LINEZOLID ORAL (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 HEART CONDITION or HIGH BLOOD PRESSURE; THYROID problem; DEPRESSION. * 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 can be taken with or without food, REGARDLESS of meal times. If stomach upset occurs, take with food. * Use this medicine for the full prescribed treatment period. * LIQUID: Before each dose, invert bottle 3-5 times. DO NOT SHAKE. 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. * Do not take for at least 14 days following the discontinuation of an MAOI. Also 14 days should be allowed after stopping it before starting an MAOI. * 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. * It is important that your doctor monitors your BLOOD CELL COUNTS at regular intervals. * If ANEMIA and/or LOW BLOOD CELL COUNT develops, dosage modification or possible discontinuation may be necessary. 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; Difficulty falling asleep; Constipation; Skin rash; Dizziness; Fever; Change in taste; Indigestion; Itching; Stomach discomfort or pain; Vomiting. 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