"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"...
Trovan - Zithromax
Patients should be advised:
- that TROVAN Tablets may be taken without regard to meals;
- that vitamins or minerals containing iron, aluminum- or magnesium-base antacids, antacids containing citric acid buffered with sodium citrate, sucralfate or Videx® (Didanosine)chewable/buffered tablets, buffered powder for oral solution, or pediatric powder for oral solution, should be taken at least two hours before or two hours after taking TROVAN Tablets. (See PRECAUTIONS: DRUG INTERACTIONS.);
- that TROVAN may cause lightheadedness and/or dizziness. Dizziness and/or lightheadedness was the most common adverse reaction reported, and for females under 45 years, it was reported significantly more frequently than in other groups. The incidence of dizziness may be substantially reduced if TROVAN Tablets are taken at bedtime or with food. Patients should know how they react to trovafloxacin before they operate an automobile or machinery or engage in activities requiring mental alertness and coordination. (See WARNINGS and ADVERSE REACTIONS.);
- that TROVAN®/Zithromax® Compliance Pak (trovafloxacin and azithromycin) has been associated with nausea, vomiting, and diarrhea within 2 hours of administration. Nausea was the most common adverse event, seen in 10/20 (50%) of participants in a pharmacokinetic trial, followed by abdominal pain seen in 5/20 (25%) of the study subjects.
- 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 tendinitis or tendon rupture has been confidently excluded;
- that TROVAN may be associated with hypersensitivity reactions, even following the first dose, and to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, difficulty in swallowing or breathing, any swelling suggesting angioedema (e.g., swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction. (See WARNINGS and ADVERSE REACTIONS.);
- to avoid excessive sunlight or artificial ultraviolet light (e.g., tanning beds) while taking TROVAN and to discontinue therapy if phototoxicity (e.g., sunburn-like reaction or skin eruption) occurs;
- that ZITHROMAX® for oral suspension in single 1-g packets can be taken with or without food after constitution;
- that they should not take aluminum- and magnesium-containing antacids and azithromycin simultaneously;
- that they should discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur.
Last reviewed on RxList: 10/3/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Trovan - Zithromax 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.