Levofloxin-Natrapharm Warnings

Tendinopathy and Tendon Rupture: Fluoroquinolones, including levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups. This risk is further increased in older adults (usually those over 60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients. Other factors that may independently increase risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have been reported in patients receiving fluoroquinolones who did not have any of these risk factors.
Fluoroquinolone-associated tendinitis and tendon rupture most frequently involve the Achilles tendon and may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (shoulder), hand, biceps, thumb, and other tendon sites also reported.
Tendon rupture can occur during or following fluoroquinolone therapy and has been reported up to several months after completion of therapy. Advise patients to rest and refrain from exercise and contact a clinician at the 1st sign of tendinitis or tendon rupture (e.g., pain, swelling or inflammation of a tendon, or weakness or inability to use a joint). Discontinue levofloxacin if pain, swelling, inflammation or rupture of a tendon occurs.
Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions reported in patients receiving fluoroquinolones, including levofloxacin. These reactions may occur with first dose. Some hypersensitivity reactions have been accompanied by cardiovascular collapse, hypotension or shock, seizures, loss of consciousness, tingling, angioedema (e.g., edema or swelling of the tongue, larynx, throat, or face), airway obstruction (e.g., bronchospasm, shortness of breath, acute respiratory distress), urticaria, pruritus, and other severe skin reactions. In addition, other possible severe and potentially fatal reactions (may be hypersensitivity reactions or of unknown etiology) have been reported most frequently after multiple doses. These include fever, rash or other severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome), vasculitis, arthralgia, myalgia, serum sickness, allergic pneumonitis, interstitial nephritis, acute renal insufficiency or failure, hepatitis, jaundice, acute hepatic necrosis or failure, anemia (including hemolytic and aplastic), thrombocytopenia (including thrombotic thrombocytopenic purpura), leukopenia, agranulocytosis, pancytopenia and/or other hematologic effects.
Discontinue levofloxacin at first appearance of rash, jaundice, or any other sign of hypersensitivity.
Institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).