Levofloxacin Viatris 500 mg
Fluoroquinolone antibiotic for serious bacterial infections
Quick Facts About Levofloxacin Viatris
Key Takeaways
- Levofloxacin is a broad-spectrum fluoroquinolone antibiotic effective against many types of bacteria causing respiratory, urinary, and skin infections.
- This antibiotic carries serious safety warnings including risk of tendon rupture, peripheral neuropathy, and aortic aneurysm — it should only be used when safer alternatives are not available.
- Do not take with antacids, iron supplements, or zinc — these reduce absorption. Allow at least 2 hours between doses.
- Avoid sunlight exposure during treatment and for 2 days afterward due to photosensitivity risk.
- Complete the full course as prescribed even if symptoms improve — stopping early promotes antibiotic resistance.
What Is Levofloxacin Viatris and What Is It Used For?
Levofloxacin belongs to a group of medicines called quinolone antibiotics, specifically fluoroquinolones. It is the levorotatory (L-) isomer of the older antibiotic ofloxacin, making it approximately twice as potent. Levofloxacin works by inhibiting two essential bacterial enzymes — DNA gyrase (topoisomerase II) and topoisomerase IV — which are critical for bacterial DNA replication, transcription, repair, and recombination. By blocking these enzymes, levofloxacin causes bacterial DNA to break down, ultimately killing the bacteria.
Levofloxacin exhibits concentration-dependent bactericidal activity, meaning that higher concentrations relative to the minimum inhibitory concentration (MIC) of the targeted bacteria lead to faster and more effective bacterial killing. It also produces a clinically significant post-antibiotic effect, meaning that bacterial growth remains suppressed for a period even after the drug concentration falls below the MIC.
Levofloxacin Viatris may be prescribed for the following types of bacterial infections:
- Acute bacterial sinusitis — infection of the sinuses (air-filled spaces behind the forehead, cheeks, and eyes)
- Acute exacerbation of chronic bronchitis — worsening of symptoms in patients with long-standing lung disease
- Community-acquired pneumonia — lung infection acquired outside of a hospital setting
- Urinary tract infections — infections of the kidneys, bladder, or ureters, including complicated and uncomplicated forms
- Chronic bacterial prostatitis — persistent infection of the prostate gland
- Skin and soft tissue infections — infections involving the skin and underlying muscles
- Inhalational anthrax (post-exposure) — in certain special circumstances, to reduce the risk or worsening of pulmonary anthrax after confirmed or suspected exposure to Bacillus anthracis
The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have issued warnings that fluoroquinolone antibiotics, including levofloxacin, should only be used as a last resort for certain conditions (such as uncomplicated sinusitis, uncomplicated urinary tract infections, and acute exacerbation of chronic bronchitis) because the risks of serious side effects outweigh the benefits when other antibiotic options are available. Your doctor will assess whether levofloxacin is the most appropriate choice for your specific situation.
Levofloxacin has broad-spectrum activity against both Gram-positive and Gram-negative bacteria. It is particularly effective against respiratory pathogens such as Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis, as well as atypical organisms including Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae. For urinary tract infections, it covers common uropathogens such as Escherichia coli and Klebsiella pneumoniae, although increasing resistance rates in some regions may affect its effectiveness.
What Should You Know Before Taking Levofloxacin Viatris?
Contraindications
You must not take Levofloxacin Viatris if any of the following conditions apply to you. These are absolute contraindications, meaning the drug should never be used in these situations:
- Allergy to levofloxacin or other quinolones — if you have ever had an allergic reaction to levofloxacin, or to any other quinolone antibiotic such as moxifloxacin, ciprofloxacin, or ofloxacin. Signs of allergic reaction include rash, difficulty swallowing or breathing, and swelling of the lips, face, throat, or tongue.
- History of tendon disorders — if you have ever experienced tendinitis (inflammation of a tendon) or tendon rupture during previous treatment with any quinolone or fluoroquinolone antibiotic.
- Epilepsy — if you have ever been diagnosed with epilepsy or a seizure disorder.
- Children and adolescents — levofloxacin must not be given to children or growing teenagers due to the risk of damage to developing cartilage and joints.
- Pregnancy — if you are pregnant, think you may be pregnant, or are planning to become pregnant.
- Breastfeeding — if you are currently breastfeeding or planning to breastfeed.
Additionally, you should not take levofloxacin if you have previously experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone antibiotic. If this applies to you, contact your doctor as soon as possible before starting treatment.
Warnings and Precautions
Before starting treatment with Levofloxacin Viatris, inform your doctor if any of the following conditions apply to you, as they may increase your risk of experiencing serious side effects:
- Age 60 years or older — the risk of tendon damage and aortic complications increases with age
- Aortic aneurysm or dissection — if you have been diagnosed with enlargement or bulging of a large blood vessel, or have a family history of this condition
- Heart valve problems — if you have been diagnosed with leaking heart valves or have congenital heart valve disease
- Connective tissue disorders — such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren’s syndrome
- Vascular diseases — such as Takayasu’s arteritis, giant cell arteritis, Behçet’s disease, high blood pressure, or atherosclerosis
- Corticosteroid use — concurrent use significantly increases the risk of tendon inflammation and rupture
- Organ transplant recipient — transplant patients are at higher risk of tendon problems
- Seizure history — previous seizures or brain injury from stroke or other causes
- Kidney problems — dose adjustment may be necessary
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency — increased risk of severe blood problems
- Mental health conditions — any history of psychiatric illness
- Heart rhythm problems — including congenital or familial prolonged QT interval, electrolyte imbalances (especially low potassium or magnesium), bradycardia, heart failure, or previous heart attack
- Diabetes — risk of blood sugar disturbances including hypoglycemia and hyperglycemia
- Liver disease — any history of liver problems
- Myasthenia gravis — levofloxacin may exacerbate muscle weakness
Fluoroquinolones have been associated with disabling and potentially permanent serious side effects including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects. These side effects can occur within hours to weeks of starting treatment and may be irreversible. At the first sign of tendon pain, swelling, or inflammation, stop taking levofloxacin immediately, rest the affected area, and contact your doctor. If you experience burning, tingling, numbness, or weakness in your limbs, stop taking levofloxacin immediately and seek medical advice to prevent permanent nerve damage.
Pregnancy and Breastfeeding
Levofloxacin must not be used during pregnancy. Animal studies have demonstrated that fluoroquinolones can cause damage to immature cartilage and developing joints. Although controlled human studies are lacking, the potential risk to the developing fetus means that levofloxacin is absolutely contraindicated in pregnancy. If you discover that you are pregnant while taking levofloxacin, stop the medication immediately and contact your doctor, who will prescribe a safer alternative.
Levofloxacin is excreted in breast milk. Due to the potential risk of cartilage damage in the nursing infant, you must not breastfeed while taking this medicine. Your doctor will advise you on when it is safe to resume breastfeeding after completing your course of treatment.
Driving and Operating Machinery
Levofloxacin may cause side effects such as dizziness, drowsiness, vertigo, and visual disturbances. These effects can impair your concentration and reaction time. If you experience any of these symptoms, do not drive, operate heavy machinery, or engage in activities requiring mental alertness until the effects have resolved. You are individually responsible for assessing whether you are fit to perform these activities.
How Does Levofloxacin Viatris Interact with Other Drugs?
Drug interactions with levofloxacin can be clinically significant and potentially dangerous. Some interactions increase the risk of serious side effects, while others reduce the effectiveness of levofloxacin or the co-administered drug. It is essential that you inform your doctor or pharmacist about all medications you are currently taking, have recently taken, or might take, including over-the-counter medicines and supplements.
Major Interactions
| Interacting Drug | Effect | Clinical Advice |
|---|---|---|
| Corticosteroids (e.g., prednisolone, dexamethasone) | Significantly increased risk of tendinitis and tendon rupture | Avoid combination if possible. If used together, monitor closely for tendon symptoms. |
| Warfarin and other anticoagulants | Increased anticoagulant effect and risk of bleeding | Regular INR monitoring required. Dose adjustment of warfarin may be needed. |
| Theophylline | Increased risk of seizures; elevated theophylline levels | Monitor theophylline serum levels. Reduce dose if necessary. |
| NSAIDs (e.g., ibuprofen, ketoprofen) | Increased risk of central nervous system stimulation and seizures | Use with caution. Monitor for CNS side effects. |
| Ciclosporin | Increased ciclosporin blood levels and effects | Monitor ciclosporin levels closely during co-administration. |
| QT-prolonging drugs (antiarrhythmics, antipsychotics, tricyclic antidepressants, macrolide antibiotics) | Additive QT prolongation, risk of serious cardiac arrhythmias | Avoid combinations where possible. ECG monitoring if co-administered. |
Substances That Reduce Absorption
Certain substances significantly reduce the absorption of levofloxacin from the gastrointestinal tract, which can render the antibiotic ineffective. Do not take any of the following at the same time as Levofloxacin Viatris. Instead, take these products at least 2 hours before or after your levofloxacin dose:
- Antacids containing magnesium or aluminium (used for heartburn or acid reflux)
- Iron tablets (used for anaemia)
- Zinc supplements
- Didanosine (an antiviral medication)
- Sucralfate (used for stomach ulcers)
The chelation of levofloxacin by multivalent metal cations (such as aluminium, magnesium, iron, and zinc) forms insoluble complexes that cannot be absorbed from the gastrointestinal tract. This interaction is clinically significant and can result in treatment failure if the drugs are taken simultaneously.
Other Important Interactions
Probenecid and cimetidine reduce the renal clearance of levofloxacin. While this is usually not clinically significant in patients with normal kidney function, your doctor may need to adjust your levofloxacin dose if you have kidney impairment and are taking either of these medications.
Urine drug tests: Levofloxacin can cause false-positive results for opiates in urine screening tests. If your doctor has ordered a urine drug test, inform them that you are taking levofloxacin so that confirmatory testing can be arranged if needed.
Tuberculosis tests: Levofloxacin may produce false-negative results in certain laboratory tests used to detect the bacteria that cause tuberculosis (such as the QuantiFERON-TB Gold test).
What Is the Correct Dosage of Levofloxacin Viatris?
Always take Levofloxacin Viatris exactly as your doctor or pharmacist has told you. Do not change your dose without consulting your doctor. The tablets should be swallowed whole with water and can be taken with meals or between meals. The 500 mg tablet has a score line and can be divided into two equal halves if a 250 mg dose is required.
Adults and Elderly
| Infection Type | Daily Dose | Typical Duration |
|---|---|---|
| Acute bacterial 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 urinary tract infection | 250 mg once daily | 3 days |
| Complicated urinary tract infection (incl. 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 |
Children and Adolescents
Levofloxacin Viatris must not be given to children or adolescents under 18 years of age. Fluoroquinolone antibiotics have been shown to cause damage to weight-bearing joint cartilage in juvenile animals, and there is a risk of similar damage in growing children and teenagers. Your doctor will prescribe an appropriate alternative antibiotic if your child requires treatment for a bacterial infection.
Elderly and Patients with Kidney Problems
Elderly patients with normal kidney function do not require dose adjustments. However, since levofloxacin is primarily eliminated through the kidneys, patients with impaired kidney function (reduced creatinine clearance) may need a lower dose. Your doctor will determine the appropriate dose based on blood tests measuring your kidney function. Patients on dialysis may also require dose modifications. It is important that kidney function is monitored throughout treatment, particularly in elderly patients who are more likely to have age-related declines in renal function.
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 take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose. Maintaining consistent blood levels of the antibiotic is important for effective treatment.
Overdose
If you take more levofloxacin than prescribed, or if a child accidentally ingests the medication, contact your doctor, go to the nearest hospital emergency department, or call your local poison control center immediately. Symptoms of overdose may include seizures, confusion, dizziness, reduced consciousness, tremors, nausea, and heart rhythm disturbances. There is no specific antidote for levofloxacin overdose; treatment is supportive and symptomatic.
It is crucial that you complete the full course of levofloxacin as prescribed by your doctor, even if you feel better before finishing. Stopping the antibiotic prematurely may allow the infection to return, worsen your condition, or promote the development of antibiotic-resistant bacteria, which is a growing global health concern.
Protect Your Skin from Sunlight
While taking levofloxacin and for 2 days after completing treatment, you must take precautions against sun exposure. Your skin becomes significantly more sensitive to ultraviolet radiation during treatment, which can result in severe sunburn, stinging, or blistering even after brief sun exposure. Follow these protective measures:
- Use a broad-spectrum sunscreen with a high SPF (30 or higher)
- Wear a hat and clothing that covers your arms and legs
- Avoid direct sunlight during peak hours (10 AM to 4 PM)
- Do not use tanning beds or sunlamps
What Are the Side Effects of Levofloxacin Viatris?
Like all medicines, Levofloxacin Viatris can cause side effects, although not everyone experiences them. Most side effects are mild to moderate and resolve shortly after stopping treatment. However, some side effects are serious and require immediate medical attention.
A severe allergic reaction (rash, difficulty swallowing or breathing, swelling of lips/face/throat, rapid drop in blood pressure); severe tendon pain or swelling; burning, tingling, numbness or weakness in your limbs; seizures; severe skin reactions with blistering; sudden severe abdominal, chest, or back pain; or altered thoughts with risk of self-harm.
Common
May affect up to 1 in 10 people
- Insomnia (difficulty sleeping)
- Headache
- Dizziness
- Nausea, vomiting, diarrhea
- Increased liver enzyme levels in blood tests
Uncommon
May affect up to 1 in 100 people
- Fungal infection (Candida)
- Changes in white blood cell counts (leukopenia, eosinophilia)
- Anxiety, confusion, nervousness, drowsiness, tremor, vertigo
- Shortness of breath (dyspnea)
- Taste changes, loss of appetite, stomach pain, bloating, constipation
- Itching, rash, hives (urticaria), excessive sweating
- Joint or muscle pain
- Abnormal kidney function tests (elevated creatinine)
- General weakness (asthenia)
Rare
May affect up to 1 in 1,000 people
- Allergic reaction (anaphylaxis)
- Tendon inflammation and tendon rupture (especially Achilles tendon)
- Seizures (convulsions)
- DRESS syndrome (drug reaction with eosinophilia and systemic symptoms)
- Low blood sugar (hypoglycemia), potentially leading to coma in diabetic patients
- SIADH (syndrome of inappropriate antidiuretic hormone secretion)
- Low platelet count (thrombocytopenia) — easy bruising or bleeding
- Hallucinations, paranoia, depression, agitation, abnormal dreams
- Tingling in hands and feet (paresthesia)
- Tinnitus (ringing in ears), blurred vision
- Rapid heart rate (tachycardia), low blood pressure
- Muscle weakness (important for patients with myasthenia gravis)
- Kidney inflammation (interstitial nephritis)
- Fixed drug eruption
- Memory impairment
- Fever
Not Known
Frequency cannot be estimated from available data
- Stevens-Johnson syndrome and toxic epidermal necrolysis (severe skin reactions)
- Altered thoughts with risk of suicidal ideation or self-harm
- Liver failure (with symptoms of jaundice, dark urine, fever)
- Severe diarrhea (Clostridioides difficile colitis)
- Life-threatening cardiac arrhythmias including cardiac arrest, QT prolongation
- Peripheral neuropathy (burning, tingling, pain, or numbness)
- Acute pancreatitis (severe abdominal pain, nausea, vomiting)
- Vision loss, eye inflammation
- Hearing loss
- Bronchospasm (difficulty breathing, wheezing)
- Photosensitivity (severe sun sensitivity)
- Vasculitis (inflammation of blood vessels)
- Rhabdomyolysis (muscle breakdown) and muscle tears
- Aortic aneurysm and dissection
- Heart valve regurgitation
- Myoclonus (involuntary muscle jerks)
- Bone marrow failure (pancytopenia, agranulocytosis)
- Benign intracranial hypertension (persistent headache with or without blurred vision)
In very rare cases, fluoroquinolone antibiotics including levofloxacin have been associated with long-lasting (months to years) or potentially permanent side effects. These include tendon inflammation and rupture, joint pain, difficulty walking, abnormal sensations (tingling, burning, numbness), neuropathic pain, fatigue, impaired memory and concentration, depression, anxiety, sleep disturbances, and impaired hearing, vision, taste, and smell. These effects have been reported regardless of pre-existing risk factors. If you experience any of these effects, stop taking levofloxacin immediately and contact your doctor before continuing treatment.
How Should You Store Levofloxacin Viatris?
Levofloxacin Viatris tablets do not require any special storage conditions. However, for optimal stability, keep the tablets in the original blister packaging and outer carton in a dry place. This protects the tablets from moisture and light, both of which can degrade the active ingredient over time.
Keep this medicine out of the sight and reach of children at all times. Store medications in a secure location that children cannot access, as accidental ingestion of fluoroquinolones by children can cause serious adverse effects, particularly to developing joints and cartilage.
Do not use Levofloxacin Viatris after the expiry date printed on the carton and blister pack after “EXP.” The expiry date refers to the last day of that month. Expired medications may have reduced potency and should not be used.
Do not throw away any medicines via wastewater or household waste. Return unused or expired medicines to your pharmacy for safe disposal. These measures help to protect the environment and reduce the risk of antibiotic contamination of water supplies, which contributes to antimicrobial resistance.
What Does Levofloxacin Viatris Contain?
Active Ingredient
Each film-coated tablet contains 500 mg levofloxacin (as levofloxacin hemihydrate). Levofloxacin hemihydrate is the pharmacologically active S-(-)-enantiomer of the racemic drug substance ofloxacin. The hemihydrate form provides chemical stability and consistent bioavailability.
Inactive Ingredients (Excipients)
The tablet core contains microcrystalline cellulose (E 460), crospovidone (E 1202), hydroxypropyl cellulose (E 463), and magnesium stearate (E 470b). The film coating consists of hydroxypropyl cellulose (E 463), macrogol 3350, macrogol 400, and titanium dioxide (E 171). These excipients serve various pharmaceutical functions including binding, disintegration, lubrication, and coating to ensure consistent drug release and tablet integrity.
Appearance and Pack Sizes
The 500 mg tablet is white to almost white, capsule-shaped, convex, and film-coated. It is engraved with “LVO” and a score line followed by “500” on one side, and “G” with a score line followed by “G” on the other side. The score line allows the tablet to be divided into two equal halves for a 250 mg dose.
Levofloxacin Viatris is available in blister packs containing 1, 2, 3, 5, 7, 8, 10, 14, 16, 50, or 200 tablets, and in bottles containing 50 or 500 tablets. Not all pack sizes may be marketed in all countries.
The marketing authorization holder is Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland. The tablets are manufactured by McDermott Laboratories Ltd (Gerard Laboratories) in Dublin, Ireland; Mylan Hungary Kft in Komárom, Hungary; Pharma Pack Hungary Kft in Budaörs, Hungary; and Mylan Germany GmbH in Bad Homburg, Germany.
Frequently Asked Questions
Levofloxacin Viatris is a fluoroquinolone antibiotic used to treat serious bacterial infections of the sinuses, lungs (including pneumonia and acute exacerbations of chronic bronchitis), urinary tract (including kidneys and bladder), prostate, and skin and soft tissues. In specific circumstances, it may also be used to prevent or treat inhalational anthrax. Due to safety concerns, it should only be prescribed when other antibiotic options are not suitable.
The most dangerous side effects include tendon rupture (particularly the Achilles tendon), which can occur during treatment or up to several months after stopping; peripheral neuropathy causing potentially permanent nerve damage with symptoms of burning, tingling, numbness, or weakness; severe allergic reactions (anaphylaxis); life-threatening cardiac arrhythmias (QT prolongation); aortic aneurysm and dissection; and severe skin reactions such as Stevens-Johnson syndrome. If you experience any of these, stop taking the medicine immediately and seek urgent medical attention.
No, you should not take levofloxacin at the same time as antacids containing magnesium or aluminium, iron tablets, zinc supplements, didanosine, or sucralfate. These substances bind to levofloxacin in the stomach and significantly reduce its absorption, potentially making the antibiotic ineffective. You must allow at least 2 hours between taking levofloxacin and any of these products. Take your levofloxacin dose either 2 hours before or 2 hours after these other products.
No. Levofloxacin is contraindicated during pregnancy and breastfeeding. Fluoroquinolones have been shown in animal studies to cause damage to developing cartilage and joints. The drug is excreted in breast milk and poses a risk to the nursing infant. If you are pregnant, suspect pregnancy, or are breastfeeding, do not take levofloxacin. Your doctor will prescribe a safer alternative antibiotic appropriate for your condition.
Levofloxacin causes photosensitivity, making your skin much more susceptible to damage from ultraviolet (UV) radiation. Even brief sun exposure can cause severe sunburn, blistering, or painful skin reactions. This increased sensitivity lasts throughout the treatment period and for 2 days after you stop taking the medicine. To protect yourself, use sunscreen with SPF 30 or higher, wear protective clothing (including a hat, long sleeves, and long trousers), avoid direct sunlight during peak hours, and never use tanning beds or sunlamps during this period.
If you miss a dose of levofloxacin, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose entirely and continue with your regular dosing schedule. Never take a double dose to compensate for a forgotten one. Maintaining consistent drug levels in your blood is important for the antibiotic to work effectively, so try to take your doses at the same time each day.
References
- European Medicines Agency (EMA). Quinolone- and fluoroquinolone-containing medicinal products – Referral. EMA/175398/2019. Available at: ema.europa.eu.
- U.S. Food and Drug Administration (FDA). FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects. 2018. Available at: fda.gov.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd edition, 2023. Geneva: World Health Organization; 2023.
- Infectious Diseases Society of America (IDSA). Practice Guidelines for the Management of Community-Acquired Pneumonia. Clinical Infectious Diseases. 2019;68(7):e1–e48. doi:10.1093/cid/ciy745.
- British National Formulary (BNF). Levofloxacin monograph. National Institute for Health and Care Excellence (NICE). Updated 2025.
- Patel K, Goldman JL. Safety Concerns Surrounding Quinolone/Fluoroquinolone Therapy. Clinical Infectious Diseases. 2020;70(5):861–863. doi:10.1093/cid/ciz633.
- Daneman N, Lu H, Redelmeier DA. Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study. BMJ Open. 2015;5(11):e010077. doi:10.1136/bmjopen-2015-010077.
- Summary of Product Characteristics (SmPC). Levofloxacin Viatris 500 mg film-coated tablets. Viatris Limited. Last updated 2025.
Editorial Team
This article was written by iMedic’s medical editorial team, comprising licensed physicians specializing in infectious disease and clinical pharmacology. All content is based on current international guidelines and peer-reviewed research.
Reviewed by the iMedic Medical Review Board — an independent panel of medical specialists who verify clinical accuracy and adherence to evidence-based medicine principles according to the GRADE framework.
Our editorial process follows strict medical publishing standards. Every article undergoes multiple rounds of review including fact-checking against primary sources, clinical accuracy verification by specialist physicians, and regular updates to reflect the latest guidelines and safety information. We have no pharmaceutical industry funding and maintain complete editorial independence.