a broad spectrum of action of a group of fluoroquinolones. The main mechanism of action is the suppression of the bacterial DNA-gyrase enzyme, as a result of which the replication of deoxyribonucleic acid and the synthesis of bacterial cell proteins are violated. The drug has a bactericidal effect on gram-negative microorganisms during rest and division and on Gram-positive microorganisms during the fission period.

Gram-negative aerobic bacteria are sensitive to ciprofloxacin: enterobacteria (Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis,Proteus vulgaris, Serratia marcescens, Hafnia alvei, Edwardsiella tarda, Providencia spp., Morganella morganii, Vibrio spp., Yersinia spp.), Other gram-negative bacteria (Haemophilus spp., Pseudomonas aeruginosa, Moraxella catarrhalis, Aeromonas spp., Pasteurella multocida, Plesiomonas shigelloides, Campylobacter jejuni, Neisseria spp.), some intracellular pathogens: Legionella pneumophila, Brucella spp. Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Mycobacterium avium-intracellulare.

Gram-positive aerobic bacteria are also sensitive to ciprofloxacin: Staphylococcus spp. (Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus), Streptococcus spp. (Streptococcus pyogenes, Streptococcus agalactiae). The majority of staphylococci, resistant to methicillin, are resistant to ciprofloxacin.

The sensitivity of bacteria Streptococcus pneumoniae, Enterococcus faecalis is moderate. To a drug resistant Corynebacterium spp., Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides. The effect of the drug against Treponema pallidum has not been adequately studied.

Pharmacokinetics:

When intravenously administered 200 mg or 400 mg of ciprofloxacin 60 minutes after the start of infusion, the concentration of the active substance in the serum is 2.1 μg / ml or 4.6 μg / ml.

The volume of distribution in the equilibrium state is 2.0-3.0 l / kg. Binding to plasma proteins is low. There is a high concentration of ciprofloxacin in bile, lungs, kidneys, liver, gall bladder, uterus, seminal fluid, prostate tissue, tonsils, endometrium, fallopian tubes and ovaries. The concentration of the drug in these tissues is higher than in the serum. Ciprofloxacin also penetrates well into bones, eye fluid, bronchial secretion, saliva, skin, muscles, pleura, peritoneum, lymph; through the blood-brain barrier penetrates in a small amount.

After intravenous administration, the concentration in the urine during the first two hours of intake is almost 100 times greater than in the serum.

In patients with unchanged kidney function, the elimination half-life is usually 3-5 hours. If the kidney function is impaired, the elimination half-life increases.

The main way to remove ciprofloxacin from the body is the kidney. The kidneys deduce 50-70%. From 15 to 30% is excreted through the intestine.

Patients with severe renal insufficiency (creatinine clearance below 20 ml / min / 1.73 m2) should be prescribed half the daily dose of the drug.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to ciprofloxacin:

- respiratory tract;

- Ear, throat and nose;

- kidney and urinary tract;

- genital organs (gonorrhea, prostatitis, adnexitis);

- gynecological and postpartum infections;

- the digestive system (including the mouth, teeth, jaws), gallbladder and bile ducts;

- skin, mucous membranes and soft tissues;

- The musculoskeletal system.

Ciprofloxacin is indicated for the treatment of sepsis and peritonitis, as well as for the prevention and treatment of infections in patients with reduced immunity (with immunosuppressant therapy).

Contraindications:

- Pregnancy;

- lactation period (breastfeeding);

- children and adolescence under 18;

- hypersensitivity to ciprofloxacin or other drugs from the group of fluoroquinolones;

- simultaneous reception with tizanidine (risk of pronounced decrease in blood pressure, drowsiness)

Carefully:

Severe atherosclerosis of cerebral vessels, cerebral circulation disorder, mental illness, epilepsy, epileptic syndrome, renal and / or hepatic insufficiency, elderly age.

Dosing and Administration:

The drug is administered intravenously, but more preferably a drip for 30 minutes (200 mg) and 60 minutes (400 mg).

The dose of ciprofloxacin depends on the severity of the disease, the type of infection, the body's condition, age, weight and kidney function in the patient. For intravenous administration, a single dose of 200 mg (with severe infections of 400 mg), the frequency of administration is 2 times a day.If necessary, in / in the treatment of especially severe, life-threatening or recurrent infections caused by Pseudomonas, Staphylococcus or Streptococcus pneumoniae, the dose may be increased to 0.4 g with a multiplicity of administration up to 3 times a day. In acute gonorrhea, 200 mg is given intravenously. For prophylaxis of postoperative infections, for 30-60 minutes before the operation, intravenously for 200 ^ 00 mg.

The duration of treatment depends on the severity of the disease and is 1-2 weeks, if necessary and more (with osteomyelitis may reach up to 2 months).

With a clearance of creatinine from 31 to 60 ml / min / 1.73 m2 or its plasma concentration from 1.4 to 1.9 mg / 100 ml, the maximum dose of ciprofloxacin for intravenous administration should be 800 mg per day.

With a creatinine clearance of 30 ml / min / 1.73 m2 or less, or a plasma concentration of 2.0 mg / 100 ml or more, the maximum dose of ciprofloxacin for intravenous administration should be 400 mg per day.

Side effects:

On the part of the digestive system: nausea, diarrhea, vomiting, abdominal pain, flatulence, decreased appetite, cholestatic jaundice (especially in patients with liver disease), hepatitis, hepatonecrosis.

From the central nervous system: dizziness, headache, increased fatigue,anxiety, tremor, insomnia, nightmarish dreams, peripheral paralysis (anomaly of perception of pain), increased sweating, increased intracranial pressure, confusion, depression, hallucinations, and other manifestations of psychotic reactions (occasionally progressing to conditions in which the patient can cause harm), migraine, fainting, thrombosis of the cerebral arteries.

From the senses: a violation of taste and smell, visual impairment (diplopia, change in color perception), noise in the ears, hearing loss.

On the part of the urinary system: hematuria, crystalluria (especially in alkaline urine and low diuresis), glomerulonephritis, dysuria, polyuria, urinary retention, albuminuria, urethral bleeding, hematuria, decreased renal nitrogen function, interstitial nephritis.

On the part of the hematopoiesis system: eosinophilia, leukopenia, neutropenia, change in the number of platelets, hemolytic anemia.

From the cardiovascular system: tachycardia, cardiac arrhythmias, arterial hypotension.

Allergic reactions: skin itching, urticaria, the formation of blisters accompanied by bleeding, and the appearance of small nodules that form scabs, drug fever, pinpoint hemorrhages on the skin (petechia), swelling of the face or larynx, dyspnea, eosinophilia, increased photosensitivity, vasculitis, nodal erythema, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome).

On the part of laboratory indicators: increased urea concentration, creatinine, increased activity of hepatic transaminases, alkaline phosphatase, lactate dehydrogenase, bilirubin.

Other: arthralgia, arthritis, tendovaginitis, tendon ruptures, asthenia, myalgia, superinfections (candidiasis, pseudomembranous colitis), "tides" of blood to the face; rarely - photosensitivity; pain, burning at the injection site, phlebitis.

Overdose:

The specific antidote is unknown. It is necessary to carefully monitor the patient's condition, make gastric lavage, carry out usual emergency measures, ensure sufficient fluid intake.With the help of hemo- or peritoneal dialysis, only a small amount (less than 10%) of the drug can be excreted.

Interaction:

With the simultaneous use of ciprofloxacin with didanosine, ciprofloxacin absorption decreases due to the formation of ciprofloxacin complexes with didanosine-containing aluminum and magnesium salts.

When combined with other antimicrobial drugs (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole) synergy is usually observed; can be successfully used in combination with azlocillin and ceftazidime in infections caused by Pseudomonas spp .; with mezlocillin, azlocillin and other beta-lactam antibiotics - with streptococcal infections; with isoxazole penicillins and vancomycin - with staphylococcal infections; with metronidazole and clindamycin - with anaerobic infections.

Non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid) increase the risk of seizures.

Metoclopramide accelerates absorption, which leads to a decrease in the time to reach its Cmax.

The joint administration of uricosuric medicines leads to a delay in excretion (up to 50%) and an increase in the plasma concentration of ciprofloxacin.

Increases the maximum concentration by 7 times (from 4 to 21 times) and AUC by 10 times (from 6 to 24 times) of tizanidine, which increases the risk of pronounced decrease in blood pressure and drowsiness.

With simultaneous use with warfarin, the risk of bleeding increases.

Due to the decrease in the activity of microsomal oxidation in hepatocytes, it increases the concentration and prolongs the half-life of theophylline and other xanthines, for example, caffeine (increasing the risk of toxic effects associated with theophylline), oral hypoglycemic drugs, indirect anticoagulants, and contributes to a decrease in the prothrombin index.

With the simultaneous use of ciprofloxacin and anticoagulants, the bleeding time is prolonged

With the simultaneous use of ciprofloxacin and cyclosporine, the nephrotoxic effect of the latter is enhanced.

Pharmaceutical interaction: a solution of ciprofloxacin is incompatible with solutions or drugs with pH 3-4 that are physically or chemically unstable. The infusion solution of ciprofloxacin is not compatible with solutions having a pH of more than 7.

Special instructions:

Patients with epilepsy, episodes of seizures in history, vascular diseases and organic brain damage due to the threat of development of adverse reactions from the central nervous system ciprofloxacin should be prescribed only for vital indications

When arising during or after treatment ciprofloxacin oh severe and prolonged diarrhea should be excluded from the diagnosis of pseudomembranous colitis, which requires immediate withdrawal of the drug and the appointment of appropriate treatment.

If pain occurs in the tendons or when the first signs of tendovaginitis appear, treatment should be discontinued due to the fact that individual cases of inflammation and even rupture of tendons during treatment with fluoroquinolones are described.

During the treatment with ciprofloxacin it is necessary to provide a sufficient amount of fluid while observing a normal diuresis.

During treatment with ciprofloxacin, contact with direct sunlight should be avoided.

The infusion solution is photosensitive, the vial should be removed from the box only before use.

Effect on the ability to drive transp. cf. and fur:

Patients receiving ciprofloxacin, caution should be exercised when driving a car and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions (especially with simultaneous use of alcohol).

Form release / dosage:

Solution for infusions 2 mg / ml.

Packaging:

Solution for infusions 2 mg / ml in sterile bottles of low density polyethylene by 100 ml. Each bottle is placed in a polypropylene bag, then in a cardboard box with instructions for use in Russian.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children. Do not freeze.

Shelf life:

2 years. Do not use after the time specified on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N011833 / 02

Date of registration:21.05.2007

The owner of the registration certificate:Protek Biosystems Pvt. Ltd.Protek Biosystems Pvt. Ltd. India

Manufacturer: & nbsp

PROTECH BIOSYSTEMS, PVT. Ltd. India

Representation: & nbspProtekh Biosystems Pvt.LtdProtekh Biosystems Pvt.LtdRussia

Information update date: & nbsp22.10.2015

Illustrated instructions

Instructions

Protsipro (Procipro)