Tavanic, 500 mg 10 pcs

Infectious diseases, Sinusitis, Prostatitis, Respiratory tract infections, Inflammation of the female genitalia, Tuberculosis, Lung inflammation (pneumonia), Skin infections, Guaymorrhitis, Bronchitis, Urinary tract infections

Levofloxacin for oral and IV administration is indicated for treatment of infections and inflammatory diseases caused by agents sensitive to levofloxacin, in adults, including: Community-acquired pneumonia; uncomplicated urinary tract infections; complicated urinary tract infections (including pyelonephritis); chronic bacterial prostatitis; skin and soft tissue infections; in complex therapy of drug-resistant forms of tuberculosis; prevention and treatment of anthrax with airborne infection; acute sinusitis (tablets); exacerbation of chronic bronchitis (tablets); hospital pneumonia (for dosage of 750 mg tablets).

When using levofloxacin, official national recommendations for the appropriate use of antibacterial agents as well as the sensitivity of pathogens in a particular country should be considered (see “Special Instructions”).

Levofloxacin 0.5% eye drops are indicated for the treatment of superficial bacterial eye infections caused by susceptible microorganisms in adults and children over 1 year of age; for prevention of complications after ocular surgery and laser operations.

Active ingredient

Composition

1 tablet contains:

The active ingredient:

levofloxacin 500 mg;

Associates:

crospovidone;

methylhydroxypropylcellulose;

MCC;

Sodium stearyl fumarate;

macrogol 8000;

t talc;

titanium dioxide (E171);

Red iron oxide (E172);

Yellow iron oxide (E172).

How to take, the dosage

Internally, intravenously, conjunctivally. Dosing regimen and duration of treatment depend on the nature and severity of the infectious process, as well as the sensitivity of the pathogen. Orally: 250-750 mg 1-2 times a day. IV: slowly drip 250-500 mg 1-2 times a day. Subsequent transfer to oral administration in the same dose is possible. In case of impaired renal function, adjustment of the regimen of administration is required, including dose reduction depending on creatinine Cl.

Conjunctival: during the first two days – in the affected eye during wakefulness – 1-2 drops every 2 hours, up to 8 times a day; thereafter 1-2 drops every 4 hours, up to 4 times a day; duration of treatment is determined by the doctor. If several drugs are used, the interval between their instillations should be at least 15 minutes.

Interaction

Chelated compounds: antacids, sucralfate, metal cations, multivitamins

Levofloxacin for oral administration. Magnesium- and aluminum-containing antacids, sucralfate; drugs containing metal cations (such as iron), zinc-containing multivitamins, didanosine (LP containing aluminum and magnesium) when administered simultaneously with levofloxacin may significantly affect absorption of the latter in the GI tract, leading to a decrease in its systemic levels. The above mentioned drugs should be taken at least 2 hours before or 2 hours after oral administration of devofloxacin.

Levofloxacin for injection. There are no data on the interaction of intravenously administered fluoroquinolones with oral antacids, sucralfate, multivitamins, didanosine or metal cations. However, none of the fluoroquinolones, including levofloxacin, should be administered together with any solution containing polyvalent cations, such as magnesium, via the same I.V. system.

Warfarin

In a clinical study in healthy volunteers, no significant effect of levofloxacin on Cmax, AUC and other pharmacokinetic parameters of R- or S-isomers of warfarin was observed. There was also no apparent effect of warfarin on the absorption and other pharmacokinetic parameters of levofloxacin. However, post-marketing studies have reported cases of increased effects of warfarin when used concomitantly with levofloxacin, with increased PV accompanied by bleeding episodes. Concomitant use of levofloxacin and warfarin requires close monitoring of INR, PV and other coagulation parameters, as well as monitoring of possible bleeding signs.

Antidiabetic drugs

In patients receiving fluoroquinolones and antidiabetic drugs concomitantly, fluctuations in blood glucose levels, including hyperglycemia and hypoglycemia, have been reported. Close monitoring of blood glucose levels is recommended when these drugs are used together.

Continuous use of NSAIDs with fluoroquinolones, including levofloxacin, may increase the risk of CNS stimulation and seizures.

Theophylline

In a clinical study in healthy volunteers, no significant effect of levofloxacin on plasma concentrations, AUC and other pharmacokinetic parameters of theophylline was observed. There was also no apparent effect of theophylline on the absorption and other pharmacokinetic parameters of levofloxacin. However, concomitant use of theophylline with other fluoroquinolones was accompanied by an increase in T1/2 and serum concentration of theophylline and a subsequent increase in the risk of theophylline-related adverse reactions. In this regard, careful monitoring of theophylline levels and appropriate dose adjustments in concomitant use of levofloxacin are necessary. Adverse reactions, including seizures, may occur regardless of the increase in serum concentration of theophylline.

Cyclosporine

In studies in healthy volunteers no clinically significant effect of levofloxacin on plasma concentrations, AUC and other pharmacokinetic parameters of cyclosporine was observed. However, elevated plasma levels of cyclosporine have been reported with other fluoroquinolones. The Cmax of levofloxacin was slightly lower, while the Tmax and T1/2 were slightly longer in the presence of cyclosporine than the same parameters observed in other studies without concomitant treatment. The differences, however, are not considered clinically significant. Therefore, no dose adjustment of levofloxacin or cyclosporine is required with their concomitant use.

Digoxin

In a clinical study in healthy volunteers no significant effect of levofloxacin on Cmax, AUC and other pharmacokinetic parameters of digoxin was found. Absorption and other pharmacokinetic parameters of levofloxacin were similar in the presence or absence of digoxin. Thus, no dose adjustment of levofloxacin or digoxin is required with concomitant use.

Probenecid and cimetidine

In a clinical study involving healthy volunteers there was no significant effect of probenecid or cimetidine on the Cmax of levofloxacin. Values of AUC and T1/2 of levofloxacin were higher, while values of clearance were lower during combination treatment of levofloxacin with probenecid or cimetidine compared to treatment with levofloxacin alone. However, these changes are not a reason to adjust the dose of levofloxacin when combined with probenecid or cimetidine.

Interactions related to laboratory or diagnostic testing

Some fluoroquinolones, including levofloxacin, may lead to false-positive urine opiate tests when using commercially available immunoassay kits (more specific opiate determination methods may be needed).

Special Instructions

Tendinopathy and tendon rupture

The use of fluoroquinolones, including levofloxacin, is associated with an increased risk of tendinitis and tendon rupture at any age. This side effect most commonly affects the Achilles tendon, and surgery may be required if the Achilles tendon ruptures. Tendinitis and rupture of the rotator cuff tendon of the shoulder, hand, biceps, thumb, and other localized tendons have also been reported. The risk of fluoroquinolone-associated tendonitis and tendon rupture is increased in elderly patients, usually older than 60 years, in patients taking corticosteroids, and in patients with kidney, heart, and lung transplants. Factors in addition to age and corticosteroid intake that may independently increase the risk of tendon rupture include greater physical activity, renal insufficiency, and prior medical conditions such as rheumatoid arthritis. Tendinitis and tendon rupture have been reported in patients taking fluoroquinolones but without the above risk factors. Tendon rupture may occur during or after completion of therapy; some cases have been reported up to several months after completion of treatment. If pain, swelling, inflammation or tendon rupture occurs, therapy with levofloxacin should be discontinued. Patients should be advised to rest and avoid exercise at the first signs of tendinitis or tendon rupture and should consult their physician for other nonquinolone antimicrobials.

Pseudoparalytic myasthenia gravis

Fluoroquinolones, including levofloxacin, are characterized by blocking neuromuscular conduction activity and may increase muscle weakness in patients with pseudoparalytic myasthenia gravis. Serious adverse reactions, including pulmonary failure requiring ventilatory ventilation and death, have been observed in the postmarketing period and have been associated with fluoroquinolones in patients with pseudoparalytic myasthenia gravis. Levofloxacin is contraindicated in patients diagnosed with pseudoparalytic myasthenia gravis (see Contraindications, Side Effects).

Hypersensitivity reactions

The development of severe and fatal hypersensitivity and/or anaphylactic reactions has been reported with fluoroquinolones, including levofloxacin, often developing after the first dose. Some reactions were accompanied by cardiovascular collapse, hypotension, shock, seizures, loss of consciousness, tingling sensation, angioedema (including tongue, pharynx, vocal cleft or facial edema), airway obstruction (bronchospasm, shortened breathing, acute respiratory distress syndrome), shortness of breath, urticaria, itching and other pronounced skin reactions. At the first manifestations of skin rash or other hypersensitivity reactions levofloxacin should be immediately discontinued. If serious acute hypersensitivity reactions develop, epinephrine and other resuscitation measures may be required, including oxygen, IV fluids, antihistamines, corticosteroids, pressor amines and airway support (for clinical indications) (see “Adverse effects”).

Other serious and sometimes fatal reactions

Rarely, other serious and sometimes fatal reactions have been reported in patients with fluoroquinolones, including levofloxacin, due to both hypersensitivity reactions and unspecified causes. These reactions occurred mainly after repeated doses were as follows: fever, rash or severe dermatological reactions (e.g., acute epidermal necrolysis, Stevens-Johnson syndrome), vasculitis, arthralgia, myalgia, serum disease, allergic pneumonitis, interstitial nephritis, acute renal failure, hepatitis, jaundice, acute liver necrosis or hepatic failure, anemia (incl.including hemolytic and hypoplastic), thrombocytopenia (including thrombocytopenic purpura), leukopenia, agranulocytosis, pancytopenia and/or other changes in blood.

In the first manifestation of skin rash, jaundice or any other manifestation of hypersensitivity, levofloxacin should be immediately discontinued and appropriate measures taken.

Hepatotoxicity

There was no evidence of severe, levofloxacin-associated hepatotoxicity in clinical studies in more than 7,000 patients. Severe hepatotoxic reactions recorded in post-marketing observations (including acute hepatitis and fatal outcome) usually occurred within the first 14 days of treatment, most cases within 6 days, in most cases severe hepatotoxicity was not associated with hypersensitivity. The most frequent cases of fatal hepatotoxicity were observed in patients aged 65 years and older and were not associated with hypersensitivity. The use of levofloxacin should be immediately discontinued if the patient develops signs and symptoms of hepatitis (see “Side effects”).

The effects on the CNS

The occurrence of seizures, toxic psychosis, increased intracranial pressure (including cerebral pseudotumor) has been reported in patients receiving fluoroquinolones, including levofloxacin. Fluoroquinolones may also cause CNS stimulation with the appearance of tremor, anxiety, dizziness, confusion, hallucinations, paranoia, depression, insomnia, nightmares, rarely suicidal thoughts and actions; these phenomena may occur after the first dose. If these reactions are observed in patients receiving levofloxacin, treatment should be discontinued and appropriate measures should be taken. As with other fluoroquinolones, levofloxacin should be used with caution in patients with known or suspected CNS diseases that predispose to seizures or lower seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower seizure threshold (e.g., certain drugs, renal dysfunction) (see “Side Effects,” “Interactions”).

Diarrhea associated with Clostridium difficile

Diarrhea associated with Clostridium difficile has been reported with virtually all antibacterials, including levofloxacin, and can range in severity from mild diarrhea to fatal colitis. Treatment with antibacterials leads to a modification of the normal flora of the large intestine and increased growth of C. difficile. Strains of C. difficile producing toxins A and B that cause diarrhea lead to an increased risk of mortality because these infections may be resistant to antimicrobial therapy and may require colectomy. The possibility of C. difficile-associated diarrhea should be considered in all patients who present with complaints of diarrhea after antimicrobial use. A careful history is necessary, as C. difficile-associated diarrhea may develop within two months after antimicrobial use. If C. difficile-associated diarrhea is suspected or confirmed, levofloxacin should be stopped and appropriate treatment (including fluids and electrolytes, protein supplements, use of antibiotics to which C. difficile strains are sensitive) and surgical evaluation should be initiated if clinically indicated (see “Adverse effects”).

Peripheral neuropathy

Cases of sensory or sensorimotor axonal polyneuropathy manifested by paresthesia, hypoesthesia, dysesthesia and weakness have been reported in patients receiving fluoroquinolones, including levofloxacin. The symptoms may occur soon after the start of levofloxacin therapy and may be irreversible. The use of levofloxacin should be immediately discontinued if the patient has symptoms of neuropathy, which include pain, burning, tingling, numbness and/or weakness or other sensory disorders, including impaired sense of touch, pain, hyperthermia, loss of sense of body position in space, changes in vibration sensitivity (see “Adverse effects”).

Prolongation of the QT interval

In the background of using fluoroquinolones, including levofloxacin, prolongation of the QT interval on ECG and infrequent cases of arrhythmia have been reported. Rare cases of torsade de pointes have been reported in post-marketing studies in patients receiving fluoroquinolones, including levofloxacin. Levofloxacin should be avoided if a patient has risk factors for QT interval prolongation, such as a history of QT interval prolongation, unadjusted hypokalemia, concomitant use with antiarrhythmic agents of class IA (quinidine, procainamide) and class III (amiodarone, sotalol). Elderly patients may be more susceptible to LS-associated effects on the QT interval.

Changes in blood glucose levels

As with other fluoroquinolones, changes (abnormalities) in blood glucose levels have been reported, including symptomatic hyper- and hypoglycemia, in most cases observed in diabetic patients concurrently receiving oral hypoglycemic agents (such as glibenclamide) or insulin. Close monitoring of blood glucose levels in these patients is recommended. If against the background of levofloxacin a hypoglycemic reaction develops, levofloxacin should be stopped immediately and appropriate therapy should be started (see “Side effects”, “Interactions”).

Photosensitivity/phototototoxicity

. Patients who have been exposed to direct sunlight or UV irradiation during treatment with fluoroquinolones may experience moderate to severe photosensitivity/phototototoxicity reactions, the latter of which may manifest as excessive tanning reactions (e.g. burning erythema, exudation, blisters, blisters, edema) in areas exposed to direct sunlight (typically the face, the neckline, the extensor surfaces of the forearms, the back of the hands). Therefore, excessive exposure to these light sources should be avoided. Drug therapy should be stopped if photosensitivity/phototototoxicity reactions develop (see side effects).

Geriatric Use

In phase III clinical trials, 1,945 patients receiving levofloxacin were aged ≥65 years (26%). Of these, 1,081 patients (14%) were 65 to 74 years of age and 864 patients (12%) were ≥75 years of age. No differences in safety or efficacy were found between these patients and younger patients, but greater sensitivity in some older patients cannot be excluded.

The patient should be warned:

– about the advisability of copious drinking;

– that levofloxacin may cause neurological side effects (e.g., dizziness of varying severity), so the patient should know how they respond to levofloxacin before engaging in activities that require rapid reaction and involve increased concentration;

– Strong sunlight or artificial ultraviolet radiation should be avoided during treatment; if phototoxic reactions occur (e.g., skin rash), treatment should be discontinued.

Wearing soft contact lenses is not recommended during treatment with levofloxacin as 0.5% eye drops.

Particular notes

The prevalence of acquired resistance of bacterial strains that are bred may vary by geographic region and over time. This requires information about levofloxacin resistance in a particular country.

At the beginning of therapy appropriate tests should be performed to identify the causative agent and assess the sensitivity to levofloxacin. Treatment with levofloxacin can be initiated before the results of these tests are available. After the results of the tests have been obtained, an appropriate therapy should be chosen. Testing on culture periodically during therapy with levofloxacin provides information about continuing sensitivity of pathogenic microorganism to levofloxacin and possible emergence of bacterial resistance.

Contraindications

For systemic use: hypersensitivity to levofloxacin or other quinolones; epilepsy; pseudoparalytic myasthenia gravis (see “Side effects”, “Precautions”); tendon lesions while taking fluoroquinolones in the history; childhood and adolescence below 18 years (due to incomplete skeletal growth, because the risk of cartilaginous growth points damage cannot be completely excluded.because the risk of cartilage growth point lesions cannot be completely excluded); pregnancy (the risk of cartilage growth point lesions in the fetus cannot be completely excluded); breastfeeding (the risk of cartilage growth point lesions in the baby cannot be completely excluded).

Eye drops: Hypersensitivity to levofloxacin or other quinolones.

Limitations on use

For systemic use:

– in patients predisposed to the development of seizures (in patients with previous CNS lesions, in patients simultaneously taking drugs that lower the threshold of seizure readiness of the brain, such as phenbufen, theophylline) (see “Interactions);

– in patients with latent or manifest glucose-6-phosphate dehydrogenase deficiency (increased risk of hemolytic reactions when treated with quinolones);

– In patients with impaired renal function (requires mandatory monitoring of renal function and dosing regimen adjustment);

– In patients with known risk factors for QT interval prolongation: elderly age; female gender, uncorrected electrolyte disorders (hypokalemia, hypomagnesemia); congenital QT interval prolongation syndrome; heart disease (heart failure, myocardial infarction, bradycardia); concurrent use of drugs that can prolong the QT interval (antiarrhythmic agents of class IA and III, tricyclic antidepressants, macrolides, neuroleptics) (see “Overdose, Interactions, Precautions);

– In patients with diabetes mellitus treated with oral hypoglycemic drugs such as glibenclamide or insulin drugs (increased risk of hypoglycemia);

– In patients with severe adverse reactions to other fluoroquinolones, such as severe neurological reactions (increased risk of similar adverse reactions with levofloxacin);

– In patients with psychosis or in patients with a history of mental illness (see “Precautions. “Precautions).

Eye drops: childhood age (safety and effectiveness of use have not been determined).

Side effects

Serious and clinically important adverse drug reactions, which are discussed in more detail in the precautions section, include:

– effects on tendons;

– aggravation of pseudoparalytic myasthenia gravis;

– hypersensitivity reactions;

– other serious and sometimes fatal reactions;

– hepatotoxicity;

– effects on the CNS;

– Clostridium difficile-associated diarrhea;

– peripheral neuropathy, which may be irreversible;

– prolongation of the QT interval;

– fluctuations in blood glucose levels;

– photosensitivity/phototototoxicity;

– development of drug resistance in bacteria.

Hypotension has been associated with rapid or bolus IV administration of levofloxacin. Levofloxacin should be administered slowly, over 60 to 90 minutes.

Crystalluria and cylinduria have been reported with fluoroquinolones, including levofloxacin. Therefore, adequate hydration should be maintained in patients during treatment with levofloxacin to avoid excessive concentrated urine.

The experience of clinical trials

Because clinical trials are conducted with a different set of conditions, the incidence of adverse reactions observed in these trials cannot be directly compared with the incidence in other clinical trials and predict the occurrence of adverse effects in clinical practice.

The data are from 29 pooled phase 3 clinical trials (n=7537). The mean age of patients was 50 years (approximately 74% of patients were younger than 65 years), 50% were male, 71% were Caucasian, and 19% were dark-skinned. Patients received levofloxacin for treatment of various infections at a dose of 750 mg once daily, 250 mg once daily, or 500 mg twice daily. The duration of therapy was usually 3-14 days (10 days on average).

The overall incidence, type, and distribution of adverse reactions were similar in patients receiving levofloxacin at a dose of 750 mg once daily compared with patients receiving 250 mg once daily or 500 mg twice daily. Therapy was discontinued because of drug-related side effects in 4.3% of patients overall, in 3.8% of patients taking 250 and 500 mg doses, and in 5.4% of patients taking 750 mg. The most common side effects leading to discontinuation of the drug at 250 and 500 mg doses were gastrointestinal complaints (1.4%), nausea (0.6%), vomiting (0.4%), dizziness (0.3%), and headache (0.2%). The most common side effects leading to discontinuation were gastrointestinal distress (1.2%), nausea (0.6%), vomiting (0.5%), dizziness (0.3%), and headache (0.3%) at the 750 mg dose.

The following are the adverse effects noted in clinical trials and observed at a rate of >0.1% in patients receiving levofloxacin (N=7537). The most common adverse reactions (≥3%) were nausea, headache, diarrhea, insomnia, constipation, and dizziness.

Nervous system and sensory organs: Headache (6%), dizziness (3%), insomnia1 (4%); 0.1-1% – anxiety, agitation, confusion, depression, hallucinations, nightmares1, sleep disturbance1, anorexia, unusual dreams1, tremors, seizures, paresthesia, vertigo, hypertension, hyperkinesis, movement coordination disorders, sleepiness1, syncope.

Cardiovascular system and blood: 0.1-1% – anemia, arrhythmia, palpitations, cardiac arrest, supraventricular tachycardia, phlebitis, nasal bleeding, thrombocytopenia, granulocytopenia.

Respiratory system: dyspnea (1%).

Gastrointestinal system disorders: nausea (7%), diarrhea (5%), constipation (3%), abdominal pain (2%), dyspepsia (2%), vomiting (2%); 0.1-1% – gastritis, stomatitis, pancreatitis, esophagitis, gastroenteritis, glossitis, pseudomembranous colitis, liver function disorders, increased liver enzymes, increased ALP.

Urogenital system disorders: vaginitis2 (1%); 0.1-1%: impaired renal function, acute renal failure, genital candidiasis.

Musculoskeletal system: 0.1-1%: arthralgia, tendinitis, myalgia, skeletal muscle pain.

Skin disorders: rash (2%), itching (1%); 0.1-1% – allergic reactions, edema (1%), urticaria.

Others: candidiasis (1%), reaction at the injection site (1%), chest pain (1%); 0.1-1%: hyperglycemia/hypoglycemia, hyperkalemia.

In clinical trials, ophthalmologic abnormalities, including cataracts and multiple pitting of the lens, have been reported in patients treated with fluoroquinolones, including levofloxacin, when multiple doses are used. A correlation between these phenomena and drug intake has not been established.

1 N=7274.

2 N=3758 (women).

Post-marketing studies

The incidence of these events and the causal relationship to drug intake cannot be reliably assessed because reports were obtained spontaneously, from a population of unspecified size.

Nervous system and sense organs: individual reports of encephalopathy, EEG abnormalities, peripheral neuropathy (may be irreversible), psychosis, paranoia, individual reports of suicide attempts and suicidal ideation, uveitis, visual impairment (including diplopia, decreased visual acuity).including diplopia, decreased visual acuity, blurred vision, scotoma), hearing loss, tinnitus, parosmia, anosmia, loss of taste, perversion of taste, dysphonia, exacerbation of myasthenia gravis, pseudotumor of the brain.

Cardiovascular and blood: single reports of torsade de pointes, prolongation of QT interval, tachycardia, vasodilation, increased INR, prolongation of PV, pancytopenia, aplastic anemia, leukopenia, hemolytic anemia, eosinophilia.

Gastrointestinal system disorders: liver failure (including fatal cases), hepatitis, jaundice.

Musculoskeletal disorders: tendon rupture, muscle damage, including rupture, rhabdomyolysis.

Skin disorders: bullous rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, photosensitivity/ phototoxicity reactions.

Allergic reactions: hypersensitivity reactions (sometimes fatal), including anaphylactic/anaphylactoid reactions, anaphylactic shock, angioedema, serum sickness; isolated reports of allergic pneumonitis.

Others: leukocytoclastic vasculitis, increased muscle enzyme activity, hyperthermia, multiorgan failure, interstitial nephritis.

When using levofloxacin as 0.5% eye drops, the most commonly reported effects were: 1-3% – transient visual impairment, transient burning, pain or discomfort in the eye, foreign body sensation in the eye, fever, headache, pharyngitis, photophobia; < 1% – allergic reaction, edema, dry eye, itching in the eye.

Overdose

The following symptoms were observed in mice, rats, dogs and monkeys after administration of a single high dose of levofloxacin: ataxia, ptosis, decreased locomotor activity, dyspnea, prostration, tremors, convulsions. Doses in excess of 1500 mg/kg orally and 250 mg/kg w/v significantly increased mortality in rodents.

The treatment of acute overdose: gastric lavage, adequate hydration. Not excreted by hemodialysis and peritoneal dialysis.

Pregnancy use

Pregnant use is possible only if the expected effect of therapy exceeds the potential risk to the fetus (adequate strictly controlled safety studies of use in pregnant women have not been conducted).

Levofloxacin had no teratogenic effect in rats when administered orally at a dose of 810 mg/kg/day (9.4 times the MRLF per body surface area) or intravenously at a dose of 160 mg/kg/day (1.9 times the MRLF per body surface area). Oral administration to pregnant rats at a dose of 810 mg/kg/day resulted in an increased incidence of intrauterine death and decreased fetal body weight. In experiments on rabbits no teratogenic effect was detected when administered orally at a dose of 50 mg/kg/day (1.1 times greater than MRLF in terms of body surface area) or intravenously at a dose of 25 mg/kg/day, which corresponds to 0.5 MRLF in terms of body surface area.

The FDA fetal category is C.

With the results of studies of other fluoroquinolones and very limited data regarding levofloxacin, it can be assumed that levofloxacin may penetrate the breast milk of breastfeeding women. Because of the potential for serious adverse reactions in breastfed infants, breastfeeding women should discontinue either breastfeeding or systemic administration of levofloxacin (given the importance of the drug to the mother).

When levofloxacin is used in the form of eye drops, caution should be exercised.

Similarities