(azithromycin dihydrate TABLET, SUSPENSION)
5 WARNINGS AND PRECAUTIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity
Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions including Acute Generalized Exanthematous Pustulosis (AGEP), Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported in patients on azithromycin therapy. [see Contraindications (4.1)]
Fatalities have been reported. Cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have also been reported. Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure. These patients required prolonged periods of observation and symptomatic treatment. The relationship of these episodes to the long tissue half-life of azithromycin and subsequent prolonged exposure to antigen is presently unknown.
If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that allergic symptoms may reappear when symptomatic therapy has been discontinued.
5.2 Hepatotoxicity
Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur.
5.3 Infantile Hypertrophic Pyloric Stenosis (IHPS)
Following the use of azithromycin in neonates (treatment up to 42 days of life), IHPS has been reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs.
5.4 QT Prolongation
Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen with treatment with macrolides, including azithromycin. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving azithromycin. Providers should consider the risk of QT prolongation which can be fatal when weighing the risks and benefits of azithromycin for at-risk groups including:
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- patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure
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- patients on drugs known to prolong the QT interval
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- patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
Elderly patients may be more susceptible to drug-associated effects on the QT interval.
5.5 Cardiovascular Death
Some observational studies have shown an approximately two-fold increased short-term potential risk of acute cardiovascular death in adults exposed to azithromycin relative to other antibacterial drugs, including amoxicillin. The five-day cardiovascular mortality observed in these studies ranged from 20 to 400 per million azithromycin treatment courses. This potential risk was noted to be greater during the first five days of azithromycin use and does not appear to be limited to those patients with preexisting cardiovascular diseases. The data in these observational studies are insufficient to establish or exclude a causal relationship between acute cardiovascular death and azithromycin use. Consider balancing this potential risk with treatment benefits when prescribing ZITHROMAX.
5.6 Clostridioides difficile-Associated Diarrhea (CDAD)
Clostridioides difficile-associated diarrhea has been reported with use of nearly all antibacterial agents, including ZITHROMAX, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antibacterial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
5.7 Exacerbation of Myasthenia Gravis
Exacerbation of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patients receiving azithromycin therapy.
5.8 Use in Sexually Transmitted Infections
ZITHROMAX, at the recommended dose, should not be relied upon to treat syphilis. Antibacterial agents used to treat non-gonococcal urethritis may mask or delay the symptoms of incubating syphilis. All patients with sexually transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate testing for gonorrhea performed at the time of diagnosis. Appropriate antibacterial therapy and follow-up tests for these diseases should be initiated if infection is confirmed.
PATIENT INFORMATION
Patient Information
ZITHROMAX® (Zith-roe-maks)
(azithromycin)
Tablets
ZITHROMAX®
(azithromycin)
Oral Suspension
Read this Patient Information leaflet before you start taking ZITHROMAX 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 ZITHROMAX?
ZITHROMAX 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:
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- acute worsening of chronic bronchitis
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- acute sinus infection
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- community-acquired pneumonia
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- infected throat or tonsils
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- skin infections
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- infections of the urethra or cervix
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- genital ulcers in men
ZITHROMAX is also used in children to treat:
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- ear infections
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- community-acquired pneumonia
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- 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:
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- have cystic fibrosis
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- have hospital acquired infections
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- have known or suspected bacteria in the blood
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- need to be in the hospital
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- are elderly
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- have any medical problems that can lower the ability of the immune system to fight infections
ZITHROMAX is not for viral infections such as the common cold.
It is not known if ZITHROMAX is safe and effective for genital ulcers in women.
It is not known if ZITHROMAX 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 ZITHROMAX is safe and effective for infected throat or tonsils in children under 2 years of age.
Who should not take ZITHROMAX?
Do not take ZITHROMAX if you:
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- have had a severe allergic reaction to certain antibiotics known as macrolides or ketolides including azithromycin and erythromycin.
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- 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 ZITHROMAX?
Before you take ZITHROMAX, tell your healthcare provider if you:
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- have pneumonia
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- have cystic fibrosis
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- have known or suspected bacteremia (bacterial infection in the blood)
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- have liver or kidney problems
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- have an irregular heartbeat, especially a problem called "QT prolongation"
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- have a problem that causes muscle weakness (myasthenia gravis)
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- have any other medical problems
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- are pregnant or plan to become pregnant. It is not known if ZITHROMAX will harm your unborn baby.
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- are breastfeeding or plan to breastfeed. ZITHROMAX has been reported to pass into breast milk. Talk to your healthcare provider about the best way to feed your baby while you take ZITHROMAX.
Contact your healthcare provider immediately if you are giving ZITHROMAX 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.
ZITHROMAX and other medicines may affect each other causing side effects. ZITHROMAX may affect the way other medicines work, and other medicines may affect how ZITHROMAX works.
Especially tell your healthcare provider if you take:
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- nelfinavir
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- a blood thinner (warfarin)
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- digoxin
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- colchicine
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- phenytoin
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- 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 ZITHROMAX?
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- Take ZITHROMAX exactly as your healthcare provider tells you to take it.
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- ZITHROMAX can be taken with or without food.
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- If you take ZITHROMAX Oral Suspension, shake the bottle well just before you take it.
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- Do not skip any doses of ZITHROMAX 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 ZITHROMAX. "See What are the possible side effects of ZITHROMAX?" If you skip doses, or do not complete the total course of ZITHROMAX your treatment may not work as well and your infection may be harder to treat. Taking all of your ZITHROMAX doses will help lower the chance that the bacteria will become resistant to ZITHROMAX.
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- If the bacteria becomes resistant to ZITHROMAX, ZITHROMAX and other antibiotic medicines may not work for you in the future.
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- If you take too much ZITHROMAX, call your healthcare provider or get medical help right away.
What are the possible side effects of ZITHROMAX?
ZITHROMAX can cause serious side effects, including:
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- Serious allergic reactions. Allergic reactions can happen in people taking azithromcyin the active ingredient in ZITHROMAX, even after only 1 dose. Stop taking ZITHROMAX and get emergency medical help right away if you have any of the following symptoms of a severe allergic reaction:
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- trouble breathing or swallowing
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- swelling of the lips, tongue, face
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- throat tightness, hoarseness
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- rapid heartbeat
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- faintness
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- skin rash (hives)
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- new onset of fever and swollen lymph nodes
- Stop taking ZITHROMAX 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 ZITHROMAX.
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- Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take ZITHROMAX. Call your healthcare provider right away if you have unexplained symptoms such as:
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- Stop taking ZITHROMAX 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 ZITHROMAX (a liver problem).
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- 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. ZITHROMAX 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:- o
- who are elderly
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- with a family history of prolonged QT interval
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- with low blood potassium
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- who take certain medicines to control heart rhythm (antiarrhythmics)
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- Worsening of myasthenia gravis (a problem that causes muscle weakness). Certain antibiotics like ZITHROMAX 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.
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- 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 ZITHROMAX.
The most common side effects of ZITHROMAX include:- o
- nausea
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- stomach pain
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- vomiting
These are not all the possible side effects of ZITHROMAX. 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 ZITHROMAX?
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- Store ZITHROMAX Tablets at 59°F to 86°F (15°C to 30°C).
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- Store ZITHROMAX Oral Suspension at 41°F to 86°F (5°C to 30°C).
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- Keep ZITHROMAX Oral Suspension in a tightly closed container.
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- Safely throw away any medicine that is out of date or no longer needed.
Keep ZITHROMAX and all medicines out of the reach of children.
General information about the safe and effective use of ZITHROMAX.
Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use ZITHROMAX for a condition for which it was not prescribed.
Do not give ZITHROMAX 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 ZITHROMAX. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ZITHROMAX that is written for health professionals.
For more information, go to www.zithromax.com or call 1-800-438-1986.
What are the ingredients in ZITHROMAX Tablets and Oral Suspension?
ZITHROMAX Tablets and Oral Suspension
Active ingredient: azithromycin dehydrate
ZITHROMAX Tablets:
Inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, hypromellose, lactose, titanium dioxide, triacetin, and D&C Red #30 aluminum lake.
ZITHROMAX Oral Suspension:
Inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and spray dried artificial cherry, creme de vanilla, and banana flavors.
This Patient Information has been approved by the U.S. Food and Drug Administration.
LAB-0372-7.0
Revised November 2021
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