Europe — EMA
Monoflox (Levofloxacin Hemihydrate)
GNH USA supplies Monoflox (Levofloxacin), a fluoroquinolone antibiotic for community‑acquired respiratory, urinary and skin infections.
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What is Levofloxacin Hemihydrate?
Levofloxacin, the active ingredient in Monoflox, is a fluoroquinolone antibiotic presented as an oral tablet for oral use. It treats a range of bacterial infections in adults and children when prescribed by a healthcare professional.
GNH USA supplies Monoflox as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Levofloxacin Hemihydrate used for?
Monoflox, a fluoroquinolone antibacterial, is indicated for several common bacterial infections. - Community‑acquired respiratory tract infections: eradicates causative pathogens and improves respiratory symptoms. - Urinary tract infections: eliminates uropathogens and resolves urinary symptoms. - Skin and soft tissue infections: treats bacterial skin involvement and promotes healing. - Acute bacterial sinusitis: clears sinus infection and reduces congestion. - Acute bacterial pharyngitis: targets streptococcal organisms and relieves throat inflammation.
What are the side effects of Levofloxacin Hemihydrate?
Levofloxacin may cause a range of adverse reactions, from mild to severe.
Common Side Effects: - Nausea: mild to moderate stomach upset. - Diarrhea: loose stools, sometimes watery. - Headache: transient cranial discomfort. - Dizziness: sensation of light‑headedness. - Insomnia: difficulty falling or staying asleep. - Rash: mild skin irritation or redness.
Serious or Rare Side Effects: - Tendon rupture: sudden tendon pain or loss of function. - QT interval prolongation: potential cardiac arrhythmias. - Severe allergic reactions: swelling, breathing difficulty, or hives. - Clostridioides difficile infection: severe colitis with watery diarrhea. - Peripheral neuropathy: numbness or tingling in extremities. - Stevens‑Johnson syndrome: severe skin blistering and mucosal involvement.
What precautions apply to Levofloxacin Hemihydrate?
Before prescribing Monoflox, clinicians should consider several safety measures. - Assess renal function: adjust dose in patients with impaired kidney function. - Avoid in known hypersensitivity: discontinue if allergic reaction occurs. - Caution with QT‑prolonging risk: monitor cardiac patients closely. - Monitor for tendon pain: advise patients to stop activity if pain arises. - Avoid concomitant antacids or supplements containing aluminum, magnesium, calcium, or iron within two hours of dosing. - Store at room temperature: keep in the original container, protect from moisture and direct sunlight.
What does Levofloxacin Hemihydrate interact with?
Levofloxacin can interact with several medicines, altering efficacy or safety.
Major Interactions (Avoid): - Antacids or sucralfate: reduce levofloxacin absorption; separate dosing by at least two hours. - Warfarin: may increase INR and bleeding risk; monitor coagulation parameters. - Theophylline: elevated plasma levels can cause toxicity; adjust theophylline dose. - Antidiabetic agents: may enhance hypoglycaemic effect; monitor blood glucose. - Certain antiarrhythmics (e.g., quinidine): increase risk of QT prolongation.
Moderate Interactions (Monitor Closely): - NSAIDs: heightened risk of central nervous system stimulation. - Corticosteroids: increased chance of tendon disorders. - Oral contraceptives: possible reduction in contraceptive effectiveness; advise backup method.



