Eleflox, 500 mg, film-coated tablets, 10 pcs.

Eleflox, 500 mg, film-coated tablets, 10 pcs.

Determination of side effect frequency categories (according to WHO): very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥ 1/10,000 and <1/1000), very rare (<1/10,000), frequency unknown (frequency cannot be estimated from available data).

Data obtained in clinical trials and post-marketing use of the drug

From the cardiovascular system: rarely - sinus tachycardia, palpitations; frequency unknown (post-marketing data) - prolongation of the QT interval, ventricular arrhythmias, ventricular tachycardia, ventricular tachycardia of the “pirouette” type, which can lead to cardiac arrest (see sections “Overdose”, “Special instructions”).

From the blood and lymphatic system: infrequently - leukopenia (decreased number of leukocytes in peripheral blood), eosinophilia (increased number of eosinophils in peripheral blood); rarely - neutropenia (decreased number of neutrophils in peripheral blood), thrombocytopenia (decreased number of platelets in peripheral blood); frequency unknown (post-marketing data) - pancytopenia (decrease in the number of all formed elements in the peripheral blood), agranulocytosis (absence or sharp decrease in the number of granulocytes in the peripheral blood), hemolytic anemia.

From the nervous system: often - headache, dizziness; infrequently - drowsiness, tremor, dysgeusia (taste perversion); rarely - paresthesia, convulsions (see section "Special instructions"); frequency unknown (post-marketing data) - peripheral sensory neuropathy, peripheral sensorimotor neuropathy (see section "Special instructions"), dyskinesia, extrapyramidal disorders, ageusia (loss of taste), parosmia (disorder of the sense of smell, especially the subjective sense of smell, objective absent), including loss of smell; syncope, benign intracranial hypertension.

On the part of the organ of vision: very rarely - visual disturbances, such as blurriness of the visible image; frequency unknown (post-marketing data) - transient vision loss, uveitis.

From the organ of hearing and labyrinthine disorders: infrequently - vertigo (a feeling of deviation or spinning of one’s own body or surrounding objects); rarely - ringing in the ears; frequency unknown (post-marketing data) - hearing loss, hearing loss.

From the respiratory system: infrequently - shortness of breath; frequency unknown (post-marketing data) - bronchospasm, allergic pneumonitis.

From the digestive system: often - diarrhea, vomiting, nausea; infrequently - abdominal pain, dyspepsia, flatulence, constipation; frequency unknown (post-marketing data) - hemorrhagic diarrhea, which in very rare cases may be a sign of enterocolitis, including pseudomembranous colitis (see section "Special Instructions"), pancreatitis.

From the liver and biliary tract: often - increased activity of liver enzymes in the blood (for example, ALT), (AST), increased activity of alkaline phosphatase and gamma-glutamyltransferase (GGT); infrequently - increased concentration of bilirubin in the blood; frequency unknown (post-marketing data) - severe liver failure, including cases of acute liver failure, sometimes fatal, especially in patients with a severe underlying disease (for example, in patients with sepsis) (see section "Special instructions"); hepatitis, jaundice.

From the urinary system: infrequently - increased concentration of creatinine in the blood serum; rarely - acute renal failure (for example, due to the development of interstitial nephritis).

From the skin and subcutaneous tissues: infrequently - rash, itching, urticaria, hyperhidrosis; frequency unknown (post-marketing data) - toxic epidermal necrolysis, Stevens-Johnson syndrome, exudative erythema multiforme, photosensitivity reactions (increased sensitivity to solar and UV radiation) (see section "Special Instructions"), leukocytoclastic vasculitis, stomatitis. Reactions from the skin and mucous membranes can sometimes develop even after taking the first dose of the drug.

From the musculoskeletal system and connective tissue: infrequently - arthralgia, myalgia; rarely - tendon damage, including tendonitis (for example, Achilles tendon), muscle weakness, which can be especially dangerous in patients with pseudoparalytic myasthenia gravis (see section "Special instructions"); frequency unknown (post-marketing data) - rhabdomyolysis, tendon rupture (for example, Achilles tendon; this side effect can be observed within 48 hours after the start of treatment and can be bilateral (see also section "Special instructions")), ligament rupture, rupture muscles, arthritis.

From the side of metabolism: infrequently - anorexia; rarely - hypoglycemia, especially in patients with diabetes mellitus (possible signs of hypoglycemia: voracious appetite, nervousness, perspiration, trembling); frequency unknown - hyperglycemia, hypoglycemic coma (see section "Special instructions").

Infectious and parasitic diseases: infrequently - fungal infections, development of resistance of pathogenic microorganisms.

From the immune system: rarely - angioedema; frequency unknown (post-marketing data) - anaphylactic shock, anaphylactoid shock. Anaphylactic and anaphylactoid reactions can sometimes develop even after taking the first dose of the drug.

Mental disorders: often - insomnia; infrequently - feeling of restlessness, anxiety, confusion; rarely - mental disorders (for example, hallucinations, paranoia), depression, agitation (excitement), sleep disturbances, nightmares; frequency unknown (post-marketing data) - mental disorders with behavioral disorders with self-harm, including suicidal thoughts and suicide attempts.

General disorders: infrequently - asthenia; rarely - pyrexia (fever); frequency unknown - pain (including pain in the back, chest and limbs).

Other possible adverse effects that apply to all fluoroquinolones

Very rare: attacks of porphyria (a very rare metabolic disease) in patients with porphyria.

Instructions for use LEFLOX

Disabling and potentially irreversible serious adverse reactions, incl. tendinitis and tendon rupture, peripheral neuropathy and central nervous system disorders

Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions across multiple body systems that may occur simultaneously in the same patient. Commonly observed adverse reactions include tendonitis, tendon rupture, joint pain, myalgia, peripheral neuropathy, and CNS effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions may develop within a few hours to several weeks after starting treatment with levofloxacin. Patients of any age and without pre-existing risk factors have experienced these adverse reactions.

If the first signs or symptoms of any serious adverse reactions appear, treatment should be discontinued immediately. Additionally, avoid the use of fluoroquinolones, including levofloxacin, in patients who have experienced any of these fluoroquinolone-related serious adverse reactions.

Because the use of fluoroquinolones, including levofloxacin, has been associated with the above serious adverse reactions, levofloxacin should be used only as a reserve antibiotic in patients for whom there are no alternative treatment options for the following indications:

• community-acquired pneumonia, complicated skin and soft tissue infections.

Advise patients at the first sign or symptom of any serious adverse reaction (eg, swelling or pain in the tendon area, joint and muscle pain, burning, tingling sensation, weakness or pain in the extremities, confusion, seizures, severe headache, or hallucinations) ) stop treatment immediately and consult a doctor.

Leflox should not be used to treat children and adolescents due to the likelihood of damage to articular cartilage.

When treating elderly patients, it should be borne in mind that patients in this group often suffer from impaired renal function (see section "Dosage regimen").

For very severe pneumonia caused by pneumococci, Leflox may not provide an optimal therapeutic effect. Hospital-acquired infections caused by certain pathogens (P. aeruginosa) may require combination treatment.

Methicillin-resistant S. aureus may be resistant to fluoroquinolones (including levofloxacin). Therefore, in cases of known or suspected methicillin-resistant Staphylococcus (MRSA) infection, levofloxacin is not recommended for treatment until results of a levofloxacin susceptibility test are available.

Resistance of E. coli (the most common cause of urinary tract infections) to fluoroquinolones varies among countries. Clinicians should consider local information on the prevalence of E. coli resistance to fluoroquinolones.

Duration of infusions

The recommended duration of administration should be strictly adhered to, which should be at least 60 minutes (100 ml of infusion solution). Experience with the use of levofloxacin shows that increased heart rate and a transient drop in blood pressure may occur during infusions. In rare cases, a severe drop in blood pressure can cause vascular collapse. If a significant drop in blood pressure is observed during the administration of levofloxacin, the infusion is stopped immediately.

Patients predisposed to seizures

Leflox is contraindicated in patients with epilepsy (like all other drugs of the fluoroquinolone class). Treatment with Leflox should be carried out with extreme caution in patients predisposed to seizures, due to the possibility of developing an attack. Convulsive readiness may also increase with simultaneous use of fenbufen and similar NSAIDs or theophylline (see section “Drug Interactions”) .

If seizures occur, treatment should be discontinued

Pseudomembranous colitis

Diarrhea, especially severe, persistent and/or bloody during or after finishing (including several weeks after treatment) levofloxacin, may be a sign of Clostridium difficile

(CDDA). The severity of the disease can vary from mild to severe (life-threatening). The most severe form is pseudomembranous colitis. This diagnosis is important to consider if patients develop severe diarrhea during or after treatment with levofloxacin. If CDDA is suspected or confirmed, treatment with levofloxacin should be stopped immediately and appropriate therapy instituted. In such cases, medications that inhibit peristalsis are contraindicated.

Tendinitis and tendon rupture

Tendonitis most often affects the Achilles tendon and can lead to rupture of the tendon. Tendonitis and tendon rupture (sometimes bilateral) can occur within 48 hours of starting treatment and up to several months after treatment ends. The risk of tendonitis and tendon rupture is greater in older patients (over 60 years of age), as well as in patients receiving daily doses of levofloxacin 1000 mg and in patients receiving corticosteroids. In elderly patients, the dose should be adjusted in accordance with QC (see section "Dosage regimen"). Such patients require careful monitoring during treatment with levofloxacin. All patients are advised to contact their healthcare provider immediately if symptoms of tendonitis occur. If tendinitis is suspected, treatment with levofloxacin should be stopped immediately and appropriate therapy for the affected tendon (eg, immobilization) should be instituted.

Hypersensitivity reactions

Levofloxacin can cause serious hypersensitivity reactions, including fatal ones (angioedema and anaphylactic shock), incl. and after the first dose. Treatment should be stopped immediately and consult a doctor.

Severe bullous reactions

Cases of severe bullous skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, have been observed with the use of levofloxacin. Patients should be advised to consult a doctor immediately if any changes in the skin and/or mucous membranes are noted before continuing treatment.

Liver failure

Cases of liver necrosis up to life-threatening conditions have been reported, especially in patients with severe pre-existing diseases, such as sepsis. If symptoms of liver failure develop (anorexia, jaundice, dark urine, itching), patients are advised to stop using the drug and consult their doctor.

Patients with kidney failure

Because Levofloxacin is excreted mainly by the kidneys; in patients with impaired renal function, mandatory monitoring of renal function is required, as well as adjustment of the dosage regimen. When treating elderly patients, it should be borne in mind that patients in this group often have impaired renal function (see section "Dosage regimen").

Prevention of photosensitivity

Despite the fact that photosensitivity is observed very rarely with the use of levofloxacin, in order to avoid it, patients are not recommended to be exposed unnecessarily to strong solar or artificial ultraviolet irradiation (for example, exposure to the sun in high mountains or visiting a solarium) during treatment and for 48 hours after its cancellation.

Superinfection

Long-term treatment with levofloxacin may lead to the growth of non-susceptible microorganisms. In case of superinfection, appropriate measures should be taken during treatment.

QT prolongation

Very rare cases of QT interval prolongation have been reported in patients using fluoroquinolones, incl. Levofloxacin. Caution should be exercised when using fluoroquinolones, incl. levofloxacin, patients with known risk factors for QT prolongation, such as:

• elderly age;
• female;
• electrolyte imbalance (eg, hypokalemia, hypomagnesemia);
• congenital long QT interval syndrome;
• heart disease (eg, heart failure, myocardial infarction, bradycardia);
• simultaneous use of drugs that are known to prolong the QT interval (for example, antiarrhythmic drugs of classes IA and III, tricyclic antidepressants, macrolides) (see sections “Dosage regimen”, “Drug interactions”).

Patients with glucose-6-phosphate dehydrogenase deficiency

Patients with glucose-6-phosphate dehydrogenase deficiency may react to fluoroquinolones with destruction of red blood cells (hemolysis). In this regard, treatment of such patients with levofloxacin should be carried out with great caution.

Dysglycemia

As with other quinolones, fluctuations in blood glucose levels, including hyper- and hypoglycemia, have been reported with levofloxacin, usually in patients with diabetes mellitus receiving oral antidiabetic agents (eg, glibenclamide) or insulin. There are reports of cases of hypoglycemic coma. Therefore, careful monitoring of blood glucose levels is recommended in patients with diabetes mellitus.

Peripheral neuropathy

Cases of sensory and sensorimotor neuropathy have been reported in patients receiving fluoroquinolones, including levofloxacin. If the patient develops symptoms of neuropathy, levofloxacin should be discontinued. This minimizes the possible risk of developing irreversible changes.

Exacerbation of myasthenia gravis

Fluoroquinolones, including levofloxacin, may cause neuromuscular blockade and increase muscle weakness in patients with myasthenia gravis. Serious adverse events (including death or the need for respiratory support) have been reported with the use of fluoroquinolones in patients with myasthenia gravis. Therefore, levofloxacin is not recommended for use in patients with a history of myasthenia gravis.

Psychotic reactions

With the use of quinolones, including levofloxacin, the development of psychotic reactions has been reported, which in very rare cases progressed to the development of suicidal thoughts and behavior disorders with self-harm (sometimes after taking a single dose of levofloxacin (see section "Side effects")). reactions, treatment with levofloxacin should be discontinued and appropriate therapy should be prescribed.The drug should be prescribed with caution to patients with a history of mental illness.

Visual impairment

If the patient experiences blurred vision or other eye side effects, contact an ophthalmologist immediately.

Patients taking vitamin K antagonists

When levofloxacin is used concomitantly with vitamin K antagonists, it is recommended to monitor blood clotting due to the increased risk of bleeding.

Impact on laboratory results

In patients receiving levofloxacin, testing for opiates in urine may give false-positive results. It may be necessary to confirm positive test results for the presence of opiates using more specific methods.

Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and lead to false negative results in the bacteriological diagnosis of tuberculosis.

Sodium Amount Information

The drug contains 15.4 mmol (354 mg) sodium per 100 ml dose. Take into account in patients on a sodium-restricted diet.

Impact on the ability to drive vehicles and machinery

Caution should be exercised given the possibility of developing side effects - drowsiness, confusion, dizziness, and impaired coordination of movements.

Directions for use and doses

Levofloxacin eye drops are instilled into the cavity of the conjunctival sac in the amount of 1-2 drops every two hours during the first two days of therapy. Subsequently, the frequency is reduced to four times a day (for 3-7 days). The duration of treatment is a week. If at the same time the doctor prescribed another drug for topical application, then the interval between medications should be 15 minutes. To prevent contamination of the vial and solution, avoid contact of the dropper tip with non-sterile surfaces.

The safety of Levofloxacin in newborns for the treatment of gonococcal conjunctivitis and corneal ulcers has not been studied. In elderly people, no dosage adjustment or frequency of administration of the drug is required.

ELEFLOX

Side effects

The frequency of a particular side effect is determined using the following table:

From the digestive system

Often:

nausea, diarrhea, increased activity of liver enzymes (for example, alanine aminotransferase and aspartate aminotransferase).

Infrequently:

loss of appetite, vomiting, abdominal pain, digestive disorders.

Rarely:

diarrhea (including blood), which in very rare cases can be a sign of intestinal inflammation and even pseudomembranous colitis (see section
“Special Instructions”),
increased concentration of bilirubin in the blood serum, dysbacteriosis.

Very rarely:

increased serum creatinine concentration, liver dysfunction, acute renal failure, hepatitis.

From the nervous system

Infrequently:

headache, dizziness, drowsiness, insomnia.

Rarely:

depression, anxiety, psychotic reactions (for example, with hallucinations), discomfort (for example, paresthesia in the hands), tremors, weakness, agitation, movement disorders, convulsions and confusion, suicidal thoughts.

Very rarely:

visual and hearing impairments, disorders of taste and smell, decreased tactile sensitivity, peripheral sensory neuropathy, peripheral sensory-motor neuropathy, dyskinesia, extrapyramidal disorders, fear, agitation, mental disorders with behavioral disorders with self-harm, suicide attempts.

From the cardiovascular
system
: Rarely:

tachycardia, decreased blood pressure.

Very rarely:

vascular collapse.

In some cases: prolongation of the QT interval, atrial fibrillation.

Metabolism

Very rarely:

a decrease in the concentration of glucose in the blood (hypoglycemia), which is of particular importance for patients with diabetes, with symptoms: increased appetite, nervousness, sweating, trembling.

From the musculoskeletal
system
Rarely:

tendon lesions (including tendinitis), arthralgia, myalgia.

Very rarely:

tendon rupture (eg Achilles tendon), muscle weakness.

In some cases:

muscle damage (rhabdomyolysis).

From the urinary system

Very rarely:

hypercreatininemia, interstitial nephritis, renal dysfunction, acute renal failure.

From the hematopoietic organs

Infrequently:

eosinophilia, leukopenia.

Rarely:

neutropenia; thrombocytopenia, hemorrhages.

Very rarely:

agranulocytosis.

In some cases:

hemolytic anemia, pancytopenia.

Allergic reactions

Infrequently:

itching and redness of the skin.

Rarely:

general hypersensitivity reactions (anaphylactic and anaphylactoid reactions) with symptoms such as urticaria, bronchospasm and laryngospasm, severe suffocation.

In very rare cases:

swelling of the skin and mucous membrane (for example, in the face and throat), anaphylactic shock, allergic pneumonitis, vasculitis.

In some cases:

severe blistering skin rashes such as Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and exudative erythema multiforme.

Others

Infrequently:

general weakness (asthenia).

Rarely:

"tinnitus".

Very rarely:

exacerbation of porphyria, fever, photosensitivity, development of superinfection, shortness of breath; development of severe infections (persistent or recurrent fever, sore throat and persistent deterioration in health).