Azithromycin Tablets

GENERIC NAME: AZITHROMYCIN (ay-ZITH-roe-MYE-sin)

COMMON USES: This medicine is a macrolide antibiotic used to treat infections caused by certain bacteria. It may also be used for other conditions as determined by your doctor.

BEFORE USING THIS MEDICINE: Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking dofetilide, nilotinib, propafenone, pimozide or tetrabenazine. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking antiarrhythmics (eg, disopyramide), anticoagulants (eg, warfarin)arsenic, astemizole, bepridil, carbamazepine, chloroquine, cisapride, cyclosporine, digoxin, dolasetron, domperidone, droperidol, ergot alkaloids (eg, ergotamine), halofantrine, haloperidol, histone deacetylase inhibitors (eg, romidepsin), lithium, maprotiline, methadone, nelfinavir, paliperidone, pentamidine, phenothiazines (eg, thioridazine), phenytoin, quinolones (eg, levofloxacin), rifamycins (eg, rifampin), terfenadine, theophylline, triazolam, tricyclic antidepressants (eg, amitriptyline), tyrosine kinase inhibitors (eg, dasatinib), ziprasidone, or medicines that may affect your heartbeat. Ask your doctor if you are unsure if any of the medicines you are taking may affect your heartbeat. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including irregular heartbeat, kidney problems, liver problems, myasthenia gravis, allergies, pregnancy or breastfeeding. USE OF THIS MEDICINE IS NOT RECOMMEIIDED if you have a history of liver problems or yellowing of the skin or eyes caused by any dose form (eg, tablets, suspension, injection) of this medicine. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

HOW TO USE THIS MEDICINE: Follow the directions for using this medicine provided by your doctor. This medicine may be taken on an empty stomach or with food. THIS MEDICINE MAY BE TAKEN WITH FOOD if it upsets your stomach. DO NOT TAKE AN ANTACID that has aluminum or magnesium in it within 1 hour before or 2 hours after you take this medicine. STORE THIS MEDICINE between 59 and 86 degrees F (15 and 30 degrees C), away from heat, moisture, and light. KEEP THIS MEDICINE out of the reach of children and away from pets. TO CLEAR UP YOUR INFECTION COMPLETELY, continue taking this medicine for the full course of treatment even if you feel better in a few days. The bacteria could also become less sensitive to this or other medicines if you do not take this medicine for the full course of treatment. Do not miss any doses. Taking this medicine at the same time each day will make it easier to remember. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. If you miss a dose, do not take 2 doses at once.

CAUTIONS: DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it, to other macrolide antibiotics (eg, erythromycin), to ketolide antibiotics (eg, telithromycin), or if you are allergic to any ingredient in this product. An allergic reaction includes a severe rash, hives, breathing difficulties, or dizziness. If you have a question about whether you are allergic is to this medicine, a macrolide, or a ketolide, contact your doctor or pharmacist. IF YOU EXPERIENCE difficulty breathing, tightness of chest, swelling of eyelids, face, or lips, or if you develop a rash or hives tell your doctor immediately. Do not take any more of this medicine unless your doctor tells you to do so. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. This medicine may cause drowsiness, dizziness, blurred vision or lightheadedness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you k how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. THIS MEDICINE MAY CAUSE increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to this medicine. Use a sunscreen or protective clothing if you must be outside for a prolonged period. MILD DIARRHEA IS COMMON with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or blood or watery stools occur. Do not treat diarrhea without first checking with your doctor. SEVERE AND SOMETIMES FATAL LIVER PROBLEMS have been reported with the use of this medicine. Contact your doctor immediately if you develop symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pales stools; severe or persistent nausea, vomiting, or loss of appetite; unusual itching). Discuss any questions or concerns with your doctor. LONG-TERM 0R REPEATED USE OF THIS MEDICINE may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this. THIS MEDICINE ONLY WORKS against bacteria; it does not treat viral infections (eg, the common cold). BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT discuss with your doctor the benefits and risks of using this medicine during pregnancy. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include diarrhea or loose stools, headache, mild stomach pain, nausea, upset stomach, or vomiting. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience bloody or watery stools, changes in hearing or hearing loss, chest pain, difficulty swallowing or speaking, eye or vision problems, irregular heartbeat, muscle weakness, pounding in the chest, red, blistered, peeling, or swollen skin, ringing in the ears, seizures, severe or persistent diarrhea, stomach cramps/pain, symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, severe or persistent nausea, vomiting, or loss of appetite, unusual itching), or unusual vaginal itching, odor, or discharge. An allergic reaction to this medium is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, hives, itching, difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue, or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include nausea, vomiting, stomach upset, and diarrhea.

ADDITIONAL INFORMATION: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.

The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.