Xenacvin - instructions for use, dose, side effects, contraindications

Auxiliary components: lactose monohydrate 128.9 mg, magnesium stearate 4.5 mg, talc 11.0 mg, crospovidone 18.0 mg, croscarmellose sodium 3.0 mg, silicon dioxide colloidal 2.0 mg.

Shell composition: Macrogol 4000 5% - 25%, hypromellose 50% - 80%, talc 5% - 20%, titanium dioxide 5% - 30%, coloring sunset yellow sunset 5% - 30%.

Shell composition: macrogol 4000, hypromellose, talc, titanium dioxide, dye sunset yellow.

Description:

Tablets of orange color, oblong form, biconcave, covered with a film sheath.

Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone

ATX: & nbsp

J.01.M.A Fluoroquinolones

J.01.M.A.07 Lomefloxacin

Pharmacodynamics:

Lomefloxacin is a synthetic antimicrobial agent of the fluoroquinolone group of a broad spectrum of bactericidal action. Inhibits the activity of bacterial DNA-gyrase, forming a complex with its tetramer (subunit of A2B2 gyrase) and disrupts transcription and replication of DNA, leads to the death of a microbial cell. Beta-lactamases, produced by pathogens, do not affect the activity of lomefloxacin.

It is active against gram-negative aerobic microorganisms: Citrobacter diversus, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa (only for urinary tract infections); Gram-positive aerobic microorganisms: Staphylococcus saprophyticus.

In vitro with a minimum inhibitory concentration (MIC) of 2 μg / ml is active against the following microorganisms (however, the clinical efficacy in infections caused by these microorganisms in strictly controlled studies has not been studied): Gram-positive aerobic microorganisms: Staphylococcus aureus (including methicillin-resistant strains), Staphylococcus epidermidis (including methicillin-resistant strains); Gram-negative aerobic microorganisms: Aeromonas hydrophila, Citrobacter freundii, Enterobacter aerogenes, Enterobacter agglomerans, Haemophilus parainfluenzae, Hafnia alvei, Klebsiella oxytoca, Klebsiella ozaenae, Morganella morganii, Proteus vulgaris, Providencia alcalifaciens, Providencia rettgeri, Serratia liquefaciens, Serratia marcescens.

Other microorganisms: Legionella pneumophila.

The drug is stable: Streptococcus spp. groups A, AT, D and G, Streptococcus pneumoniae, Pseudomonas cepacia, Ureaplasma urealyticum, Mycoplasma hominis and anaerobic bacteria.

It acts both on the outside and on the intracellularly located Mycobacterium tuberculosis, reduces the time of their isolation from the body, provides a faster resolution of infiltrates. Most microorganisms act at low concentrations (the concentration necessary to suppress the growth of 90% strains, usually not more than 1 μg / ml).

Pharmacokinetics:

After oral administration lomefloxacin almost completely absorbed from the gastrointestinal tract (absorption - 93-98%, food intake reduces it by 12%). After taking 400 mg, the maximum concentration (C_max) in blood plasma "Achieved through^-1-2 hours and is-3-5.2-mg / l. Eating reduces C_maxon 18%. The equilibrium concentration in plasma is determined after 48 hours. The connection with plasma proteins is 9-11%. It penetrates well into the organs and tissues (respiratory tract, ENT organs, soft tissues, bones, joints, abdominal cavity organs, pelvis, genitalia), where the concentration of lomefloxacin is 2-7 times higher than in plasma. A small part of the drug is metabolized, with the formation of metabolites.The half-life (T_1/2) - 8-9 hours; the average renal clearance is 143-147 ml / min. In elderly patients, plasma clearance is reduced by 25%. With a decrease in the clearance of creatinine to 10-40 ml / min / 1.73 square. m T_1/2 increases. By the kidneys, 70-80% of the tubular secretion is excreted (mostly unchanged, 9% - in the form of glucuronides, 0.5% - in the form of other metabolites); through the intestine-20-30%.

Indications:

Uncomplicated urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus.

Complicated urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Citrobacter diversus or Enterobacter cloacae.

Prevention of urinary tract infections with transrectal biopsy of the prostate gland, transurethral operative interventions.

Exacerbation of chronic bronchitis caused by Haemophilus influenzae or Moraxella catarrhalis.

Tuberculosis of lungs (as part of complex therapy): extensive caseous-non-necrotic tissue damage, expressed nonspecific component of inflammation, drug resistance of mycobacteria to rifampicin, or poor tolerance of rifampicin.

Contraindications:

Hypersensitivity (including to other fluoroquinolones), pregnancy, lactation,age to 18 years (period of formation and growth of the skeleton), lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Carefully:

Cerebral atherosclerosis, epilepsy and other diseases of the central nervous system with epileptic syndrome, lengthening of the interval QT, hypokalemia, simultaneous reception of antiarrhythmic drugs IA class (quinidine, procainamide) and III class (amiodarone, sotalol).

Dosing and Administration:

Inside (regardless of food intake, squeezed a sufficient amount of liquid), 1 time per day.

The dose and duration of treatment depends on the severity of the disease and the sensitivity of the pathogen.

Uncomplicated cystitis in women caused by Escherichia coli: 400 mg / day for 3 days.

Uncomplicated cystitis caused by Klebsiella pneumoniae, Proteus mirabilis or Staphylococcus saprophyticus: 400 mg / day for 10 days.

Complicated urinary tract infections: 400 mg / day for 14 days.

Exacerbation of chronic bronchitis: 400 mg / day for 14 days.

Prevention of urinary tract infections: with a transrectal biopsy of the prostate - 400 mg once for 1-6 hours before the procedure; transurethral surgery - 400 mg once per day 2-6 hours before surgical intervention.

Tuberculosis: 400 mg / day, for 14-28 days or more.

With a creatinine clearance of less than 30 ml / min and a patient on hemodialysis, the initial dose is 400 mg / day, followed by a decrease to 200 mg / day.

Side effects:

From the digestive system: nausea, vomiting, dry mouth, gastralgia, abdominal pain, diarrhea or constipation, flatulence, pseudomembranous colitis, dysphagia, discoloration of the tongue, anorexia or bulimia, taste distortion, dysbiosis, increased activity of "liver" transaminases.

From the nervous system: fatigue, malaise, asthenia, headache, dizziness, insomnia, hallucinations, convulsions, hyperkinesia, tremor, paresthesia, nervousness, anxiety, depression, agitation.

From the genitourinary system: glomerulonephritis, dysuria, polyuria, anuria, albuminuria, urethral bleeding, crystalluria, hematuria, urinary retention, edema; in women - vaginitis, leukorrhea, intermenstrual bleeding, pain in the perineum, vaginal candidiasis; in men - orchitis, epididymitis.

From the side of metabolism: hypoglycemia, gout.

From the side of the musculoskeletal system: arthralgia, vasculitis, calf muscle cramps, back and chest pain.

From the hemostasis and hematopoiesis system: bleeding from the organs of the gastrointestinal tract, thrombocytopenia, purpura, increased fibrinolysis, epistaxis, lymphadenopathy.

From the respiratory system: dyspnea, bronchospasm, cough, hypersecretion of phlegm, influenza-like symptoms.

From the sense organs: visual impairment, pain and noise in the ears, pain in the eyes.

From the side of the cardiovascular system: lowering blood pressure, tachycardia, bradycardia, extrasystole, arrhythmias, progression of heart failure, angina pectoris, pulmonary embolism, myocardiopathy, phlebitis.

Allergic reactions: itching, hives, photosensitivity, malignant exudative erythema (Stevens-Johnson syndrome).

Influence on the fetus: in the experiment fetotoxic action (arthropathy) is described.

Other: Candidiasis, increased sweating, chills, thirst, superinfection.

Overdose:

Treatment: induction of vomiting or gastric lavage, adequate hydration, symptomatic therapy. Hemo- and peritoneal dialysis with an overdose are ineffective.

Interaction:

Do not take antacids and sucralfate for 4 hours before and 2 hours after taking Lomefloxacin (forms with them chelate compounds, which reduces its bioavailability).

In the treatment of patients with tuberculosis lomefloxacin use together with isoniazid, pyrazinamide, streptomycin and ethambutol (not recommended combination with rifampicin - antagonism).

Does not affect the pharmacokinetics of isoniazid.

Does not interact with theophylline, caffeine.

Drugs that block tubular secretion, slow down excretion.

There is no cross-resistance with penicillins, cephalosporins, aminoglycosides, co-trimoxazole, metronidazole.

Increases the activity of indirect anticoagulants and increases the toxicity of non-steroidal anti-inflammatory drugs.

Vitamins with mineral supplements should be used 2 hours before or 2 hours after taking Lomefloxacin.

Special instructions:

With cirrhosis of the liver, there is no need for correction of the dosing regimen (with normal kidney function).

During the treatment period, prolonged exposure to sunlight and the use of artificial ultraviolet light should be avoided (evening reception reduces the risk of reaction to ultraviolet radiation).At the first sign of photosensitivity (increased sensitivity of the skin, burns, redness, swelling, blisters, rashes, itching and dermatitis) or hypersensitivity neurotoxicity (agitation, convulsions, tremor, photophobia, confusion, toxic psychoses, hallucinations) manifestations therapy should be discontinued.

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

During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions (possible only after evaluating the patient's individual reaction).

Form release / dosage:

Tablets, film-coated, 400 mg.

Packaging:

5 tablets are packed in PVC / aluminum foil blisters.

1 blister is placed in a cardboard box along with instructions for use.

Storage conditions:

Store at a temperature of no higher than 25 ° C in a dry, protected from light place.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N014188 / 01-2002

Date of registration:20.06.2008

Expiration Date:Unlimited

The owner of the registration certificate:Promed Exports Pvt. Ltd.Promed Exports Pvt. Ltd. India

Manufacturer: & nbsp

PROMED EXPORTS, Pvt. Ltd. India

Representation: & nbspPROMED EXPORTS Pvt. Ltd. PROMED EXPORTS Pvt. Ltd. India

Information update date: & nbsp25.01.2018

Illustrated instructions

Instructions

Xenacvin® (Ksenakvin)