Zithromax Injection

DRUG DESCRIPTION

ZITHROMAX (azithromycin for injection) contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, for intravenous injection. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O -methyl-?-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-?-D-xylo-hexopyranosyl]oxy]-1-oxa- 6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.00. Azithromycin has the following structural formula:

ZITHROMAX® (azithromycin for injection) Structural Formula Illustration

Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12• 2H2O and a molecular weight of 785.0.

ZITHROMAX (azithromycin for injection) consists of azithromycin dihydrate and the following inactive ingredients: citric acid and sodium hydroxide. ZITHROMAX (azithromycin for injection) is supplied in lyophilized form in a 10-mL vial equivalent to 500 mg of azithromycin for intravenous administration. Reconstitution, according to label directions, results in approximately 5 mL of ZITHROMAX for intravenous injection with each mL containing azithromycin dihydrate equivalent to 100 mg of azithromycin.

What are the possible side effects of azithromycin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • diarrhea that is watery or bloody;
  • chest pain, uneven heartbeats;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin...

Read All Potential Side Effects and See Pictures of Zithromax Injection »

What are the precautions when taking azithromycin (Zithromax Injection)?

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 infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate...

Read All Potential Precautions of Zithromax Injection »


Zithromax Injection Consumer (continued)

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 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, persistent nausea/vomiting, severe abdominal/stomach pain, unusual weakness/tiredness, change in the amount of urine, 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 (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.

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 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.


Zithromax Injection Patient Information Including Side Effects

Brand Names: Azithromycin 3 Day Dose Pack, Azithromycin 5 Day Dose Pack, Zithromax, Zithromax TRI-PAK, Zithromax Z-Pak, Zmax

Generic Name: azithromycin (Pronunciation: a ZITH roe MYE sin)

  • What is azithromycin (Zithromax Injection)?
  • What are the possible side effects of azithromycin?
  • What is the most important information I should know about azithromycin?
  • What should I discuss with my healthcare provider before taking azithromycin?
  • How should I take azithromycin?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking azithromycin?
  • What other drugs will affect azithromycin?
  • Where can I get more information?

What is azithromycin (Zithromax Injection)?

Azithromycin is in a group of drugs called macrolide antibiotics. Azithromycin fights bacteria in the body.

Azithromycin is used to treat many different types of infections caused by bacteria, such as respiratory infections, skin infections, ear infections, and sexually transmitted diseases.

Azithromycin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of azithromycin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • diarrhea that is watery or bloody;
  • chest pain, uneven heartbeats;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea, constipation;
  • stomach pain or upset;
  • dizziness, tired feeling, or headache;
  • nervous feeling, sleep problems (insomnia);
  • vaginal itching or discharge;
  • mild itching or skin rash;
  • ringing in your ears, problems with hearing; or
  • decreased sense of taste or smell.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about azithromycin?

Do not use this medication if you have ever had an allergic reaction to azithromycin or similar drugs such as erythromycin (E-Mycin, Ery-Tab, E.E.S.), clarithromycin (Biaxin), telithromycin (Ketek), or troleandomycin (Tao).

There are many other medicines that can interact with azithromycin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Azithromycin will not treat a viral infection such as the common cold or flu.

Take azithromycin on an empty stomach 1 hour before or 2 hours after meals.

Do not take antacids that contain aluminum or magnesium within 2 hours before or after you take azithromycin. This includes Rolaids, Maalox, Mylanta, Milk of Magnesia, Pepcid Complete, and others. These antacids can make azithromycin less effective when taken at the same time.

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