Tsiprinol

Active material: Ciprofloxacin
When ATH: J01MA02
CCF: Fluoroquinolone antibacterial drug
ICD-10 codes (testimony): A40, A41, A54, H66, J01, J02, J03, J04, J15, J20, J31, J32, J35.0, J37, J42, K05, K12, K65.0, K81.0, K81.1, K83.0, L01, L02, L03, L08.0, M00, M86, N10, N11, N30, N34, N41, N70, N71, N72, N73.0, O08.0, Z29.2
When CSF: 06.17.02.01
Manufacturer: KRKA d.d. (Slovenia)

Pharmaceutical form, composition and packaging

Pills, Film-coated white, round, lenticular, with beveled edges and a notch on one side.

Excipients: sodium carboxymethyl starch, Colloidal anhydrous silica, Croscarmellose sodium, magnesium stearate, povidone, microcrystalline cellulose, propylene glycol, talc, Titanium dioxide (E171).

The composition of the coating film: gipromelloza, propylene glycol, talc, Titanium dioxide.

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

Pills, Film-coated white, Oval, lenticular, with a notch on one side.

Excipients: sodium carboxymethyl starch, Colloidal anhydrous silica, Croscarmellose sodium, magnesium stearate, povidone, microcrystalline cellulose.

The composition of the coating film: gipromelloza, propylene glycol, talc, Titanium dioxide.

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

Pills, coated white or nearly white, Oval, with a notch on both sides.

Excipients: microcrystalline cellulose, sodium starch glycolate, povidone, sodium carboxymethylcellulose, colloidal silicon dioxide, magnesium stearate, hydroxypropyl (gipromelloza), propylene glycol, talc, Titanium dioxide (E171).

10 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (2) – packs cardboard.

Concentrate for solution for infusion as a clear, colourless or slightly greenish-yellow colour of solution, without mechanical impurities.

Excipients: lactic acid, hydrochloric acid, disodium эdetat, water d / and.

10 ml – ampoule (5) – packings Valium planimetric (1) – packs cardboard.

Solution for infusion clear, yellowish-greenish color.

Excipients: Sodium lactate, sodium chloride, hydrochloric acid, water d / and.

50 ml – bottles (1) – packs cardboard.

Solution for infusion clear, yellowish-greenish color.

Excipients: Sodium lactate, sodium chloride, hydrochloric acid, water d / and.

100 ml – bottles (1) – packs cardboard.

Solution for infusion clear, yellowish-greenish color.

Excipients: Sodium lactate, sodium chloride, hydrochloric acid, water d / and.

200 ml – bottles (1) – packs cardboard.

Pharmacological action

Antibacterial drug broad-spectrum fluoroquinolones from the Group. Effective bactericidal. Inhibits the enzyme DNA gyrase, as a result of which violated DNA replication and synthesis of cell proteins of bacteria. Ciprofloxacin acts as the breeding of microorganisms, and micro-organisms, are in the resting phase.

Preparation active against gram-negative bacteria: Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus is wonderful, Proteus vulgaris, Serratia wilting, Hafnia avenue, edwardsiella tarda, Providencia spp., Morganella morganii, Vibrio spp., Yersinia spp., Haemophilus spp., Pseudomonas aeruginosa, Moraxella catarrhalis, Aeromonas spp., Pasteurella multocida, Plesiomonas shigelloides, Campylobacter jejuni, Neisseria spp.; intracellular microorganisms: Legionella pneumophila, Brucella spp., Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Mycobacterium avium-intracellular; Gram-positive bacteria: Streptococcus spp. (incl. Streptococcus pyogenes, Streptococcus agalactiae), Staphylococcus spp. (incl. Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus man, Staphylococcus saprophyticus). Most Staphylococcus, resistant to metitillino, resistant to ciprofloxacin.

C drug moderately sensitive Streptococcus pneumoniae, Enterococcus faecalis.

C drug resistant Corynebacterium spp., Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophila, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroids.

The drug against Treponema pallidum unclear.

When taking Ciprinola^® development does not occur parallel resistance to other antibiotics, do not belong to the Group of gyrase inhibitors, that makes it highly effective against bacteria, that is resistant to aminoglycosides, penicillins, cephalosporins, tetracycline.

Pharmacokinetics

Absorption

After taking the drug inside ciprofloxacin is rapidly absorbed from the digestive tract. Meal slows absorption, but no effect on the C_max and bioavailability. Bioavailability varies from 50% to 85%. C_max in the serum of healthy volunteers after intake of the drug in a dose 250 mg, 500 mg, 750 mg 1000 mg achieved through 1-1.5 h and is 0.76 mg / ml, 1.6 mg / ml, 2.5 mg / ml 3.4 mg / ml, respectively.

Distribution

Ciprofloxacin is well distributed in the tissues and body fluids, While high concentrations are set in bile, light, kidney, liver, gallbladder, uterus, seminal fluid, Prostate tissue, tonsils, the endometrium, the fallopian tubes and ovaries. Concentration of ciprofloxacin in these tissues above, than serum. Ciprofloxacin also penetrates the liquid eyes Wednesday, bone, bronchial secretion, spittle, skin, muscle, in the pleura, the peritoneum and lymph. In spinnomozgovu liquid penetrates into the small number of, concentration of ciprofloxacin in nevospalennyh brain membranes is 6-10% from that in serum, When inflamed – 14-37%. Concentration of ciprofloxacin in neutrophils in 2-7 times higher, than serum.

V_d is 2-3.5 l / kg.

Plasma protein binding – 30%.

It penetrates through the placental barrier.

Metabolism and excretion

Biotransformed in the liver (15-30%) with the formation of low metabolites (dijetilciprofloksacin, sul'fociprofloksacin, oksiciprofloksacin, formilciprofloksacin). Write mainly with urine (50-70%); 15-30% – with feces. T_1/2 is 3-5 no.

Pharmacokinetics in special clinical situations

In chronic renal failure T_1/2 increases to 12 no.

Testimony

Infectious-inflammatory diseases, caused by susceptible to malaria infections, including:

- Respiratory tract infections;

-ear infections, nose and throat;

- Infections of the kidneys and urinary tract;

-infections of the reproductive organs (gonorrhea, prostatitis, adnexitis, puerperal infection);

-infections of the digestive system (incl. mouth, teeth, jaws), gallbladder and biliary tract;

-infections of the skin, mucous membranes and soft tissues;

— infection of musculoskeletal system;

- Sepsis;

- Peritonitis;

-Prevention and treatment of infections in patients with low immunity (While therapy immunodepressantami).

Dosage regimen

The mode set individually, Depending on the location and severity of the current infection, condition of the body, age, body weight, renal patients.

At uncomplicated kidney and urinary tract the drug is prescribed for 250 mg 2 times / day, at Complicated – by 500-750 mg 2 times / day.

At diseases of the lower respiratory tract infection – by 250 mg 2 times / day, in severe cases – by 500-750 mg 2 times / day.

At treatment of gonorrhea the preparation appoint one dose 250-500 mg.

At enteritis, colitis heavy currents, gynecological infections, prostatitis, osteomielite – by 500-750 mg 2 times / day.

To treatment of diarrhea – by 250 mg 2 times / day.

To prevention of surgical site infections – by 500-750 mg a day.

The duration of treatment depends on the severity of the disease.

Patients with impaired renal function single dose oral is one half of the average daily dose.

At chronic renal failure the preparation appoint depending on creatinine clearance.

Patients, in gemodialise or peritoneal dialysis, the drug is prescribed after dialysis dose 250-500 mg 1 once every 24 no.

The tablets should be taken on an empty stomach, drinking plenty of fluids.

Perhaps in/with the introduction of the drug. Dose Ciprinola^® Depending on the severity of the disease, type of infection, condition of the body, age, body weight, renal patients.

The average recommended single dose – 200 mg (at severe infections – 400 mg), multiplicity of introduction – 2 times / day; duration of treatment – 1-2 of the week, if necessary – more durable.

The drug can be entered in/in struino, but more preferably in/in drip during the introduction 30 m (200 mg) and 60 m (400 mg).

At acute gonorrhoea once introduced 100 mg.

To Prevention of postoperative infections – for 30-60 minutes before the operation in/in introducing 200-400 mg Ciprinola^®.

Side effect

From the digestive system: nausea, vomiting, diarrhea, psevdomembranoznыy colitis, flatulence, decreased appetite, cholestatic jaundice (especially in patients with pre-existing liver disease), hepatitis, gepatonekroz, increase in liver transaminases, Alkaline phosphatase, LDH, bilirubin.

From the central and peripheral nervous system: headache, dizziness, fatigue, anxiety, tremor, intracranial hypertension, peripheral paralgezija, insomnia, nightmares, confusion, depression, hallucinations and other manifestations of psychotic reactions (occasionally progressive to States, in which the patient may cause harm), fainting, migraine, thrombosis of cerebral arteries.

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

Cardio-vascular system: tachycardia, abnormal heart rhythm, hypotension, tides (at / in the introduction).

From the hematopoietic system: eozinofilija, leukopenia, thrombocytopenia, neutropenia; the on/in the introduction are also possible granulocytopenia, anemia, thrombocytosis, gemoliticheskaya anemia.

On the part of the musculoskeletal system: rarely – arthritis, tendinitis, tendon rupture; arthralgia, myalgia (at / in the introduction).

From the urinary system: kristallurija, interstitial nephritis, glomerulonephritis, dizurija, polyuria, albuminuria, hematuria, increase in urea, creatinine; urinary retention, azotvydelitel'noj reduced kidney function.

Allergic reactions: itching, hives, angioedema, Stevens-Johnson syndrome, arthralgia; vasculitis, uzlovataya эritema, mnogoformnaya Erythema ekssoudatus, Lyell's syndrome (at / in the introduction).

Adverse Reactions, chemotherapy-related action: candidiasis.

Other: generalized weakness, photosensitivity; increased perspiration, giperglikemiâ (at / in the introduction).

Local reactions: at / in the introduction – pain and burning, phlebitis.

Contraindications

- Psevdomembranoznыy colitis (for / in the);

- Deficiency of glucose-6-fosfatdegidrogenazы (for / in the);

- Pregnancy;

- Lactation (breast-feeding);

- Childhood and adolescence up 18 years;

-hypersensitivity to ciprofloxacin or other drugs from this group of fluoroquinolones.

FROM caution assign product in atherosclerosis cerebrovascular, cerebrovascular disorders, psychic diseases, epilepsy, sudorozhnom syndrome, expressed kidney or liver failure, elderly patients.

Pregnancy and lactation

The drug is contraindicated during pregnancy and lactation (breast-feeding).

Cautions

When development during or after treatment of ciprofloxacin is severe and prolonged diarrhea should exclude the diagnosis psevdomembranoznogo colitis, that requires the immediate withdrawal of the drug and the appropriate treatment.

If you experience pain in the joints or at the first signs of treatment should be discontinued because, that describes selected cases of inflammation and even rupture the tendons during treatment with fluoroquinolones.

During the period of treatment to avoid christallurii unacceptably increase the recommended daily dose.. Patients should receive plenty of fluids to maintain normal urine acid reaction urine.

As a result of fotosencibilization during treatment Ciprinolom^® avoid contact with direct sunlight.

Effects on ability to drive vehicles and management mechanisms

In applying the drug should refrain from activities potentially hazardous activities, require high concentration and speed of psychomotor reactions.

Overdose

Treatment: spetsificheskiy antidote unknown. Displaying gastric lavage, patient monitoring, if necessary, symptomatic therapy. It is necessary to ensure adequate flow of fluid in the body. Using hemodialysis or peritoneal dialysis can be inferred a negligible amount of ciprofloxacin (less 10%).

Drug Interactions

If you are applying to Ciprinola^® with DDI absorption of ciprofloxacin reduced due to formation of complexes of ciprofloxacin with didanozine salts of magnesium and aluminum.

As a result of reduced activity processes mikrosomalnogo oxidation in gepatocitah ciprofloxacin improves concentration and increases the half-life of theofillina and other xantinov.

Together with the use of ciprofloxacin and oral hypoglycemic drugs, indirect anticoagulants decrease prothrombin index.

Together with the use of ciprofloxacin and NSAIDS (excluding acetylsalicylic acid) increases the risk of seizures.

Admission antatsidov, as well as preparations, containing ions aluminium, Zinc, iron and magnesium, can cause reduced intake of ciprofloxacin, Therefore, the interval between the destination of these drugs should not be less than 4 no.

Together with the use of ciprofloxacin and Cyclosporine amplified nefrotoksicescoe effects last.

Metoclopramide accelerates the absorption of ciprofloxacin, that leads to a decrease in time achieve its maximum concentration in plasma.

Joint appointment urikozuricheskih drugs leads to slower excretion (to 50%) and increased plasma concentration of ciprofloxacin.

When combined with other antimicrobial drugs (beta-lactam antibiotics, aminoglikozidy, klindamiцin, metronidazol) usually observed synergy. Ciprinol^® can be used in combination with azlocillinom and ceftazidimom infections, caused by Pseudomonas spp.; with mezlocillinom, azlocillinom and other beta-lactam antibiotics – when streptococcal infections; with izoksazolpenicillinami and vankomitinom – When staphylococcal infections; with metronidazole and clindamycin – under anaerobic infections.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored away from light and moisture, inaccessible to children at temperature not exceeding 25 ° C. Shelf life – 5 years.