Levofloxacin (Tablets, Capsules, Solution, Drops) Instructions for Use

Instructions
Dosage forms

ATC Code

J01MA12 (Levofloxacin)

Active Substance

Levofloxacin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antibacterial drug of the fluoroquinolone group

Pharmacotherapeutic Group

Systemic antibacterial agents; quinolone derivatives; fluoroquinolones

Pharmacological Action

A synthetic broad-spectrum antibacterial agent from the fluoroquinolone group, the levorotatory isomer of ofloxacin. Levofloxacin blocks DNA gyrase and topoisomerase IV, disrupts DNA supercoiling and cross-linking of breaks, inhibits DNA synthesis, and causes profound morphological changes in the cytoplasm, cell wall, and membranes of microbial cells.

Levofloxacin is active against most strains of microorganisms both in vitro and in vivo.

Aerobic Gram-positive microorganisms Bacillus anthracis, Corynebacterium diphtheriae, Corynebacterium jeikeium, Enterococcus spp. (including Enterococcus faecalis), Listeria monocytogenes, Staphylococcus coagulase-negative methi-S(I), Staphylococcus aureus methi-S, Staphylococcus epidermidis methi-S, Staphylococcus spp. (CNS), Streptococcus groups C and G, Streptococcus agalactiae, Streptococcus pneumoniae peni I/S/R, Streptococcus pyogenes, Streptococcus viridans peni-S/R.

Aerobic Gram-negative microorganisms Acinetobacter spp. (including Acinetobacter baumannii), Actinobacillus actinomycetemcomitans, Citrobacter freundii, Eikenella corrodens, Enterobacter spp. (including Enterobacter aerogenes, Enterobacter cloacae), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae ampi-S/R, Haemophilus parainfluenzae, Helicobacter pylori, Klebsiella spp. (including Klebsiella oxytoca, Klebsiella pneumoniae), Moraxella catarrhalis (β+/β-), Morganella morganii, Neisseria gonorrhoeae non-PPNG/PPNG, Neisseria meningitidis, Pasteurella spp. (including Pasteurella dagmatis, Pasteurella multocida, Pasteurella canis), Proteus mirabilis, Proteus vulgaris, Providencia spp. (including Providencia rettgeri, Providencia stuartii), Pseudomonas aeruginosa, Pseudomonas spp. (including Pseudomonas aeruginosa), Salmonella spp., Serratia spp. (including Serratia marcescens).

Anaerobic microorganisms Bacteroides fragilis, Bifidobacterium spp., Clostridium perfringens, Fusobacterium spp., Peptostreptococcus, Propionibacterium spp., Veillonella spp.

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

Moderately susceptible microorganisms aerobic Gram-positive microorganisms – Corynebacterium urealyticum, Corynebacterium xerosis, Enterococcus faecium, Staphylococcus epidermidis methi-R, Staphylococcus liaemolyticus methi-R; aerobic Gram-negative microorganisms – Campylobacter jejuni, Campylobacter coli; anaerobic microorganisms – Prevotella spp., Porphyromonas spp.

Microorganisms resistant to levofloxacin aerobic Gram-positive microorganisms – Staphylococcus aureus methi-R, Staphylococcus coagulase-negative methi-R, Corynebacterium jeikeium; aerobic Gram-negative microorganisms – Alcaligenes xylosoxidans; anaerobic microorganisms – Bacteroides thetaiotaomicron; other microorganisms – Mycobacterium avium.

Pharmacokinetics

The pharmacokinetics of levofloxacin are linear in the dose range from 50 to 1000 mg. After a 60-minute IV infusion of levofloxacin at a dose of 500 mg to healthy volunteers, the mean C_max in blood plasma was 6.2 µg/ml. When 500 mg of levofloxacin is administered once or twice daily, C_ss in blood plasma is reached within 48 hours. Binding to plasma proteins is 30-40%. The V_d of levofloxacin averages 100 L after single and multiple IV administration of 500 mg, indicating good penetration of levofloxacin into the organs and tissues of the body.

Levofloxacin penetrates well into the bronchial mucosa, epithelial lining fluid, alveolar macrophages, lung tissue, alveolar fluid, cortical and cancellous bone tissue, and prostate tissue. Levofloxacin poorly penetrates into the cerebrospinal fluid. High concentrations of levofloxacin are created in the urine, several times higher than the concentrations of levofloxacin in blood plasma.

Levofloxacin is metabolized to a small extent (5% of the administered dose) to form dimethyllevofloxacin and levofloxacin-N-oxide, which are excreted by the kidneys. After IV administration, levofloxacin is relatively slowly eliminated from the blood plasma (T_1/2 – 6-8 hours), mainly in the urine (more than 85% of the administered dose). The total clearance of levofloxacin after a single 500 mg dose was 175±29.2 ml/min.

In renal failure, the pharmacokinetics of levofloxacin change. As renal function deteriorates, urinary excretion and renal clearance decrease, and T_1/2 increases.

Indications

Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to levofloxacin: complicated urinary tract infections and pyelonephritis; chronic bacterial prostatitis; for the complex treatment of drug-resistant forms of tuberculosis; prevention and treatment of anthrax with airborne infection.

For the treatment of the following infectious and inflammatory diseases, Levofloxacin can be used only as an alternative to other antimicrobial drugs: community-acquired pneumonia; complicated skin and soft tissue infections; uncomplicated cystitis.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
A15	Respiratory tuberculosis, bacteriologically and histologically confirmed
A22	Anthrax
J15	Bacterial pneumonia, not elsewhere classified
L01	Impetigo
L02	Cutaneous abscess, furuncle and carbuncle
L03	Cellulitis
L08.0	Pyoderma
L08.8	Other specified local infections of skin and subcutaneous tissue
N10	Acute tubulointerstitial nephritis (acute pyelonephritis)
N11	Chronic tubulointerstitial nephritis (chronic pyelonephritis)
N30	Cystitis
N34	Urethritis and urethral syndrome
N41	Inflammatory diseases of prostate
T79.3	Posttraumatic wound infection, not elsewhere classified
Z29.2	Other prophylactic chemotherapy (administration of antibiotics for prophylactic purposes)

ICD-11 code	Indication
1B10.0	Respiratory tuberculosis, bacteriologically or histologically confirmed
1B70.1	Streptococcal cellulitis of the skin
1B70.2	Staphylococcal cellulitis of the skin
1B70.Z	Bacterial cellulitis or lymphangitis caused by unspecified bacterium
1B72.0	Bullous impetigo
1B72.1	Nonbullous impetigo
1B72.Z	Impetigo, unspecified
1B75.0	Furuncle
1B75.1	Carbuncle
1B75.2	Furunculosis
1B75.3	Pyogenic skin abscess
1B7Y	Other specified pyogenic bacterial infections of skin or subcutaneous tissue
1B97	Anthrax
1C44	Non-pyogenic bacterial infections of skin
CA40.0Z	Bacterial pneumonia, unspecified
EA50.3	Staphylococcal scarlet fever
EB21	Pyoderma gangrenosum
GA91.Z	Inflammatory and other diseases of prostate, unspecified
GB50	Acute tubulo-interstitial nephritis
GB51	Acute pyelonephritis
GB55.Z	Chronic tubulo-interstitial nephritis, unspecified
GB5Z	Renal tubulo-interstitial diseases, unspecified
GC00.Z	Cystitis, unspecified
GC02.Z	Urethritis and urethral syndrome, unspecified
NF0A.3	Posttraumatic wound infection, not elsewhere classified
QC05.Y	Other specified prophylactic measures

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

The drug is taken orally once or twice a day. The tablets should not be chewed and should be taken with a sufficient amount of liquid (from 0.5 to 1 glass), can be taken before meals or between meals. Doses are determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen.

For patients with normal or moderately impaired renal function (creatinine clearance > 50 ml/min), the following dosing regimen is recommended

Acute bacterial sinusitis 500 mg once a day – 10-14 days.

Exacerbation of chronic bronchitis 250 mg or 500 mg once a day – 7-10 days.

Community-acquired pneumonia 500 mg 1-2 times a day – 7-14 days.

Uncomplicated urinary tract infections 250 mg once a day – 3 days.

Chronic bacterial prostatitis 500 mg – once a day – 28 days.

Complicated urinary tract infections, including pyelonephritis 250 mg once a day – 7-10 days.

Skin and soft tissue infections 250-500 mg 1-2 times a day – 7-14 days.

Intra-abdominal infection 500 mg once a day – 7-14 days (in combination with antibacterial drugs acting on anaerobic flora).

For tuberculosis (as part of complex therapy) – 500 mg 1-2 times a day, course of treatment – up to 3 months.

Dose adjustment of levofloxacin in adult patients with impaired renal function (creatinine clearance less than 50 ml/min)

Dose with normal renal function every 24 h	Creatinine clearance from 20 to 49 ml/min	Creatinine clearance from 10 to 19 ml/min	Creatinine clearance less than 10 ml/min, incl. during hemodialysis or chronic ambulatory peritoneal dialysis
1000 mg	Initial dose 500 mg every 12 h, then 250 mg every 12 h	Initial dose 500 mg every 12 h, then 125 mg every 12 h	Initial dose 500 mg every 12 h, then 125 mg every 24 h
500 mg	Initial dose 500 mg, then 250 mg every 24 h	Initial dose 500 mg, then 250 mg every 48 h	Initial dose 500 mg, then 250 mg every 48 h
250 mg	No dose adjustment required	250 mg every 48 h. For uncomplicated urinary tract infections, no dose adjustment is required	No information on dose adjustment

After hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), no additional doses are required.

In case of impaired liver function, no special dose selection is required, since Levofloxacin is metabolized in the liver only to an extremely insignificant extent. For elderly patients, no change in the dosage regimen is required, except in cases of low creatinine clearance.

As with the use of other antimicrobial drugs, treatment with levofloxacin is recommended to be continued for at least 48-72 hours after normalization of body temperature or after reliable eradication of the pathogen.

If a dose is missed, the tablet should be taken as soon as possible before the next dose is due. Then continue taking the drug according to the scheme.

Solution

Administered intravenously by drip. The dosage regimen is set individually, depending on the indications, clinical situation, and sensitivity of the pathogen. The duration of treatment varies depending on the course of the disease. Treatment with levofloxacin is recommended to be continued for at least 48-72 hours after normalization of body temperature or reliable eradication of the pathogen.

Drops

Used topically, in the affected eye according to a special scheme.

The duration of the course of treatment is determined by the severity of the condition, clinical manifestations and bacteriological characteristics. The average duration of the course of therapy is 5 days.

When using several drugs, the interval between their instillations should be at least 15 minutes.

Capsules

Orally. The dosage regimen is determined by the nature and severity of the infection, as well as the sensitivity of the suspected pathogen. Single dose – 250-500 mg, frequency of administration 1-2 times/day. The duration of treatment varies depending on the course of the disease.

Adverse Reactions

Infections and infestations uncommon – fungal infections, development of resistance of pathogenic microorganisms.

From the hematopoietic system uncommon – leukopenia, eosinophilia; rare – neutropenia, thrombocytopenia; frequency unknown – pancytopenia, agranulocytosis, hemolytic anemia.

From the immune system rare – angioedema; frequency unknown – anaphylactic shock, anaphylactoid shock.

From the metabolism rare – hypoglycemia, especially in patients with diabetes mellitus; frequency unknown – hyperglycemia, hypoglycemia, up to the development of hypoglycemic coma.

Psychiatric disorders common – insomnia; uncommon – feeling of restlessness, anxiety, confusion; rare – mental disorders (e.g., hallucinations, paranoia), depression, agitation, sleep disorders, nightmares; frequency unknown – mental disorders with behavioral disorders with self-harm, including suicidal thoughts and suicide attempts, nervousness, memory impairment, delirium (including attention disturbances, disorientation).

From the nervous system common – headache, dizziness; uncommon – drowsiness, tremor, dysgeusia; rare – paresthesia, convulsions; frequency unknown – peripheral sensory neuropathy, peripheral sensorimotor neuropathy, dyskinesia, extrapyramidal disorders, ageusia, parosmia, including loss of smell, syncope, increased intracranial pressure (benign intracranial hypertension, pseudotumor cerebri).

From the organ of vision rare – visual disturbances, such as blurred vision; frequency unknown – transient loss of vision, uveitis.

From the ear and labyrinth disorders uncommon – vertigo; rare – tinnitus; frequency unknown – hearing loss, hearing impairment.

From the cardiovascular system common – phlebitis; rare – decreased blood pressure, sinus tachycardia, palpitations; frequency unknown – QT interval prolongation, ventricular arrhythmias, ventricular tachycardia, torsades de pointes, which can lead to cardiac arrest.

From the respiratory system uncommon – dyspnea; frequency unknown – bronchospasm, allergic pneumonitis.

From the digestive system common – 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, pancreatitis.

From the liver and biliary tract common – increased activity of ALT, AST, ALP, GGT; uncommon – increased blood bilirubin concentration; frequency unknown (post-marketing data) – severe liver failure, including cases of acute liver failure (sometimes fatal), especially in patients with severe underlying disease (e.g., sepsis); hepatitis, jaundice.

From the skin and subcutaneous tissues uncommon – rash, itching, urticaria, hyperhidrosis; frequency unknown – toxic epidermal necrolysis, Stevens-Johnson syndrome, exudative multiforme erythema, photosensitivity reactions, fixed drug eruption, leukocytoclastic vasculitis, stomatitis.

From the musculoskeletal system uncommon – arthralgia, myalgia; rare – tendon damage, including tendinitis (e.g., Achilles tendon), muscle weakness, which may be particularly dangerous in patients with myasthenia gravis; frequency unknown – rhabdomyolysis, tendon rupture (e.g., Achilles tendon), ligament rupture, muscle rupture, arthritis.

From the urinary system uncommon – increased serum creatinine concentration; rare – acute renal failure (e.g., due to the development of interstitial nephritis).

Other common – reaction at the injection site (pain, skin redness); uncommon – asthenia; rare – pyrexia; frequency unknown – pain (including back, chest, limb pain); very rare – porphyria attacks in patients with porphyria.

Contraindications

Hypersensitivity to levofloxacin or other quinolones; epilepsy; myasthenia gravis; history of tendon lesions when using fluoroquinolones; age under 18 years; pregnancy, breastfeeding period.

With caution should be used in patients predisposed to the development of seizures; in patients simultaneously taking drugs that lower the seizure threshold of the brain (such as fenbufen, theophylline); with latent or manifested glucose-6-phosphate dehydrogenase deficiency; with impaired renal function; in patients with known risk factors for QT interval prolongation or with congenital long QT syndrome; in heart disease (heart failure, myocardial infarction, bradycardia); with simultaneous use of drugs that can prolong the QT interval (class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, antipsychotics); in patients with diabetes mellitus receiving oral hypoglycemic drugs or insulin preparations; in patients with severe adverse reactions to other fluoroquinolones (such as severe neurological reactions), with psychoses or in patients with a history of mental illness; in elderly patients; after transplantation; with concomitant use of corticosteroids (increased risk of developing tendinitis and tendon rupture); in patients with a family history of aortic aneurysm or in patients with a diagnosed aortic aneurysm and/or aortic dissection or in the presence of other risk factors or conditions predisposing to the development of aortic aneurysm or aortic dissection.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during breastfeeding.

Use in Hepatic Impairment

No dose adjustment is required in patients with hepatic impairment.

Use in Renal Impairment

Caution should be exercised when using in patients with renal impairment.

Pediatric Use

Use in children and adolescents under the age of 18 is contraindicated.

Geriatric Use

Caution should be exercised when using in elderly patients.

Special Precautions

Hospital-acquired infections caused by Pseudomonas aeruginosa may require combination therapy.

The prevalence of acquired resistance of isolated microbial strains may vary across geographic regions and over time. Therefore, information on levofloxacin resistance in a specific country is required. For the treatment of severe infections or in case of treatment failure, a microbiological diagnosis should be established with isolation of the pathogen and determination of its susceptibility 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 the treatment of established or suspected infections caused by methicillin-resistant Staphylococcus aureus, unless laboratory tests confirm the susceptibility of this microorganism to levofloxacin.

The use of fluoroquinolones, including levofloxacin, has been associated with disability and the development of irreversible serious adverse reactions from various body systems, which may occur simultaneously in the same patient. Adverse reactions caused by fluoroquinolones include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and nervous system side effects ( hallucinations, anxiety, depression, insomnia, headaches, and confusion). These reactions may develop within a few hours to several weeks after starting levofloxacin therapy. The development of these adverse reactions has been observed in patients of all ages and without prior risk factors. At the first signs or symptoms of any serious adverse reactions, levofloxacin should be discontinued immediately. The use of fluoroquinolones, including levofloxacin, should be avoided in patients who have experienced any of these serious adverse reactions.

During infusion, palpitations and transient decrease in blood pressure may occur. In rare cases, vascular collapse may develop. If a pronounced decrease in blood pressure is observed during the infusion, the administration of levofloxacin should be stopped immediately.

Levofloxacin should be used with great caution in patients predisposed to seizures: patients with previous CNS lesions, such as stroke, severe traumatic brain injury; patients concurrently taking drugs that lower the seizure threshold of the brain (e.g., theophylline; fenbufen and other NSAIDs). If seizures develop, levofloxacin treatment should be discontinued.

If pseudomembranous colitis is suspected, levofloxacin treatment should be stopped immediately and specific antibiotic therapy (oral vancomycin, teicoplanin, or metronidazole) should be started immediately. Drugs that inhibit intestinal peristalsis are contraindicated.

Tendinitis, rarely occurring with the use of quinolones, can sometimes lead to tendon rupture, including the Achilles tendon, and can be bilateral. This side effect can develop within 48 hours after starting treatment or several months after completing fluoroquinolone therapy. Elderly patients are more predisposed to developing tendinitis; in patients taking fluoroquinolones, the risk of tendon rupture may increase with the concomitant use of corticosteroids. In addition, patients after transplantation have an increased risk of developing tendinitis, so caution is recommended when prescribing fluoroquinolones to this category of patients. If tendinitis or tendon rupture is suspected, levofloxacin treatment should be stopped immediately and appropriate treatment for the affected tendon should be initiated, for example, by ensuring sufficient immobilization.

Levofloxacin can cause serious, potentially life-threatening hypersensitivity reactions ( angioedema, anaphylactic shock) even with the initial doses. If they develop, the drug administration should be stopped immediately.

Cases of severe bullous skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, have been observed with the use of levofloxacin. If any skin or mucous membrane reactions occur, the patient should consult a doctor immediately and not continue treatment until consultation.

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. Patients should be warned to discontinue treatment and seek immediate medical attention if signs and symptoms of liver damage appear, such as anorexia, jaundice, dark urine, skin itching, and abdominal pain.

Since Levofloxacin is excreted mainly by the kidneys, in patients with impaired renal function, mandatory monitoring of renal function and dose regimen adjustment are required. When treating elderly patients, it should be taken into account that this group of patients often has impaired renal function.

Although photosensitivity develops very rarely with the use of levofloxacin, to prevent its development, patients are not recommended to be exposed to strong sunlight or artificial UV radiation (e.g., visiting a solarium) during treatment and for 48 hours after completion of levofloxacin treatment.

The use of levofloxacin, especially over a long period, can lead to the overgrowth of microorganisms (bacteria and fungi) resistant to it, which can cause changes in the normal human microflora, resulting in an increased risk of developing superinfection. Therefore, during treatment, it is necessary to regularly reassess the patient’s condition and, if a superinfection develops during treatment, appropriate measures should be taken.

Patients with latent or manifested glucose-6-phosphate dehydrogenase deficiency are predisposed to the development of hemolytic reactions when treated with quinolones, which should be taken into account when treating with levofloxacin.

Cases of hyperglycemia and hypoglycemia have been observed with the use of levofloxacin. During levofloxacin therapy, dysglycemia developed more often in elderly patients and patients with diabetes mellitus receiving concomitant therapy with oral hypoglycemic drugs (e.g., glibenclamide) or insulin. When using levofloxacin in such patients, the risk of hypoglycemia increases, up to hypoglycemic coma. If a patient develops hypoglycemia, it is necessary to immediately discontinue levofloxacin treatment and initiate appropriate therapy. In these cases, it is recommended to switch to therapy with another antibiotic, other than fluoroquinolones, if possible. When conducting levofloxacin treatment in elderly patients and patients with diabetes mellitus, careful monitoring of blood glucose levels is recommended.

Cases of sensory and sensorimotor peripheral neuropathy have been reported in patients receiving therapy with fluoroquinolones, including Levofloxacin, the onset of which can be rapid. If a patient develops symptoms of neuropathy, the use of levofloxacin should be discontinued. This minimizes the potential risk of developing irreversible changes. Fluoroquinolones should not be prescribed to patients with a history of clinical cases indicating peripheral neuropathy.

Fluoroquinolones, including Levofloxacin, are characterized by neuromuscular blocking activity and can increase muscle weakness in patients with myasthenia gravis. In the post-registration period, adverse reactions, including respiratory failure requiring mechanical ventilation and fatal outcome, have been observed, which were associated with the use of fluoroquinolones in patients with myasthenia gravis. The use of levofloxacin in patients with an established diagnosis of myasthenia gravis is not recommended.

Psychotic reactions, including suicidal thoughts/attempts, have been noted in patients using fluoroquinolones, including Levofloxacin, sometimes after a single dose of levofloxacin. If any CNS side effects occur, including mental disorders, levofloxacin treatment should be stopped immediately and appropriate therapy should be prescribed. In these cases, it is recommended to switch to therapy with another antibiotic, other than fluoroquinolones, if possible.

Fluoroquinolones should be used only after a careful benefit-risk assessment and consideration of other treatment options in patients with a family history of aortic aneurysm, or in patients with a diagnosed aortic aneurysm and/or aortic dissection or in the presence of other risk factors or conditions predisposing to the development of aortic aneurysm or aortic dissection (e.g., Marfan syndrome, vascular type Ehlers-Danlos syndrome, Takayasu’s arteritis, giant cell arteritis, Behçet’s disease, arterial hypertension, atherosclerosis).

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

In patients receiving levofloxacin therapy, urine opiate tests may yield false-positive results, which should be confirmed by more specific methods.

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

Effect on the Ability to Drive Vehicles and Operate Machinery

Side effects such as dizziness or vertigo, drowsiness, and visual disturbances may reduce psychomotor reactions and the ability to concentrate. This may pose a certain risk when engaging in activities requiring quick psychomotor reactions and the ability to concentrate (e.g., driving a car, operating machinery, working in an unstable position).

Drug Interactions

With the simultaneous use of quinolones and theophylline, NSAIDs and other agents that lower the seizure threshold of the brain, a pronounced decrease in the seizure threshold of the brain is possible.

In patients receiving levofloxacin treatment in combination with indirect anticoagulants (e.g., warfarin), an increase in prothrombin time/INR and/or the development of bleeding, including severe bleeding, has been observed. Therefore, with the simultaneous use of indirect anticoagulants and levofloxacin, regular monitoring of blood coagulation parameters is necessary.

Caution should be exercised with the simultaneous use of drugs that impair renal tubular secretion, such as probenecid and cimetidine, and levofloxacin, especially in patients with renal failure.

Concomitant use of corticosteroids increases the risk of tendon rupture.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Levofloxacin [Jivdhara Pharma, Private Limited (India)]
Film-coated tablets, 250 mg: 5 or 10 pcs.
Film-coated tablets, 500 mg: 5 or 10 pcs.
Film-coated tablets, 750 mg: 5 or 10 pcs.

Marketing Authorization Holder

Jivdhara Pharma, Private Limited (India)

Manufactured By

NPC Scan Biotek, LLC (Russia)

Dosage Forms

	Levofloxacin	Film-coated tablets, 250 mg: 5 or 10 pcs.
		Film-coated tablets, 500 mg: 5 or 10 pcs.
		Film-coated tablets, 750 mg: 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets red-orange in color, round, biconvex, with a score on one side, the tablet core is yellow at the break.

	1 tab.
Levofloxacin hemihydrate	256.23 mg,
Equivalent to Levofloxacin	250 mg

Excipients: corn starch – 29.62 mg, microcrystalline cellulose 102 – 20 mg, sodium carboxymethyl starch – 7.5 mg, crospovidone – 7.5 mg, colloidal silicon dioxide – 7.5 mg, talc – 5 mg, hypromellose – 3.4 mg, magnesium stearate – 3.25 mg.

Shell composition film coating WT-19022P pink – 8.07 mg (polyvinyl alcohol – 49%, titanium dioxide (E171) – 21.79%, polyethylene glycol 6000 – 13.2%, talc – 12.6%, soy lecithin – 3.4%, iron oxide red dye (E172) – 0.01%), sunset yellow dye (E110) – 0.43 mg.

5 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.

Film-coated tablets red-orange in color, capsule-shaped, biconvex, with a score on one side, the tablet core is yellow at the break.

	1 tab.
Levofloxacin hemihydrate	512.45 mg,
Equivalent to Levofloxacin	500 mg

Excipients: corn starch – 59.25 mg, microcrystalline cellulose 102 – 40 mg, sodium carboxymethyl starch – 15 mg, crospovidone – 15 mg, colloidal silicon dioxide – 15 mg, talc – 10 mg, hypromellose – 6.8 mg, magnesium stearate – 6.5 mg.

Shell composition film coating WT-19022P pink – 16.14 mg (polyvinyl alcohol – 49%, titanium dioxide (E171) – 21.79%, polyethylene glycol 6000 – 13.2%, talc – 12.6%, soy lecithin – 3.4%, iron oxide red dye (E172) – 0.01%), sunset yellow dye (E110) – 0.86 mg.

5 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.

Film-coated tablets red-orange in color, capsule-shaped, biconvex, with a score on one side, the tablet core is yellow at the break.

	1 tab.
Levofloxacin hemihydrate	768.68 mg,
Equivalent to Levofloxacin	750 mg

Excipients: corn starch – 88.87 mg, microcrystalline cellulose 102 – 60 mg, sodium carboxymethyl starch – 22.5 mg, crospovidone – 22.5 mg, colloidal silicon dioxide – 22.5 mg, talc – 15 mg, hypromellose – 10.2 mg, magnesium stearate – 9.75 mg.

Shell composition film coating WT-19022P pink – 24.21 mg (polyvinyl alcohol – 49%, titanium dioxide (E171) – 21.79%, polyethylene glycol 6000 – 13.2%, talc – 12.6%, soy lecithin – 3.4%, iron oxide red dye (E172) – 0.01%), sunset yellow dye (E110) – 1.29 mg.

5 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.

Levofloxacin [Avexima Siberia LLC (Russia)]
Infusion solution 5 mg/1 ml: containers 100 ml

Marketing Authorization Holder

Avexima Siberia LLC (Russia)

Dosage Form

Levofloxacin

Infusion solution 5 mg/1 ml: containers 100 ml

Dosage Form, Packaging, and Composition

Infusion solution in the form of a clear, yellow to greenish-yellow liquid.

	1 ml
Levofloxacin hemihydrate	5.125 mg,
Equivalent to Levofloxacin	5 mg

Excipients: sodium chloride – 9 mg, sodium hydroxide solution 1M and/or hydrochloric acid solution 1M – to pH 3.8-5.8, water for injections – up to 1 ml.

Theoretical osmolarity: 322 mOsm/l.

100 ml – polymer containers (1) for infusion solutions – bags (1) – cardboard packs.

Levofloxacin [Alvils, LLC (Russia)]
Infusion solution 5 mg/ml: 100 ml bottle

Marketing Authorization Holder

Alvils, LLC (Russia)

Manufactured By

Belarusian-Dutch Joint Venture "FARMLAND", LLC (Republic of Belarus)

Dosage Form

Levofloxacin

Infusion solution 5 mg/ml: 100 ml bottle

Dosage Form, Packaging, and Composition

Infusion solution greenish-yellow in color, transparent.

	100 ml
Levofloxacin lactate hemihydrate	637.1 mg
Which corresponds to the levofloxacin content	500 mg

Excipients: sodium chloride – 900 mg, lactic acid – 25 mg, water for injections – up to 100 ml.

100 ml – glass bottles (1) – cardboard packs.
100 ml – polyethylene bottles (1) – cardboard packs.
100 ml – glass bottles (10) – Heat-sealable bags (10) – cardboard boxes (for hospitals).

Levofloxacin [Atoll LLC (Russia)]
Film-coated tablets, 250 mg: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 35, 40, 50, 70, or 100 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Ozon Pharm, LLC (Russia)

Dosage Form

Levofloxacin

Film-coated tablets, 250 mg: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 35, 40, 50, 70, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex, with a score; at the break, two layers are visible – a light yellow core and a film coating.

	1 tab.
Levofloxacin hemihydrate	256.23 mg,
Equivalent to levofloxacin content	250 mg

Excipients: microcrystalline cellulose (MCC-101) – 30 mg, sodium carboxymethyl starch – 17.5 mg, povidone K25 – 15 mg, croscarmellose sodium – 8.27 mg, magnesium stearate – 5 mg, colloidal silicon dioxide – 3 mg.

Shell composition: polyvinyl alcohol – 7.035 mg, macrogol-4000 – 4.845 mg, talc – 2.61 mg, titanium dioxide – 3.12 mg.

5 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.
5 pcs. – contour cell packs (3) – cardboard packs.
5 pcs. – contour cell packs (4) – cardboard packs.
5 pcs. – contour cell packs (5) – cardboard packs.
5 pcs. – contour cell packs (10) – cardboard packs.
7 pcs. – contour cell packs (1) – cardboard packs.
7 pcs. – contour cell packs (2) – cardboard packs.
7 pcs. – contour cell packs (3) – cardboard packs.
7 pcs. – contour cell packs (4) – cardboard packs.
7 pcs. – contour cell packs (5) – cardboard packs.
7 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.

Levofloxacin [Atoll LLC (Russia)]
Film-coated tablets, 500 mg: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 35, 40, 50, 70, or 100 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Ozon Pharm, LLC (Russia)

Dosage Form

Levofloxacin

Film-coated tablets, 500 mg: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 35, 40, 50, 70, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, round, biconvex; the cross-section shows two layers – a light yellow core and a film coating.

	1 tab.
Levofloxacin hemihydrate	512.46 mg,
Equivalent to levofloxacin content	500 mg

Excipients: microcrystalline cellulose (MCC-101) – 60 mg, sodium carboxymethyl starch – 35 mg, povidone K25 – 30 mg, croscarmellose sodium – 16.54 mg, magnesium stearate – 10 mg, colloidal silicon dioxide – 6 mg.

Shell composition: polyvinyl alcohol – 14.07 mg, macrogol-4000 – 9.69 mg, titanium dioxide – 6.24 mg.

Levofloxacin [Atoll LLC (Russia)]
Film-coated tablets, 750 mg: 5, 10, 15, 20, 25, 30, 40, 50, or 100 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Levofloxacin

Film-coated tablets, 750 mg: 5, 10, 15, 20, 25, 30, 40, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets white or almost white, capsule-shaped, biconvex, with a score on one side; on the cross-section – a light yellow core.

	1 tab.
Levofloxacin hemihydrate	768.7 mg,
Equivalent to levofloxacin content	750 mg

Excipients: microcrystalline cellulose – 90 mg, sodium carboxymethyl starch – 52.5 mg, povidone K25 – 45 mg, magnesium stearate – 15 mg, croscarmellose sodium – 24.8 mg, colloidal silicon dioxide – 9 mg.

Shell composition Opadry II White – 45 mg, including polyvinyl alcohol – 21.105 mg, macrogol 3350 – 10.62 mg, talc – 7.83 mg, titanium dioxide – 5.445 mg.

5 pcs. – contour cell packs (aluminum/PVC) (1) – cardboard packs.
5 pcs. – contour cell packs (aluminum/PVC) (2) – cardboard packs.
5 pcs. – contour cell packs (aluminum/PVC) (3) – cardboard packs.
5 pcs. – contour cell packs (aluminum/PVC) (4) – cardboard packs.
5 pcs. – contour cell packs (aluminum/PVC) (5) – cardboard packs.
5 pcs. – contour cell packs (aluminum/PVC) (10) – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (1) – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (2) – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (3) – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (4) – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (5) – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (10) – cardboard packs.
5 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
10 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
20 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
30 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
40 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
50 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
100 pcs. – polyethylene terephthalate jars (1) – cardboard packs.
5 pcs. – polypropylene jars (1) – cardboard packs.
10 pcs. – polypropylene jars (1) – cardboard packs.
20 pcs. – polypropylene jars (1) – cardboard packs.
30 pcs. – polypropylene jars (1) – cardboard packs.
40 pcs. – polypropylene jars (1) – cardboard packs.
50 pcs. – polypropylene jars (1) – cardboard packs.
100 pcs. – polypropylene jars (1) – cardboard packs.

Levofloxacin [Belmedpreparaty RUP (Republic of Belarus)]
Infusion solution 5 mg/ml: bottle 100 ml 1 or 56 pcs.

Marketing Authorization Holder

Belmedpreparaty RUP (Republic of Belarus)

Manufactured By

Belmedpreparaty RUP (Republic of Belarus)

Dosage Form

Levofloxacin

Infusion solution 5 mg/ml: bottle 100 ml 1 or 56 pcs.

Dosage Form, Packaging, and Composition

Infusion solution	1 ml
Levofloxacin	5 mg

100 ml – bottles (1) – cardboard packs.
100 ml – bottles (56) – corrugated cardboard boxes.

Levofloxacin [Belmedpreparaty RUP (Republic of Belarus)]
Eye drops 0.5 %: bottle 5 ml in set with dropper cap

Marketing Authorization Holder

Belmedpreparaty RUP (Republic of Belarus)

Dosage Form

Levofloxacin

Eye drops 0.5 %: bottle 5 ml in set with dropper cap

Dosage Form, Packaging, and Composition

Eye drops as a clear yellowish-green solution.

	1 ml
Levofloxacin hemihydrate	5.12 mg,
Equivalent to levofloxacin content	5 mg

Excipients: benzalkonium chloride, sodium chloride, disodium edetate, 1M hydrochloric acid solution, water for injections.

5 ml – glass bottles (1) in a set with a dropper cap – cardboard packs.

Levofloxacin [Biosintez, PJSC (Russia)]
Infusion solution 5 mg/ml: 100 ml bottles

Marketing Authorization Holder

Biosintez, PJSC (Russia)

Dosage Form

Levofloxacin

Infusion solution 5 mg/ml: 100 ml bottles

Dosage Form, Packaging, and Composition

Infusion solution greenish-yellow, clear.

	1 ml
Levofloxacin hemihydrate	5.125 mg
Equivalent to levofloxacin content	5 mg

Excipients: sodium chloride – 9 mg, 1 M hydrochloric acid solution – 0.012-0.016 ml, sodium hydroxide – 0-0.3 mg, water for injections – up to 1 ml.

Theoretical osmolarity – 322 mOsm/l.

100 ml – blood and blood substitute bottles (1) – cardboard packs.
100 ml – blood and blood substitute bottles (1) (1-56) – cardboard boxes (for hospitals).

Levofloxacin [Dalkhimpharm, JSC (Russia)]
Film-coated tablets, 250 mg: 5 or 10 pcs.
Film-coated tablets, 500 mg: 5 or 10 pcs.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Forms

	Levofloxacin	Film-coated tablets, 250 mg: 5 or 10 pcs.
		Film-coated tablets, 500 mg: 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow, round, biconvex shape; light yellow on the break.

	1 tab.
Levofloxacin hemihydrate (calculated as Levofloxacin)	250 mg

Excipients: croscarmellose sodium (primellose) – 7 mg, magnesium stearate – 3.2 mg, medium molecular weight povidone (medium molecular weight medical polyvinylpyrrolidone) – 14 mg, microcrystalline cellulose – 21.6 mg, colloidal silicon dioxide (aerosil 380) – 5 mg, talc – 6.4 mg, pregelatinized starch (Starch-1500) – 12.8 mg.

Shell composition opadry II (polyvinyl alcohol, partially hydrolyzed) – 4 mg, macrogol (polyethylene glycol 3350) – 2.02 mg, talc – 1.48 mg, titanium dioxide (E171) – 1.459 mg, aluminum lake based on quinoline yellow (E104) – 0.84 mg, iron oxide (II) dye (E172) – 0.198 mg, aluminum lake based on indigo carmine (E132) – 0.003 mg.

5 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – polymer jars (1) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.

Film-coated tablets yellow, round, biconvex shape; light yellow on the break.

	1 tab.
Levofloxacin hemihydrate (calculated as Levofloxacin)	500 mg

Excipients: croscarmellose sodium (primellose) – 14 mg, magnesium stearate – 6.4 mg, medium molecular weight povidone (medium molecular weight medical polyvinylpyrrolidone) – 28 mg, microcrystalline cellulose – 43.2 mg, colloidal silicon dioxide (aerosil 380) – 10 mg, talc – 12.8 mg, pregelatinized starch (Starch-1500) – 25.6 mg.

Shell composition opadry II (polyvinyl alcohol, partially hydrolyzed) – 8 mg, macrogol (polyethylene glycol 3350) – 4.04 mg, talc – 2.96 mg, titanium dioxide (E171) – 2.918 mg, aluminum lake based on quinoline yellow (E104) – 1.68 mg, iron oxide (II) dye (E172) – 0.396 mg, aluminum lake based on indigo carmine (E132) – 0.006 mg.

Levofloxacin [Dalkhimpharm, JSC (Russia)]
Infusion solution 5 mg/1 ml: bottle 100 ml

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Levofloxacin

Infusion solution 5 mg/1 ml: bottle 100 ml

Dosage Form, Packaging, and Composition

Infusion solution as a clear greenish-yellow liquid.

	1 ml
Levofloxacin hemihydrate (calculated as Levofloxacin)	5 mg

Excipients: sodium chloride – 9 mg, 2M hydrochloric acid solution – to pH 4.3-5.3, water for injections – up to 1 ml.

Theoretical osmolarity 348 mOsm/l.

100 ml – glass bottles (1) – cardboard packs.

Levofloxacin [Dalkhimpharm, JSC (Russia)]
Eye drops 0.5%: bottle or dropper bottle 5 ml 1 pc.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Form

Levofloxacin

Eye drops 0.5%: bottle or dropper bottle 5 ml 1 pc.

Dosage Form, Packaging, and Composition

Eye drops as a clear light yellow or greenish-yellow solution.

	1 ml
Levofloxacin hemihydrate	5.12 mg,
Equivalent to levofloxacin content	5 mg

Excipients: sodium chloride – 9 mg, benzalkonium chloride – 0.05 mg, 1M hydrochloric acid solution or 1M sodium hydroxide solution – to pH 6.0-7.0, water for injections – up to 1 ml.

5 ml – polyethylene bottles (1) with dropper caps – cardboard packs.
5 ml – polyethylene dropper bottles (1) – cardboard packs.

Levofloxacin [Kraspharma, PJSC (Russia)]
Solution for infusion 500 mg/100 ml: bottle or container 1 pc.

Marketing Authorization Holder

Kraspharma, PJSC (Russia)

Dosage Form

Levofloxacin

Solution for infusion 500 mg/100 ml: bottle or container 1 pc.

Dosage Form, Packaging, and Composition

Infusion solution as a clear greenish-yellow liquid.

	100 ml
Levofloxacin (in the form of levofloxacin hemihydrate)	500 mg

Excipients: sodium chloride – 900 mg, 2M hydrochloric acid solution – to pH 4.3-5.3, water for injections – up to 100 ml.

Theoretical osmolarity: 321.8 mOsm/l.

100 ml – glass bottles (1) – cardboard packs.
100 ml – glass containers (1) – cardboard packs.

Levofloxacin [Moscow Endocrine Plant FSUE (Russia)]
Eye drops 0.5%: dropper bottle 5 ml

Marketing Authorization Holder

Moscow Endocrine Plant FSUE (Russia)

Dosage Form

Levofloxacin

Eye drops 0.5%: dropper bottle 5 ml

Dosage Form, Packaging, and Composition

Eye drops 0.5% as a clear, light yellow or light greenish-yellow liquid.

	1 ml
Levofloxacin (in the form of hemihydrate)	5 mg

Excipients: benzethonium chloride – 0.05 mg, sodium chloride – 9 mg, 1M hydrochloric acid solution or 1M sodium hydroxide solution – to pH 6.0-7.0, water for injections – up to 1 ml.

5 ml – dropper bottles (1) – cardboard packs.

Levofloxacin [Mosfarm LLC (Russia)]
Infusion solution 5 mg/ml: 50 ml or 100 ml bottles or containers

Marketing Authorization Holder

Mosfarm LLC (Russia)

Dosage Form

Levofloxacin

Infusion solution 5 mg/ml: 50 ml or 100 ml bottles or containers

Dosage Form, Packaging, and Composition

Solution for infusion greenish-yellow in color, transparent.

	1 ml
Levofloxacin hemihydrate	5.1246 mg,
Equivalent to levofloxacin content	5 mg

Excipients : sodium chloride – 9 mg, hydrochloric acid – to pH 4.3 – 5.8, sodium hydroxide solution 0.1 M – to pH 4.3 – 5.8, water for injections – to 1 ml.

Theoretical osmolarity 320 mOsm/kg.

50 ml – bottles – cardboard packs.
50 ml – bottles 1-112 pcs. – cardboard boxes (for hospitals).
50 ml – containers – cardboard packs.
50 ml – containers 1-112 pcs. – cardboard boxes (for hospitals).
100 ml – bottles – cardboard packs.
100 ml – bottles 1-112 pcs. – cardboard boxes (for hospitals).
100 ml – containers – cardboard packs.
100 ml – containers 1-112 pcs. – cardboard boxes (for hospitals).

Levofloxacin [Nika Pharmatsevtika, LLC (Republic Of Belarus)]
Solution for infusion 5 mg/1 ml: 100 ml bottles

Marketing Authorization Holder

Nika Pharmatsevtika, LLC (Republic Of Belarus)

Manufactured By

Nesvizh Medical Products Plant OJSC (Republic Of Belarus)

Labeled By

NESVIZH MEDICAL PRODUCTS PLANT, OJSC (Republic of Belarus)

Packaging and Quality Control Release

Nika Pharmatsevtika, LLC (Republic Of Belarus)

Dosage Form

Levofloxacin

Solution for infusion 5 mg/1 ml: 100 ml bottles

Dosage Form, Packaging, and Composition

Solution for infusion greenish-yellow in color, transparent.

	1 ml
Levofloxacin hemihydrate	5.1246 mg,
Equivalent to levofloxacin content	5 mg

Excipients : anhydrous glucose, disodium edetate, hydrochloric acid solution 5%, water for injections.

If necessary, to adjust pH 4.8, add: hydrochloric acid solution 5% and/or sodium hydroxide 5% solution q.s.

100 ml – polyethylene bottles (1), using “form-fill-seal” technology – cardboard packs.

Levofloxacin [Production Of Medicaments, LLC (Russia)]
Capsules 250 mg: 5, 7, 10, 14 or 20 pcs.
Capsules 500 mg: 5, 7, 10, 14 or 20 pcs.

Marketing Authorization Holder

Production Of Medicaments, LLC (Russia)

Dosage Forms

	Levofloxacin	Capsules 250 mg: 5, 7, 10, 14 or 20 pcs.
		Capsules 500 mg: 5, 7, 10, 14 or 20 pcs.

Dosage Form, Packaging, and Composition

Capsules hard, gelatin, size #0, with an opaque white body and an opaque blue cap; capsule contents – a mixture of granules and powder, light yellow in color.

	1 caps.
Levofloxacin hemihydrate	256.23 mg,
Equivalent to levofloxacin content	250 mg

Excipients : microcrystalline cellulose type 101 – 84.86 mg, hypromellose – 1.2 mg, povidone K30 – 4.71 mg, calcium stearate – 3 mg.

Capsule shell composition:
Body: titanium dioxide (E171) – 2%, gelatin – to 100%;
Cap: titanium dioxide (E171) – 1%, indigo carmine (E132) – 0.1333%, gelatin – to 100%.

5 pcs. – contour cell blisters – cardboard packs.
5 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters – cardboard packs.
7 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.

Capsules hard, gelatin, size #00, with an opaque white body and an opaque blue cap; capsule contents – a mixture of granules and powder, light yellow in color.

	1 caps.
Levofloxacin hemihydrate	512.46 mg,
Equivalent to levofloxacin content	500 mg

Excipients : microcrystalline cellulose type 101 – 71.07 mg, hypromellose – 2.4 mg, povidone K30 – 8.07 mg, calcium stearate – 6 mg.

Capsule shell composition:
Body: titanium dioxide (E171) – 2%, gelatin – to 100%;
Cap: titanium dioxide (E171) – 1%, indigo carmine (E132) – 0.1333%, gelatin – to 100%.

Levofloxacin [Promomed Rus LLC (Russia)]
Infusion solution 5 mg/ml: bottles 100 ml 1 or 35 pcs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Form

Levofloxacin

Infusion solution 5 mg/ml: bottles 100 ml 1 or 35 pcs.

Dosage Form, Packaging, and Composition

Solution for infusion in the form of a transparent, greenish-yellow colored liquid.

	1 ml
Levofloxacin hemihydrate	5.1246 mg,
Equivalent to levofloxacin content	5 mg

Excipients : sodium chloride – 9 mg, hydrochloric acid solution 1 M – to pH 5.5-7.0, water for injections – to 1 ml.

100 ml – bottles (1) – cardboard packs.
100 ml – bottles (35) – cardboard boxes (for hospitals).

Levofloxacin [Promomed Rus LLC (Russia)]
Film-coated tablets, 250 mg: 3, 5, 6, 7, 9, 10, 12, 14, 15, 20, 21, 25, 28, 30, 35, 40, 50, 70, or 100 pcs.
Film-coated tablets, 500 mg: 3, 5, 6, 7, 9, 10, 12, 14, 15, 20, 21, 25, 28, 30, 35, 40, 50, 70, or 100 pcs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Forms

	Levofloxacin	Film-coated tablets, 250 mg: 3, 5, 6, 7, 9, 10, 12, 14, 15, 20, 21, 25, 28, 30, 35, 40, 50, 70, or 100 pcs.
		Film-coated tablets, 500 mg: 3, 5, 6, 7, 9, 10, 12, 14, 15, 20, 21, 25, 28, 30, 35, 40, 50, 70, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow in color, round, biconvex in shape; on cross-section, two layers are visible; the uncoated core is from almost white to light yellow in color.

	1 tab.
Levofloxacin hemihydrate	256.23 mg,
Equivalent to levofloxacin content	250 mg

Excipients : povidone (kollidon 30) – 12.9 mg, microcrystalline cellulose (type 101) – 91.27 mg, magnesium stearate – 4 mg, crospovidone – 17.6 mg, sodium lauryl sulfate – 8 mg.

Film coating composition hypromellose – 5.78 mg, macrogol 6000 – 2.35 mg, titanium dioxide – 0.89 mg, polysorbate 80 – 0.89 mg, quinoline yellow dye (E104) – 0.09 mg.

3 pcs. – contour cell blisters (1) – cardboard packs.
3 pcs. – contour cell blisters (2) – cardboard packs.
3 pcs. – contour cell blisters (3) – cardboard packs.
3 pcs. – contour cell blisters (4) – cardboard packs.
3 pcs. – contour cell blisters (5) – cardboard packs.
3 pcs. – contour cell blisters (10) – cardboard packs.
5 pcs. – contour cell blisters (1) – cardboard packs.
5 pcs. – contour cell blisters (2) – cardboard packs.
5 pcs. – contour cell blisters (3) – cardboard packs.
5 pcs. – contour cell blisters (4) – cardboard packs.
5 pcs. – contour cell blisters (5) – cardboard packs.
5 pcs. – contour cell blisters (10) – cardboard packs.
7 pcs. – contour cell blisters (1) – cardboard packs.
7 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters (3) – cardboard packs.
7 pcs. – contour cell blisters (4) – cardboard packs.
7 pcs. – contour cell blisters (5) – cardboard packs.
7 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
10 pcs. – glass jars (1) – cardboard packs.

Film-coated tablets yellow in color, oval, biconvex in shape, with a score on one side; on cross-section, two layers are visible; the uncoated core is from almost white to light yellow in color.

	1 tab.
Levofloxacin hemihydrate	512.46 mg,
Equivalent to levofloxacin content	500 mg

Excipients : povidone (kollidon 30) – 25.8 mg, microcrystalline cellulose (type 101) – 182.54 mg, magnesium stearate – 8 mg, crospovidone – 35.2 mg, sodium lauryl sulfate – 16 mg.

Film coating composition hypromellose – 11.56 mg, macrogol 6000 – 4.7 mg, titanium dioxide – 1.78 mg, polysorbate 80 – 1.78 mg, quinoline yellow dye (E104) – 0.18 mg.

Levofloxacin [PFC Alium, LLC (Russia)]
Solution for infusion 5 mg/1 ml: 100 ml vial

Marketing Authorization Holder

PFC Alium, LLC (Russia)

Dosage Form

Levofloxacin

Solution for infusion 5 mg/1 ml: 100 ml vial

Dosage Form, Packaging, and Composition

Solution for infusion transparent, greenish-yellow in color.

	100 ml
Levofloxacin hemihydrate	512.5 mg,
Equivalent to levofloxacin content	500 mg

Excipients : sodium chloride, sodium edetate, sodium hydroxide or concentrated hydrochloric acid, water for injections.

Theoretical osmolarity 320 mOsm/L.

100 ml – plastic vials (1) – cardboard packs.

Levofloxacin [Rapharma, JSC (Russia)]
Film-coated tablets, 250 mg: 5 or 10 pcs.
Film-coated tablets, 500 mg: 5 or 10 pcs.

Marketing Authorization Holder

Rapharma, JSC (Russia)

Dosage Forms

	Levofloxacin	Film-coated tablets, 250 mg: 5 or 10 pcs.
		Film-coated tablets, 500 mg: 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pink in color, round in shape, biconvex, with a score; on cross-section, the core is from white with a yellowish tint to light yellow in color.

	1 tab.
Levofloxacin hemihydrate	256.23 mg,
Equivalent to levofloxacin content	250 mg

Excipients : lactose monohydrate, microcrystalline cellulose (MCC-101), crospovidone, hypromellose, magnesium stearate.

Coating composition Opadry II pink 85F34355: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, allura red AC dye (E129), quinoline yellow dye (E104), indigo carmine (E132).

5 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.

Film-coated tablets pink in color, oval in shape, biconvex, with a score; on cross-section, the core is from white with a yellowish tint to light yellow in color.

	1 tab.
Levofloxacin hemihydrate	512.46 mg,
Equivalent to levofloxacin content	500 mg

Excipients : lactose monohydrate, microcrystalline cellulose (MCC-101), crospovidone, hypromellose, magnesium stearate.

Coating composition Opadry II pink 85F34355: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, allura red AC dye (E129), quinoline yellow dye (E104), indigo carmine (E132).

5 pcs. – contour cell blisters (1) – cardboard packs.
10 pcs. – contour cell blisters (1) – cardboard packs.

Levofloxacin [Pharmconcept, LLC (Russia)]
Film-coated tablets, 250 mg: 20 or 50 pcs.
Film-coated tablets, 500 mg: 20 or 50 pcs.
Film-coated tablets, 750 mg: 20 or 50 pcs.

Marketing Authorization Holder

Pharmconcept, LLC (Russia)

Dosage Forms

	Levofloxacin	Film-coated tablets, 250 mg: 20 or 50 pcs.
		Film-coated tablets, 500 mg: 20 or 50 pcs.
		Film-coated tablets, 750 mg: 20 or 50 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pale yellowish-pink in color, oblong, biconvex; on cross-section, from white with a yellowish tint to yellow in color.

	1 tab.
Levofloxacin hemihydrate	256.23 mg,
Equivalent to levofloxacin content	250 mg

Excipients : microcrystalline cellulose (type 101) – 20.77 mg, low-substituted hypromellose – 5 mg, sodium carboxymethyl starch – 8 mg, povidone K30 – 6 mg, croscarmellose sodium – 3 mg, colloidal silicon dioxide – 4 mg, talc – 4 mg, magnesium stearate – 2 mg.

Finished water-soluble coating/tablet coating composition hypromellose E6 – 7.014 mg, talc – 0.52 mg, titanium dioxide – 1.45 mg, iron oxide yellow dye – 0.008 mg, iron oxide red dye – 0.008 mg.

10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.

Film-coated tablets pale yellowish-pink in color, oblong, biconvex, with a score on both sides; on cross-section of the tablet from white with a yellowish tint to yellow in color.

	1 tab.
Levofloxacin hemihydrate	512.46 mg,
Equivalent to levofloxacin content	500 mg

Excipients : microcrystalline cellulose (type 101) – 41.54 mg, low-substituted hypromellose – 10 mg, sodium carboxymethyl starch – 16 mg, povidone K30 – 12 mg, croscarmellose sodium – 6 mg, colloidal silicon dioxide – 8 mg, talc – 8 mg, magnesium stearate – 4 mg.

Finished water-soluble coating/tablet coating composition hypromellose E6 – 14.028 mg, talc – 1.04 mg, titanium dioxide – 2.9 mg, iron oxide yellow dye – 0.016 mg, iron oxide red dye – 0.016 mg.

10 pcs. – contour cell blisters (2) – cardboard packs.
10 pcs. – contour cell blisters (5) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.

Film-coated tablets pale yellowish-pink in color, capsule-shaped; on the cross-section, the tablet is white with a yellowish tint to yellow.

	1 tab.
Levofloxacin hemihydrate	768.69 mg,
Equivalent to levofloxacin content	750 mg

Excipients: microcrystalline cellulose (type 101) – 62.31 mg, low-substituted hypromellose – 15 mg, sodium starch glycolate – 24 mg, povidone K30 – 18 mg, croscarmellose sodium – 9 mg, colloidal silicon dioxide – 12 mg, talc – 12 mg, magnesium stearate – 6 mg.

Composition of the finished water-soluble tablet coating/film: hypromellose E6 – 21.042 mg, talc – 1.56 mg, titanium dioxide – 4.35 mg, iron oxide yellow dye – 0.024 mg, iron oxide red dye – 0.024 mg.

10 pcs. – blister packs (2) – cardboard packs.
50 pcs. – jars (1) – cardboard packs.

Levofloxacin [Pharmstandard-Lexredstva OJSC (Russia)]
Film-coated tablets, 250 mg: 3, 5, 7, 10, or 14 pcs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Levofloxacin

Film-coated tablets, 250 mg: 3, 5, 7, 10, or 14 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pinkish-orange in color, round, biconvex; on the cross-section from white to light yellow.

	1 tab.
Levofloxacin hemihydrate	256.23 mg,
Equivalent to levofloxacin content	250 mg

Excipients: microcrystalline cellulose – 2.9 mg, crospovidone – 12.3 mg, sodium stearyl fumarate – 5 mg, croscarmellose sodium – 15.38 mg, colloidal silicon dioxide – 9.23 mg, maltodextrin – 6.15 mg, magnesium stearate – 0.31 mg.

Coating composition Opadry orange 20A230018 – 7.5 mg (hypromellose 2910 [hypromellose 6cP] (E464) – 3.3 mg, titanium dioxide (E171) – 0.688 mg, talc – 1.575 mg, hypromellose [hydroxypropyl cellulose, klucel EF] (E463) – 1.925 mg, sunset yellow dye (E110) – 0.012 mg).

3 pcs. – blister packs (1) – cardboard packs.
5 pcs. – blister packs (1) – cardboard packs.
7 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.
5 pcs. – blister packs (2) – cardboard packs.
7 pcs. – blister packs (2) – cardboard packs.

Levofloxacin [Pharmstandard-Lexredstva OJSC (Russia)]
Film-coated tablets, 500 mg: 3, 5, 7, 10, or 14 pcs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Levofloxacin

Film-coated tablets, 500 mg: 3, 5, 7, 10, or 14 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pinkish-orange in color, oval, biconvex; on the cross-section from white to light yellow.

	1 tab.
Levofloxacin hemihydrate	512.46 mg,
Equivalent to levofloxacin content	500 mg

Excipients: microcrystalline cellulose – 44.69 mg, crospovidone – 7.85 mg, sodium stearyl fumarate – 1.41 mg, croscarmellose sodium – 6.15 mg, colloidal silicon dioxide – 15.38 mg, maltodextrin – 24.6 mg, magnesium stearate – 2.46 mg.

Coating composition Opadry orange 20A230018 – 15 mg (hypromellose 2910 [hypromellose 6cP] (E464) – 6.6 mg, titanium dioxide (E171) – 1.375 mg, talc – 3.150 mg, hypromellose [hydroxypropyl cellulose, klucel EF] (E463) – 3.851 mg, sunset yellow dye (E110) – 0.024 mg).

Levofloxacin [Pharmstandard-Lexredstva OJSC (Russia)]
Film-coated tablets, 750 mg: 3, 5, 7, 10, or 14 pcs.

Marketing Authorization Holder

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Levofloxacin

Film-coated tablets, 750 mg: 3, 5, 7, 10, or 14 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pinkish-orange in color, oval, biconvex; on the cross-section from white to light yellow.

	1 tab.
Levofloxacin hemihydrate	768.69 mg,
Equivalent to levofloxacin content	750 mg

Excipients: microcrystalline cellulose – 67.04 mg, crospovidone – 11.77 mg, sodium stearyl fumarate – 12.27 mg, croscarmellose sodium – 8.3 mg, colloidal silicon dioxide – 23.06 mg, maltodextrin – 27.68 mg, magnesium stearate – 3.69 mg.

Coating composition Opadry orange 20A230018 – 22.5 mg (hypromellose 2910 [hypromellose 6cP] (E464) – 9.9 mg, titanium dioxide (E171) – 2.063 mg, talc – 4.725 mg, hypromellose [hydroxypropyl cellulose, klucel EF] (E463) – 5.776 mg, sunset yellow dye (E110) – 0.036 mg).

Levofloxacin [Mir Chemical and Pharmaceutical Concern, LLC (Russia)]
Infusion solution 5 mg/1 ml: bottles or containers 50 ml or 100 ml

Marketing Authorization Holder

Mir Chemical and Pharmaceutical Concern, LLC (Russia)

Manufactured By

Medpolymer Firm, JSC (Russia)

NPC Eskom, PJSC (Russia)

Dosage Form

Levofloxacin

Infusion solution 5 mg/1 ml: bottles or containers 50 ml or 100 ml

Dosage Form, Packaging, and Composition

Infusion solution greenish-yellow in color, transparent.

	1 ml
Levofloxacin hemihydrate	5.125 mg,
In terms of Levofloxacin	5 mg

Excipients: sodium chloride – 9 mg, water for injection – up to 1 ml.

Theoretical osmolarity 308 mOsmol/L.

50 ml – single-use polymer containers for infusion solutions (1) with SFC type injection ports (1) – film.
50 ml – single-use polymer containers for infusion solutions (1) with SFC type injection ports (2) – film.
100 ml – single-use polymer containers for infusion solutions (1) with SFC type injection ports (1) – film.
100 ml – single-use polymer containers for infusion solutions (1) with SFC type injection ports (2) – film.
50 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.

Levofloxacin-Optic [Lekko, CJS (Russia)]
Eye drops 0.5%: bottle 5 ml or 10 ml 1 pc.

Marketing Authorization Holder

Lekko, CJS (Russia)

Dosage Form

Levofloxacin-Optic

Eye drops 0.5%: bottle 5 ml or 10 ml 1 pc.

Dosage Form, Packaging, and Composition

Eye drops in the form of a transparent solution, yellow or greenish-yellow in color.

	1 ml
Levofloxacin hemihydrate	5.12 mg,
Equivalent to levofloxacin content	5 mg

Excipients: sodium chloride – 9 mg, benzalkonium chloride in terms of dry substance – 0.05 mg, hydrochloric acid 1 M solution or sodium hydroxide 1 M solution – to pH 6.0-7.0, purified water – up to 1 ml.

5 ml – polymer bottles (1) – cardboard packs.
10 ml – polymer bottles (1) – cardboard packs.

Medixlife (Author)

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