Azithromycin: Dosage, Side Effects, and More

Azithromycin is a macrolide antibiotic that is one of the most commonly prescribed antibiotics in the United States.

It treats bacterial infections by stopping the multiplication of bacteria.

Azithromycin does not treat illnesses caused by viruses, like the flu, COVID-19, or common colds. 

In this article, I’ll share everything you need to know about using azithromycin, including what the drug is and how it works, what infections it’s prescribed for, and how to take the medication.

I’ll also list some of the side effects, drug interactions, and risks of azithromycin.

Finally, I’ll tell you when you should see a doctor or healthcare professional.

What is Azithromycin?

Azithromycin is a macrolide antibiotic that treats bacterial infections by stopping bacteria from producing certain proteins.

Without these proteins, the bacteria cannot multiply.

This protein inhibition makes azithromycin effective against many “atypical” bacteria, bacteria that do not respond to other types of antibiotics.

Azithromycin is a prescription drug, which means you cannot legally purchase it without a doctor’s prescription.

It is usually sold as azithromycin, which is its generic name, or as Zithromax, a popular brand name.

It can also be called a Z-pak, when prescribed in a specific dose pack.

The U.S. Food and Drug Administration (FDA) has approved azithromycin to treat infections in both children and adults.

It is available as tablet, capsule, liquid, and injection forms.

Uses for Azithromycin

Azithromycin is used to treat many bacterial infections. These include:

• Community-acquired pneumonia: Viruses, bacteria, or fungi can cause community-acquired pneumonia. Azithromycin is effective in the treatment of atypical bacterial pneumonia, often known as “walking pneumonia.” It may need to be combined with another antibiotic, and is not generally used for pneumonia in young children or infants. Studies show that it reduces hospital stay and improves outcomes even with a shorter treatment course.

The CDC recommends azithromycin as the first line of treatment for pneumonia caused by Chlamydia pneumoniae. Azithromycin does not work for COVID-19 pneumonia or other viral pneumonias. 

• Mycobacterium avium complex infection: Azithromycin prevents and controls Mycobacterium avium complex (MAC) disease, especially in HIV patients.

• Ear infection: Studies prove that azithromycin is effective in treating uncomplicated middle ear infections (otitis media) when caused by bacteria, for those with allergies to first-line antibiotics. 

• Chlamydia: Chlamydia is a sexually transmitted infection (STI). Delayed treatment can lead to pelvic inflammatory disease (PID). The CDC recommends doxycycline but suggests an alternate treatment plan using azithromycin or levofloxacin.

• Cervicitis: Azithromycin is effective in treating cervicitis, although doxycycline is the preferred choice. If there is a risk of contracting a gonococcal infection, your health provider will add a different antibiotic to the regimen.

• Pharyngitis: Most pharyngitis is caused by viruses.  Penicillin is the first choice drug for bacterial pharyngitis, but azithromycin also treats Group A strep pharyngitis, and may be used in those with allergies to other antibiotics.

• Lyme disease: The CDC recommends that people with early Lyme disease who cannot tolerate doxycycline, cefuroxime, or amoxicillin be treated with azithromycin—although it is less effective than the other three in this case.

Because it is an antibiotic, azithromycin cannot treat viral infections like the flu, COVID-19, or the common cold. 

Using this drug unnecessarily increases the risk of developing antibiotic resistance.

Antibiotic resistance means that the medication may no longer be as effective as the bacteria have developed ways to avoid the antibiotics.

How to Take Azithromycin

Azithromycin can be prescribed in various forms:

• Injection: This is for patients with severe infections, like community-acquired pneumonia or pelvic inflammatory disease, who need initial intravenous therapy. It will be combined with other antibiotics in most cases.

• Tablet: Azithromycin tablets are usually taken once daily for 1-5 days. They can be taken with or without food and should always be taken exactly as prescribed. 

• Liquid: Azithromycin suspensions typically come in a powdered form. These powders are dissolved in varying fluid volumes to achieve different concentrations—the pharmacist will prepare this according to your provider’s instructions. Suspensions are especially useful for pediatric patients and those unable to swallow pills.

• Extended-release liquid: Extended-release drug forms allow a slow release of the medication into the body for a prolonged period after a single dose. Most patients find them easier to take consistently. This may be used for otitis media and other infections. This is a less-commonly used form of azithromycin and can be toxic in infants.

Dosage

Azithromycin is available in various strengths:

• Tablets: Available as 250 mg and 500 mg tablets

• Oral suspension: Available as 100 mg or 200 mg per 5 mL

• Extended-release suspension: Available as 2000 mg as a single dose

• Injection: Available in a 10 mL vial of 500 mg

Your provider will prescribe different azithromycin forms, dosages, and strengths for various infections, depending on the following:

• Yourt age
• Condition treated
• Severity of infection
• Possible drug interaction
• Pre-existing health conditions

For example, to treat community-acquired atypical pneumonia or bacterial pharyngitis in adults, most healthcare providers prescribe 500 mg on day 1, and 250 mg per day on days 2-5.

The dosage for various infections is usually written on the patient information leaflet contained in the drug packet.

Your healthcare provider, doctor, or pharmacist can give you further advice.

Antibiotics can take time to work.

On average, doctors prescribe azithromycin for 1-5 days. Other antibiotics take 7-14 days for a full course, depending on the infection being treated. 

Do not take your medication for longer than your doctor prescribed, and make sure to complete your prescribed course even if you start to feel better.

An unfinished medication regimen can lead to antibiotic resistance, making the drug ineffective for future infections.

Side Effects of Azithromycin

Some common side effects of azithromycin include:

• Nausea
• Vomiting
• Stomach pain 
• Diarrhea
• Headache

Rare, severe side effects include:

• Dizziness
• Irregular heartbeat rhythm 
• Fainting
• Extreme fatigue
• Lack of appetite
• Muscle weakness
• Yellowing eyes
• Dark urine

For use in children, the most common side effects are:

• Abdominal pain
• Nausea
• Vomiting
• Rash
• Headache

This is not a complete list of possible side effects. Talk to your doctor immediately if you experience any side effects. 

Azithromycin may be prescribed with caution if you have liver problems since it is eliminated by the liver. 

Azithromycin is also known to worsen symptoms of myasthenia gravis or, in some cases, cause new symptoms. 

If you have a history of torsades de pointes, QT interval prolongation, or bradyarrhythmia, tell your doctor.

Azithromycin can cause or worsen QT prolongation.

Drug Interactions with Azithromycin

Using azithromycin with other drugs can have an impact on its efficacy. In the same way, azithromycin can also affect the effectiveness of other medications.

This effect is known as drug interaction. 

Tell your healthcare provider about any medications you’re currently using.

This includes other prescription medicines, but also non-prescription medicines like vitamins, nutritional supplements, and herbal products.

These are some of the drugs azithromycin reacts with:

• Antacids containing magnesium hydroxide or aluminum hydroxide
• Blood thinners like warfarin
• Gout medication like colchicine
• Migraine medication like ergotamine
• Nelfinavir used in the treatment of HIV
• Amiodarone used for treating irregular heartbeat

Your doctor may change your prescription, dosage or ask you to discontinue using the other drugs for some time if there are possible drug interactions.

They can also choose to watch you closely for possible side effects.

Risks and Warnings Before Taking Azithromycin

Your healthcare provider will only prescribe medications if the benefits far outweigh the risks.

For azithromycin, these are some risks to consider.

Allergic reaction

Most people do not record severe allergic reactions while using azithromycin, but it’s possible. Symptoms include, but are not limited to:

• Difficulty breathing
• Hives or other rash
• Swelling of the face, throat, or tongue 

Do not use azithromycin if you have a medical history of adverse reactions while using azithromycin or similar drugs like erythromycin and clarithromycin.

In the rare case that you notice any signs of a severe allergic reaction, seek emergency medical care or call 9-1-1.

Pregnant or lactating

The FDA classifies azithromycin as a category B drug, meaning they found it safe in reproduction studies using animals.

However, since there are no well-controlled studies in pregnant women, they recommend that pregnant women use azithromycin only when necessary.

Azithromycin can be passed through breastmilk and can cause side effects like diarrhea, rash, and vomiting in a nursing baby.

However, studies show no adverse effect on the baby as the amount of azithromycin in breast milk is less than the standard dose used for treating children. 

If you’re pregnant or breastfeeding, your doctor will decide if azithromycin is the right choice for your infection and condition. 

When to See a Doctor

See your doctor or healthcare provider if you feel unwell and think it might be a bacterial infection.

They will decide on what antibiotic to prescribe based on your test results. 

Remember, you cannot purchase azithromycin over the counter, so you will need a doctor’s prescription to get one. 

Contact your doctor immediately if you experience severe side effects or allergic reactions.

If you do not feel any better after using your medication for the prescribed duration, speak with your doctor or health provider.

Do not discontinue the medicine without your doctor’s approval.

How K Health Can Help

If you’re wondering whether you need azithromycin, it may be time to talk to a doctor. Did you know you can get affordable primary care with the K Health app? Download K to check your symptoms, explore conditions and treatments, and if needed, text with a doctor in minutes. K Health’s AI-powered app is HIPAA compliant and based on 20 years of clinical data.

Frequently Asked Questions

Do you need to have a certain diet to take azithromycin?

No, you do not need a special diet to take azithromycin. Azithromycin can cause gastrointestinal side effects like nausea and diarrhea. This is because antibiotics typically affect good and bad bacteria in your body. Once your antibiotic regimen is complete, the body will work to restore its balance.

Can azithromycin be used to treat COVID-19?

No. The FDA has not approved azithromycin for the treatment of COVID-19. COVID-19 is a viral illness and antibiotics do not have any effect in treating viruses. A controlled trial showed no significant difference in COVID-19 symptoms when they were prescribed azithromycin. Therefore, azithromycin should only be used to treat bacterial infections as prescribed by your doctor.

Can you overdose on azithromycin?

Yes, you can overdose on azithromycin. This commonly occurs when trying to make up for a skipped dose. If you miss a dose, you can take it when you remember. But if it is close to the next dose, skip it to avoid taking a double dose. An increased level of azithromycin can worsen side effects like diarrhea or irregular heart rhythm. If you have already taken an overdose of azithromycin, contact your healthcare provider, your local poison control center, or call 9-1-1.

K Health articles are all written and reviewed by MDs, PhDs, NPs, or PharmDs and are for informational purposes only. This information does not constitute and should not be relied on for professional medical advice. Always talk to your doctor about the risks and benefits of any treatment.

K Health has strict sourcing guidelines and relies on peer-reviewed studies, academic research institutions,
and medical associations. We avoid using tertiary references.

• Azithromycin: mechanisms of action and their relevance for clinical applications. (2014).
  https://pubmed.ncbi.nlm.nih.gov/24631273/

• Azithromycin. (2021).
  https://www.ncbi.nlm.nih.gov/books/NBK557766/

• Lyme Disease. (2021).
  https://www.cdc.gov/lyme/treatment/index.html

• Chlamydia Infection Among Adolescents and Adults. (2021).
  https://www.cdc.gov/std/treatment-guidelines/chlamydia.htm

• Chlamydia Pneumoniae Infection. (2021).
  https://www.cdc.gov/pneumonia/atypical/cpneumoniae/hcp/treatment.html

• Diseases Characterized by Urethritis and Cervicitis. (2021).
  https://www.cdc.gov/std/treatment-guidelines/urethritis-and-cervicitis.htm

• Mechanistic Study of the Azithromycin Dosage-Form-Dependent Food Effect. (2010).
  https://pubmed.ncbi.nlm.nih.gov/20372991/

• Azithromycin. (2006).
  https://www.ncbi.nlm.nih.gov/books/NBK501200/#_NBK501200_pubdet_

• Single Dose Azithromycin for the Treatment of Uncomplicated Otitis Media. (2004).
  https://pubmed.ncbi.nlm.nih.gov/14770073/

• Comparison of Azithromycin and Cefadroxil for the Treatment of Uncomplicated Skin and Skin Structure Infections. (2003).
  https://pubmed.ncbi.nlm.nih.gov/14533837/

• Is Azithromycin the First-Choice Macrolide for Treatment of Community-Acquired Pneumonia? (2003).
  https://pubmed.ncbi.nlm.nih.gov/12746768/

Zithromax (Azithromycin) Drug / Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

tablets and oral suspension

Azithromycin (a-zithro-my-sin)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Zithromax. It does not contain all
the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking
Zithromax against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with your medicine.

You may need to read it again.

What Zithromax is used for

Zithromax is used to treat infections in different parts of the body caused by bacteria.

It is commonly used to treat Chlamydia. Zithromax is also used to prevent infections
by a bacterium called Mycobacterium Avium-intracellulare Complex (MAC) in some people.

Zithromax is an antibiotic, which belongs to a group of medicines called azalides.

The azalides are a sub-class of a group of antibiotics called macrolides.

Zithromax works by killing or stopping the growth of bacteria causing your infection.

Zithromax will not work against viral infections such as colds or flu.

Ask your doctor if you have any questions about why Zithromax has been prescribed
for you.

Your doctor may have prescribed it for another reason.

Zithromax is only available with a doctor’s prescription.

This medicine is not addictive.

This medicine is not expected to affect your ability to drive a car or operate machinery.

Before you take Zithromax

When you must not take it

Do not take Zithromax if you are allergic to:

azithromycin

any other macrolide or ketolide antibiotics (e.g., clarithromycin, erythromycin, roxithromycin,
telithromycin)

any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty
breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching
or hives on the skin.

Do not take this medicine if the expiry date (EXP) printed on the packaging has passed
or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.

Tell your doctor if you have any other health problems, including:

any liver problems

any kidney problems

any heart problems, including abnormalities of the rhythm

diabetes, hereditary fructose intolerance, glucose-galactose malabsorption or saccharise-isomaltase
deficiency

cystic fibrosis

muscle weakness

low levels of potassium or magnesium in your blood

if you are pregnant or if you plan to become pregnant or are breastfeeding. Your doctor
can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you start
taking Zithromax.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from a pharmacy, supermarket or health food shop.

Some medicines may interfere with Zithromax or increase the risk of side effects.
These include:

antacids (medicines used to treat indigestion)

colchicine (a medicine used to treat gout)

coumarin-type oral anti-coagulants (a medicine used to prevent blood clots)

cyclosporin (a medicine used to prevent organ transplant rejection or to treat certain
problems with the immune system)

digoxin (a medicine used to treat abnormal heart rhythm or heart failure)

ergot derivatives (such as ergotamine, which is used to treat migraines)

terfenadine or astemizole (medicines used to treat allergies and hay fever)

zidovudine, a medicine used to treat patients with AIDS

diphenoxylate (Lomotil), a medicine used to treat diarrhoea

some medicines used to treat heart rhythm problems (heart arrhythmia) such as amiodarone,
disopyramide, ibutilide and sotalol

antipsychotic medicines used to treat schizophrenia or bipolar mania such as haloperidol,
quetiapine and risperidone

medicines used to treat depression (antidepressants) such as fluoxetine, sertraline
and venlafaxine

fluoroquinolone antibiotics such as ciprofloxacin, lomefloxacin, moxifloxacin and
norfloxacin

These medicines may be affected by Zithromax or may affect how well it works. You
may need different amounts of your medicines, or you may need to take different medicines.

Your doctor or pharmacist has more information on medicines to be careful with or
to avoid while taking Zithromax.

Talk to your doctor about the need for additional contraception while taking Zithromax.

Some antibiotics may decrease the effectiveness of some birth control pills, although
this has not been shown with Zithromax.

How to take Zithromax

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist
for help.

How much to take

The dose will depend on your infection.

The usual dose to treat Chlamydia is two 500 mg tablets taken as a single dose.

For other infections Zithromax is usually taken once a day. Sometimes the dose is
taken once a week. Your doctor will decide the right dose for you.

The dose for your child will depend on his or her body weight. Zithromax oral suspension
is for use by children.

Your pharmacist will explain how to use it if you are not sure.

How to take it

Tablets:

Swallow the tablets whole with liquid.

Oral Suspension:

Shake the bottle well before use and use the measuring syringe supplied.

Zithromax may be taken with or without food.

If you are taking an antacid (e.g., Gastrogel, Mylanta), take it at least one hour
before or two hours after your Zithromax dose.

This will avoid any possible effect of the antacid on the absorption of Zithromax.

How long to take it

Continue taking Zithromax until you finish the pack or bottle or until your doctor
recommends.

Do not stop taking it because you are feeling better.

If you do not complete the full course prescribed by your doctor, the infection may
not clear completely or your symptoms may return.

If you are not sure how long you should be taking Zithromax, check with your doctor.

If you forget to take it

If you are taking Zithromax for three days or longer and you miss a dose, take it
as soon as you remember (within a 24- hour period), then continue as normal.

Do not try to make up for missed doses by taking more than one dose at a time.

If you are not sure what to do, check with your doctor or pharmacist.

If you have trouble remembering to take your Zithromax, ask your pharmacist for some
hints.

If you take too much (Overdose)

Immediately telephone your doctor or Poisons Information Centre (13 11 26) for advice
if you think that you or anyone else may have taken too much Zithromax.

Do this even if there are no signs of discomfort or poisoning. You may need urgent
medical attention.

If you take too many tablets or too much oral suspension, you may get an upset stomach,
diarrhoea or skin rashes.

While you are using Zithromax

Things you must do

If the symptoms of your infection do not improve within a few days, or if they become
worse, tell your doctor.

If you get severe diarrhoea, tell your doctor, pharmacist or nurse immediately. Do
this even if it occurs several weeks after Zithromax has been stopped.

Diarrhoea may mean that you have a serious condition affecting your bowel. You may
need urgent medical care. Do not take any diarrhoea medicine without first checking
with your doctor.

If you get a sore, white mouth or tongue while taking, or soon after stopping Zithromax,
tell your doctor. Also tell your doctor if you get vaginal itching or discharge.

This may mean you have a yeast infection called thrush. Sometimes the use of Zithromax
allows yeast to grow and the above symptoms to occur. Zithromax does not work against
yeast.

If you become pregnant while taking Zithromax, tell your doctor.

Tell your doctor immediately if during treatment with Zithromax your baby develops
irritability with feeding or starts vomiting.

This may be a sign of a stomach disorder in the infant.

If you are about to start any new medicines, tell your doctor and pharmacist that
you are taking Zithromax.

Tell any other doctors, dentists and pharmacists who are treating you that you are
taking Zithromax.

Things you must not do

Do not stop taking Zithromax or lower the dosage without checking with your doctor.

If you do not complete the full course prescribed by your doctor, all the organisms
causing your infection may not be killed. These organisms may continue to grow and
multiply so that your infection may not clear completely or may return.

Do not give Zithromax to anyone else, even if they have the same condition as you.

Do not use Zithromax to treat any other medical complaints unless your doctor tells
you to.

Things to be careful of

Protect your skin when you are in the sun, especially between 10am and 3pm.

Some macrolide antibiotics may cause your skin to be more sensitive to sunlight than
it is normally. Exposure to sunlight may cause a skin rash, itching, redness or severe
sunburn.

If outdoors, wear protective clothing and use a 30+ sunscreen. If your skin does appear
to be burning tell your doctor immediately.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Zithromax.

Like other medicines, Zithromax can cause some side effects. If they occur, most are
likely to be minor and temporary. However, some may be serious and need medical attention.

Ask your doctor or pharmacist to answer any questions you may have.

Do not be alarmed by the following list of side effects. You may not experience any
of them.

While taking it

Tell your doctor or pharmacist if you notice any of the following and they worry you:

oral thrush – white, furry, sore tongue and mouth

vaginal thrush – sore and itchy vagina and/or white discharge

nausea (feeling sick), loss of appetite, vomiting, stomach pain, indigestion, wind,
constipation, diarrhoea

dizziness, headache, spinning sensation

tiredness, drowsiness, fatigue

muscle or joint aches

rash

hearing loss or ringing in the ears

altered taste and smell.

These side effects are usually mild.

See your doctor immediately and before you take your next dose of Zithromax if you
notice any of the following:

severe persistent diarrhoea (loose bowel motions)

fast or irregular heart beat

symptoms of sunburn such as redness, itching, swelling or blistering which may occur
more quickly than normal

decreased feeling or sensitivity, especially in the skin

hives, itching or skin rash

widespread body rash, fever and swollen lymph nodes

aggressive reaction, nervousness, agitation or anxiety

bleeding or bruising more easily than normal, reddish or purplish blotches under the
skin

signs of frequent or worrying infections such as fever, severe chills, sore throat
or mouth ulcers

dark urine or blood in the urine or bowel motions

severe upper stomach pain, often with nausea and vomiting.

These are serious side effects. You may need urgent medical attention. Serious side
effects are rare.

If any of the following happen, stop taking Zithromax and tell your doctor immediately
or go to casualty at your nearest hospital:

sudden signs of allergy such as rash, itching or hives on the skin, swelling of the
face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble
breathing

blisters or ulcers on the skin, in the mouth or airways that may occur after a period
of fever

diarrhoea, usually with blood and mucus, stomach pain and fever

yellowing of the eyes or skin, also called jaundice

chest pain

fainting

convulsions (fits)

These are very serious side effects. You may need urgent medical attention or hospitalisation.
These side effects are rare.

After finishing it

Tell your doctor immediately if you notice any of the following side effects, particularly
if they occur several weeks after stopping treatment with Zithromax:

severe stomach cramps

watery and severe diarrhoea, which may be bloody

fever, in combination with one or both of the above.

Zithromax can cause some bacteria, which are normally present in the bowel and normally
harmless to multiply and therefore cause the above symptoms. You may need urgent medical
attention. However this side effect is rare.

Do not take any medicine for this diarrhoea without first checking with your doctor.

Tell your doctor if you notice anything else that is making you feel unwell.

Other side effects not listed above may also occur in some patients. Some of these
side effects (for example certain liver conditions, and blood abnormalities) can only
be found when your doctor does tests from time to time to check your progress.

Do not be alarmed at this list of possible side effects.

You may not experience any of them

After using Zithromax

Storage

Keep Zithromax in its original packaging until it is time to use it.

If you take Zithromax out of its packaging, it may not keep as well.

Keep your Zithromax in a cool, dry place where the temperature stays below 30°C.

Do not store Zithromax or any other medicine in the bathroom or near a sink. Do not
leave it in the car or on a window sill.

Heat and dampness can destroy some medicines.

Keep your Zithromax where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.

Disposal

If your doctor tells you to stop taking this medicine, or it has passed its expiry
date, ask your pharmacist what to do with any that is left over.

Discard any oral suspension left over after 10 days.

Product description

What it looks like

Zithromax tablets come in two strengths:

Zithromax 500 mg – white to off white, unscored, modified capsule-shaped film coated
tablets, engraved with ‘ZTM 500’ on one side and ‘Pfizer’ on the other. Blister packs
of 2 and 3.

Zithromax 600 mg – white to off white, scored, modified oval film coated tablets,
engraved with ‘ZTM 600’ on one side and ‘PFIZER’ on the other. Blister pack of 8.

Zithromax Powder for Oral Suspension is a white to off-white powder in a 15 mL bottle,
and it is an off-white to orange to brown liquid when made up with water.

Ingredients

Active ingredient

500 mg Tablets

500 mg azithromycin per tablet

600 mg Tablets

600 mg azithromycin per tablet

Powder for Oral Suspension

200 mg azithromycin per 5 mL

Other ingredients

Tablets

pregelatinsed-maize starch

calcium hydrogen phosphate

croscarmellose sodium

magnesium stearate

sodium lauryl sulfate

lactose

hypromellose

titanium dioxide

glycerol triacetin

Powder for Oral Suspension

sucrose

sodium phosphate

hyprolose

xanthan gum

cherry flavour

banana flavour

vanilla flavour (contains milk products)

Supplier

Pfizer Australia Pty Ltd

Sydney NSW

Toll Free Number: 1800 675 229

Australian Registration Numbers

500 mg Tablets: AUST R 58797

600 mg Tablets: AUST R 60057

Powder for Oral Suspension

200 mg/5mL: AUST R 60049

This leaflet was prepared in January 2022.

© Pfizer Australia Pty Ltd 2022

® Registered Trademark

Azithromycin: questions and answers | Compendium – drug guide

03.12.2021

Azithromycin is a macrolide antibiotic. Its peculiarity lies in the fact that the concentration of azithromycin in the focus of infection exceeds the concentration in blood plasma by almost 50 times (for this it is also called a “tissue” antibiotic). In addition, unlike other macrolides, it can act not only bacteriostatically, but also bactericidal (that is, not only slow down the growth and reproduction of bacteria, but also “kill” them). Already on the first day after administration, the concentration of azithromycin in the focus of infection is many times higher than the minimum inhibitory concentration (MIC) of this antibiotic. Another important feature is that the MIC of azithromycin persists for 7 days after the end of the 3-day course of treatment with this antibiotic. This means that by taking 3 doses of the drug within 3 days, we get essentially a 10-day course of treatment.

Indications for use of azithromycin

Azithromycin is used for various infections caused by microorganisms sensitive to azithromycin. So, this antibiotic is prescribed for the treatment of patients with bacterial pharyngitis and tonsillitis, sinusitis, otitis media, bacterial bronchitis and pneumonia, various soft tissue infections, including pustular skin lesions, erysipelas and acne vulgaris, erythema migrans (the initial stage of Lyme disease caused by borelia transmitted by tick bite), some genital infections (uncomplicated genital chlamydia).

Which group of antibiotics does azithromycin belong to?

Azithromycin belongs to the group of macrolides.

How to take azithromycin?

Azithromycin at a dose of 500 mg should be taken 1 tablet (capsule) 1 time per day, every day at the same time, for 3 days. The course dose is 1.5 g of the drug.

At the same time, in some cases (for example, with erythema migrans, sexually transmitted diseases), the regimen and course dose of the drug may differ.

It is important that azithromycin should not be taken with food: its absorption is impaired. So, azithromycin is taken one hour before meals, or 2 hours after.

Azithromycin is also available in 125 mg and 250 mg capsules and tablets. When using such doses of the drug, an adult will need to take 4 or 2 capsules / tablets at a time, respectively.

For children, it is convenient to use granular powder for the preparation of a suspension. The finished suspension contains 200 mg of azithromycin in 5 ml. The recommended dose for children is calculated based on the child’s body weight – the usual recommended dose is 10 mg per 1 kg of body weight. It is convenient to measure the required amount of the drug using a special measuring spoon, which is in the package with the drug. Children weighing 45 kg or more can use azithromycin in the form of tablets or capsules.

For the treatment of pneumonia and some infections, azithromycin in the form of a lyophilisate for the preparation of a solution for intravenous infusion can be used. It is administered at 500 mg once a day for 3 days.

How often can I take azithromycin?

Repeated courses of azithromycin are recommended not earlier than 3 months after completion of the previous course. This is due to the possible development of resistance of pathogenic microorganisms to antibacterial drugs.

How many days to use azithromycin for bronchitis?

Acute bronchitis is most often caused by viruses and is not treated with antibiotics. At the same time, if there are symptoms indicating the probable bacterial nature of bronchitis (purulent sputum discharge, febrile fever, characteristic changes in the clinical blood test), azithromycin may be recommended. For the treatment of bronchitis in patients over the age of 18, azithromycin is prescribed 500 mg once a day for 3 days.

How many days can I take azithromycin?

Usually, azithromycin is recommended for 3 days at 500 mg (total course dose for adult patients is 1500 mg). At the same time, for some diseases, the duration of the course of treatment may differ. So, for example, with erythema migrans on the 1st day of treatment, it is recommended to take 1000 mg and from the 2nd to the 5th day – 500 mg 1 time per day (the total course dose is 3000 mg).

For acne vulgaris, the total course dose is 6000 mg. In the first 3 days, it is recommended to take 500 mg per day, then for 9weeks – 500 mg once a week.

For what diagnoses is azithromycin prescribed?

Azithromycin is used for various infections caused by microorganisms sensitive to azithromycin. So, this antibiotic is prescribed for the treatment of patients with bacterial pharyngitis and tonsillitis, sinusitis, otitis media, bacterial bronchitis and pneumonia, various soft tissue infections, including pustular skin lesions, erysipelas and acne vulgaris, erythema migrans (the initial stage of Lyme disease caused by borelia transmitted by tick bite), some genital infections (uncomplicated genital chlamydia).

How much azithromycin is taken for pneumonia?

Azithromycin for the treatment of pneumonia must be taken once a day at 500 mg for 3 days

How quickly does azithromycin start to work?

Azithromycin begins to act within 2-3 hours after the first dose of the drug – since it is during this period that its maximum concentration in the blood plasma is reached.

When might azithromycin be recommended for patients with pneumonia?

According to national and international guidelines for the treatment of community-acquired pneumonia, azithromycin is used to treat people with non-severe pneumonia. So, it can be used as monotherapy in patients with non-severe pneumonia who have not taken antibiotics for the previous 3 months and do not have concomitant diseases. In such cases, indications for the use of azithromycin are the suspicion that pneumonia is caused by “atypical” flora ( Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella spp. ) or there is no clinical effect when using beta-lactam antibiotics.

In cases where the patient has comorbidities or has taken antibiotics within the previous 3 months, combination therapy with azithromycin and a “protected” penicillin (eg, amoxicillin/clavulanate) is recommended.

Is it possible to use azithromycin in combination with other antibiotics?

Combination of azithromycin with other antibiotics is possible. The combined use of azithromycin with antibiotics of almost all major groups of antibacterial drugs (β-lactam antibiotics, fluoroquinolones, aminoglycosides, rifampicin) may be recommended.

How is azithromycin combined with other drugs used in pneumonia?

Azithromycin is allowed to be used with drugs such as aminophylline, methylprednisolone, since it has a mild inhibitory effect on the cytochrome P450 isoenzyme and does not interfere with the metabolism of these drugs.

Does azithromycin increase immunity?

It has been established that azithromycin and other antibiotics of the macrolide group have immunomodulatory and anti-inflammatory effects. Thus, azithromycin enhances the body’s natural immune response to infection: it increases the activity of immune cells and contributes to the completion of the inflammatory process. In addition, azithromycin helps to reduce airway hyperreactivity in respiratory diseases.

What is better Sumamed or Azithromycin?

Azithromycin and Sumamed contain the same active ingredient – azithromycin.

How do I take probiotics with antibiotics?

Probiotics in the treatment of antibiotics are prescribed to prevent the development of dysbacteriosis, antibiotic-associated diarrhea. It is recommended to take a probiotic from the first day of antibiotic therapy.

Can azithromycin be used for more than 3 days?

Azithromycin is used for more than 3 days strictly according to the indications specified in the instructions. Usually, a 3-day course of treatment is sufficient, since after 3 days of taking the drug, the effective concentration of the drug in the focus of inflammation remains for another 7 days (which corresponds to the usual 10-day course of treatment with other antibiotics).

traditional indications and new clinical uses

Author:
L.P. Zharkova, I.V. Andreeva, Department of Clinical Pharmacology, Smolensk State Medical Academy,

03/27/2015

Azithromycin is the first representative of a group of semi-synthetic 15-membered azalide macrolide antibiotics, which were obtained by inserting a nitrogen atom into the 14-membered lactone ring of the classic macrolide (erythromycin) between the 9th and 10th carbon atoms.
This modification of the chemical structure leads to its improved pharmacokinetics, in particular more stable absorption from the gastrointestinal tract and higher bioavailability.

Clinical and pharmacological properties of azithromycin

Antimicrobial activity
Azithromycin, like other macrolides, has a predominantly bacteriostatic effect. The mechanism of the antibacterial action of azithromycin is based on the suppression of protein synthesis in a microbial cell due to binding to the 5OS subunit of ribosomes.
Both in vitro and according to the results of clinical studies, azithromycin is active against many gram-positive cocci: Streptococcus pneumoniae, group A β-hemolytic streptococcus (GABHS), Streptococcus agalactiae, methicillin-susceptible strains of Staphylococcus aureus. Staphylococci and streptococci resistant to erythromycin are resistant to azithromycin. Azithromycin has no effect on methicillin-resistant strains of Staphylococcus aureus.
Among gram-negative microorganisms, azithromycin is active against Neisseria gonorrhoeae, Haemophilus ducreyi, Moraxella catarrhalis and is the most active among macrolides against Haemophilus influenzae, including β-lactamase-producing strains. Thus, the activity of azithromycin against this pathogen is 2-8 times higher than that of erythromycin. In addition, azithromycin is active against Campylobacter spp. , Bordetella pertussis, Bartonella spp. Unlike other macrolides, azithromycin acts in vitro on individual members of the Enterobacteriaceae family: Escherichia coli, Shigella, Salmonella.
Intracellular pathogens (Chlamydia trachomatis, Chlamydia pneumoniae, Mycoplasma pneumoniae, Ureaplasma urealyticum, Mycoplasmа hominis, Legionella pneumophila), spirochetes (Borrelia burgdorferi, Treponema pallidum) and some protozoa (Toxoplasma gondii, Cryptosporidium spp.) are also sensitive to azithromycin.
Since the world is currently experiencing an increase in the resistance of the main pathogens of respiratory tract infections (primarily pneumococci) to macrolides, this fact can potentially limit the clinical efficacy and the possibility of using this class of antibiotics in the future. In a number of European countries, the resistance of S. pneumoniae to macrolides exceeds 20-25%, and in the USA it is 27.9%.
For Russia, the resistance of respiratory pathogens to macrolides in general and to azithromycin in particular is not yet a significant problem. Thus, according to the data of a multicenter epidemiological study conducted in Russia, only 6.2% of pneumococci and 8% of GABHS were resistant to azithromycin, and Haemophilus influenzae strains resistant to azithromycin were not isolated.

Pharmacokinetics

The bioavailability of azithromycin when administered orally is about 40%. The drug is resistant to the action of hydrochloric acid of gastric juice. The maximum concentration in blood serum is reached 2.5-3 hours after ingestion at a dose of 500 mg and is 0.3-0.45 mg / l. With a course three- or five-day intake, fluctuations in concentration are possible due to the absorption of the antibiotic by tissues with its subsequent release.
Azithromycin is recommended to be taken before meals, as under the influence of food, its bioavailability, according to some reports, may decrease. However, three special studies have shown that food does not significantly affect the bioavailability of azithromycin when using its dosage forms, such as tablets of 250 mg, powders of 1000 mg and pediatric suspension of 500 mg. The results of these studies indicate that azithromycin can be administered regardless of food intake, which further facilitates the use of the drug.
Plasma protein binding depends on the concentration of azithromycin in the blood and can vary from 7 to 51%. Due to its high lipophilicity, azithromycin is well distributed in the body, penetrating into many organs and tissues and accumulating in them in very large quantities. Azithromycin concentrations in tissues are tens to hundreds of times higher than serum levels and persist for a long time. The highest concentrations of azithromycin are observed in the tonsils, adenoids, bronchial secretion, bronchial mucosa, alveolar fluid, middle ear exudate.
In tissues, azithromycin is localized mainly intracellularly, mainly in the lysosomes of alveolar macrophages, neutrophils, monocytes and fibroblasts, the latter being the most voluminous and stable reservoir of azithromycin. According to the degree of accumulation in these cells, azithromycin has advantages over all other macrolides. Due to the accumulation in phagocytic cells capable of capturing azithromycin from the blood, interstitial fluid and fibroblasts, the drug is selectively distributed to the foci of bacterial inflammation. The concentration of the antibiotic in the foci of inflammation is 24-36% higher than in healthy tissues.
Azithromycin is excreted from the body mainly unchanged in the bile. Only 6-14% of the administered dose is excreted in the urine. The elimination half-life in children, according to different authors, ranges from 32 to 55 hours. Azithromycin is slowly released from the tissues, which prolongs its elimination and thus allows it to be administered once a day. In children, 4-10% of the drug is found in the urine within 5 days after the administration of the capsules and 8% after the administration of the suspension.
In two studies, M.C. Nahata et al. demonstrated that the pharmacokinetic parameters of azithromycin administered orally at a dose of 10 mg/kg once a day to children with acute otitis media or streptococcal pharyngitis do not differ significantly in patients younger than and older than 5 years.
The advantages of azithromycin over both most β-lactam antibiotics and other macrolides are the ability to use once a day and use in short courses, which significantly increases compliance.

Adverse reactions

Azithromycin is generally well tolerated. Adverse drug reactions (ADRs) develop quite rarely and, as a rule, are moderately expressed. In pediatric studies, the most common reported ADRs were diarrhea (1-6%), abdominal pain (1-4%), nausea (0.5-2%), vomiting (1-6%), headache (1-6%). 2%), rash (0.4-2%).
Dizziness, agitation, sleep disturbance, fatigue, fever, constipation, loss of appetite, chest pain were much less common. The discontinuation rate due to ADRs was approximately 1%. Extremely rarely, with the use of azithromycin, severe reactions (anaphylactic shock, angioedema, Stevens-Johnson and Lyell syndromes), as well as cholestatic jaundice and transient neutropenia, are noted.

Drug interactions

With regard to drug interactions, azithromycin is safer than most other macrolides, since, compared with them, it minimally affects the activity of the hepatic cytochrome P450 enzyme system. However, it has been reported that azithromycin may increase the serum concentration of cyclosporine when co-administered. Antacids reduce the peak concentration of azithromycin in the blood serum. The appointment of azithromycin with nelfinavir leads to an increase in the serum concentration of the antibiotic. The use of azithromycin in patients receiving statins (lovastatin, simvastatin) may be a risk factor for the development of myopathy or rhabdomyolysis. Incompatible with heparin.

Clinical indications for the use of azithromycin

Currently, the range of clinical indications for the use of azithromycin in pediatrics is quite wide – these are infections of the upper and lower respiratory tract, infections of the skin and soft tissues, whooping cough, and a number of other diseases. It should be noted that there are a large number of publications and practical recommendations (both foreign and Russian) devoted to the place of macrolides in the treatment of acute otitis media, streptococcal tonsillitis/pharyngitis, bacterial rhinosinusitis and community-acquired pneumonia in children. At the same time, much less attention is paid to the place of azithromycin in the treatment of whooping cough, cystic fibrosis, cat scratch disease, chlamydial infection in newborns. Therefore, we will only briefly summarize the recommendations for the use of azithromycin in respiratory tract and ENT infections in pediatrics (Table 1) and dwell in more detail on its use in other less frequently mentioned nosological forms.

Whooping cough

Erythromycin is considered the drug of choice for the treatment and post-exposure prophylaxis of whooping cough. However, despite the effectiveness of erythromycin therapy, the need to use 4 times a day and a fairly high incidence of ADR from the gastrointestinal tract became the reasons for the low compliance of the recommended 14-day course. In recent decades, azithromycin has been shown to be active against B. pertussis in vitro studies and clinically proven to be effective (Table 2), making azithromycin included in recommendations for the treatment of whooping cough.
It should be prescribed to children under 6 months at a dose of 10 mg/kg once a day for 5 days; children older than 6 months – 10 mg / kg on the first day (but not more than 500 mg), then 5 mg / kg (2-5 days of therapy).

Intestinal infections

The limited possibilities of antibiotic therapy for intestinal infections in children and the growth of resistance of pathogens to antibiotics dictate the need to find new approaches to the treatment of shigellosis in pediatric practice. One of the new directions is to study the effectiveness of azithromycin in this nosological form, which is based on pharmacokinetic and pharmacodynamic data and clinical experience with the use of azithromycin in adults. The first successful clinical studies of its effectiveness in treating shigellosis in children have also been carried out.
During the 2003 shigellosis outbreak in Israel, 73 people were infected, of whom 83% were children aged 6 months to 18 years. All children with shigellosis confirmed by a positive fecal culture received nalidixic acid at a dose of 55 mg/kg/day in 4 oral doses for 5 days. Since diarrhea persisted in 25 children at the end of its course, it was decided to replace nalidixic acid with azithromycin, which was administered orally at a dose of 10 mg/kg/day for 3 days. In all (100%) children treated with azithromycin, diarrhea was relieved 48 hours after the start of therapy, while in the group receiving only nalidixic acid, diarrhea was relieved in only 65% ​​of patients.
Another study, conducted in 1998-2000, involved 75 children aged 6 months to 5 years diagnosed with shigellosis. Patients were randomized into two groups: the first received cefixime at a dose of 8 mg/kg/day (maximum dose 400 mg/day) for 5 days, the second received azithromycin at a dose of 12 mg/kg on the first day (maximum dose 500 mg ), then 6 mg / kg (maximum – 250 mg / day) over the next 4 days. The therapy was clinically effective in 93% of patients in the first group and in 78% of the second group (p = 0.1, i.e., the differences are not significant). The mean duration of diarrhea since the start of treatment averaged 2. 5 days in the first group and about 4 days in the second. Eradication of the pathogen on the 3rd day of therapy was achieved in 59% of patients taking cefixime and 93% of patients taking azithromycin; these differences were statistically significant. On day 7, a positive bacteriological test result was obtained in one child in the azithromycin group and in two children in the cefixime group.
Thus, the results of the presented studies demonstrate the clinical and microbiological efficacy of azithromycin in shigellosis in children. A simple dosing regimen, a good rate of clinical improvement, and a sufficient rate of eradication of Shigella, most likely due to high intracellular concentrations of azithromycin, are the basis for further research aimed at confirming the correctness of this therapeutic strategy.

Cystic fibrosis

Cystic fibrosis is characterized by a constant relapsing course with the development of inflammation in the lungs and the addition of a secondary infection. Recommended treatment regimens for pulmonary cystic fibrosis include the use of antibiotics, mucolytics, and anti-inflammatory drugs. Antibiotics are prescribed in connection with the development of pulmonary infections, which are a characteristic clinical sign of cystic fibrosis. However, the spectrum of microorganisms that cause these infections can make it difficult to adequately select antibacterial drugs. Thus, Pseudomonas aeruginosa, which is a frequent causative agent of infections in this category of patients, is resistant to the vast majority of oral antibiotics. And although macrolides do not directly have activity against P. aeruginosa, there is evidence of their indirect action against this microorganism and, as a result, a positive effect in the treatment of cystic fibrosis.
It is assumed that macrolides, including azithromycin, prevent the adhesion of P. aeruginosa to the mucous membrane, and also inhibit the formation of biofilms by Pseudomonas aeruginosa, facilitating the phagocytosis of bacteria by neutrophils. Violation of the formation of biofilms occurs due to the inhibition of alginate formation by macrolides, which in turn is due to the inhibition of the enzyme guanosine-D-mannose dehydrogenase.
Currently, a sufficient number of studies have been conducted on the use of macrolides (in particular, azithromycin) in cystic fibrosis. Most of the studies were summarized in a special Cochrane systematic review, which aimed to test the hypothesis that macrolides are able to improve the clinical condition of patients with cystic fibrosis compared with other antibiotics or placebo and, in addition, are characterized by the absence of significant ADRs. As it turned out, the use of azithromycin leads to a statistically significant improvement in the function of external respiration (according to FEV ₁ and FZhEL).
The results of Russian studies also showed that long-term use of small doses of macrolides slows down the progression of chronic bronchopulmonary process in patients with cystic fibrosis, improves the FEV ₁ , which makes it possible to recommend azithromycin to patients with cystic fibrosis with chronic colonization of Pseudomonas aeruginosa.
With regard to the dosing regimen of azithromycin in cystic fibrosis in children, various dosage options have been used. The drug was used at 250 mg 2 times a week for 12 weeks; 250 mg (weighing less than 40 kg) or 500 mg (weighing more than 40 kg) 3 times a week for 168 days; in the same dosage range, but daily for 6 months; 250 mg / day daily for 3 months. In Russian studies on this issue, azithromycin was administered at a dose of 250 mg/day every 2 days for 6 months or 250 mg/day once every 3 days in courses of 6 months for 2 years. However, generally accepted recommendations on the dosage regimen and duration of use of azithromycin in the treatment of cystic fibrosis have not yet been developed.

Cat scratch disease

Cat-scratch disease was first described in 1931, but its causative agent, Bartonella henselae, was isolated only in 1992 from the blood of a domestic cat. The disease is ubiquitous. Typical manifestations in individuals without immunodeficiency include the appearance of a red-brown painless papule after 3-10 days at the site of an injury inflicted by an animal. After 1-3 weeks, unilateral regional lymphadenopathy develops. The disease progresses slowly. The condition of patients is usually satisfactory, with mild non-specific manifestations such as general malaise, loss of appetite, abdominal pain, and muscle or joint pain. The duration of the infectious process usually does not exceed 6 months.
Despite the fact that cat-scratch disease in immunocompetent people is prone to self-healing and without therapy, recovery occurs after 1-3 months, a moderate acceleration of resolution of lymphadenopathy has been shown with azithromycin treatment. In children, azithromycin is prescribed in a short course (5 days) at a dose of 10 mg/kg on the first day, and 5 mg/kg on the next 4 days.
It should be noted that other antibacterial drugs that are potentially effective in this infection include rifampicin, doxycycline, gentamicin, co-trimoxazole and ciprofloxacin (monotherapy or a combination of two drugs). Some of them are not approved for use in pediatrics, others are characterized by an unfavorable safety profile, so it is advisable to give preference to azithromycin in the treatment of children.

Chlamydia infection in newborns

C. trachomatis is the most common causative agent of sexually transmitted microbial infections in the United States. Perinatal transmission of C. trachomatis usually occurs during vaginal delivery, but infection can also be secondary, resulting from damage to the membranes of the fetus, direct contamination of the nasopharynx and lungs of the newborn. Cases of chlamydial infection in newborns after caesarean section are described. 35-50% of newborns whose mothers are infected with chlamydia develop conjunctivitis and 11-20% develop pneumonia. Chlamydial infection is the most common cause of neonatal conjunctivitis occurring between days 5 and 12 of life. Because chlamydia spreads through the tear duct and into the nasopharynx, at least 33% of newborns develop chlamydial pneumonia. In cases where there are no signs of conjunctivitis, pneumonia develops in 11-20% of newborns from infected and untreated mothers.
The American Academy of Pediatrics and the US Centers for Disease Control and Prevention recommend erythromycin ethylsuccinate at a dose of 50 mg/kg/day orally in 4 doses for 14 days for the treatment of chlamydial conjunctivitis and pneumonia in newborns. However, attention is drawn to the possibility of a serious undesirable effect of erythromycin in children under 6 weeks of age – hypertrophic pyloric stenosis, which occurs 8 times more often in children receiving erythromycin orally (but not topically) between the 3rd and 13th days of life. This phenomenon is presumably based on the well-known prokinetic properties of erythromycin. The risk of developing pyloric stenosis with the use of other macrolides (azithromycin, clarithromycin) has not been established. Although data on the use of azithromycin in the treatment of neonatal chlamydial infection is limited, there is evidence of the effectiveness of a short course of this antibiotic at a dose of 20 mg/kg/day (single or for 3 days), i.e. it may be a safer alternative to erythromycin .
Thus, the presented data indicate a wide range of clinical indications for the use of azithromycin in pediatrics, evidence of its efficacy and safety.

References are under revision.

Published in the journal “Farmateka”, No. 2,
(Obstetrics, Gynecology, Pediatrics)

• Number:
• No. 18/1 October – Pediatrics

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