Levomax 500 mg/100 mL solution for infusion – levofloxacin for serious bacterial infections

Levomax contains levofloxacin, an antibiotic from the fluoroquinolone group, as a 500 mg/100 mL solution for infusion (100 mL bag). The medicine kills the bacteria that caused the infection.

Levomax is a hospital medicine: it is dispensed on restricted prescription and given only in hospital as an intravenous infusion by a doctor or nurse. After a few days of infusion the doctor may switch to tablets of the same medicine.

What is Levomax used for and how is it given in hospital?

Key facts about the medicine

What is Levomax used for?

According to the SmPC, in adults for the treatment of:

• acute pyelonephritis and complicated urinary tract infections;
• chronic bacterial prostatitis;
• inhalational anthrax – post-exposure prophylaxis and treatment.

In community-acquired pneumonia and complicated skin and soft tissue infections Levomax is used only when the antibiotics usually recommended are considered inappropriate. Official guidance on the appropriate use of antibiotics should be taken into account.

How is Levomax given and dosed?

• The medicine is given by a doctor or nurse as an intravenous infusion; a 500 mg infusion lasts at least 60 minutes, with monitoring of heart function and blood pressure (the infusion is stopped if blood pressure falls markedly).
• Adults and elderly: pneumonia – 500 mg once or twice daily; urinary tract infections – 500 mg once daily; prostate infection – 500 mg once daily; skin and soft tissue infections – 500 mg once or twice daily.
• Kidney disease: the doctor gives a lower dose.
• Duration depends on the severity of infection; after a few days the doctor may switch to levofloxacin tablets.
• The solution may be given alone or with 0.9% NaCl, 5% glucose or 2.5% glucose in Ringer’s solution; it is not mixed with sodium bicarbonate or heparin.

Special patient groups

• Growing children and adolescents: must not be used.
• Over 60 years: higher risk of tendon damage and rhythm disorders.
• Kidney impairment: lower dose.
• Sodium-controlled diet: 100 mL of solution contains 354.2 mg sodium.

Contraindications – when the medicine must not be used

• allergy to levofloxacin, other quinolones (moxifloxacin, ciprofloxacin, ofloxacin) or the excipients;
• epilepsy (including previous seizures);
• previous tendon problems (e.g. tendinitis) related to quinolone antibiotics;
• children and growing adolescents;
• pregnancy, suspected or planned pregnancy; breast-feeding.
• It must not be used if you have previously had a serious adverse reaction to any quinolone or fluoroquinolone.

Warnings and precautions

• age 60 and over, organ transplant, corticosteroid treatment, kidney disease – higher risk of tendon inflammation and rupture (possible within the first 48 hours and up to several months after treatment);
• previous seizures, brain damage after stroke or injury, mental health problems;
• glucose-6-phosphate dehydrogenase deficiency; diabetes (risk of hypo- and hyperglycaemia); liver disease; myasthenia gravis; peripheral neuropathy;
• heart problems and prolonged QT interval, low potassium or magnesium, slow heart rate, heart failure, previous heart attack; female sex and older age increase the risk;
• aortic aneurysm or dissection (also in the family), leaking heart valves, Marfan or Ehlers-Danlos syndrome, Turner or Sjögren syndrome, vasculitis, high blood pressure, atherosclerosis, rheumatoid arthritis, endocarditis;
• serious skin reactions (SJS, TEN, DRESS, AGEP) – in case of blistering rash, peeling skin or mouth ulcers stop the medicine and contact a doctor immediately;
• very rare long-lasting and potentially permanent reactions: tendon, muscle and joint pain, tingling and numbness, disturbances of vision, taste, smell and hearing, depression, memory impairment, severe fatigue, sleep disorders – contact your doctor before continuing treatment.

Interactions with other medicines, food and drink

• Corticosteroids – higher risk of tendon inflammation and rupture.
• Warfarin – higher risk of bleeding; regular clotting tests.
• Theophylline and NSAIDs (aspirin, ibuprofen, ketoprofen, indometacin) – greater likelihood of seizures.
• Ciclosporin – more frequent ciclosporin side effects.
• Medicines affecting heart rhythm: antiarrhythmics (quinidine, sotalol, amiodarone etc.), tricyclic antidepressants, antipsychotics, macrolides (erythromycin, azithromycin, clarithromycin).
• Probenecid and cimetidine – in kidney disease the doctor may lower the dose.
• Levofloxacin may give a false-positive urine test for opiates and a false-negative test for tuberculosis.

Pregnancy and breast-feeding

• The medicine must not be used during pregnancy, if pregnancy is suspected or planned, or during breast-feeding.

Driving and using machines

• Dizziness, drowsiness, vertigo or changes in vision may occur and affect concentration and reaction speed – if so, do not drive or use machines.

Possible side effects

• Common: sleep problems, headache, dizziness, nausea, vomiting, diarrhoea, raised liver enzymes.
• Uncommon: fungal infections (candida), changes in white blood cell counts, anxiety, confusion, nervousness, drowsiness, tremor, shortness of breath, taste changes, loss of appetite, indigestion, stomach pain, bloating, constipation, itching, rash, hives, sweating, joint and muscle pain, general weakness.
• Rare: watery or bloody diarrhoea, tendon pain and inflammation (most often Achilles) up to rupture, seizures, hallucinations, depression, nightmares, DRESS, SIADH, hypoglycaemia, tingling, tinnitus, blurred vision, fast heartbeat, low blood pressure, muscle weakness, interstitial nephritis, low platelet and neutrophil counts.
• Not known: serious skin reactions (SJS, TEN, AGEP), liver damage, psychotic reactions, pancreatitis, photosensitivity, QT prolongation and dangerous rhythm disorders, aortic aneurysm and dissection, loss of hearing, vision, taste or smell, rhabdomyolysis, hyperglycaemia, myoclonus.
• Specific to infusion (common): reaction at the infusion site, inflammation of the vein.

Overdose, missed dose and stopping treatment

• Overdose: unlikely, as the medicine is given by medical staff; symptoms may include seizures, confusion, light-headedness, reduced consciousness, tremor, heart rhythm problems and vomiting.
• Missed dose: if you think a dose has been missed, tell the doctor or nurse.
• Stopping: treatment continues even when you feel better – stopping too early may bring the infection back and cause resistance.
• Sun protection: avoid direct sun and sunbeds during treatment and for 2 days afterwards.

Related information

Levomax is used only in hospital, according to the doctor’s assessment. For questions about treatment, ask your treating doctor or hospital pharmacist.

Composition, pack and manufacturer

• Active substance: levofloxacin 500 mg in 100 mL (5 mg/mL, as levofloxacin hemihydrate).
• Excipients: sodium chloride; sodium hydroxide 0.1 N; hydrochloric acid 1 N; water for injections.
• Appearance: clear, greenish-yellow solution in a 100 mL LDPE bag with InsoCap closure.
• Pack: 10 bags of 100 mL.
• Marketing authorisation holder: Beohem-3 d.o.o., Trstenjakova 9, Belgrade – Rakovica; manufacturer: PharmaSwiss d.o.o., Batajnički drum 5A, Belgrade.
• Authorisation: 003146121 2025 of 09.04.2026.

Storage

• No special temperature storage conditions; store in the original package to protect from light (no protection needed during the infusion itself).
• Use immediately after opening; after dilution chemical stability has been shown for up to 8 hours at up to 25 °C, but the solution should be used immediately.
• Do not use if the solution is not clear and greenish-yellow or contains visible particles.

Frequently asked questions

Can Levomax be bought in a pharmacy?

No. Levomax is a solution for infusion dispensed on restricted prescription and used only in hospital.

How long does the infusion take?

A 500 mg infusion lasts at least 60 minutes, with monitoring of heart function and blood pressure.

Is there a switch to tablets after the infusion?

After a few days of infusion therapy the doctor may decide that you finish treatment with tablets of the same medicine (levofloxacin).

Which side effects should be reported immediately?

Tendon pain or swelling, tingling and numbness, sudden severe pain in the abdomen, chest or back, serious rash, watery or bloody diarrhoea, palpitations or fainting.

Sources

• ALIMS – Package leaflet Levomax (PIL, Serbian, 04/2026)
• ALIMS – Summary of product characteristics Levomax (SmPC, Serbian)

Date sources were checked: 25.10.2026.