ABACAVIR ORAL (ZIAGEN) * Stop using abacavir and call your doctor at once if you have any of these signs of an allergic reaction: fever; rash; nausea, vomiting, diarrhea, stomach pain; general tiredness, body aches; shortness of breath, cough, sore throat. * Once you have had an allergic reaction to abacavir, you must never use it again. * You may need a blood test before you start taking abacavir for the first time, or if you are restarting the medication after stopping for reasons not related to an allergic reaction. * Do not allow this medicine to run out completely before you get your prescription refilled. If you miss several doses in a row, you could have a dangerous or even fatal allergic reaction when you start taking abacavir again. If you stop taking abacavir for any reason, talk to your doctor before you start taking the medication again. * Abacavir may cause lactic acidosis (the build up of lactic acid in the body). Lactic acidosis can start slowly and gradually get worse. Symptoms include unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Contact your doctor at once if you have any of these symptoms, even if they are only mild. Early signs of lactic acidosis generally get worse over time and this condition can be fatal. * Abacavir can also cause severe or life-threatening effects on the liver . Call your doctor at once if you have any of these liver symptoms while taking abacavir: nausea, stomach pain, loss of appetite, low fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). BEFORE USING THIS MEDICINE: Tell your doctor: TOP If you are PREGNANT. Tell your doctor if you are having any of the following conditions: TOP HIGH CHOLESTEROL; LIVER PROBLEMS. * 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. * Patient should read specific "MEDICATION GUIDE" provided with this medicine before starting treatment and each time their prescription is renewed. * This medicine is NOT A CURE. Patients need long-term management. * Use this medicine for the full prescribed treatment period. * Your doctor should check your progress at REGULAR VISITS to make sure this medicine is working properly and to check for unwanted effects. * Notify physician if symptoms do not improve, or if they become worse. WARNINGS/PRECAUTIONS: TOP * STOP TAKING MEDICINE & GET EMERGENCY HELP IMMEDIATELY IF A HYPERSENSITIVITY OR ANAPHYLACTIC REACTION occurs: (see symptoms below):- * 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. * SYMPTOMS OF HYPERSENSITIVITY (eg, fever, rash, itching, difficulty breathing, vision problems, fatigue, nausea, vomiting, diarrhea, abdominal pain). * Taking this medicine does not eliminate the risk of TRANSMISSION OF INFECTION to others through sexual contact or blood contamination. * LACTIC ACIDOSIS is a medical EMERGENCY that must be treated in a hospital setting. STOP taking the drug and seek emergency treatment immediately. * Notify doctor IMMEDIATELY of symptoms of LACTIC ACIDOSIS (malaise, muscle pain, respiratory distress, increased sleepiness, & abdominal distress). * Pediatric: The appropriate dosing and safety have not been established below the age of 13 years old. * Patients with Hepatic Impairment: Contraindicated for use in patients with hepatic impairment. * You should not breast feed if you are HIV-positive because of the chance of passing the HIV virus to your baby. 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; Skin rash; Fever; Difficulty breathing; Feeling of general discomfort; Inflammation of the pharynx. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: Cough. Other Common Side Effects: TOP Nausea; Vomiting; Diarrhea; Difficulty falling asleep; Decreased appetite; Lactic acidosis; High triglycerides level; Fat redistribution; Severe skin reactions. 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