AZITHROMYCIN I.V. 500 MG VIAL

USES: This medication is an antibiotic used to treat certain bacterial infections. 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.

Indications : inflammatory disease of female pelvic organs, Chlamydia trachomatis pelvic inflammatory disease, pelvic inflammatory disease with Neisseria gonorrhea, Mycoplasma hominis pelvic inflammatory disease, pediatric fever without a source, chlamydial pneumonia, bacterial infection, pneumococcal pneumonia, Haemophilus influenzae pneumonia, pneumonia due to Staphylococcus aureus, Legionella pneumophila pneumonia, Moraxella catarrhalis pneumonia, bacterial pneumonia, mycoplasmal pneumonia

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.

SIDE EFFECTS: 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 this medication has been prescribed because your doctor 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 right away 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), trouble speaking, muscle weakness, persistent nausea/vomiting, severe abdominal/stomach pain, unusual weakness/tiredness, dark urine, yellowing skin/eyes. 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. Get medical help right away 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 due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool. If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse. 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: fever that doesn't go away, new or worsening lymph node swelling, 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

HOW TO USE: This medication is usually given by injection into a vein as directed by your doctor, usually once daily. It should be injected slowly over 1 hour. If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely. 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. For the best effect, use this antibiotic at evenly spaced times. To help you remember, use this medication at the same time(s) every day. 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, which may result in a return of the infection. Tell your doctor if your condition persists or worsens.

PRECAUTIONS: 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. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. 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 rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using azithromycin, tell your doctor or pharmacist of all the drugs you take and 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). Azithromycin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using azithromycin before having any immunizations/vaccinations. Older adults may be more sensitive to the side effects of this drug, especially swelling legs/feet (due to sodium and water retention) and QT prolongation (see above). Babies (especially younger than 6 weeks) may be at higher risk for a certain serious stomach problem. Contact your child's doctor right away if your child vomits or becomes irritable with feeding. 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.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: lovastatin. Many drugs besides azithromycin may affect the heart rhythm (QT prolongation), including amiodarone, chloroquine, disopyramide, dofetilide, dronedarone, hydroxychloroquine, ibutilide, pimozide, procainamide, quinidine, sotalol, among others.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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