Leflobakt Forte, 750 mg 10 pcs

Indications

Infectious inflammatory diseases caused by microorganisms sensitive to levofloxacin in adults:

– lower respiratory tract infections (hospital pneumonia, community-acquired pneumonia);

– acute bacterial sinusitis;

– complicated urinary tract infections (including.

– complicated infections of the urinary tract (including acute pyelonephritis);

– complicated infections of the skin and soft tissues (including suppurated atheromas, abscesses, furunculosis).

When using Leflobakt® Forte, official national recommendations for the appropriate use of antibacterial agents, as well as the sensitivity of pathogenic microorganisms in a particular country should be taken into account.

Active ingredient

Composition

Composition of the core:

The active ingredient: levofloxacin hemihydrate – 768.69 mg (in terms of levofloxacin – 750 mg);

Excipients: Calcium stearate, pregelatinized starch (starch 1500), crospovidone (collidone CL-M, collidone CL), povidone (polyvinylpyrrolidone low molecular weight medical 12600±2700, povidone K 15, povidone K 17), lactose monohydrate (milk sugar), talc, microcrystalline cellulose, potato starch;

The composition of the shell: Hypromellose (hydroxy-propyl methylcellulose), macrogol-4000 (polyethylene glycol-4000), titanium dioxide (titanium dioxide), tropeolin O.

How to take, the dosage

The drug should be taken orally before meals or between meals, without chewing, with plenty of fluid (0.5 to 1 cup).

In adults with normal renal function (creatinine clearance greater than 50 ml/min), use according to the routes shown in the table:

Infection

Daily

dose, mg

Frequency of administration per day

Duration treatment, days

Hospital pneumonia

750

1

7-14

Out-of-hospital pneumonia

750

1

5

This regimen is indicated for the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae

Acute bacterial sinusitis

750

1

5

Complicated urinary tract infections, including.ч. Acute pyelonephritis

7-14

It is possible to use levofloxacin in tablet form to continue treatment in patients who have initially been treated with intravenous levofloxacin infusion solution and have had an improvement in their condition which allows further oral administration of levofloxacin.

In patients with impaired renal function (CK ≤ 50 ml/min) other doses of levofloxacin should be used.

Additional doses are not required after hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).

Dose adjustment is not required if liver function is impaired because the amount of metabolism of levofloxacin in the liver is limited.

In elderly patients no dosing adjustment is required unless the CK is lowered to 50 ml/min or lower.

Interaction

Interactions requiring caution

Calcium salts have minimal effect on absorption of levofloxacin when taken orally.

The effect of Leflofloxac® Forte is significantly impaired by concomitant use of sucralfate (gastric mucosa protection agent). For patients receiving levofloxacin and sucralfate it is recommended to take sucralfate 2 hours after levofloxacin administration.

Pharmacokinetic interaction of levofloxacin with theophylline has not been revealed. However, with concomitant use of quinolones and theophylline, nonsteroidal anti-inflammatory drugs and other drugs which decrease cerebral seizure threshold, a marked decrease in cerebral seizure threshold is possible.

The concentration of levofloxacin with concomitant administration of phenbufen is increased only by 13%.

In patients treated with levofloxacin in combination with indirect anticoagulants (e.g., warfarin) an increase in prothrombin time/international normalized ratio and/or development of bleeding has been observed, including severe bleeding. Therefore, when concomitant use of indirect anticoagulants and levofloxacin, regular monitoring of blood clotting parameters is necessary.

Concomitant use with Leflobact® FORTE increases the half-life of cyclosporine by 33%. Since this increase is clinically insignificant, no dose adjustment of cyclosporine is required when used concomitantly with levofloxacin.

The concomitant use of Leflofloxac® Forte with glucocorticosteroids increases the risk of tendon rupture.

Levofloxacin, like other fluoroquinolones, should be used with caution in patients receiving medications that prolong the QT interval (e.g., antiarrhythmic agents of class IA and III, tricyclic antidepressants, macrolides, neuroleptics).

Other

. Clinical and pharmacological studies conducted to investigate possible pharmacokinetic interactions of levofloxacin with digoxin, glibenclamide, ranitidine and warfarin have shown that the pharmacokinetics of levofloxacin when used concurrently with these drugs does not change sufficiently to be of clinical significance.

Special Instructions

After normalization of body temperature, it is recommended to continue treatment for at least 48-72 h.

Hospital infections caused by Pseudomonas aeruginosa may require combined treatment.

The prevalence of acquired resistance of bacillary strains may vary by geographic region and over time. This requires information about resistance to the drug in a specific country.

For therapy of severe infections or in case of ineffective treatment a microbiological diagnosis with isolation of the causative agent and determination of its sensitivity to levofloxacin should be established.

There is a high probability that methicillin-resistant Staphylococcus aureus is resistant to fluoroquinolones, including levofloxacin. Therefore, levofloxacin is not recommended for treatment of established or suspected infections caused by methicillin-resistant Staphylococcus aureus if laboratory tests have not confirmed sensitivity of this microorganism to levofloxacin.

Patients susceptible to seizures

Pseudomembranous colitis

Tendinitis

If tendinitis is suspected, treatment with levofloxacin should be stopped immediately and appropriate treatment of the affected tendon should be initiated, such as adequate immobilization.

Hypersensitivity reactions

Levofloxacin can cause serious, potentially fatal, hypersensitivity reactions (angioedema, anaphylactic shock), even when initial doses are used. Patients should stop taking the drug immediately and consult a physician.

Serious bullous reactions

There have been cases of severe bullous skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis when taking levofloxacin. If any skin or mucous membrane reactions develop, the patient should immediately consult a physician and not continue treatment until he or she has been consulted.

Hepatic and biliary tract disorders

Hepatic necrosis, including the development of fatal hepatic failure, has been reported with levofloxacin, mainly in patients with severe underlying diseases such as sepsis.

Patients should be warned to discontinue treatment and seek prompt medical attention if signs and symptoms of liver damage, such as anorexia, jaundice, darkened urine, itching, and abdominal pain occur.

Patients with renal impairment

Preventing photosensitization reactions

While photosensitization by levofloxacin use is very rare, in order to prevent its development the patients are not recommended during the treatment and within 48 hours after the treatment with levofloxacin to be exposed to strong sunlight or artificial UV radiation without any special need (for example, to visit solarium). If phototoxicity develops, treatment with the drug should be discontinued.

Superinfection

As with other antibiotics, the use of levofloxacin, especially for a long time, may lead to increased reproduction of microorganisms that are not sensitive to it (bacteria and fungi), which may cause changes in the microflora that are normally present in humans. As a result, superinfection may develop. Therefore, it is imperative to reassess the patient during treatment, and if superinfection develops during treatment, appropriate measures should be taken.

Translongation of the QT interval

Patients with glucose-6-phosphate dehydrogenase deficiency

Patients with latent or manifest glucose-6-phosphate dehydrogenase deficiency are predisposed to hemolytic reactions when treated with quinolones and this should be taken into account when treating with levofloxacin.

Hypo- and hyperglycemia (dysglycemia)

As with the use of other quinolones, cases of hypoglycemia and hyperglycemia have been observed with levofloxacin, usually in patients with diabetes receiving simultaneous treatment with oral hypoglycemic agents (e.g., glibenclamide) or insulin drugs. Cases of hypoglycemic coma have been reported. In patients with diabetes mellitus, monitoring of blood glucose concentrations is required.

Peripheral neuropathy

Pseudoparalytic myasthenia gravis

Fluoroquinolones, including levofloxacin, are characterized by neuromuscular conduction blocking activity and may increase muscle weakness in patients with pseudoparalytic myasthenia gravis.

There have been adverse reactions, including pulmonary failure requiring artificial ventilation and death, associated with fluoroquinolones in patients with pseudoparalytic myasthenia gravis. The use of levofloxacin in a patient diagnosed with pseudoparalytic myasthenia gravis is not recommended.

Psychotic reactions

Visual impairment

If any visual impairment develops, immediate consultation with an ophthalmologist is necessary (see section “Side effects”).

Impact on laboratory tests

The side effects of Leflobakt® FORTE such as dizziness or vertigo, drowsiness, and visual disturbances (see side effects section) may impair psychomotor reactions and ability to concentrate. This may pose some risk in situations where these abilities are particularly important (e.g., driving, operating machinery, working in unsteady positions).

Contraindications

– Hypersensitivity to levofloxacin, other fluoroquinolones or any other component of the drug.

– Epilepsy.

– Pseudoparalytic myasthenia gravis.

– Tendon lesions with a history of fluoroquinolones.

– Pregnancy (the risk of cartilage growth point lesions in the fetus cannot be completely excluded).

– Breastfeeding period (the risk of cartilaginous bone growth point lesions in the baby cannot be completely excluded).

– Childhood and adolescence before 18 years of age (due to incomplete skeletal growth, because the risk of cartilage growth points cannot be completely excluded).

– Patients with impaired renal function (CK ≤ 50 ml/min).

– Lactase deficiency, galactose intolerance, glucose-galactose malabsorption.

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

In patients with known risk factors for QT interval prolongation: In elderly patients (high likelihood of concomitant decreased renal function); in female patients, in patients with uncorrected electrolyte disturbances (with hypokalemia, hypomagnesemia); with congenital QT interval prolongation syndrome; with heart disease (heart failure, myocardial infarction, bradycardia); with concomitant use of drugs that may prolong the QT interval (antiarrhythmic agents of class IA and III, tricyclic antidepressants, macrolides, neuroleptics).

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.

Side effects

The side effects listed below are presented according to the following frequency gradations: very common (≥ 1/10); common (≥ 1/100, < 1/10); infrequent (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000), including individual reports; of unknown frequency (frequency of occurrence could not be determined).

Allergic reactions: infrequent – skin rash, skin itching and hyperemia, urticaria, hyperhidrosis; rare – general hypersensitivity reactions (anaphylactic, anaphylactoid) such as bronchospasm, choking, angioedema; very rare – skin and mucous membrane edema, anaphylactic shock, anaphylactoid shock, photosensitization reactions (hypersensitivity to solar and ultraviolet radiation), allergic pneumonitis, leukocytoclastic vasculitis, stomatitis; unspecified frequency – malignant exudative erythema (Stevens-Johnson syndrome), exudative erythema multiforme, toxic epidermal necrolysis (Lyell’s syndrome).

Nervous system disorders: frequent – headache, dizziness; infrequent – weakness, drowsiness, insomnia, dysgeusia (perversion of taste), anxiety; rare – tremor, paresthesias, seizures, fear, hallucinations, anxiety, confusion, depression, motor disorders, epileptic seizures (in predisposed patients), psychiatric disorders (eg, hallucinations, paranoia), sleep disorders; unspecified frequency – peripheral sensory neuropathy, peripheral sensory-motor neuropathy, dyskinesia, agitation (agitation), “nightmares”, mental disorders with self-injurious behavior, including suicidal ideation and suicide attempts, extrapyramidal disorders, syncope, benign intracranial hypertension.

Urinary system disorders: infrequent – increase of serum creatinine concentration; rare – acute renal failure (e.g., due to interstitial nephritis).

Metabolism: infrequent – anorexia; rare – hypoglycemia (including increased appetite, increased sweating, trembling, nervousness); unspecified frequency – hyperglycemia, hypoglycemic coma.

Musculoskeletal system: infrequent – arthralgia, myalgia; rare – tendon involvement, including tendinitis (e.g., Achilles tendon), muscle weakness; unspecified frequency – rhabdomyolysis, tendon rupture (e.g., Achilles tendon. This side effect may occur within 48 hours of treatment start and may be bilateral), ligament rupture, muscle rupture, arthritis.

Digestive system disorders: frequent – nausea, vomiting, diarrhea, increased activity of “hepatic” transaminases, increased activity of alkaline phosphatase (ALP) and gamma-glutamyltransferase (GGT); infrequent – abdominal pain, dyspepsia, flatulence, constipation, reduced appetite, increased blood bilirubin concentration; rare – diarrhea with blood, pseudomembranous colitis; very rare – pancreatitis, hepatitis; unspecified frequency – severe liver failure, including cases of acute liver failure, sometimes with fatal outcome, especially in patients with severe underlying disease (e.g., patients with sepsis), jaundice.

Hematopoietic organs: infrequent – eosinophilia, leukopenia, rarely – neutropenia, thrombocytopenia; very rarely – hemolytic anemia, agranulocytosis, pancytopenia.

Sensory organs: infrequent – vertigo (feeling of deviation or spinning of own body or surrounding objects); rare – ringing in the ears, very rare – disorders of vision (blurring of visible image), smell, taste and tactile sensitivity; unspecified frequency – aguesia (loss of taste sensation), parosmia (disorder of smell sense, especially subjective sense of smell objectively absent), including loss of smell, uveitis, transient vision loss, hearing loss, hearing loss.

Cardiovascular system disorders: rare – palpitations, sinus tachycardia, decreased blood pressure; very rare – prolongation of QT interval, ventricular arrhythmias, ventricular tachycardia, ventricular tachycardia type “pirouette”, which can lead to cardiac arrest; unspecified frequency – pain (including back, chest and limb pain).

Others: infrequent – general weakness, asthenia, dyspnea, fungal infections; very rare – persistent fever, development of superinfection; unspecified frequency – exacerbation of porphyria.

Overdose

Symptoms: nausea, gastrointestinal mucosal erosions, prolonged QT interval, confusion, dizziness, seizures, hallucinations, tremors.

Pregnancy use

Pregnancy

The use of the drug in pregnancy is contraindicated.

Lactation period

If the drug is prescribed during lactation, it is necessary to consider stopping breastfeeding.

Similarities