Flexid, 500 mg 5 pcs.

Respiratory tract infections, maxillary sinusitis, Lung inflammation (pneumonia), Boils, Inflammation of the female reproductive organs, Bronchitis, Urinary tract infections, Infectious diseases, Tuberculosis, Skin infections

Infections caused by strains of microorganisms sensitive to levofloxacin:
– infections of ENT organs (acute sinusitis);
– infections of the lower respiratory tract (exacerbation of chronic bronchitis, out-of-hospital pneumonia);
– infections of the urinary tract;
– Chronic bacterial prostatitis;
– Skin and soft tissue infections;
– In the complex therapy of drug-resistant forms of tuberculosis.

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Active ingredient

Levofloxacin

Composition

1 tablet contains levofloxacin (in hemihydrate form) 500 mg;

excipients:

lactose monohydrate,

povidone,

sodium carboxymethyl starch,

talk,

colloidal anhydrous silica,

croscarmellose sodium,

glyceryl dibegenate;

coating composition:

Hypromellose, hyprolose, macrogol 6000, iron oxide yellow, iron oxide red, titanium dioxide, talc

How to take, the dosage

Flexid® tablets should be taken once or twice a day, regardless of meals, without chewing and with plenty of fluids.

Flexid® tablets may also be used for continuation of therapy in patients who have improved during initial/primary treatment with levofloxacin administered intravenously; given the bioequivalence of parenteral and oral forms of the drug, the same dosage can be used.

The drug should be taken at least 2 hours before or 2 hours after taking antacids containing magnesium and/or aluminum, iron salts, zinc salts, sucralfate or didanosine (only those didanosine preparations that contain magnesium and aluminum as excipients).

The drug dose and duration of treatment depend on the indication and severity of the disease.

When selecting doses the tablet may be divided into portions by division. Treatment with Flexid® should be continued for at least 48-72 hours after the disease symptoms have disappeared.

Interaction

Iron salts, zinc salts, antacids containing magnesium or aluminum, didanosine (only those preparations of didanosine that contain magnesium and aluminum as excipients) significantly reduce absorption of levofloxacin when administered simultaneously.

If levofloxacin is used simultaneously with iron salts, zinc salts, antacids containing magnesium or aluminum, didanosine it is recommended to administer the latter two hours after levofloxacin administration (or two hours before levofloxacin administration).

Calcium salts slightly affect oral absorption of levofloxacin.

Sucralfate significantly reduces the bioavailability of levofloxacin. In concomitant use of levofloxacin and sucralfate it is recommended to administer the latter 2 hours after levofloxacin administration.

No pharmacokinetic interaction between levofloxacin and theophylline was found.

However, concomitant use of quinolones with theophylline, with NSAIDs and other drugs that reduce the seizure threshold may lower the seizure threshold.

In the presence of fenbufen levofloxacin concentration is approximately 13% higher than when used as monotherapy.

When concomitant use of levofloxacin T1/2 of cyclosporine is increased by 33%. When concomitant use with indirect anticoagulants, coumarin derivatives (eg, coumarin derivatives (e.g., warfarin), an increase in blood clotting (prothrombin time/international normalized ratio (INR)) and/or bleeding is observed.
Cimetidine and probenecid, due to blocking of tubular secretion, decrease renal clearance of levofloxacin by 24 % and 34 %, respectively, therefore levofloxacin should be used with caution together with agents affecting tubular secretion (for example, probenecid and cimetidine), especially in patients with renal function disorders.

Levofloxacin may prolong QT interval, so caution should be exercised when concomitant use with antiarrhythmic drugs of classes IA and III, tricyclic antidepressants, macrolides and neuroleptics.

Glucocorticosteroids increase the risk of tendon rupture.

There was no clinically significant effect on the pharmacokinetics of levofloxacin by concomitant use of calcium carbonate, glibenclamide, ranitidine, digoxin.

Special Instructions

The prevalence of acquired resistance of bacterial strains being bred may vary by geographic region and over time. Therefore, information on the resistance of microorganisms to the drug in a particular country is required. For therapy of severe infections or in case of ineffective treatment it is necessary to establish microbiological diagnosis with pathogen isolation and determination of its sensitivity to levofloxacin.

There is a high probability that methicillin-resistant Staphylococcus aureus will be resistant to fluoroquinolones, including levofloxacin. Therefore, levofloxacin is not recommended for treatment of established or suspected infections caused by methicillin-resistant Staphylococcus aureus in case laboratory tests have not confirmed sensitivity of this microorganism to levofloxacin. Levofloxacin may cause serious, potentially fatal hypersensitivity reactions (angioedema, anaphylactic shock), even when using initial doses (see section “Side effects”). Patients should immediately stop taking the drug and consult a physician.

When taking levofloxacin there have been cases of severe bullous skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (see section “Adverse effects”). In case of any reactions of the skin and mucous membranes, the patient should immediately consult a physician and do not continue treatment until he or she has been consulted.

Cases of hepatic necrosis, including the development of fatal hepatic failure, have been reported when using levofloxacin, mainly in patients with severe underlying diseases such as sepsis (see section “Adverse effects”). Patients should be warned to discontinue treatment and seek urgent medical attention if signs and symptoms of liver damage, such as anorexia, jaundice, darkened urine, itching and abdominal pain appear.

The Flexid® tablets should be taken 2 hours before or 2 hours after taking iron salts, zinc salts, sucralfate, or didanosine (only those didanosine preparations that contain magnesium and aluminum as excipients) because there may be a decrease in its absorption.

In patients concomitantly taking indirect anticoagulants, coumarin derivatives the parameters of blood clotting should be controlled.

In rare cases observed during treatment with quinolones tendinitis can lead to ligament rupture, especially of the Achilles tendon. This side effect occurs within 48 hours of starting therapy. For the elderly and patients taking glucocorticosteroids, there is an increased risk of tendinitis. Therefore, during treatment with levofloxacin it is necessary to closely monitor the condition of such patients.

If tendinitis is suspected (patients must be informed of their symptoms) then Flexid® therapy must be stopped immediately and appropriate treatment (e.g,

Diarrhea (especially in cases of severe, persistent and/or mixed blood) during or after taking Flexid® tablets may be a symptom of the disease caused by Clostridium difficile, the most severe form of which is pseudomembranous colitis. If pseudomembranous colitis is suspected, Flexid® tablets should be stopped immediately and symptomatic treatment (e.g. oral vancomycin) should be given. Drugs that inhibit peristalsis are contraindicated in this condition.

The treatment of hospital infections caused by P.aeruginosa requires combination therapy.

During treatment with Flexid® it is necessary to avoid direct sunlight and artificial ultraviolet radiation (solarium) to avoid the development of photosensitization reactions.

Please note that patients with a history of brain damage (stroke, severe craniocerebral trauma) may experience seizures, with insufficiency of glucose-6-phosphate dehydrogenase – risk of hemolytic reactions.

Since levofloxacin is excreted mainly through the kidneys, in patients with impaired renal function it is necessary to monitor renal function and adjust the dosing regimen.

There have been reports of prolongation of the QT interval in patients treated with fluoroquinolones, including levofloxacin. When using fluoroquinolones, including levofloxacin, care should be taken in patients with known risk factors for QT interval prolongation: uncorrected electrolyte-water imbalance (hypokalemia, hypomagnesemia); congenital QT interval prolongation syndrome; heart disease (heart failure, myocardial infarction, bradycardia); simultaneous use of drugs that can prolong the QT interval.

Elderly patients and female patients may be more sensitive to drugs that prolong the QT interval. Therefore, fluoroquinolones, including Flexid® tablets, should be used with caution in them.

In patients with diabetes mellitus receiving oral hypoglycemic agents (e.g., glibenclamide) or insulin, the risk of hypo/hyperglycemia increases when using levofloxacin. Cases of hypoglycemic coma have been reported. In patients with diabetes mellitus monitoring of blood glucose concentration is required.

In patients receiving fluoroquinolones, including levofloxacin, sensory and sensory-motor peripheral neuropathy has been reported, the onset of which may be rapid. If the patient develops symptoms of neuropathy, the use of Flexid® Tablets should be discontinued (minimizing the possible risk of developing irreversible changes). Flexid® tablets should not be used in patients with pseudoparalytic myasthenia gravis.

When using quinolones, including levofloxacin, psychotic reactions have been reported, which in very rare cases have progressed to the development of suicidal thoughts and self-harming behavioral disorders (sometimes after a single dose of levofloxacin). If such reactions develop, treatment with Flexid® tablets should be discontinued and appropriate therapy should be prescribed. Caution should be exercised when prescribing the drug in patients with psychosis or patients with a history of mental illness.

If any visual disturbances develop, immediate consultation with an ophthalmologist is necessary.

In severe community-acquired pneumonia caused by Streptococcus pneumoniae, Flexid® tablets may not give optimal therapeutic effect.

Levofloxacin may inhibit the growth of Mycobacterium tuberculosis, therefore a false negative result of bacteriological examination for tuberculosis is possible.

In patients taking Flexid® tablets, urinary opioid determination may lead to false-positive results that should be confirmed by more specific methods.

Impact on the ability to drive vehicles and perform other activities requiring concentration and quick psychomotor reactions

Impact on the ability to drive vehicles and perform other activities requiring concentration and quick psychomotor reactions. During treatment with levofloxacin dizziness, visual impairment, confusion may occur, therefore caution should be exercised when driving motor vehicles and performing other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions.

Contraindications

– hypersensitivity to levofloxacin or other quinolones and/or other components of the drug;
– epilepsy;
– Rare hereditary forms of lactose intolerance, lactase deficiency or glucose/galactose absorption disorders (as the preparation contains lactose).
– childhood and adolescence (up to 18 years);
– pregnancy and lactation;
– myasthenia gravis.

With caution

With caution, levofloxacin should be used in patients with renal impairment; with glucose-6-phosphate dehydrogenase deficiency (increased risk of hemolytic anemia); with diabetes; with a history of psychosis and other psychiatric disorders; with known risk factors for QT interval prolongation (congenital prolonged QT interval syndrome; concomitant administration of drugs that can prolong the QT interval (e.g., antiarrhythmic drugs of classes IA and III, tricyclic antidepressants, macrolides, neuroleptics); elderly patients and women may be more sensitive to drugs that prolong the QT interval) with uncorrected electrolyte disorders (e.g., hypomagnesemia, hypokalemia, hyponatremia); in elderly patients; patients with heart disease (e.g., heart failure, myocardial infarction, bradycardia); with predisposition to seizure reactions (atherosclerosis of cerebral vessels, cerebrovascular disorders (anamnesis), organic diseases of the central nervous system) hepatic porphyria; concomitant use of drugs that lower the threshold of seizure readiness of the brain (phenbufen and other similar non-steroidal anti-inflammatory drugs (NSAIDs), theophylline); concomitant use of drugs that affect tubular secretion (eg, probenecid and cimetidine).

Side effects

The following side effects were classified as follows: very common (>10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0.1%), very rare (Digestive system disorders: common – nausea, diarrhea (incl.with blood admixture), increased activity of liver enzymes (ALT, AST); uncommon – decreased appetite, vomiting, abdominal pain, dyspepsia, hyperbilirubinemia; rare – enterocolitis, pseudomembranous colitis; very rare – hypoglycemia, hepatitis.

Nervous system disorders: uncommon – headache, dizziness, sleep disturbance; rare – paresthesias, tremor, anxiety, agitation, confusion, convulsions; very rare – hallucinations, extrapyramidal disorders and other coordination disorders.

Sensory organs: very rare – disorders of vision, hearing, smell, taste and tactile sensitivity.

Cardiovascular system disorders: rare – tachycardia, hypotension; very rare – vascular collapse.

Muscular system: rare – arthralgia, myalgia, tendinitis; very rare – tendon rupture (e.g., Achilles tendon), muscle weakness (of particular importance for myasthenic patients); in rare cases – rhabdomyolysis.

Urinary system disorders: uncommon – hypercreatininemia; very rare – interstitial nephritis, deterioration of renal function up to acute renal failure.

With the blood system and organs of blood formation: uncommon – eosinophilia, leukopenia; rare – neutropenia, thrombocytopenia; very rare – agranulocytosis; in single cases – hemolytic anemia, pancytopenia.

Allergic reactions: uncommon – itching, skin rash; rare – urticaria, bronchospasm, shortness of breath; very rare – angioedema, hypotension, anaphylactic shock, allergic pneumonitis, photosensitization; in single cases – Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), erythema multiforme.

Others: uncommon – asthenia; very rare – fever, vasculitis.

Overdose

Symptoms: nausea, gastrointestinal mucosal erosions, confusion, dizziness, loss of consciousness, hallucinations, tremors and seizures, prolongation of QT interval.

Treatment: symptomatic; ECG parameters control; prescription of antacids; hemodialysis is ineffective; no specific antidote.

Pregnancy use

It is unknown whether levofloxacin penetrates into the breast milk, therefore, due to the possible risk of cartilage tissue damage in the growing organism during the drug treatment it is necessary to decide on stopping breastfeeding.

Similarities

Signicef, Tavanic, Oftavix, Flexid, Levolet R, Levofloxacin-Teva, Glevo, Haileflox, Leflobakt, L-Optik Rompharm, Levofloxacin, Korfecin