Europe — EMA
Gray (Levofloxacin Hemihydrate)
Gray levofloxacin oral antibiotic – EU prescription drug for pneumonia, sinusitis, UTI, bronchitis, and skin infections. Learn uses, side effects, and precautions.
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What is Levofloxacin Hemihydrate?
Gray is an oral tablet containing levofloxacin hemihydrate, a fluoroquinolone antibiotic, marketed in the European Union. The product’s strength is not specified in the available data, and it is supplied as a prescription‑only medication. Levofloxacin works by inhibiting bacterial DNA gyrase and topoisomerase IV, which blocks DNA replication and transcription in susceptible bacteria. It is intended for systemic treatment of a range of bacterial infections as determined by a healthcare professional.
What is Levofloxacin Hemihydrate used for?
Gray is prescribed for the treatment of several common bacterial infections where levofloxacin is appropriate.
- Community‑acquired pneumonia - Acute bacterial sinusitis - Uncomplicated urinary tract infection - Acute exacerbation of chronic bronchitis - Skin and soft‑tissue infections
What are the side effects of Levofloxacin Hemihydrate?
Levofloxacin may cause a range of adverse effects, most of which are mild and reversible.
Common: - Nausea or vomiting - Diarrhea - Headache - Dizziness - Rash
Serious: - Tendon rupture or inflammation - Peripheral neuropathy - Severe allergic reactions such as anaphylaxis or Stevens‑Johnson syndrome - QT interval prolongation - Clostridioides difficile‑associated diarrhea
What precautions apply to Levofloxacin Hemihydrate?
Before prescribing Gray, clinicians should evaluate patient‑specific factors and potential risks associated with fluoroquinolone therapy.
- Known hypersensitivity to levofloxacin or other fluoroquinolones - History of tendon disorders or recent corticosteroid use - Renal impairment requiring dose adjustment - Pregnancy or breastfeeding status (safety not established) - Concomitant use of drugs that prolong QT interval - Patients with myasthenia gravis (may exacerbate symptoms)
What does Levofloxacin Hemihydrate interact with?
Levofloxacin can interact with other medicines, affecting efficacy or safety.
Avoid: - Antacids containing aluminum or magnesium, or iron supplements (reduce absorption) - Warfarin (increased anticoagulant effect) - Non‑steroidal anti‑inflammatory drugs (risk of CNS stimulation)
Use with caution: - Theophylline (possible increased levels) - Cyclosporine or tacrolimus (monitor concentrations) - Diabetic agents (may affect blood glucose)



