Azithromycin Monohydrate (Page 7 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

Azithromycin for oral suspension, USP is supplied in the following strengths and package configurations:

Azithromycin for oral suspension, USP after constitution contains a flavored suspension. Azithromycin for oral suspension, USP is supplied to provide 100 mg/5 mL or 200 mg/5 mL suspension in bottles as follows:

Azithromycin, USP contents per bottle

NDC

300 mg

65162-708-83

600 mg

65162-758-83

900 mg

65162-759-39

1200 mg

65162-760-84

[see Dosage and Administration (2)] for constitution instructions with each bottle type.

Storage: Store dry powder at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.

Store constituted suspension between 5° to 30°C (41° to 86°F) and discard when full dosing is completed.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

General Patient Counseling
Azithromycin for oral suspension can be taken with or without food.

Patients should also be cautioned not to take aluminum- and magnesium-containing antacids and azithromycin simultaneously.

The patient should be directed to discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur.

Direct parents or caregivers to contact their physician if vomiting and irritability with feeding occurs in the infant.

Patients should be counseled that antibacterial drugs including azithromycin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When azithromycin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of the therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by azithromycin or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibacterials which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible.

This product’s label may have been updated. For current full prescribing information, please visit www.amneal.com

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 07-2022-07

Patient Information

Azithromycin (ay zith” roe mye’ sin) for Oral Suspension

Read this Patient Information leaflet before you start taking azithromycin for oral suspension and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is azithromycin for oral suspension?

Azithromycin for oral suspension is a macrolide antibiotic prescription medicine used in adults 18 years or older to treat certain infections caused by certain germs called bacteria. These bacterial infections include:

  • acute worsening of chronic bronchitis
  • acute sinus infection
  • community-acquired pneumonia
  • infected throat or tonsils
  • skin infections
  • infections of the urethra or cervix
  • genital ulcers in men

Azithromycin for oral suspension is also used in children to treat:

  • ear infections
  • community-acquired pneumonia
  • infected throat or tonsils

Azithromycin should not be taken by people who cannot tolerate oral medications because they are very ill or have certain other risk factors including:

  • have cystic fibrosis
  • have hospital acquired infections
  • have known or suspected bacteria in the blood
  • need to be in the hospital
  • are elderly
  • have any medical problems that can lower the ability of the immune system to fight infections

Azithromycin for oral suspension is not for viral infections such as the common cold.

It is not known if azithromycin for oral suspension is safe and effective for genital ulcers in women.

It is not known if azithromycin for oral suspension is safe and effective for children with ear infections, sinus infections, and community-acquired pneumonia under 6 months of age.

It is not known if azithromycin for oral suspension is safe and effective for infected throat or tonsils in children under 2 years of age.

Who should not take azithromycin for oral suspension?

Do not take azithromycin for oral suspension if you:

  • have had a severe allergic reaction to certain antibiotics known as macrolides or ketolides including azithromycin and erythromycin.
  • have a history of cholestatic jaundice or hepatic dysfunction that happened with the use of azithromycin.

What should I tell my healthcare provider before taking azithromycin for oral suspension?

Before you take azithromycin for oral suspension, tell your healthcare provider if you:

  • have pneumonia
  • have cystic fibrosis
  • have known or suspected bacteremia (bacterial infection in the blood)
  • have liver or kidney problems
  • have an irregular heartbeat, especially a problem called “QT prolongation”
  • have a problem that causes muscle weakness (myasthenia gravis)
  • have any other medical problems
  • are pregnant or plan to become pregnant. It is not known if azithromycin for oral suspension will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. Azithromycin has been reported to pass into breast milk. Talk to your healthcare provider about the best way to feed your baby while you take azithromycin for oral suspension.

Contact your healthcare provider immediately if you are giving azithromycin for oral suspension to a young child (less than 6 weeks of age) and he or she vomits or becomes irritable when fed.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Azithromycin for oral suspension and other medicines may affect each other causing side effects. Azithromycin for oral suspension may affect the way other medicines work, and other medicines may affect how azithromycin for oral suspension works.

Especially tell your healthcare provider if you take:

  • nelfinavir
  • a blood thinner (warfarin)
  • digoxin
  • colchicine
  • phenytoin
  • an antacid that contains aluminum or magnesium

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take azithromycin for oral suspension?

  • Take azithromycin for oral suspension exactly as your healthcare provider tells you to take it.
  • Azithromycin for oral suspension can be taken with or without food.
  • If you take azithromycin for oral suspension, shake the bottle well just before you take it.
  • Do not skip any doses of azithromycin for oral suspension or stop taking it, even if you begin to feel better, until you finish your prescribed treatment unless you have a serious allergic reaction or your healthcare provider tells you to stop taking azithromycin for oral suspension. See “What are the possible side effects of azithromycin for oral suspension?” If you skip doses, or do not complete the total course of azithromycin for oral suspension your treatment may not work as well and your infection may be harder to treat. Taking all of your azithromycin for oral suspension doses will help lower the chance that the bacteria will become resistant to azithromycin for oral suspension.
  • If the bacteria becomes resistant to azithromycin for oral suspension, azithromycin for oral suspension and other antibiotic medicines may not work for you in the future.
  • If you take too much azithromycin for oral suspension, call your healthcare provider or get medical help right away.

What are the possible side effects of azithromycin for oral suspension?

Azithromycin for oral suspension can cause serious side effects, including:

  • Serious allergic reactions. Allergic reactions can happen in people taking azithromycin the active ingredient in azithromycin for oral suspension, even after only 1 dose. Stop taking azithromycin for oral suspension and get emergency medical help right away if you have any of the following symptoms of a severe allergic reaction:
  • trouble breathing or swallowing
  • swelling of the lips, tongue, face
  • throat tightness, hoarseness
  • rapid heartbeat
  • faintness
  • skin rash (hives)
  • new onset of fever and swollen lymph nodes

Stop taking azithromycin for oral suspension at the first sign of a skin rash and call your healthcare provider.

Skin rash may be a sign of a more serious reaction to azithromycin for oral suspension.

  • Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take azithromycin for oral suspension. Call your healthcare provider right away if you have unexplained symptoms such as:
  • nausea or vomiting
  • loss of appetite
  • stomach pain
  • change in the color of your bowel movements
  • fever
  • weakness
  • dark colored urine
  • abdominal pain or tenderness
  • yellowing of your skin or of the whites of your eyes
  • itching
  • unusual tiredness


Stop taking azithromycin for oral suspension and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to azithromycin for oral suspension (a liver problem).

  • Serious heart rhythm changes that can be life-threatening, including heart stopping (cardiac arrest), QT prolongation, torsades de pointes, feeling that your heart is pounding or racing (palpitations), chest discomfort, or irregular heartbeat.
    Tell your healthcare provider right away if you or your child feel a fast or irregular heartbeat, get dizzy or faint. Azithromycin for oral suspension may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this happening are higher in people:
  • who are elderly
  • with a family history of prolonged QT interval
  • with low blood potassium
  • who take certain medicines to control heart rhythm (antiarrhythmics)
  • Worsening of myasthenia gravis (a problem that causes muscle weakness). Certain antibiotics like azithromycin for oral suspension may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
  • Diarrhea. Tell your healthcare provider right away if you have watery diarrhea, diarrhea that does not go away, or bloody stools. You may experience cramping and a fever. This could happen after you have finished your azithromycin for oral suspension.

    The most common side effects of azithromycin for oral suspension include:

  • nausea
  • stomach pain
  • vomiting

These are not all the possible side effects of azithromycin for oral suspension. Tell your healthcare provider about any side effect that bothers you or that does not go away.

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

How should I store azithromycin for oral suspension?

  • Store azithromycin for oral suspension at 41° to 86°F (5° to 30°C).
  • Keep azithromycin for oral suspension in a tightly closed container.
  • Safely throw away any medicine that is out of date or no longer needed.

Keep azithromycin for oral suspension and all medicines out of the reach of children.

General information about the safe and effective use of azithromycin for oral suspension.

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use azithromycin for oral suspension for a condition for which it was not prescribed. Do not give azithromycin for oral suspension to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about azithromycin for oral suspension. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about azithromycin for oral suspension that is written for health professionals.

For more information, go to www.amneal.com or call 1-877-835-5472.

What are the ingredients in azithromycin for oral suspension?

Azithromycin for oral suspension

Active ingredient: azithromycin monohydrate

Azithromycin for oral suspension:

Inactive ingredients: artificial banana flavor, colloidal silicon dioxide, FD&C Red #40, hydroxypropyl cellulose, natural and artificial cherry flavor, natural and artificial crème de vanilla flavor, sucrose, tribasic sodium phosphate anhydrous and xanthan gum.

* Trademarks are the property of their respective owners.

This Patient Information has been approved by the U.S. Food and Drug Administration.


Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807


Revised: 07/2022

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