GNH USA

Europe — EMA

Gray

Gray levofloxacin oral antibiotic – EU prescription drug for pneumonia, sinusitis, UTI, bronchitis, and skin infections. Learn uses, side effects, and precautions.

Levofloxacin Hemihydrate

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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)

Frequently asked questions

What type of medication is Gray?+
Gray is a prescription‑only oral tablet that contains the fluoroquinolone antibiotic levofloxacin hemihydrate.
Which infections can be treated with Gray?+
Gray is indicated for community‑acquired pneumonia, acute bacterial sinusitis, uncomplicated urinary tract infections, acute exacerbations of chronic bronchitis, and skin or soft‑tissue infections.
How does levofloxacin work against bacteria?+
Levofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for DNA replication and transcription, leading to bacterial cell death.
Is Gray safe to use during pregnancy?+
The safety of levofloxacin in pregnancy has not been established; it should be used only if the potential benefit justifies the potential risk to the fetus.
What are the most common side effects of Gray?+
Common adverse effects include nausea, vomiting, diarrhea, headache, dizziness, and skin rash.
What serious adverse reactions should be reported?+
Serious reactions may include tendon rupture, peripheral neuropathy, severe allergic responses such as anaphylaxis or Stevens‑Johnson syndrome, QT prolongation, and Clostridioides difficile‑associated colitis.
Should Gray be avoided in patients with a history of tendon problems?+
Yes, patients with previous tendon disorders or those taking corticosteroids are at higher risk for tendon injury and should generally avoid fluoroquinolones like Gray.
Can Gray be taken with antacids or iron supplements?+
Antacids containing aluminum, magnesium, or iron can reduce levofloxacin absorption and should be taken at least two hours apart from Gray.
Does Gray interact with blood thinners such as warfarin?+
Levofloxacin can increase the anticoagulant effect of warfarin, so more frequent monitoring of INR is recommended when the drugs are co‑administered.
What monitoring is recommended for patients on Gray?+
Clinicians may monitor renal function, signs of tendon pain, QT interval on ECG, and for any signs of severe allergic reactions during therapy.
Is dose adjustment needed for patients with kidney impairment?+
Levofloxacin is primarily excreted by the kidneys; dose adjustment may be required in patients with reduced renal function.
Can Gray be used in children?+
Levofloxacin is generally not recommended for routine use in children unless no alternative antibiotic is available and the benefits outweigh the risks.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Levofloxacin Hemihydrate
Route
Oral Use
Manufacturer
Aurora Biofarma S.R.L
Origin
EU

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