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

Active substanceLomefloxacinLomefloxacin

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Dosage form: & nbspfilm-coated tablets

Composition:

Active substance:

Lomefloxacin hydrochloride (in terms of Lomefloxacin) 0.4 g

Excipients: to a core mass of 0.78 g

Microcrystalline cellulose 0.0640 g

Povidone (polyvinylpyrrolidone) 0.0325 g

Lactose monohydrate (milk sugar) 0.140 g

Potato starch 0.0391 g

Crospovidone (collidine CML) 0.0312 g

Talc 0.0234 g

Magnesium stearate 0.0039 g

Stearic acid 0.0039 g

Sheath: to obtain a tablet weighing 0.8 g

Hypromellose (hydroxypropylmethylcellulose or hydroxypropylmethylcellulose) 0.0080 g

Macrogol 4000 (polyethylene oxide 4000) 0.0039 g

Titanium dioxide (titanium dioxide) 0.0021 g

Propylene glycol 0.0060 g

Description:Oval biconvex tablets, covered with a film coating of white or almost white color. On the cross-section, two layers are visible: a thin shell and a core of white or almost white color.

Pharmacotherapeutic group:Antimicrobial agent - fluoroquinolone

ATX: & nbsp

J.01.M.A Fluoroquinolones

J.01.M.A.07 Lomefloxacin

Pharmacodynamics:

Antimicrobial bactericide of broad spectrum of action from the group of fluoroquinolones. Affects the bacterial enzyme DNA-gyrase, which provides supercoiling of DNA, forms a complex with its tetramer (subunit of gyrase A2B2) and disrupts transcription and replication of DNA, which leads to the death of the microbial cell.

Beta-lactamases, produced by pathogens, do not affect the activity of lomefloxacin. Highly active against Gram-negative aerobes: Citrobacter diversus, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa (only for urinary tract infections); Gram-positive aerobes: Staphylococcus saprophyticus.

Gram-positive microorganisms are moderately sensitive to the preparation: Staphylococcus aureus (including methicillin-resistant strains), Staphylococcus epidermidis (including methicillin-resistant strains), gram-negative aerobes: Aeromonas hydrophila, Citrobaster freundii, Enterobacter aerogenes, Haemophilus parainfluenzae, Hafnia alvei, Klebsiella oxytoca, Klebsiella ozaenae , Morganella morganii, Proteus vulgaris, Providencia alcalifaciens, Providencia rettgeri, Serratia liquefaciens n Serratia marcescens, other microorganisms: Legionella pneumophila, Enterobacter agglomerans.

Resistant to Streptococcus spp. Groups A, B, D and G, Streptococcus pneumoniae, Pseudomonas cepacia, Ureaplasma urealyticum, Mycoplasma hominis and anaerobic bacteria.

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

Pharmacokinetics:

Absorption - 95-98%; food intake reduces absorption by 12%. The time to reach the maximum concentration (TCmax) is 0.8-1.5 hours. The maximum concentration (Cmax) after oral administration is 3-5.2 μg / ml. The intake of food reduces Cmax by 18% and increases TCmax to 2 hours. The equilibrium concentration (Css) in plasma is determined after 48 hours. The connection with plasma proteins is 10%. It penetrates well into the organs and tissues (respiratory tract, ENT organs, soft tissues, bones, joints, abdominal organs, pelvis, genitals), where the concentration of lomefloxacin is 2-7 times higher than in plasma.

A small part of the drug is metabolized. The half-life (T1 / 2) is 8-9 hours; the average renal clearance is 145 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-T1 / 2 increases.

The kidneys produce 70-80% of the tubular secretion (mostly unchanged, 9% - in the form of glucuronides, 0.5% - in the form of other metabolites); through the intestines -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 surgery;

- exacerbation of chronic bronchitis caused by Haemophilus influenza or Moraxella catarrhalis;

urogenital chlamydiosis;

- pulmonary tuberculosis (as part of complex therapy) - extensive caseous necrotic lesions, tissues, expressed nonspecific component of inflammation, drug resistance of mycobacteria to rifampicin, or poor tolerance of rifampicin.

Contraindications:Hypersensitivity (including to other fluoroquinolones), renal failure (creatinine clearance less than 30 ml / min), pregnancy, the period of breastfeeding, age to 18 years.

Carefully:

Cerebral atherosclerosis, epilepsy and other diseases of the central nervous system with epileptic syndrome, prolongation of the Q-T interval, hypokalemia, simultaneous administration of antiarrhythmic drugs of the IA class (quinidine, procainamide) and IIIA class (amiodarone, sotalol).

If you have any of these diseases, consult a doctor before taking the drug.

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 is 400 mg / day for 3 days.

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

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

Prevention of urinary tract infections: with transrectal biopsy, the prostate - 400 mg once for 1-6 hours before the procedure; transurethral operative interventions - 400 once 2 to 6 hours prior to surgery.

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

Urogenital chlamydia - 400 mg / day, duration of treatment - up to 28 days.

Tuberculosis of the lungs (as part of complex therapy) - 400 mg / day for 14-28 days or more.

Side effects:

From the digestive system: nausea, vomiting, dryness of the oral mucosa, gastralgia, abdominal pain, diarrhea or constipation, flatulence,pseudomembranous colitis, dysphagia, discoloration of the tongue, decreased appetite or bulimia, taste distortion, dysbacteriosis, increased activity of "liver" transaminases; lactose intolerance / lactase deficiency, glucose-galactose malabsorption.

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

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

On the part of the organs of hematopoiesis and the system of hemostasis: bleeding from the organs of the gastrointestinal tract, thrombocytopenia, purpura, .increase in fibrinolysis, epistaxis, lymphadenopathy.

From the respiratory system: shortness of breath, bronchospasm, cough, hypersecretion of sputum, flu-like symptoms.

From the sense organs: impaired vision, pain and noise in the ears, pain in the eyes.

From the cardiovascular system: lowering of arterial pressure, tachycardia, bradycardia, extrasystole, arrhythmias, progression of heart failure and angina, pulmonary embolism, cardiomyopathy, phlebitis.

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

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

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

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:Information about overdose is very limited, symptomatic therapy, induction of vomiting or gastric lavage, adequate hydration is carried out. Hemo- and peritoneal dialysis with an overdose are ineffective.

Interaction:

Does not affect the pharmacokinetics of isoniazid. Does not interact with theophylline, caffeine.

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

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 in conjunction with isoniazid, pyrazinamide, streptomycin and ethambutol (not recommended combination with rifampicin-anatagonia).

Drugs that block tubular secretion, slow down excretion.

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

Vitamins with mineral supplements should be used 2 hours before or 2 hours after the application of Lomefloxacin.

Joint application with antiarrhythmic drugs IA (quinidine, procainamide) and IIIA (amiodarone, sotalol) classes can cause an extension of the Q-T interval.

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 UV radiation should be avoided (evening reception reduces the risk of reaction to UV radiation). At the first sign of photosensitization (increased skin sensitivity, burn, redness, swelling, blisters, rashes, itching, dermatitis) or hypersensitivity, neurotoxicity (excitation, convulsions, tremors, photophobia, confusion, toxic psychosis, hallucinations) therapy should be discontinued.

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles or engaging in other potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Form release / dosage:Film coated tablets 400 mg.

Packaging:

For 5 or 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

1 or 2 contour mesh packages with instructions for use are placed in a pack of cardboard.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:3 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LS-000990

Date of registration:30.08.2011 / 06.12.2017

Expiration Date:Unlimited

The owner of the registration certificate:BIOKOM TECHNOLOGY, LLC BIOKOM TECHNOLOGY, LLC Republic of Belarus

Manufacturer: & nbsp

SYNTHESIS, OJSC Russia

Information update date: & nbsp20.03.2018

Illustrated instructions

Instructions

Lofox (Lofox)