Levolet R, 500 mg 10 pcs.

Pharmacodynamics

Fluoroquinolone, broad spectrum antimicrobial bactericidal agent. It blocks DNA-hymerase (topoisomerase II) and topoisomerase IV, disrupts superspiralization and cross-linking of DNA breaks, inhibits DNA synthesis, causes profound morphological changes in cytoplasm, cell wall and membranes.

Levofloxacin is active against the following strains of microorganisms, both in vitro and in vivo.

Sensitive microorganisms

MAC Aerobic Gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus faecalis, Enterococcus spp, Listeria monocytogenes, Staphylococcus coagulase-negative methi-S(J) (methicillin-sensitive/moderately sensitive strains), Staphylococcus aureus methi-S (methicillin-sensitive strains), Staphylococcus epidermidis methi-S (methicillin-sensitive strains), Staphylococcus spp. Streptococci of groups C and G (including Streptococcus agalactiae, Streptococcus pneumoniae peni-S/UR (penicillin-sensitive/moderately sensitive/resistant strains)), Streptococcus pyogenes, Viridans streptococci peni-S/R (penicillin-sensitive/resistant strains).

Aerobic Gram-negative microorganisms: Acinetobacter baumannil, Acinetobacter spp, Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter spp. (including Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae ampi-S/R (ampicillin-sensitive/resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxela catarrhalis β+/β- (P-lactamase producing and non-producing strains), Morganella morganii, Neisseria gonorrhoeae non-PPNG/PPNG (penicillinase producing and non-producing strains), Neisseria meningitidis, Pasteurella spp. (including Pasteurella conis, Pasteurella dagmatis, Pasteurella multocida), Proteus mirabilis, Proteus vulgaris, Providencia spp. (including Providencia rettgeri, Providencia stuartii), Pseudomonas spp. (including Pseudomonas aeruginosa), Serratia spp, Serratia marcescens).

Anaerobic microorganisms: Bacteroides jragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp, Peptostreptococcus spp., Propionibacterium spp., Veilonella spp.

Other microorganisms: Bartonella spp, Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella pneumophila, Legionella spp., Mycobacterium spp. (including Mycobacterium leprae, Mycobacterium tuberculosis, Mycoplasma hominis, Mycoplasma pneumoniae), Ricketsia spp, Ureaplasma urealyticum.

Moderately susceptible microorganisms (MPC>4 mg/L):

Aerobic Gram-positive microorganisms: Corynebacterium urealiticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis methi-R (methicillin-resistant strains), Staphylococcus haemolyticus methi-R (methicillin-resistant strains).

Aerobic Gram-negative microorganisms: Burkholderia cepacia, Campilobacter jejuni, Campilobacter coli.

Anaerobic microorganisms: Bacteroides thetaiotaomicron, Bacteroides vulgatus, Bacteroides ovaius, Prevotella spp, Porphyromonas spp.

Resistant microorganisms (MPC>8 mg/L):

Aerobic Gram-positive microorganisms: Corynebacterium jeikeium, Staphylococcus aureus methi-R (methicillin-resistant strains), Staphylococcus coagulase-negative methi-R (coagulazonegative methicillin-resistant strains).

Aerobic Gram-negative microorganisms: Alcaligenes xylosoxidans.

Other microorganisms: Mycobacterium avium.

Pharmacokinetics

When administered orally it is quickly and almost completely absorbed (eating has little effect on the speed and completeness of absorption). Bioavailability is 99%.
Time of maximal concentration achievement (Tmax) is 1-2 hours; at intake of 250 and 500 mg averaged value of maximal concentration (Сmax) is 2.8 and 5.2 µg/ml, respectively. Binding with plasma proteins is 30-40%.

It penetrates into organs and tissues: lungs, bronchial mucosa, sputum, urogenital organs, polymorphonuclear leukocytes, alveolar macrophages. A small part is oxidized and/or deacetylated in the liver. It is eliminated from the body mainly by the kidneys by glomerular filtration and tubular secretion. The half-life (T½) is 6-8 hours.

Renal clearance is 70% of total clearance. Less than 5% of levofloxacin is excreted as metabolites. In urine it is detected unchanged 70% during 24 hours and in 48 hours – 87% of the ingested dose. In the feces, during 72 hours, 4% of the oral dose is detected.

In renal insufficiency decrease of clearance of the drug and its excretion by the kidneys depends on the degree of decrease of creatinine clearance (CK).

Indications

Bacterial infections sensitive to levofloxacin in adults:

– acute sinusitis;

– exacerbation of chronic bronchitis;

– community-acquired pneumonia;

– uncomplicated urinary tract infections;

– complicated urinary tract infections (including pyelonephritis);

– chronic bacterial prostatitis;

– infections of the skin and soft tissues;

– for complex treatment of drug-resistant forms of tuberculosis;

– prevention and treatment of anthrax through airborne droplets.

When using Levolet® R, official national recommendations for the proper use of antibacterial drugs, as well as the sensitivity of pathogenic microorganisms in a particular country, should be taken into account (see section “Special instructions”).

Pharmacological effect

Pharmacodynamics

Fluoroquinolone, a broad-spectrum antimicrobial bactericidal agent. Blocks DNA gyrase (topoisomerase II) and topoisomerase IV, disrupts supercoiling and cross-linking of DNA breaks, suppresses DNA synthesis, causes profound morphological changes in the cytoplasm, cell wall and membranes.

Levofloxacin is active against the following strains of microorganisms, both in vitro and in vivo.

Sensitive microorganisms

MIC Aerobic gram-positive microorganisms: Corynebacterium diphtheriae, Enterococcus faecalis, Enterococcus spp., Listeria monocytogenes, Staphylococcus coagulase-negative methi-S(J) (methicillin-sensitive/moderately sensitive strains), Staphylococcus aureus methi-S (methicillin-sensitive strains), Staphylococcus epidermidis methi-S (methicillin-sensitive strains), Staphylococcus spp. (CNs – leukotoxin-containing; Streptococci groups C and G (including Streptococcus agalactiae, Streptococcus pneumoniae peni-S/UR (penicillin-sensitive/moderately sensitive/resistant strains)), Streptococcus pyogenes, Viridans streptococci peni-S/R (penicillin-sensitive/resistant strains).

Aerobic gram-negative microorganisms: Acinetobacter baumannil, Acinetobacter spp., Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter spp. (including Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae ampi-S/R (ampicillin-sensitive/resistant strains), Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxela catarrhalis β+/β- (P-lactamase-producing and non-producing strains), Morganella morganii, Neisseria gonorrhoeae non-PPNG/PPNG (penicillinase-producing and non-producing strains), Neisseria meningitidis, Pasteurella spp. (including Pasteurella conis, Pasteurella dagmatis, Pasteurella multocida), Proteus mirabilis, Proteus vulgaris, Providencia spp. (including Providencia rettgeri, Providencia stuartii), Pseudomonas spp. (including Pseudomonas aeruginosa), Serratia spp. (including Salmonella spp., Serratia marcescens).

Anaerobic microorganisms: Bacteroides jragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus spp., Propionibacterum spp., Veilonella spp.

Other microorganisms: Bartonella spp., Chlamydia pneumoniae, Chlamydia psittaci, Chlamydia trachomatis, Legionella pneumophila, Legionella spp., Mycobacterium spp. (including Mycobacterium leprae, Mycobacterium tuberculosis, Mycoplasma hominis, Mycoplasma pneumoniae), Ricketsia spp., Ureaplasma urealyticum.

Moderately sensitive microorganisms (MIC>4 mg/l):

Aerobic gram-positive microorganisms: Corynebacterium urealiticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis methi-R (methicillin-resistant strains), Staphylococcus haemolyticus methi-R (methicillin-resistant strains).

Aerobic gram-negative microorganisms: Burkholderia cepacia, Campilobacter jejuni, Campilobacter coli.

Anaerobic microorganisms: Bacteroides thetaiotaomicron, Bacteroides vulgatus, Bacteroides ovaius, Prevotella spp., Porphyromonas spp.

Resistant microorganisms (MIC>8 mg/l):

Aerobic gram-positive microorganisms: Corynebacterium jeikeium, Staphylococcus aureus methi-R (methicillin-resistant strains), Staphylococcus coagulase-negative methi-R (coagulase-negative methicillin-resistant strains).

Aerobic gram-negative microorganisms: Alcaligenes xylosoxidans.

Other microorganisms: Mycobacterium avium.

Pharmacokinetics

When taken orally, it is quickly and almost completely absorbed (food intake has little effect on the speed and completeness of absorption). Bioavailability – 99%.
Time to reach maximum concentration (Tmax) – 1-2 hours; when taking 250 and 500 mg, the average maximum concentration (Cmax) is 2.8 and 5.2 μg/ml, respectively. Communication with plasma proteins – 30-40%.

Penetrates well into organs and tissues: lungs, bronchial mucosa, sputum, genitourinary organs, polymorphonuclear leukocytes, alveolar macrophages. In the liver, a small portion is oxidized and/or deacetylated. It is excreted from the body mainly by the kidneys through glomerular filtration and tubular secretion. Half-life (T½) – 6-8 hours

Renal clearance accounts for 70% of the total clearance. Less than 5% of levofloxacin is excreted as metabolites. In urine, over a period of 24 hours, 70% is found unchanged, and over 48 hours – 87% of the dose taken orally. In feces, over a period of 72 hours, 4% of the dose taken orally is detected.

In renal failure, a decrease in the clearance of the drug and its excretion by the kidneys depends on the degree of decrease in creatinine clearance (CC).

Special instructions

Nosocomial infections caused by Pseudomonas aeruginosa may require combination treatment. The prevalence of acquired resistance in cultured strains may vary by geographic region and over time. In this regard, information on drug resistance in a specific country is required.

For the treatment of severe infections or if treatment is ineffective, a microbiological diagnosis must be established with the isolation of the pathogen and determination of its sensitivity to levofloxacin.

Methicillin-resistant Streptococcus aureus

There is a high likelihood that methicillin-resistant Staphylococcus aureus will be resistant to fluoroquinolones, including levofloxacin. Therefore, levofloxacin is not recommended for the treatment of known or suspected infections caused by methicillin-resistant Staphylococcus aureus unless laboratory tests have confirmed the organism’s sensitivity to levofloxacin.

Patients predisposed to developing seizures

Like other quinolones, levofloxacin should be used with great caution in patients with a predisposition to seizures. Such patients include patients with previous lesions of the central nervous system, such as stroke, severe traumatic brain injury; patients concomitantly receiving drugs that lower the seizure threshold of the brain, such as fenbufen and other similar non-steroidal anti-inflammatory drugs, or other drugs that lower the seizure threshold, such as theophylline (see section “Interactions with other drugs”).

Pseudomembranous colitis

Diarrhea that develops during or after treatment with levofloxacin, especially severe, persistent and/or bloody, may be a symptom of pseudomembranous colitis caused by Clostridium difficile. If pseudomembranous colitis is suspected, treatment with levofloxacin should be stopped immediately and specific antibiotic therapy (vancomycin, teicoplanin or oral metronidazole) should be started immediately. Drugs that inhibit intestinal motility are contraindicated.

Tendinitis

Rarely observed, tendonitis with quinolones, including levofloxacin, can lead to rupture of tendons, including the Achilles tendon. This side effect can develop within 48 hours after starting treatment and can be bilateral. Elderly patients are more prone to developing tendinitis. The risk of tendon rupture may be increased when taking corticosteroids concomitantly. If tendinitis is suspected, treatment with Levolet® R should be stopped immediately and appropriate treatment of the affected tendon should be initiated, for example by providing sufficient immobilization (see sections “Contraindications” and “Side effects”).

Hypersensitivity reactions

Levofloxacin may cause serious, potentially fatal, hypersensitivity reactions (angioedema, anaphylactic shock), even with initial doses (see section “Side effects”). Patients should stop taking the drug 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 while taking levofloxacin (see section “Side effects”). In case of development of any reactions from the skin or mucous membranes, the patient should immediately consult a doctor and not continue treatment until his consultation.

Disorders of the liver and biliary tract

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

Patients with renal failure

Since levofloxacin is excreted mainly through the kidneys, patients with impaired renal function require mandatory monitoring of renal function, as well as adjustment of the dosage regimen (see section “Dosage and Administration”). When treating elderly patients, it should be borne in mind that patients in this group often have impaired renal function (see section “Dosage and Administration”).

Preventing the development of photosensitivity reactions

Although photosensitivity occurs very rarely with the use of levofloxacin, to prevent its development, patients are not recommended to be unnecessarily exposed to strong solar or artificial ultraviolet irradiation (for example, visiting a solarium) during treatment and for 48 hours after the end of treatment with levofloxacin.

Superinfection

As with the use of other antibiotics, the use of levofloxacin, especially for a long time, can lead to increased proliferation of microorganisms (bacteria and fungi) that are insensitive to it, which can cause changes in the microflora that is normally present in humans. As a result, superinfection may develop. Therefore, during treatment, it is necessary to re-evaluate the patient’s condition, and, in the event of superinfection developing during treatment, appropriate measures should be taken.

QT interval prolongation

Very rare cases of QT prolongation have been reported in patients taking fluoroquinolones, including levofloxacin. When using fluoroquinolones, including levofloxacin, caution should be exercised in patients with known risk factors for prolongation of the QT interval: in patients with uncorrected electrolyte disturbances (with hypokalemia, hypomagnesemia); with congenital long QT syndrome; with heart disease (heart failure, myocardial infarction, bradycardia); while taking medications that can prolong the QT interval, such as class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics.
Elderly and female patients may be more sensitive to drugs that prolong the QT interval. Therefore, fluoroquinolones, including levofloxacin, should be used with caution (see sections “With caution”, “Dosage and administration”, “Side effects”, “Overdose” and “Interaction with other drugs”).

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, which should be taken into account when treated with levofloxacin.

Hypo- and hyperglycemia (dysglycemia)

As with the use of other quinolones, cases of hyperglycemia and hypoglycemia have been observed with the use of levofloxacin, usually in patients with diabetes mellitus receiving concomitant treatment with oral hypoglycemic drugs (for example, glibenclamide) or insulin preparations. Cases of hypoglycemic coma have been reported. In patients with diabetes mellitus, monitoring of blood glucose concentrations is required (see section “Side effects”).

Peripheral neuropathy

Sensory and sensorimotor peripheral neuropathy, which may have a rapid onset, has been reported in patients taking 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 pseudoparalytic myasthenia gravis

Fluoroquinolones, including levofloxacin, have neuromuscular blocking activity and may increase muscle weakness in patients with myasthenia gravis. In the post-marketing period, adverse reactions, including pulmonary failure requiring mechanical ventilation and death, have been associated with the use of fluoroquinolones in patients with pseudoparalytic myasthenia. The use of levofloxacin in patients with an established diagnosis of pseudoparalytic myasthenia is not recommended (see section “Side effects”).

Application for airborne anthrax infection

The use of levofloxacin in humans for this indication is based on susceptibility data from Bacillus anthracis obtained from in vitro and experimental animal studies, as well as limited data from the use of levofloxacin in humans. Treating physicians should refer to national and/or international documents that reflect the collectively developed point of view on the treatment of anthrax.

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”)). If such reactions develop, treatment with levofloxacin should be discontinued and appropriate therapy should be prescribed. The drug should be prescribed with caution to patients with psychosis or patients with a history of mental illness.

Visual impairment

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

Effect on laboratory tests

In patients taking levofloxacin, the determination of opiates in urine may lead to false-positive results, which should be confirmed by more specific methods. Levofloxacin can inhibit the growth of Mycobacterium tuberculosis and subsequently lead to false-negative results of the bacteriological diagnosis of tuberculosis. Side effects of Levolet® R such as dizziness or vertigo, drowsiness and visual disturbances (see section “Side effects”) may reduce psychomotor reactions and the ability to concentrate. This may pose a risk in situations where these abilities are of particular importance (for example, when driving a car, when servicing machinery, when performing work in an unstable position).

Active ingredient

Levofloxacin

Composition

Each 500 mg film-coated tablet contains:

Active ingredient:

levofloxacin hemihydrate 512.466 mg, equivalent to 500 mg levofloxacin.

Excipients:

microcrystalline cellulose (Avicel PH 101) 50.667 mg,

corn starch 50.2 mg,

colloidal silicon dioxide 10 mg,

crospovidone 42.667 mg,

hypromellose (15 cps) 14 mg,

microcrystalline cellulose (Avicel PH 102) 60 mg,

magnesium stearate 10 mg.

Shell:

Opadry white OY 58900 (hypromellose (5 cP) 62.5%, titanium dioxide (E171) 31.25%, macrogol 400 6.25%) 22.5 mg.

Pregnancy

Levofloxacin is contraindicated for use in pregnant and breastfeeding women.

Contraindications

– Hypersensitivity to levofloxacin or other quinolones, as well as to any of the excipients of the drug Levolet® R.

– Epilepsy.

– Pseudoparalytic myasthenia gravis (myasthenia gravis) (see sections “Side effects”, “Special instructions”).

– History of tendon damage when taking fluoroquinolones.

– Creatinine clearance 50 ml/min or less in patients with uncomplicated urinary tract infections (impossibility of selecting a dose for this release form).

– Creatinine clearance 19 ml/min or less (impossibility of selecting a dose for this release form).

– Children and adolescents up to 18 years of age (due to incomplete growth of the skeleton, since the risk of damage to cartilaginous growth points cannot be completely eliminated).

– Pregnancy (the risk of damage to the cartilaginous growth points of the fetus cannot be completely excluded).

– The period of breastfeeding (the risk of damage to the cartilaginous growth points of bones in a child cannot be completely eliminated).

With caution:

In patients predisposed to the development of seizures [in patients with previous lesions of the central nervous system (CNS), in patients simultaneously receiving drugs that lower the threshold of convulsive readiness of the brain, such as fenbufen, theophylline] (see section “Interaction with other drugs”).

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 (mandatory monitoring of renal function is required, as well as correction of the dosage regimen, see section “Dosage and Administration”).

In patients with known risk factors for QT interval prolongation: in elderly patients; in female patients; in patients with uncorrected electrolyte disturbances (with hypokalemia, hypomagnesemia); with congenital long QT syndrome; with heart disease (heart failure, myocardial infarction, bradycardia); while taking medications that can prolong the QT interval (antiarrhythmic drugs of class IA and III, tricyclic antidepressants, macrolides, antipsychotics) (see sections “Overdose”, “Interaction with other drugs”, “Special instructions”).

In patients with diabetes mellitus receiving oral hypoglycemic drugs, such as glibenclamide or insulin drugs (the risk of hypoglycemia increases).

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 section “Special instructions”).

Side Effects

The side effects listed below are presented in accordance with the following gradations of frequency of their occurrence: very often (≥1/10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (< 1/10000) (including isolated reports); frequency is unknown (it is not possible to determine the frequency of occurrence based on available data).Data obtained in clinical trials and post-marketing use of the drugCardiac disordersRarely: sinus tachycardia, palpitations.Frequency unknown (post-marketing data): QT prolongation, ventricular arrhythmias, ventricular tachycardia, torsade de pointes, which can lead to cardiac arrest (see sections “Overdose”, “Special instructions”).Blood and lymphatic system disordersUncommon: 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.Nervous system disordersCommon: headache, dizziness.Uncommon: 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 sensation of an objectively absent smell), including loss of smell; syncope, benign intracranial hypertension.Visual disordersRare: visual disturbances such as blurred vision.Frequency unknown (post-marketing data): transient vision loss, uveitis.Hearing and labyrinth disordersUncommon: vertigo (feeling of being swung or spinning in one’s own body or surrounding objects).Rare: ringing in the ears.Frequency unknown (post-marketing data): hearing loss, hearing loss.Disorders of the respiratory system, chest and mediastinal organsUncommon: shortness of breath.Frequency unknown (post-marketing data): bronchospasm, allergic pneumonitis.Gastrointestinal disordersCommon: diarrhea, vomiting, nausea.Uncommon: 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.Nocturnal and urinary tract disordersUncommon: increased serum creatinine concentration.Rare: acute renal failure (for example, due to the development of interstitial nephritis).Disorders of the skin and subcutaneous tissuesUncommon: 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 ultraviolet 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.Musculoskeletal and connective tissue disordersUncommon: arthralgia, myalgia.Rare: tendon involvement, including tendinitis (eg, Achilles tendon), muscle weakness, which may be especially dangerous in patients with myasthenia gravis (see section “Special instructions”).Not known (post-marketing data): rhabdomyolysis, tendon rupture (eg, 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, muscle rupture, arthritis.Metabolic and nutritional disordersUncommon: anorexia.Rare: 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 diseasesUncommon: fungal infections, development of resistance of pathogenic microorganisms.Vascular disordersRarely: decreased blood pressure.General disordersUncommon: asthenia.Rare: pyrexia (increased body temperature).Not known: pain (including pain in the back, chest and limbs).Immune system disordersRare: 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.Disorders of the liver and biliary tractOften: increased activity of “liver” enzymes in the blood (for example, alanine aminotransferase (ALT), aspartate aminotransferase (AST)), increased activity of alkaline phosphatase (ALP) and gamma-glutamyltransferase (GGT).Uncommon: 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 severe underlying disease (for example, in patients with sepsis) (see section “Special Instructions”); hepatitis, jaundice.Mental disordersOften: insomnia.Uncommon: 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 ideation and suicide attempts.

Other possible adverse effects relevant to all fluoroquinolones

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

Storage conditions

At a temperature not exceeding 25 °C.
Keep out of the reach of children!

Shelf life

3 years.

Manufacturer

Dr. Reddy’s Laboratories Ltd, India