Квинтор®

General characteristics. Structure:

Active ingredient: 200 mg of ciprofloxacin a lactate monohydrate in terms of ciprofloxacin in 100 ml of solution.

Excipients: sodium chloride, lactic acid, эдетат dinatrium, water for injections.

Antibacterial drug of a broad spectrum of activity of group of ftorkhinolon.

Pharmacological properties:

Pharmacodynamics. Antimicrobic drug of a broad spectrum of activity from group of ftorkhinolon. Works bakteritsidno. Drug inhibits DNK-girazu enzyme of bacteria owing to what DNA replication and synthesis of cellular proteins of bacteria are broken.

Ciprofloxacin affects both the breeding microorganisms, and on being in a resting phase. Gram-negative aerobic bacteria are sensitive to ciprofloxacin: enterobakteriya (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 activators: Legionella pneumophila, Brucella spp., Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Mycobacterium avium-intracellulare.

Also gram-positive aerobic bacteria are sensitive to ciprofloxacin: Staphylococcus spp. (S.aureus, S.haemolyticus, S.hominis, S.saprophyticus), Streptococcus spp. (St. pyogenes, St.agalactiae). The majority of the stafilokokk steady against Methicillinum are steady also against ciprofloxacin.
Sensitivity of bacteria of Streptococcus pneumoniae, Enterococcus faecalis is moderate.

To Corynebacterium spp rezistentna drug., Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides. Effect of drug concerning Treponema pallidum is studied insufficiently.

Pharmacokinetics. Later in/in infusion of 200 mg or 400 mg of TCmax - 60 min., Cmax - 2.1 mkg/ml and 4.6 mkg/ml, respectively. Distribution volume - 2-3 l/kg, communication with proteins of plasma - 20-40%.

It is well distributed in body tissues (excepting the fabric rich with fats, for example, nervous tissue). Content in fabrics is 2-12 times higher, than in plasma. Therapeutic concentration are reached in saliva, almonds, a liver, a gall bladder, bile, intestines, abdominal organs and a small pelvis, a uterus, semen, prostate tissue, an endometria, fallopian pipes and ovaries, kidneys and urinary bodies, pulmonary fabric, a bronchial secret, a bone tissue, muscles, synovial fluid and joint cartilages, peritoneal liquid, skin. Gets into SMZh in a small amount where its concentration at an uninflammed meninx makes 6-10% of that in blood serum, and at inflamed - 14-37%. Ciprofloxacin also well gets into eye liquid, a bronchial secret, a pleura, a peritoneum, a lymph, through a placenta. Concentration of ciprofloxacin in neutrophils of blood is 2-7 times higher, than in serum.

Activity decreases at acid values рН a little. It is metabolized in a liver (15-30%) with formation of low-active metabolites (diethylciprofloxacin, sulfociprofloxacin, oxociprofloxacin, formylciprofloxacin).

At in introduction of T½ - 5-6 h, at HPN - to 12 h. It is removed generally by kidneys by tubular filtering and canalicular secretion in not changed look (at in/in introductions - 50-70%) and in the form of metabolites (at in introduction - 10%), other part - through a GIT. A small amount is removed with breast milk. Later in/in introductions concentration in urine during the first 2 h after introduction almost in 100 times more, than in serum that considerably surpasses MPK for the majority of causative agents of infections of urinary tract.

Renal clearance - 3-5 ml/min.; the general clearance - 8-10 ml/min. At HPN (KK is higher than 20 ml/min.) the percent of the drug removed through kidneys decreases, but cumulation in an organism does not happen owing to compensatory increase in metabolism of drug and removal with fecal masses. Patients with a heavy renal failure (KK is lower than 20 ml/min. / 1.73 of sq.m) need to appoint a half of a daily dose.

Indications to use:

The infectious and inflammatory diseases caused by microorganisms, sensitive to ciprofloxacin:

• respiratory tracts;
• fish soup, throat and nose;
• kidneys and urinary tract;
• generative organs (gonorrhea, prostatitises); gynecologic (adnexites) and puerperal infections;
• alimentary system (including mouth, teeth, jaws); gall bladder and biliary tract;
• integuments, mucous membranes and soft tissues;
• musculoskeletal system.

Квинтор® it is shown for treatment of sepsis and peritonitis, and also for prevention and treatment of infections at patients with reduced immunity (at therapy by immunodepressants).

Route of administration and doses:

It is appointed intravenously. The drug should be administered intravenously kapelno within 30 minutes (200 mg) also 60 minutes (400 mg). Solution for infusions can be combined from 0,9% chloride sodium solution, Ringer's solution, 5% and 10% solution of a dextrose, 10% fructose solution, and also the solution containing 5% dextrose solution from 0,225% or 0,45% chloride sodium solution.

The dose of Kvintora® depends on disease severity, type of an infection, a condition of an organism, age, weight and function of kidneys at the patient. The doses recommended usually: for intravenous administration a single dose – 200 mg (at heavy infections – 400 mg), frequency rate of introduction - 2 times/days; duration of treatment depends on disease severity - 1-2 weeks, if necessary and more.

At acute gonorrhea – once intravenously 100 mg. For prevention of postoperative infections – in 30-60 minutes prior to operation in/in 200-400 mg.

Features of use:

At emergence in time or after treatment of Kvintorom® of heavy and long diarrhea it is necessary to exclude the diagnosis of pseudomembranous colitis which demands immediate drug withdrawal and purpose of the corresponding treatment.

When developing pains in sinews or at emergence of the first symptoms of a tendovaginitis treatment should be stopped.

During treatment of Kvintorom® it is necessary to provide enough liquid at observance of a normal diuresis.

During treatment of Kvintorom® it is necessary to avoid contact with direct sunshine.

Side effects:

From the alimentary system: nausea, diarrhea, vomiting, abdominal pains, a meteorism, anorexia, cholestatic jaundice (especially at patients with the postponed liver diseases), hepatitis, гепатонекроз.

From a nervous system: dizziness, a headache, increased fatigue, uneasiness, a tremor, sleeplessness, "dreadful" dreams, a peripheral paralgeziya (anomaly of perception of feeling of pain), perspiration, increase in intracranial pressure, uneasiness, confusion of consciousness, a depression, hallucinations, and also other manifestations of psychotic reactions (which are occasionally progressing to states in which the patient can do himself harm), migraine, a faint, thrombosis of cerebral arteries.

From sense bodys: disturbances of taste and sense of smell, vision disorder (diplopia, change of color perception), sonitus, decrease in hearing.

From CCC: tachycardia, disturbances of a cordial rhythm, decrease in the ABP, rushes of blood to face skin.

From the hemopoietic system: leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolitic anemia.

From laboratory indicators: prothrombinopenia, increase in activity of "hepatic" transaminases and ShchF, giperkreatininemiya, hyperbilirubinemia, hyperglycemia.

From an urinary system: a hamaturia, a crystalluria (first of all at alkalinuria and a hypouresis), a glomerulonephritis, a dysuria, a polyuria, an ischuria, an albuminuria, urethral bleedings, a hamaturia, decrease in azotvydelitelny function of kidneys, intersticial nephrite.

Allergic reactions: a skin itch, a small tortoiseshell, blistering, followed by bleedings, and the small small knots forming crusts, medicinal fever, dot hemorrhages (petechias), a face edema or throats, an asthma, an eosinophilia, the raised photosensitivity, a vasculitis, a nodal erythema, an exudative multiformny erythema, Stephens-Johnson's syndrome (a malignant exudative erythema), a toxic epidermal necrolysis (Lyell's disease).

Others: an arthralgia, arthritis, a tendovaginitis, ruptures of sinews, the general weakness, a mialgiya, superinfections (candidiasis, pseudomembranous colitis), pain and burning in an injection site, phlebitis.

Interaction with other medicines:

The patients accepting Kvintor® should be careful during the driving of the car and occupations other potentially dangerous types of activity requiring special attention and speed of psychomotor reactions (especially at simultaneous alcohol intake).

Contraindications:

Hypersensitivity, deficit glyukozo-6-fosfatdegidrogenazy, pseudomembranous colitis, children's age (up to 18 years - completion of process of formation of a skeleton), pregnancy, the lactation period.

With care – the expressed atherosclerosis of vessels of a brain, disturbance of cerebral circulation, mental diseases, a convulsive syndrome, epilepsy, the expressed renal and/or liver failure, advanced age.

Overdose:

The specific antidote is unknown. It is necessary to control carefully a condition of the patient, to make a gastric lavage, to carry out usual measures of acute management, to provide sufficient intake of liquid.

By means of haemo - or peritoneal dialysis the amount of drug can be removed only insignificant (less than 10%).

Storage conditions:

To store in the place protected from light at a temperature not above 30 °C. Not to allow freezing. To store in the place, unavailable to children. A period of validity - 2,5 years. Not to use after expiry date.

Issue conditions:

According to the recipe

Packaging:

Solution for infusions of 2 mg/ml. The polyethylene bottle of 100 ml in a plastic bag is packed into a cardboard pack with the application instruction.