Levofloxacin Krka
Fluoroquinolone antibiotic containing levofloxacin for bacterial infections
Quick Facts about Levofloxacin Krka
Key Takeaways
- Fluoroquinolone antibiotic: Levofloxacin Krka kills bacteria by inhibiting DNA replication enzymes and is effective against a broad range of bacterial infections
- Reserved for serious infections: Due to potential serious side effects, fluoroquinolones should only be used when other antibiotics are not suitable
- Tendon and nerve risks: Can cause tendinitis, tendon rupture, and peripheral neuropathy, especially in patients over 60, those on corticosteroids, or organ transplant recipients
- Complete the full course: Do not stop taking levofloxacin early even if you feel better, as this may lead to antibiotic resistance
- Sun sensitivity: Avoid direct sunlight during treatment and for 2 days after stopping, as the skin becomes more sensitive to UV radiation
What Is Levofloxacin Krka and What Is It Used For?
Levofloxacin Krka is a fluoroquinolone antibiotic containing the active substance levofloxacin. It works by inhibiting bacterial DNA gyrase and topoisomerase IV, which are essential enzymes for bacterial DNA replication, effectively killing the bacteria responsible for the infection.
Levofloxacin belongs to a group of medicines called quinolone antibiotics, specifically the fluoroquinolone subclass. It is one of the most widely prescribed fluoroquinolones worldwide and has been listed on the World Health Organization's List of Essential Medicines. The drug was first approved for medical use in the 1990s and has since become available as a generic medicine from multiple manufacturers including KRKA.
As a broad-spectrum antibiotic, levofloxacin is effective against both Gram-positive bacteria (such as Streptococcus pneumoniae and Staphylococcus aureus) and Gram-negative bacteria (such as Escherichia coli, Haemophilus influenzae, and Pseudomonas aeruginosa). This broad coverage makes it a versatile option for treating various types of bacterial infections when first-line antibiotics are not appropriate or effective.
Levofloxacin Krka is available in multiple formulations to treat different conditions. The film-coated tablets (250 mg and 500 mg) are the most commonly prescribed oral form. An intravenous infusion solution (5 mg/ml) is available for hospital use when oral administration is not feasible. Eye drops (5 mg/ml) are used for bacterial eye infections, and a nebuliser solution (240 mg) is specifically indicated for chronic Pseudomonas aeruginosa lung infections in cystic fibrosis patients.
Approved Indications
Levofloxacin Krka tablets and infusion solution may be prescribed for the following infections in adults:
- Acute bacterial sinusitis – infection of the nasal sinuses
- Acute exacerbation of chronic bronchitis – lung infections in people with long-standing breathing problems
- Community-acquired pneumonia – lung infection acquired outside hospital
- Complicated urinary tract infections – including kidney infections (pyelonephritis)
- Chronic bacterial prostatitis – long-standing prostate gland infection
- Skin and soft tissue infections – including infections of the skin layers and underlying muscles
- Inhalational anthrax (post-exposure prophylaxis) – to reduce the risk or slow the progression of anthrax disease after confirmed exposure to Bacillus anthracis
According to both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), fluoroquinolones including levofloxacin should be reserved for use only in patients who do not have alternative treatment options. For uncomplicated infections, other antibiotics with a more favourable safety profile should be considered first. This recommendation reflects the serious, potentially irreversible side effects associated with fluoroquinolone use.
How Does Levofloxacin Work?
Levofloxacin exerts its bactericidal effect by targeting two essential bacterial enzymes: DNA gyrase (topoisomerase II) and topoisomerase IV. These enzymes are critical for bacterial DNA replication, transcription, repair, and recombination. By inhibiting these enzymes, levofloxacin prevents the bacteria from copying their DNA and dividing, ultimately leading to bacterial cell death.
One notable pharmacological advantage of levofloxacin is its excellent oral bioavailability, approaching 99-100%. This means that virtually the entire oral dose reaches the bloodstream, making the oral tablets nearly as effective as intravenous administration. Peak plasma concentrations are typically achieved within 1-2 hours after oral dosing, and the drug distributes well into most body tissues and fluids, including lung tissue, skin, and the urinary tract.
What Should You Know Before Taking Levofloxacin Krka?
Do not take Levofloxacin Krka if you are allergic to levofloxacin or any quinolone antibiotic, have epilepsy, have had tendon problems from previous quinolone use, are a child or growing adolescent, or are pregnant or breastfeeding. Inform your doctor about all medical conditions and medications before starting treatment.
Contraindications
You must not take Levofloxacin Krka and should inform your prescribing doctor if any of the following apply to you:
- Allergy to levofloxacin or other quinolones: If you are allergic to levofloxacin, or any other quinolone antibiotic such as moxifloxacin, ciprofloxacin, or ofloxacin, or any of the other ingredients in this medicine. Signs of an allergic reaction include rash, difficulty swallowing or breathing, and swelling of the lips, face, throat, or tongue.
- History of epilepsy: Levofloxacin can lower the seizure threshold and should not be used in patients with a known history of epilepsy.
- Previous tendon problems with quinolones: If you have ever experienced tendinitis (tendon inflammation) or tendon rupture during treatment with any quinolone antibiotic.
- Children and growing adolescents: Levofloxacin is not approved for use in patients under 18 years of age due to the risk of damage to developing cartilage and joints.
- Pregnancy and breastfeeding: Do not take this medicine if you are pregnant, may become pregnant, or are breastfeeding.
Regulatory agencies including the FDA (United States), EMA (Europe), and MHRA (United Kingdom) have issued serious safety warnings for fluoroquinolone antibiotics. These drugs have been associated with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves, and the central nervous system. Do not take fluoroquinolone antibiotics, including Levofloxacin Krka, if you have previously experienced any serious adverse reaction from a quinolone or fluoroquinolone antibiotic.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Levofloxacin Krka if any of the following conditions apply to you, as extra caution may be needed:
- You are 60 years of age or older
- You are taking corticosteroids (sometimes called steroids)
- You have undergone an organ transplant
- You have ever had a seizure (convulsion) or brain injury from stroke
- You have kidney problems – your dose may need to be reduced
- You have glucose-6-phosphate dehydrogenase (G6PD) deficiency
- You have a history of mental health problems
- You have heart problems, including QT prolongation, bradycardia, heart failure, or a previous heart attack
- You have or have a family history of aortic aneurysm, aortic dissection, or heart valve disease
- You have connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome
- You have diabetes – levofloxacin can affect blood sugar levels
- You have liver problems
- You have myasthenia gravis – levofloxacin may worsen muscle weakness
- You have peripheral neuropathy (nerve problems in hands or feet)
While taking Levofloxacin Krka, seek immediate medical attention if you experience sudden, severe pain in the abdomen, chest, or back, as these may be symptoms of aortic aneurysm or dissection. If you develop sudden breathlessness, particularly when lying down, or notice swelling in your ankles, feet, or abdomen, or experience new onset of heart palpitations, contact your doctor immediately as these could be signs of heart valve regurgitation.
Tendon inflammation and rupture can occur within the first 48 hours of treatment but also up to several months after stopping Levofloxacin Krka. At the first sign of pain or inflammation in a tendon (commonly the Achilles tendon in the ankle, but also the wrist, elbow, shoulder, or knee), stop taking levofloxacin immediately, rest the affected area, and contact your doctor.
Pregnancy and Breastfeeding
Levofloxacin Krka must not be used during pregnancy or while breastfeeding. Animal studies have shown that fluoroquinolones can cause damage to cartilage in developing joints, and there is insufficient safety data in pregnant women. If you become pregnant during treatment, stop taking the medication and contact your doctor immediately.
Levofloxacin passes into breast milk and may cause harm to a nursing infant, including potential damage to developing cartilage. Women who need to take levofloxacin should not breastfeed during treatment and for at least 48 hours after the last dose.
Driving and Operating Machinery
Levofloxacin may cause side effects such as dizziness, drowsiness, visual disturbances, or vertigo that can impair your ability to drive or operate machinery. If you experience these effects, do not drive or perform tasks requiring alertness until you know how this medicine affects you.
How Does Levofloxacin Krka Interact with Other Drugs?
Levofloxacin interacts significantly with corticosteroids (increased tendon rupture risk), warfarin (increased bleeding risk), theophylline and NSAIDs (increased seizure risk), and ciclosporin (increased side effects). Do not take iron supplements, zinc, antacids, or sucralfate at the same time – separate doses by at least 2 hours.
Levofloxacin can interact with many other medicines, potentially increasing the risk of side effects or reducing the effectiveness of either drug. It is essential to tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or might take. The following interactions are the most clinically significant.
Major Interactions
| Drug/Class | Interaction Effect | Clinical Significance |
|---|---|---|
| Corticosteroids | Significantly increased risk of tendon inflammation and tendon rupture | Avoid combination if possible; monitor closely |
| Warfarin | Enhanced anticoagulant effect, increased bleeding risk | Monitor INR frequently; dose adjustment may be needed |
| Theophylline | Increased seizure risk; elevated theophylline levels | Monitor theophylline levels; consider dose reduction |
| NSAIDs (ibuprofen, aspirin, ketoprofen) | Increased seizure risk | Use with caution; avoid in patients with seizure history |
| Ciclosporin | Increased ciclosporin side effects | Monitor ciclosporin levels closely |
| QT-prolonging drugs (amiodarone, sotalol, antidepressants, antipsychotics) | Additive QT prolongation, risk of life-threatening cardiac arrhythmia | Avoid combination; ECG monitoring if essential |
Absorption Interactions
Certain medicines and supplements can significantly reduce the absorption of levofloxacin from the gut if taken at the same time. Do not take the following at the same time as Levofloxacin Krka – take them at least 2 hours before or 2 hours after your levofloxacin dose:
- Iron supplements (for anaemia)
- Zinc supplements
- Antacids containing magnesium or aluminium (for heartburn or indigestion)
- Didanosine (antiretroviral medication)
- Sucralfate (for stomach ulcers)
These substances form insoluble complexes with levofloxacin in the gastrointestinal tract, which prevents the antibiotic from being absorbed into the bloodstream. Separating the doses by at least 2 hours avoids this interaction and ensures full antibiotic efficacy.
Other Notable Interactions
Probenecid and cimetidine can reduce the kidney's ability to eliminate levofloxacin, potentially leading to higher drug levels in the body. If you are taking either of these medicines and have kidney problems, your doctor may prescribe a lower dose of levofloxacin.
False test results: Levofloxacin may cause false-positive results in urine screening tests for opioids. If you are being tested for drugs, inform the testing laboratory that you are taking levofloxacin. This medicine can also produce false-negative results in certain tuberculosis tests.
What Is the Correct Dosage of Levofloxacin Krka?
The standard adult dose of Levofloxacin Krka is 250 mg or 500 mg once or twice daily, depending on the type and severity of infection. Treatment duration ranges from 3 to 28 days. Swallow tablets whole with water; they can be taken with or without food. Always complete the full prescribed course.
Always take Levofloxacin Krka exactly as your doctor has prescribed. The dose and duration of treatment depend on the type, location, and severity of your infection, as well as your kidney function. Do not change the dosage yourself without consulting your doctor.
Adults and Elderly
| Infection Type | Daily Dose | Duration |
|---|---|---|
| Acute sinusitis | 500 mg once daily | 10–14 days |
| Acute exacerbation of chronic bronchitis | 500 mg once daily | 7–10 days |
| Community-acquired pneumonia | 500 mg once or twice daily | 7–14 days |
| Uncomplicated UTI | 250 mg once daily | 3 days |
| Complicated UTI / pyelonephritis | 500 mg once daily | 7–10 days |
| Chronic bacterial prostatitis | 500 mg once daily | 28 days |
| Skin and soft tissue infections | 500 mg once or twice daily | 7–14 days |
| Inhalational anthrax | 500 mg once daily | 8 weeks |
How to Take the Tablets
- Take the tablets by mouth, swallowing them whole with water
- The tablets can be taken with meals or between meals
- The tablets can be split into two equal halves along the score line if needed
- Protect your skin from direct sunlight during treatment and for 2 days after stopping
Patients with Kidney Problems
If you have impaired kidney function, your doctor may need to prescribe a lower dose of Levofloxacin Krka. This is because levofloxacin is primarily eliminated through the kidneys, and reduced kidney function leads to slower drug clearance and higher blood levels. Your doctor will determine the appropriate dose based on your creatinine clearance (a measure of kidney function).
Children and Adolescents
Levofloxacin Krka must not be given to children or growing adolescents under 18 years of age. Fluoroquinolone antibiotics can cause damage to the developing cartilage in weight-bearing joints. The only exceptions are specific paediatric indications (such as anthrax prophylaxis) under specialist supervision, which are not covered by the Levofloxacin Krka product licence.
Missed Dose
If you forget to take a dose, take it as soon as you remember unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.
Overdose
If you take more Levofloxacin Krka than prescribed, or if a child accidentally swallows the medicine, contact your doctor or emergency services immediately. Symptoms of overdose may include seizures, confusion, dizziness, reduced consciousness, tremors, and heart rhythm disturbances including nausea and a burning feeling in the stomach. Bring the medicine package with you so the doctor knows what has been taken.
Do not stop taking Levofloxacin Krka just because you feel better. It is essential to complete the full course prescribed by your doctor. Stopping antibiotics early can allow the infection to return, make your condition worse, or cause the bacteria to become resistant to the medicine, making future infections harder to treat.
What Are the Side Effects of Levofloxacin Krka?
Common side effects include sleep problems, headache, dizziness, nausea, vomiting, and diarrhoea. Serious but rare side effects include tendon rupture, peripheral neuropathy, seizures, severe skin reactions, and liver failure. Stop taking the medicine and seek immediate medical attention for tendon pain, numbness/tingling, severe diarrhoea, or allergic reactions.
Like all medicines, Levofloxacin Krka can cause side effects, although not everybody gets them. The side effects are usually mild to moderate and often resolve within a short time. However, some side effects can be serious and require immediate medical attention.
- An allergic reaction: rash, difficulty swallowing or breathing, swelling of lips, face, throat, or tongue
- Severe, watery or bloody diarrhoea with stomach cramps and high fever
- Pain, inflammation, or rupture of a tendon
- Burning, tingling, numbness, or weakness in your hands or feet (neuropathy)
- Seizures (convulsions)
- Severe skin rash with blisters or peeling, or sores in the mouth, throat, or eyes
Common
- Sleep problems (insomnia)
- Headache
- Dizziness
- Nausea, vomiting, diarrhoea
- Increase in certain liver enzyme levels
Uncommon
- Fungal infections (e.g., Candida)
- Changes in white blood cell count
- Anxiety, confusion, nervousness, drowsiness, tremor, vertigo
- Shortness of breath (dyspnoea)
- Taste changes, appetite loss, indigestion, abdominal pain, flatulence, constipation
- Itching, skin rash, hives (urticaria), excessive sweating
- Joint or muscle pain
- General weakness
Rare
- Tendon inflammation or rupture (most commonly Achilles tendon)
- Seizures (convulsions)
- Hallucinations, paranoia, depression, agitation, abnormal dreams
- Low blood platelet count (easy bruising, bleeding)
- Low white blood cell count (neutropenia)
- Rapid heartbeat (tachycardia), low blood pressure
- Muscle weakness (important in myasthenia gravis)
- Kidney inflammation (interstitial nephritis)
- Tinnitus (ringing in the ears), blurred vision
- Tingling in hands or feet (paraesthesia)
- DRESS syndrome (drug reaction with eosinophilia and systemic symptoms)
- SIADH (syndrome of inappropriate antidiuretic hormone secretion)
- Hypoglycaemia (low blood sugar), including hypoglycaemic coma – especially important for patients with diabetes
Very Rare or Frequency Not Known
- Peripheral neuropathy – burning, tingling, numbness (may be permanent)
- Stevens-Johnson syndrome and toxic epidermal necrolysis (severe skin reactions)
- Liver failure, hepatitis
- Aortic aneurysm, dissection, and heart valve regurgitation
- Life-threatening cardiac arrhythmias, including cardiac arrest and QT prolongation
- Psychotic reactions, suicidal thoughts or actions
- Acute pancreatitis
- Agranulocytosis (severe drop in white blood cells), pancytopenia, bone marrow failure
- Myoclonus (sudden involuntary muscle jerks)
- Rhabdomyolysis (muscle breakdown)
- Loss of hearing, smell, or taste
- Temporary vision loss, eye inflammation
- Anaphylactic shock
In very rare cases, fluoroquinolone antibiotics including levofloxacin have been associated with long-lasting (months to years), disabling, and potentially permanent side effects. These include tendon inflammation and rupture, joint pain, muscle pain, difficulty walking, abnormal sensations (tingling, burning, numbness), sensory disturbances (impaired vision, taste, smell, and hearing), depression, memory impairment, severe fatigue, and sleep disorders. If you experience any of these effects, stop taking the medicine immediately and consult your doctor before continuing treatment.
How Should You Store Levofloxacin Krka?
Store Levofloxacin Krka out of the sight and reach of children. No special storage conditions are required. Do not use the medicine after the expiry date shown on the packaging. Dispose of unused medicines through your pharmacy, not in household waste or down the drain.
Levofloxacin Krka film-coated tablets do not have any special storage requirements – they can be stored at normal room temperature. Keep the tablets in their original blister packaging until ready to use, to protect them from light and moisture.
Always check the expiry date on the outer carton and blister pack before taking a tablet. The expiry date refers to the last day of the stated month. Do not use the medicine after this date.
Do not dispose of medicines via wastewater or household waste. Return any unused or expired medicines to your local pharmacy for safe disposal. These measures help to protect the environment, particularly aquatic ecosystems, as antibiotics in wastewater can contribute to the development of antibiotic-resistant bacteria.
What Does Levofloxacin Krka Contain?
Each tablet contains either 250 mg or 500 mg of levofloxacin (as levofloxacin hemihydrate) as the active ingredient. The tablets also contain inactive excipients in the core and a film coating. The 250 mg tablets are pink and the 500 mg tablets are orange.
Active Ingredient
The active substance is levofloxacin. Each film-coated tablet contains either 250 mg or 500 mg of levofloxacin, present as levofloxacin hemihydrate. Levofloxacin is the L-isomer (levorotatory form) of the racemic drug substance ofloxacin, and is approximately twice as potent as ofloxacin.
Inactive Ingredients (Excipients)
Tablet core: microcrystalline cellulose, hydroxypropylcellulose, crospovidone (type A), and magnesium stearate.
Film coating: hypromellose, indigotine (E132), sunset yellow FCF (E110), macrogol 4000, titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172) (the latter only in the 500 mg tablets).
Levofloxacin Krka tablets contain the colouring agent sunset yellow FCF (E110, also known as Orange Yellow S), which may cause allergic reactions in some individuals. If you have a known sensitivity to azo dyes, inform your doctor or pharmacist.
Tablet Appearance and Packaging
250 mg tablets: Pink, oblong, biconvex film-coated tablets with a score line. Dimensions: 13.7 mm x 6.7 mm, thickness 3.8 mm. The tablet can be divided into two equal halves.
500 mg tablets: Orange, oblong, biconvex film-coated tablets with a score line. Dimensions: 19.3 mm x 7.8 mm, thickness 5.0 mm. The tablet can be divided into two equal halves.
Both strengths are available in blister packs of 1, 5, 7, 10, and 14 tablets. Not all pack sizes may be marketed in every country.
What Other Brands Contain Levofloxacin?
Levofloxacin is available from multiple manufacturers worldwide. Common brand names include Tavanic (the original brand by Sanofi), Quinsair (nebuliser solution), Oftaquix (eye drops), Levofloxacin Orion, Levofloxacin Actavis, and Levonicopto. All contain the same active substance and work the same way.
Levofloxacin was originally developed and marketed by Daiichi Sankyo (later licensed to Sanofi-Aventis) under the brand name Tavanic in Europe and Levaquin in the United States. Since the expiry of the original patent, numerous generic versions have become available, making levofloxacin more widely accessible and affordable.
Common brand names for levofloxacin-containing products include:
- Tavanic – original brand (film-coated tablets and infusion solution)
- Quinsair – nebuliser solution for cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infection
- Oftaquix – eye drops for bacterial conjunctivitis and corneal ulcers
- Levofloxacin Orion – generic tablets and infusion solution
- Levofloxacin Actavis – generic tablets
- Levonicopto – generic formulation
All generic versions of levofloxacin have been approved by regulatory authorities after demonstrating bioequivalence to the original brand product. This means they contain the same active substance in the same amount and are absorbed into the body at the same rate and to the same extent, providing equivalent therapeutic effect. Your doctor or pharmacist may switch between brands depending on availability without any difference in clinical outcomes.
Frequently Asked Questions about Levofloxacin Krka
Medical References and Sources
This article is based on current medical research, approved product information, and international guidelines. All claims are supported by scientific evidence from peer-reviewed sources.
- European Medicines Agency (EMA). "Levofloxacin – Summary of Product Characteristics." EMA Product Information European approved prescribing information for levofloxacin.
- U.S. Food and Drug Administration (FDA) (2024). "FDA Drug Safety Communication: Fluoroquinolone antibiotics." FDA Safety Communication Updated safety information and black box warnings for fluoroquinolones.
- World Health Organization (WHO) (2023). "Model List of Essential Medicines – 23rd List." WHO Essential Medicines Levofloxacin included on the WHO Model List of Essential Medicines.
- British National Formulary (BNF) (2025). "Levofloxacin – Drug Monograph." BNF Online UK prescribing reference for levofloxacin dosing and interactions.
- Zhanel GG, et al. (2012). "Comparison of the next-generation aminoglycoside plazomicin to gentamicin, tobramycin and amikacin." Expert Review of Anti-infective Therapy. 10(4):459-473. Review of fluoroquinolone pharmacology and clinical applications.
- Daneman N, et al. (2015). "Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study." BMJ Open. 5(11):e010077. doi:10.1136/bmjopen-2015-010077 Evidence on collagen-related adverse events with fluoroquinolone use.
Evidence grading: This article uses the GRADE framework (Grading of Recommendations Assessment, Development and Evaluation) for evidence-based medicine. Information is sourced from approved product labelling (SmPC/PI), international guidelines, and peer-reviewed research.
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