LORATADINE ORAL (CLARITIN) PROMETHAZINE SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PHENERGAN IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS. CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PHENERGAN BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED. BEFORE USING THIS MEDICINE: Tell your doctor if you are having any of the following conditions: TOP PROSTATE problem; GLAUCOMA; PEPTIC ULCER; LIVER PROBLEMS; KIDNEY DISEASE; ASTHMA; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD); LACTOSE INTOLERANCE. * 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. * Swallow whole, unless otherwise directed by your physician. DO NOT crush or chew sustained release preparations. WARNINGS/PRECAUTIONS: TOP * STOP TAKING MEDICINE & GET EMERGENCY HELP IMMEDIATELY IF A HYPERSENSITIVITY OR ANAPHYLACTIC REACTION occurs: (see symptoms below):- * shortness of breath, fast or irregular breathing, fever, joint pain, fast pulse, lightheadedness or fainting, swelling of face, hives, & itching. * There are no adequate or well-controlled safety studies in pregnant women. NOTIFY YOUR DOCTOR IF PREGNANT or intend to become pregnant. * This medicine may cause drowsiness, dizziness, or blurred vision. DO NOT drive or operate machines until you know how you react to this medicine. * AVOID concurrent use of alcohol or other CNS depressants as it may intensify the drowsiness, dizziness, or lightheadedness effect of this medicine. * Because of INTERACTIONS, report the use of any other prescription or nonprescription medicines, including natural/herbal remedies, to your doctor. * The results of some MEDICAL or LAB tests may be affected by this medicine. Inform the doctor in charge that you are taking this medicine. * This medicine may cause increased sensitivity to the sun. You should AVOID prolonged or excessive exposure to direct and/or artificial sunlight. ADVERSE REACTIONS: Stop taking this medicine and get emergency help IMMEDIATELY if you experience: Shortness of breath, fast or irregular breathing, fever, joint pain, fast pulse, lightheadedness or fainting, swelling of face, hives, & itching. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: Low blood pressure; Blurred vision; Difficult urination. Other Common Side Effects: TOP Headache; Drowsiness; Sleepiness; Unusual tiredness or weakness; Dry throat; Dry mouth; High blood pressure; Anxiety; Depression; Difficulty breathing; Joint pain; Nasal dryness; Irregular heartbeat; Sweating. 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. 09/10. All rights reserved