Levofloxacin

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2024-01-31 05:02

Levofloxacin: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Use in childhood
10. In case of impaired renal function
11. For violations of liver function
12. Drug interactions
13. Analogs
14. Terms and conditions of storage
15. Terms of dispensing from pharmacies
16. Reviews
17. Price in pharmacies

Latin name: Levofloxacin

ATX code: J01MA12

Active ingredient: Levofloxacin (Levofloxacin)

Manufacturer: Belmedpreparaty RUE (Republic of Belarus), Sintez OJSC, Dalkhimpharm, Active ingredient, MAKIZ-PHARMA, Krasfarma, VERTEX, Ozone LLC (Russia), VMG Pharmaceuticals Pvt. Ltd. (India), Zhejiang Apeloa Pharmaceutical Co. (China)

Description and photo update: 2019-12-08

Prices in pharmacies: from 59 rubles.

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Levofloxacin is an antibacterial drug.

Release form and composition

Levofloxacin is available in the following dosage forms:

Film-coated tablets: biconvex, round, yellow, two layers are visible in the cross-section (5, 7 or 10 pcs. In blisters, 1-5 or 10 packs in a cardboard box; 3 pcs. In blisters packages, 1 package in a cardboard box; 5, 10, 20, 30, 40, 50 or 100 pieces in cans or bottles, 1 can or bottle in a cardboard box);
Solution for infusion: transparent, yellowish-green in color (100 ml in bottles or vials, 1 bottle or vial in a cardboard box);
Eye drops 0.5%: transparent, yellowish-green (1 ml each in dropper tubes, 2 tubes in a cardboard box; 5 or 10 ml each in bottles with a dropper cap, 1 bottle each in a cardboard box).

The composition of 1 tablet includes:

Levofloxacin - 250 or 500 mg (levofloxacin hemihydrate - 256.23 or 512.46 mg);
Auxiliary components (tablets of 250 or 500 mg, respectively): microcrystalline cellulose - 30.83 / 61.66 mg, hypromellose - 8.99 / 17.98 mg, croscarmellose sodium - 9.3 / 18.6 mg, polysorbate 80 - 1.55 / 3.1 mg, calcium stearate 3.1 / 6.2 mg.

The composition of the shell (tablets of 250 or 500 mg, respectively): hypromellose - 7.5 / 15 mg, hydroxypropyl cellulose (hyprolose) - 2.91 / 5.82 mg, talc - 2.89 / 5.78 mg, titanium dioxide - 1, 63 / 3.26 mg, yellow iron oxide (yellow oxide) - 0.07 / 0.14 mg or dry mixture for film coating (hypromellose 50%, hyprolose (hydroxypropyl cellulose) - 19.4%, talc - 19.26 %, titanium dioxide - 10.87%, yellow iron oxide (yellow oxide) - 0.47%) - 15/30 mg.

The composition of 100 ml solution for infusion includes:

Active ingredient: levofloxacin - 500 mg (in the form of a hemihydrate);
Auxiliary components: sodium chloride - 900 mg, water for injection - up to 100 ml.

The composition of 1 ml of eye drops includes:

Active ingredient: levofloxacin - 5 mg (in the form of hemihydrate);
Auxiliary components: benzalkonium chloride - 0.04 mg, sodium chloride - 9 mg, disodium edetate - 0.1 mg, 1 M hydrochloric acid solution - up to pH 6.4, water for injection - up to 1 ml.

Pharmacological properties

Pharmacodynamics

Levofloxacin is the optically active levorotatory isomer of ofloxacin. Its other name is L-ofloxacin (S - (-) - enantiomer). It is characterized by a wide range of antibacterial activity. The substance is a blocker of bacterial topoisomerase IV and DNA gyrase (topoisomerase II). Levofloxacin disrupts the processes of supercoiling and stitching of DNA breaks, provokes deep morphological changes in the membranes and walls of microbial cells, as well as the cytoplasm. When used in doses similar to or exceeding the minimum inhibitory concentration (MIC), it predominantly has a bactericidal effect. Levofloxacin is active against most strains of microorganisms both in vivo and in vitro.

The following microorganisms are sensitive to levofloxacin (zone of inhibition more than 17 mm, MIC less than 2 mg / l):

aerobic gram-positive microorganisms: Viridans streptococci peni-S / R (penicillin-susceptible / resistant strains), Bacillus anthracis, Streptococcus pyogenes, Streptococcus pneumoniae peni I / S / R (penicillin-susceptible / moderately susceptible / resistant spp. strains) groups C and G, Corynebacterium jeikeium, Corynebacterium diphtheriae, Enterococcus spp., Enterococcus faecalis, Staphylococcus spp. CNS (coagulase-negative type), Staphylococcus epidermidis methi-S (methicillin-susceptible strains), Staphylococcus coagulase-negative methi-S (I) (coagulase-negative methicillin susceptible / moderately susceptible strains), including Staphylococcus-methi-S (methicillin-susceptible strains), Staphylococcus-methi-Surethi monocythia
aerobic gram-negative microorganisms: Salmonella spp., Acinetobacter spp., including Acinetobacter baumannii, Serratia spp., including Serratia marcescens, Actinobacillus actinomycetemcomitans, Pseudomonas spp., including Pseudomonas aeruginosa, combined with Pseudomonas aeruginosa (hospital infections, Pseudomonas aeruginosa (hospital infections, triggered by Pseudomonas aeruginosa), Providencia stuartii, Providencia spp. Including Providencia rettgeri, Eikenella corrodens, Proteus mirabilis, Proteus vulgaris, Enterobacter cloacae, Enterobacter spp., Including Enterobacter aerogenes, Pasteurella multocida, Pasteurella dagmatis, including Pasteuretella spp., Including Pasteurella dagmatis, including Pasteuretella spp. meningitides, Neisseria gonorrhoeae non.png" />
anaerobic microorganisms: Veilonella spp., Bacteroides fragilis, Propionibacterium spp., Bifidobacterium spp., Peptostreptococcus spp., Fusobacterium spp., Clostridium perfringens;
other microorganisms: Ureaplasma urealyticum, Bartonella spp., Rickettsia spp., Chlamydia pneumoniae, Chlamydia trachomatis, Chlamydia psittaci, Mycoplasma pneumoniae, Mycoplasma hominis, Mycobacterium tuberculosis, Mycobacterium lepella spp.

Moderate sensitivity (zone of inhibition 16-14 mm, MIC more than 4 mg / l) to levofloxacin are:

anaerobic microorganisms: Porphyromonas spp., Prevotella spp.;
aerobic gram-negative microorganisms: Campylobacter coli, Campylobacter jejuni;
aerobic gram-positive microorganisms: Staphylococcus haemolyticus methi-R and Staphylococcus epidermidis methi-R (methicillin-resistant strains), Corynebacterium xerosis, Corynebacterium urealylicum, Enterococcus faecium.

The following microorganisms are resistant to the effects of levofloxacin (zone of inhibition is less than 13 mm, MIC is more than 8 mg / l):

anaerobic microorganisms: Bacteroides thetaiotaomicron;
aerobic gram-negative microorganisms: Alcaligenes xylosoxidans;
aerobic gram-positive microorganisms: Staphylococcus coagulase-negative methi-R (methicillin resistant coagulase negative strains), Staphylococcus aureus methi-R (methicillin resistant strains);
other microorganisms: Mycobacterium avium.

The cause of resistance to levofloxacin is the stepwise process of gene mutations, due to which both type II topoisomerases are encoded: topoisomerase IV and DNA gyrase. Other mechanisms of resistance development are also known, including the efflux mechanism (active elimination of the antimicrobial drug from microbial cells) and the mechanism of action on the penetration barriers of the microbe cell (this is typical for Pseudomonas aeruginosa). They can also reduce the sensitivity of microorganisms to levofloxacin.

In connection with some aspects of the action of levofloxacin, cases of cross-resistance between this substance and other antimicrobial drugs are practically not encountered.

Pharmacokinetics

When taken orally, levofloxacin is almost completely and quickly absorbed from the gastrointestinal tract. With a single intake of the drug in a dose of 500 mg, its maximum level in blood plasma is recorded after 1-2 hours. Absolute bioavailability reaches 99-100%. The rate and completeness of absorption of levofloxacin are slightly dependent on food intake. The equilibrium concentration of this compound in blood plasma when taken in an amount of 500 mg 1-2 times a day is achieved within 48 hours.

Levofloxacin binds to plasma proteins by about 30-40%. Its volume of distribution is approximately 100 liters, which indicates good penetration of the drug into the organ systems and tissues of the human body: sputum, bronchial mucosa, lungs, alveolar macrophages, organs of the urinary system, polymorphonuclear leukocytes, genitals, prostate gland, bone tissue, to insignificant concentrations - into the cerebrospinal fluid. After oral administration of 500 mg of levofloxacin 2 times a day, its slight accumulation in the body is observed.

In the liver, a small amount of levofloxacin is metabolized to form levofloxacin N-oxide and demethyl levofloxacin. The levofloxacin molecule is stereochemically stable and does not undergo chiral inversion. After oral administration of a single dose of 500 mg, the half-life is 6-8 hours. Levofloxacin is excreted mainly in the urine through tubular secretion and glomerular filtration. Approximately 85% of the administered dose is excreted unchanged through the kidneys. Less than 5% of the dose is excreted by the kidneys as metabolites.

The pharmacokinetics of levofloxacin in men and women are similar. Pharmacokinetics in elderly patients is the same as in younger patients, excluding differences due to differences in creatinine clearance.

Renal failure affects the pharmacokinetics of levofloxacin. After a single oral intake of 500 mg of the drug with a CC of 50-80 ml / min, the renal clearance is 57 ml / min with a half-life of 9 hours, with a CC of 20-49 ml / min, renal clearance is 26 ml / min with a half-life of 27 hours and CC less than 20 ml / min, renal clearance is 13 ml / min with a half-life of 35 hours.

Indications for use

Levofloxacin in the form of tablets and solution for infusion is prescribed for the treatment of the following infectious and inflammatory diseases caused by microorganisms sensitive to the action of its active substance:

Acute sinusitis (tablets);
Exacerbation of chronic bronchitis (tablets);
Infections of soft tissues and skin (tablets);
Bacterial prostatitis;
Community-acquired pneumonia;
Uncomplicated and complicated urinary tract infections, including pyelonephritis;
Bacteremia / septicemia associated with the above indications;
Intra-abdominal infections;
Drug-resistant forms of tuberculosis (infusion solution, simultaneously with other drugs).

Eye drops are prescribed for infections of the anterior part of the eye caused by microorganisms sensitive to the action of levofloxacin.

Contraindications

Age up to 1 year (eye drops), up to 18 years (tablets and infusion solution);
Pregnancy and lactation;
Hypersensitivity to the components of the drug or to other quinolones.

Additional contraindications to the use of Levofloxacin in the form of tablets and infusion solution are:

Tendon lesions during previous treatment with quinolones;
Epilepsy;
Renal failure with creatinine clearance less than 20 ml per minute (tablets);
Prolonged Q-T interval (infusion solution);
Simultaneous use with class IA antiarrhythmic drugs (quinidine, procainamide) or class III (amiodarone, sotalol) (infusion solution).

Levofloxacin in these dosage forms should be used with caution in elderly patients (due to the high likelihood of a concomitant decrease in renal function), as well as in patients with glucose-6-phosphate dehydrogenase deficiency.

Instructions for the use of Levofloxacin: method and dosage

Levofloxacin tablets are taken orally with a sufficient amount of liquid (from 0.5 to 1 glass), preferably before meals or between meals. Do not chew the tablets. The frequency of taking the drug is 1-2 times a day.

Levofloxacin infusion solution is administered intravenously, dropwise, slowly. The duration of administration of 100 ml of infusion solution (500 mg) should be at least 60 minutes 1-2 times a day. Depending on the patient's condition, after a few days of therapy, you can switch to oral administration of the drug without changing the dosage regimen.

Doses and duration of drug use are determined by the severity and nature of the infection, as well as the sensitivity of the alleged pathogen.

With normal or moderately reduced renal function (with creatinine clearance> 50 ml per minute), the following dosage regimen of Levofloxacin in the form of tablets and infusion solution is recommended:

Sinusitis: 500 mg once a day, course - 10-14 days (tablets);
Exacerbation of chronic bronchitis: once a day, 250 mg or 500 mg, course - 7-10 days (tablets);
Infections of the skin and soft tissues: once a day, 250 mg or 1-2 times a day, 500 mg, course - 7-14 days (tablets);
Drug-resistant forms of tuberculosis: 1-2 times a day, 500 mg, course - up to 3 months (infusion solution, simultaneously with other drugs);
Community-acquired pneumonia: 1-2 times a day, 500 mg, course - 7-14 days;
Bacterial prostatitis: 500 mg once a day, course - 28 days;
Uncomplicated urinary tract infections: once a day, 250 mg, course - 3 days;
Complicated urinary tract infections, including pyelonephritis: once a day, 250 mg, course - 7-10 days;
Septicemia / bacteremia: 1-2 times a day, 250 mg or 500 mg, course - 10-14 days;
Intra-abdominal infection: once a day, 250 mg or 500 mg, course - 7-14 days (simultaneously with the use of antibacterial drugs acting on the anaerobic flora).

Patients after hemodialysis or continuous outpatient peritoneal dialysis do not need additional doses.

When creatinine clearance is <50 ml per minute, a decrease in doses and an increase in the intervals between drug administration is required.

Patients with functional impairment of the liver do not require special dose selection.

It is recommended to continue therapy with the drug for at least 48-78 hours after normalization of body temperature or after recovery confirmed by laboratory tests (as is the case with other antibiotics).

Levofloxacin in the form of eye drops is applied topically. The drug should be instilled into the conjunctival sac, 1-2 drops in one or both affected eyes. The following treatment regimen is usually used:

1-2 days: every 2 hours (up to 8 times a day);
3-7 days: every 4 hours (up to 4 times a day).

The duration of therapy is 5-7 days.

When several local ophthalmic drugs are used together, a 15-minute break must be observed between instillations.

To avoid contamination of the solution, do not touch the tissues around the eye and eyelids with the dropper tip.

Side effects

When using Levofloxacin in the form of tablets and infusion solution, disorders may occur from some body systems:

Digestive system: often - nausea, diarrhea, increased activity of liver enzymes (for example, aspartate aminotransferase and alanine aminotransferase); sometimes - digestive disorders, loss of appetite, abdominal pain, vomiting; rarely - diarrhea with an admixture of blood, which in very rare cases can be a symptom of intestinal inflammation and / or pseudomembranous colitis;
Cardiovascular system: rarely - lowering blood pressure, increased heart rate; very rarely - shock-like (vascular) collapse; in some cases - lengthening of the QT interval;
Nervous system: sometimes - headache, numbness and / or dizziness, sleep disturbances, drowsiness; rarely - psychotic reactions such as depression and hallucinations, anxiety, tremors, paresthesias in the hands, agitation, confusion and convulsions; very rarely - impaired hearing and vision, impaired sense of smell and taste sensitivity, decreased tactile sensitivity;
Urinary system: rarely - an increase in serum creatinine and bilirubin levels; very rarely - interstitial nephritis, deterioration of renal function up to acute renal failure;
Musculoskeletal system: rarely - tendon lesions (including tendonitis), muscle and joint pain; very rarely - tendon rupture (for example, Achilles tendon), muscle weakness (should be taken into account in patients with bulbar syndrome); in some cases, muscle lesions (rhabdomyolysis);
Hematopoietic organs: sometimes - an increase in the number of eosinophils, a decrease in the number of leukocytes; rarely - thrombocytopenia, neutropenia; very rarely - agranulocytosis and the development of severe infections (deterioration of health, recurrent or persistent increase in body temperature); in some cases - hemolytic anemia, pancytopenia;
Metabolism: very rarely - a decrease in the concentration of glucose in the blood, which is important for patients with diabetes mellitus (possible symptoms of hypoglycemia: increased appetite, perspiration, nervousness, trembling); possibly - exacerbation of porphyria (in the presence of a disease);
Allergic reactions: sometimes - skin redness and itching; rarely - general hypersensitivity reactions (anaphylactoid and anaphylactic) with signs such as narrowing of the bronchi, urticaria, possibly severe suffocation; very rarely - swelling of the mucous membranes and skin (for example, in the pharynx and face), a sudden sharp drop in blood pressure and shock, hypersensitivity to ultraviolet and solar radiation, vasculitis, allergic pneumonitis; in some cases, severe skin rashes with blistering (for example, toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, and exudative erythema multiforme). The development of general hypersensitivity reactions can sometimes be preceded by milder skin reactions. The above reactions may occur a few minutes after the first dose or several hours after the infusion solution is administered;
Others: sometimes - general weakness; very rarely - fever;
Local reactions (when using an infusion solution): redness, pain at the injection site, phlebitis.

The use of Levofloxacin can lead to a change in the microflora that is normally present in humans, which can lead to an increased multiplication of fungi and bacteria that are resistant to the action of the drug. In rare cases, this may require additional therapy.

When using Levofloxacin in the form of eye drops, the following side effects may develop:

Often (1-10%): redness of the eyes, short burning sensation in the eye, decreased visual acuity;
Uncommon (0.1-1%): the appearance of mucus in the form of strands;
Rarely (0.1-0.01%): chemosis, blepharitis, the appearance of follicles and papillary growths on the conjunctiva, erythema of the eyelids, dry eye syndrome, photophobia, itching and pain in the eye, headache, allergic reactions, rhinitis.

Eye drops contain benzalkonium chloride, which can cause eye irritation and contact dermatitis.

Overdose

Taking Levofloxacin in high doses has the strongest effect on the functioning of the central nervous system: in such cases, dizziness, fainting, blurred consciousness and seizures like epileptic seizures are observed. Disorders of the gastrointestinal tract (for example, nausea), erosive lesions of the mucous membranes and lengthening of the QT interval are also sometimes noted.

Overdose treatment consists of symptomatic therapy. Elimination of levofloxacin by dialysis (peritoneal dialysis, continuous peritoneal dialysis and hemodialysis) is ineffective. There is no specific antidote.

special instructions

It is impossible to use Levofloxacin in the treatment of children and adolescents due to the likelihood of damage to the articular cartilage.

When using the drug in elderly patients, it should be borne in mind that renal function is often impaired in patients of this group.

In severe pneumococcal pneumonia, the drug may not provide the optimal therapeutic effect. Some of the nosocomial infections with certain pathogens (P. aeruginosa) may require combination therapy.

During the use of Levofloxacin in patients with previous brain damage, associated, for example, with severe trauma or stroke, a seizure attack may develop.

Photosensitization during therapy is noted in very rare cases, however, patients are not recommended to be exposed unnecessarily to artificial ultraviolet or strong solar irradiation.

If you suspect the development of pseudomembranous colitis, Levofloxacin should be discontinued immediately by starting appropriate treatment. It is impossible to use drugs that inhibit intestinal motility in these cases.

Tendinitis (primarily, inflammation of the Achilles tendon), which rarely occurs with the use of Levofloxacin, can lead to tendon rupture (elderly patients are more prone to its development). With the use of glucocorticosteroids, the risk of tendon rupture is likely to increase. If tendonitis is suspected, the drug should be discontinued immediately and appropriate therapy for the affected tendon should be initiated.

Patients with hereditary metabolic disorders (with deficiency of glucose-6-phosphate dehydrogenase) can react to fluoroquinolones by destroying erythrocytes (hemolysis). These patients must be treated with great care.

When wearing soft contact lenses, it is not recommended to use eye drops, since benzalkonium chloride, which is part of Levofloxacin, can be absorbed by them, having an adverse effect on the eye tissues, and also cause discoloration of contact lenses.

If a transient decrease in visual acuity occurs after instillation of the drug, you should not drive vehicles or perform potentially hazardous types of work until it is completely restored.

Side effects of Levofloxacin such as numbness, dizziness, visual disturbances and drowsiness can impair the ability to concentrate and reaction speed. This can be a certain risk in situations where it plays an important role (for example, when performing work in an unstable position, driving vehicles, servicing mechanisms and machines).

Pediatric use

According to the instructions, Levofloxacin is not recommended for use in the treatment of children and adolescents (under 18 years of age) due to the risk of damage to articular cartilage.

With impaired renal function

Levofloxacin tablets should not be prescribed to patients with severe renal impairment (CC less than 20 ml / min) due to the impossibility of accurate dosing of the drug in this dosage form. Hemodialysis does not require additional doses.

For violations of liver function

Patients with liver dysfunctions do not need special dose adjustment, since levofloxacin is slightly metabolized in the liver.

Drug interactions

With the simultaneous use of Levofloxacin with some drugs, undesirable effects may occur:

Quinolones: marked lowering of the seizure threshold;
Sucralfate, magnesium- or aluminum-containing antacids, iron salts: significant weakening of the effect of levofloxacin (it is necessary to observe a break between medications for at least 2 hours);
Vitamin K antagonists: violation of the blood coagulation system (control is necessary);
Cimetidine, probenicid: renal clearance of levofloxacin slightly slows down (treatment should be performed with caution, especially in patients with limited renal function);
Cyclosporine: increased half-life;
Glucocorticosteroids: Increased risk of tendon rupture.

When using Levofloxacin in the form of eye drops, the development of drug interactions with other drugs is unlikely.

Analogs

Levofloxacin analogs are: Levofloxacin-Teva, Levostar, Leflobact, L-Optic Rompharm, Signicef, Oftaquix, Tavanik, Eleflox, Cipromed, Betacyprol, Vitabact, Decametoxin, Lofox, Okacin, Ofloxiplokiplok, Oftalmol-Ophthalmic, Ciprofloxacin Bufus, Ophtocypro, Vigamox, Dancil, Zimar, Normax, Okomistin, Oftadek, Uniflox, Ciloxan, Ciprolone, Moxifur, Zarquin, Xenaquin, Lomacin, Lomflox, Nolitsin, Norilet, Norfacid, Ofaricid, Ofaricid, Ofariticid, Ciprex, Ciprodox, Cipropan, Ecocifol, Gatispan, Loxon-400, Lomefloxacin, Lofox, Moximak, Norbactin, Norfloxacin, Oflox, Oflomak, Plevilox, Sparbact, Taricin, Tseprova, Cipraz, Ablox, Dzheloxinal, Oflomak, Pefloxacin, Procypro, Tsiplox, Tsiprobay, Tsifran, Avelox, Zanocin, Zoflox, Quintor, Tarivid,Ciprobid, Unicpef, Basigen, Ofloxabol, Ciprolaker, Cipronate, Ciprofloxabol, Cifracid, Pefloxabol, Ciprinol.

Terms and conditions of storage

Store in a dark, dry place out of reach of children at temperatures up to 25 ° C.

Shelf life:

Tablets, infusion solution - 2 years;
Eye drops - 3 years.

After opening the bottle with drops, Levofloxacin can be used for 4 weeks.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Levofloxacin

Numerous reviews of Levofloxacin characterize it as an effective drug that quickly eliminates the symptoms of the disease and promotes recovery. Some patients speak negatively about him due to the development of side reactions: clouding of consciousness, severe weakness, muscle and joint pain. Their severity, like other side effects, depends on the individual patient. However, even in this case, Levofloxacin helps to cope well with the disease and contributes to a rapid improvement in well-being.

Price for Levofloxacin in pharmacies

The approximate price for Levofloxacin in the form of tablets with a dosage of 250 mg is 51–67 rubles (per pack 5 pcs.) Or 126–135 rubles (per pack 10 pcs.). The drug with a dosage of 500 mg can be purchased for 97–135 rubles (per pack of 5) or 206–280 rubles (per pack of 10). The solution for infusion is available for purchase for 104-133 rubles (for 1 bottle). Eye drops 0.5% will cost 164–206 rubles (for a 5 ml bottle).

Levofloxacin: prices in online pharmacies

Drug name

Price

Pharmacy

Levofloxacin (eye drops) 0.5% eye drops 5 ml 1 pc.

RUB 59

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Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!