Zithromax (Azithromycin Oral)

Generic name: Azithromycin
Drug class: Macrolides

Usage of Zithromax (Azithromycin Oral)

Azithromycin is used to treat certain bacterial infections in many different parts of the body. This medicine may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.

Azithromycin belongs to the class of drugs known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Zithromax (Azithromycin Oral) side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Diarrhea

loose stools

Less common

Blistering, crusting, irritation, itching, or reddening of the skin

cracked, dry, or scaly skin

fever

swelling

Rare

Blistering, peeling, or loosening of the skin

bloody or cloudy urine

bloody, black, or tarry stools

body aches or pain

burning while urinating

chest pain or tightness

chills

congestion

cough increased

cough producing mucus

dark urine

difficult or labored breathing

difficult or painful urination

dizziness

drowsiness

dryness or soreness of the throat

earache

fainting

fast, irregular, pounding, or racing heartbeat or pulse

general feeling of discomfort or illness

headache

indigestion

irregular or slow heart rate

itching or rash

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

loss of appetite

muscle aches and pains

nausea or vomiting

noisy breathing

passing of gas

red skin lesions, often with a purple center

red, irritated eyes

redness or swelling in the ear

runny nose

shivering

sneezing

sores, ulcers, or white spots on the lips or in the mouth

stomach pain, continuing

stomach pain, fullness, or discomfort

stuffy nose

sweating

swelling of the face, ankles, hands, feet, or lower legs

tender, swollen glands in the neck

trouble with sleeping

trouble with swallowing

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

upper right abdominal or stomach pain

voice changes

vomiting of blood

yellow eyes or skin

Incidence not known

Bleeding gums

bloating

blood in the urine or stools

blurred vision

change in hearing

clay-colored stools

coma

confusion

constipation

continuing ringing or buzzing or other unexplained noise in the ears

decreased urine output

depression

diarrhea, watery and severe, which may also be bloody

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

greatly decreased frequency of urination or amount of urine

hives

hostility

increased thirst

irritability

lethargy

loss of hearing

lower back or side pain

muscle twitching

no blood pressure or pulse

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

pinpoint red spots on the skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid weight gain

seizures

stomach cramps or tenderness

stopping of heart

stupor

unconsciousness

unusual weight loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

Acid or sour stomach

aggressive or angry

bad, unusual, or unpleasant (after) taste

belching

burning feeling in the chest or stomach

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in taste

changes in the color of the tongue

crying

depersonalization

dry mouth

dysphoria

euphoria

excess air or gas in the stomach or intestines

feeling of constant movement of self or surroundings

full feeling

heartburn

hyperventilation

increase in body movements

itching of the vagina or genital area

lack or loss of strength

mental depression

nervousness

pain during sexual intercourse

paranoia

quick to react or overreact emotionally

rapidly changing moods

rash with flat lesions or small raised lesions on the skin

redness of the skin

restlessness

sensation of spinning

shaking

sleepiness or unusual drowsiness

stomach upset

thick, white vaginal discharge with no odor or with a mild odor

white patches in the mouth, tongue, or throat

Incidence not known

Difficulty with moving

increased sensitivity of the skin to sunlight

muscle pain or stiffness

pain in the joints

redness or other discoloration of the skin

severe sunburn

trouble sitting still

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Before taking Zithromax (Azithromycin Oral)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of azithromycin to treat sinusitis in children or to treat pneumonia in children younger than 6 months of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of azithromycin oral suspension and tablets to treat pharyngitis or tonsillitis in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of azithromycin in the elderly. However, elderly patients are more likely to have heart rhythm problems (eg, torsades de pointes) which may require caution in patients receiving azithromycin.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil

Cisapride

Dronedarone

Levoketoconazole

Pimozide

Piperaquine

Saquinavir

Sparfloxacin

Terfenadine

Thioridazine

Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide

Adagrasib

Alfuzosin

Amiodarone

Amisulpride

Amitriptyline

Amoxapine

Anagrelide

Apomorphine

Aripiprazole

Aripiprazole Lauroxil

Arsenic Trioxide

Asenapine

Astemizole

Atazanavir

Azimilide

Bretylium

Buprenorphine

Buserelin

Ceritinib

Chloroquine

Chlorpromazine

Cholera Vaccine, Live

Ciprofloxacin

Citalopram

Clarithromycin

Clofazimine

Clomipramine

Clothiapine

Clozapine

Crizotinib

Dabrafenib

Dasatinib

Degarelix

Delamanid

Desipramine

Deslorelin

Deutetrabenazine

Dexmedetomidine

Digoxin

Dihydroergotamine

Disopyramide

Dofetilide

Dolasetron

Domperidone

Donepezil

Doxorubicin

Doxorubicin Hydrochloride Liposome

Droperidol

Edoxaban

Efavirenz

Encorafenib

Entrectinib

Ergotamine

Erythromycin

Escitalopram

Etrasimod

Fexinidazole

Fingolimod

Flecainide

Fluconazole

Fluoxetine

Formoterol

Foscarnet

Fostemsavir

Gatifloxacin

Gemifloxacin

Gepirone

Glasdegib

Gonadorelin

Goserelin

Granisetron

Halofantrine

Haloperidol

Histrelin

Hydroxychloroquine

Hydroxyzine

Ibutilide

Iloperidone

Imipramine

Inotuzumab Ozogamicin

Ivabradine

Ivosidenib

Ketoconazole

Lapatinib

Lefamulin

Lenvatinib

Leuprolide

Levofloxacin

Lofexidine

Lopinavir

Lumefantrine

Macimorelin

Mefloquine

Methadone

Methotrexate

Metronidazole

Mifepristone

Mirtazapine

Mobocertinib

Morphine

Morphine Sulfate Liposome

Moxifloxacin

Nafarelin

Nilotinib

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

Olanzapine

Ondansetron

Osilodrostat

Osimertinib

Oxaliplatin

Ozanimod

Pacritinib

Paliperidone

Panobinostat

Paroxetine

Pasireotide

Pazopanib

Pentamidine

Phenobarbital

Pimavanserin

Pitolisant

Pixantrone

Ponesimod

Posaconazole

Primidone

Procainamide

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinidine

Quinine

Quizartinib

Ranolazine

Relugolix

Ribociclib

Risperidone

Selpercatinib

Sematilide

Sertraline

Sevoflurane

Simvastatin

Siponimod

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

Sulpiride

Sunitinib

Tacrolimus

Tedisamil

Telithromycin

Tetrabenazine

Toremifene

Trazodone

Triclabendazole

Trifluoperazine

Trimipramine

Triptorelin

Vandetanib

Vardenafil

Vemurafenib

Vilanterol

Vinflunine

Voclosporin

Voriconazole

Warfarin

Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Atorvastatin

Lovastatin

Nelfinavir

Rifabutin

Theophylline

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Relate drugs

How to use Zithromax (Azithromycin Oral)

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take Zithromax® oral liquid or tablets with or without food.

Shake well the bottle of Zithromax® oral liquid before each use. Measure your dose correctly with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Measure the Zmax® extended-release oral suspension with a marked measuring spoon, syringe, or cup. You or your child must take this medicine within 12 hours after it has been mixed with water. It is best to take the Zmax® extended-release oral suspension on an empty stomach or at least 1 hour before or 2 hours after a meal. If your child does not use all of the medicine in the bottle, throw it away after you give the dose.

If you or your child vomits within one hour of taking the Zmax® extended-release oral suspension, call your doctor right away to see if more medicine is needed.

Keep using this medicine for the full treatment time, even if you or your child feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

If you are taking aluminum or magnesium-containing antacids, do not take them at the same time that you take Zithromax®. These medicines may keep azithromycin from working properly. However, you can take antacids with Zmax®.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (extended-release suspension):

For treatment of pneumonia:

Adults—2 grams (g) once as a single dose.

Children weighing 34 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. The dose is usually 2 grams once a day, taken as a single dose.

Children 6 months of age and older weighing less than 34 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 60 milligrams (mg) per kilogram (kg) of body weight once a day, taken as a single dose.

For treatment of sinusitis:

Adults—2 grams (g) once a day as a single dose.

Children—Use and dose must be determined by your doctor.

For oral dosage forms (suspension or tablets):

For treatment of infections:

Adults—500 to 2000 milligrams (mg) once a day, taken as a single dose. Depending on the type of infection, this may be followed with doses of 250 to 500 mg once a day for several days.

Children 6 months of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 10 to 30 milligrams (mg) per kilogram (kg) of body weight once a day, taken as a single dose. Depending on the type of infection, this may be followed with doses of 5 to 10 mg per kg of body weight once a day for several days.

Children younger than 6 months of age—Use and dose must be determined by your doctor.

For treatment of pharyngitis or tonsillitis:

Adults—500 milligrams (mg) on Day 1 (the first day), taken as a single dose. Then, 250 mg on Day 2 through Day 5.

Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 12 milligrams (mg) per kilogram (kg) of body weight once a day for 5 days.

Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not refrigerate or freeze the Zmax® extended-release oral suspension. After water has been added to the powder, use the dose within 12 hours and throw away any unused liquid after your dose.

You may store the Zithromax® oral liquid at room temperature or in the refrigerator. Do not freeze the bottle. Do not keep the oral liquid for more than 10 days. Throw away any unused liquid after all doses are completed.

Warnings

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

If you or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash, itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you take this medicine.

Serious skin reactions, including Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with this medicine. Check with your doctor right away if you or your child have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising or unusual tiredness or weakness while you are using this medicine.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Call your child's doctor right away if your child feels irritable or vomits after feeding. These may be symptoms of a condition called infantile hypertrophic pyloric stenosis.

Azithromycin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you or your child have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

This medicine can cause changes in heart rhythms, including QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you or your child have any symptoms of heart rhythm problems, including fast, pounding, or irregular heartbeats.

This medicine may increase the risk of serious heart or blood vessel problems. Call your doctor right away if you have blurred vision, chest pain, confusion, lightheadedness, dizziness, fainting, fast or irregular heartbeat, trouble breathing, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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