LINEZOLID INJ (ZYVOX) ANTIBIOTIC ASSOCIATED COLITIS: Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to lifethreatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of any antibacterial agent. 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 the primary cause of "antibiotic-associated colitis." After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild 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 Clostridium difficile colitis. BEFORE USING THIS MEDICINE: Tell your doctor if you are having any of the following conditions: TOP THYROID problem; DEPRESSION; HEART CONDITION or HIGH BLOOD PRESSURE. * Inform your Doctor or Pharmacist if you are allergic to any prescription or non-prescription medicine; taking other medicines or have other medical problems; pregnant, planning a pregnancy, or breastfeeding. * Check with your Doctor, Pharmacists, or Nurse if information in this leaflet causes you special concern or if you want additional information about your medicine and its use. HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * This medicine is administered only by or under the supervision of your doctor. * Your doctor should check your progress at REGULAR VISITS to make sure this medicine is working properly and to check for unwanted effects. * Use this medicine for the full prescribed treatment period. WARNINGS/PRECAUTIONS: TOP * Safety of use during pregnancy has not been established. This medicine SHOULD NOT BE USED DURING PREGNANCY unless benefit justifies potential risk to the fetus. CALL YOUR DOCTOR. * If DIARRHEA develops/persists and is severe or lasts more than 2 or 3 days, call your doctor. * To prevent drug resistance, this medication should be used to treat BACTERIAL INFECTIONS ONLY. It is not effective against viral infections. * Do not eat foods with high TYRAMINE content (aged cheese, red wine, herring, soy sauce) while taking and for 2 weeks after stopping this medicine. * MAY INCREASE the effects of blood-thinning medications (including ASPIRIN, NSAIDS, COUMADIN, etc..). * Inform doctor or dentist that you are taking this medicine BEFORE HAVING ANY KIND OF SURGERY including dental surgery or medical procedure. * Because of INTERACTIONS, report the use of any other prescription or nonprescription medicines, including natural/herbal remedies, to your doctor. * If ANEMIA and/or LOW BLOOD CELL COUNT develops, dosage modification or possible discontinuation may be necessary. ADVERSE REACTIONS: Stop taking this medicine and get emergency help IMMEDIATELY if you experience: Supression of blood cell production. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: High blood pressure; Unusual bleeding or bruising; Vaginal fungal infections. Other Common Side Effects: TOP Diarrhea; Headache; Nausea; Constipation; Dizziness; Change in taste; Itching; Stomach discomfort or pain; Difficulty falling asleep; Indigestion; Vomiting; Skin rash. Other Common Side Effects: If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients. Copyright © CliniDATA Source, Inc. 03/14. All rights reserved