"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(Generic versions may still be available.)
Patients should be advised:
- to avoid exposure to direct or indirect sunlight (including through glass, while using sunscreens and sunblocks, reflected sunlight, and cloudy weather) and exposure to artificial ultraviolet light (e.g., sunlamps) during treatment with sparfloxacin and for five days after therapy. If brief exposure to the sun cannot be avoided, patients should cover as much of their skin as possible with clothing;
- to discontinue sparfloxacin therapy at the first sign or symptom of phototoxicity reaction such as a sensation of skin burning, redness, swelling, blisters, rash, itching or dermatitis;
- that a patient who has experienced a phototoxic reaction with sparfloxacin should also be advised to avoid further exposure to sunlight and artificial ultraviolet light until the phototoxicity reaction has resolved and he or she has completely recovered from the reaction or for five days whichever is longer. In rare cases, reactions have recurred up to several weeks after stopping sparfloxacin therapy;
- that sparfloxacin may cause neurologic adverse effects (e.g., dizziness, lightheadedness) and that patients should know how they react to sparfloxacin before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination. (See WARNINGS and ADVERSE REACTIONS.);
- to discontinue treatment and inform their physician if they experience pain, inflammation, or rupture of a tendon, and to rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been confidently excluded;
- that sparfloxacin can be taken with food or milk or caffeine-containing products;
- that mineral supplements or vitamins with iron, or zinc, or calcium may be taken 4 hours after sparfloxacin administration;
- that sucralfate or magnesium- and aluminum-containing antacids or Videx® (Didanosine), chewable/buffered tablets or the pediatric powder for oral solution may be taken 4 hours after sparfloxacin administration. (See PRECAUTIONS: DRUG INTERACTIONS.);
- that sparfloxacin may be associated with hypersensitivity reactions, even following the first dose, and to discontinue the drug at the first sign of a skin rash or other allergic reaction;
- to drink fluids liberally;
- that convulsions have been reported in patients taking quinolones, including sparfloxacin, and to notify their physician before taking this drug if there is a history of this condition.
Last reviewed on RxList: 4/7/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Zagam Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.