This medication is an antibiotic given by vein (IV) to treat certain bacterial infections when medications taken by mouth can't be used. This medication is known as a macrolide (erythromycin-type) antibiotic. It works by stopping the growth of bacteria. This medication is used to treat lung infections (pneumonia) or female pelvic infections (e.g., PID) caused by bacteria.

This antibiotic treats only bacterial infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for other types of bacterial infections.

This medication is mixed in the correct fluid and given slowly into a vein by a health care professional, usually once daily over at least 60 minutes. Follow all instructions for proper mixing, dilution, and use. Consult your pharmacist if you are unclear on any instructions. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Do not inject the medication undiluted into a vein. Do not inject this medication into a muscle or under the skin. Do not mix azithromycin with other medications in the same IV fluid or give with other medications into the same vein at the same time.

You should use this injectable medication only until you are able to take an antibiotic by mouth or until your treatment is finished. Dosage and length of treatment are based on your medical condition and response to therapy.

Antibiotics work best when used regularly. Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, resulting in a return of the infection.

Notify your doctor if your condition/symptoms do not improve or if they worsen.

Nausea, vomiting, diarrhea/loose stools, stomach pain, or pain/redness at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: hearing changes (e.g., ringing in the ears, hearing loss), swelling legs/feet, eye problems (e.g., drooping eyelids, blurred vision), slurred speech, muscle weakness.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches/sores in your mouth, a change in vaginal discharge, or other new symptoms.

Tell your doctor immediately if any of these rare but serious side effects occur: persistent nausea/vomiting, severe abdominal/stomach pain, unusual weakness/tiredness, change in the amount of urine, dark urine, yellowing skin/eyes.

Seek immediate medical attention if any of these rare but serious side effects occur: severe dizziness, fainting, fast/irregular heartbeat.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

An allergic reaction to this medication may return even if you stop the drug. If you have an allergic reaction, continue to watch for any of the above symptoms for several days after your last dose.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using azithromycin, tell your doctor or pharmacist if you are allergic to it; or to any other macrolide/ketolide antibiotics (e.g., clarithromycin, erythromycin); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, a certain muscle disease (myasthenia gravis).

Azithromycin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using azithromycin, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using azithromycin safely.

This medication contains sodium. Consult your doctor for more information if you are on a salt-restricted diet or if increased salt intake could worsen your condition (e.g., congestive heart failure).

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially swelling legs/feet (due to sodium and water retention).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: digoxin, live bacterial vaccines, lovastatin, nelfinavir, warfarin.

This medication may decrease the effectiveness of combination-type birth control pills. This can result in pregnancy. You may need to use an additional form of reliable birth control while using this medication. Consult your doctor or pharmacist for details.

Many drugs besides azithromycin may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, and propafenone, among others. Therefore, before using azithromycin, report all medications you are currently using to your doctor or pharmacist.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Laboratory and/or medical tests may be performed to monitor for side effects and response to treatment.

If the dose is missed, contact your doctor immediately to establish a new dosing schedule.

For the US product, store the unmixed medication vial at 68-77 degrees F (20-25 degrees C) away from light and moisture. After mixing and dilution in IV fluids, this product is stable at or below 86 degrees F (30 degrees C) for 24 hours. When stored in the refrigerator at 41 degrees F (5 degrees C), the mixed product is stable for 7 days. Discard any unused liquid.

For the Canadian product, store the unmixed medication vial at 59-86 degrees F (15-30 degrees C) away from light and moisture. After mixing and dilution in IV fluids, this product is stable at or below 86 degrees F (30 degrees C) for 24 hours. When stored in the refrigerator at 41 degrees F (5 degrees C), the mixed product is stable for 3 days. Discard any unused liquid.

Keep all medicines out of reach of children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2009 Copyright(c) 2009 First DataBank, Inc.