Levores Special Precautions

Ruptures of the shoulder, hand and Achilles tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones. If there is such a symptom, the drug should be withdrawn. Patients should be advised to rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been confidently excluded.
Convulsions and toxic psychoses have been reported in patients receiving quinolones, including levofloxacin. Quinolones may also cause increased intracranial pressure and central confusion, hallucinations, paranoia, depression, nightmares, insomnia, and rarely, suicidal thoughts or acts.
Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones. These reactions often occur following the 1^st dose. Some reactions have been accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat or facial edema/swelling), airway obstruction including broncho-spasm, shortness of breath, and acute respiratory distress, dyspnoea, urticaria, itching and other serious skin reactions. Levofloxacin should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of Clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of "antibiotic-associated colitis".
After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Most cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C. difficile colitis.
Use in Pregnancy & Lactation: The safety and efficacy of levofloxacin in pregnant and nursing women have not been established.
Use in Children: The safety and efficacy of levofloxacin in children, and adolescent (< 18 years) have not been established.