Pronunciation:

ay-zith-roe-MYE-sin

Brand Names:

• Zithromax

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Antibiotic

Chemical—

Macrolide

Uses of This Medicine:

Azithromycin injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV).

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. Azithromycin injection may be used for other problems as determined by your doctor.

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

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of azithromycin injection in children younger than 16 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of azithromycin injection in the elderly. However, elderly patients are more likely to have age-related heart problems, which may require caution in patients receiving azithromycin injection.

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.

Other 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 receiving 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
• 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

Other interactions—

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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Congestive heart failure or
• Diarrhea or
• Heart disease or
• Heart rhythm problems (eg, bradyarrhythmia, prolonged QT interval), history of or
• Hypokalemia (low potassium levels in the blood), uncorrected or
• Hypomagnesemia (low magnesium levels in the blood), uncorrected or
• Liver disease or
• Myasthenia gravis (severe muscle weakness)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body. .

• Liver disease, history of—Should not be used in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins. This medicine is given slowly, so the needle will remain in place for about an hour.

Your doctor may give you a few doses of this medicine until your condition improves, and then you may be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

If your 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, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this medicine.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Check with your doctor right away if you 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.

Infantile hypertrophic pyloric stenosis (tube is too narrow where food passes out of the stomach) may occur in newborn babies after receiving this medicine. Tell your child's doctor right away if your child vomits or irritability with feeding occurs.

Azithromycin injection 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 checking first with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Tell your doctor if you have bleeding, blistering, burning, discoloration of the skin, itching, lumps, pain, rash, redness, or swelling at the injection site.

This medicine can cause changes in heart rhythms, such as a condition called 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 have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

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.

Side Effects of This Medicine:

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 or nurse immediately if any of the following side effects occur:

More common

Pain, redness, and swelling at the injection site

Less common

Difficult or labored breathing

loose stools

tightness in the chest

Rare

Abdominal or stomach cramps or pain (severe)

abdominal or stomach tenderness

diarrhea (watery and severe, which may be bloody)

fever

joint pain

skin rash

swelling of the face, mouth, neck, hands, and feet

Incidence not known

Agitation

black, tarry stools

bleeding gums

blistering, peeling, or loosening of the skin

bloating

blood in the urine or stools

bloody or cloudy urine

blurred vision

chest pain or discomfort

chills

coma

confusion

constipation

convulsions

cough

darkened urine

decreased urine output

depression

difficulty with swallowing

dizziness

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

fainting

fast, pounding, or irregular heartbeat or pulse

fever with or without chills

general feeling of discomfort or illness

greatly decreased frequency of urination or amount of urine

headache

hives or itching

hostility

increased thirst

indigestion

irregular heartbeat recurrent

irregular or slow heart rate

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

lethargy

light-colored stools

loss of appetite

muscle pain

muscle twitching

nausea or vomiting

pain

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

pinpoint red spots on the skin

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

rapid weight gain

red skin lesions, often with a purple center

red, irritated eyes

sore throat

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

stupor

sweating

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

unusual bleeding or bruising

unusual tiredness or weakness

yellow eyes or skin

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:

Less common

Diarrhea (mild)

nausea

stomach pain or discomfort (mild)

weight loss

Less common or rare

Acid or sour stomach

belching

burning feeling in the chest or stomach

cracked lips

excess air or gas in the stomach or intestines

full feeling

heartburn

passing gas

sleepiness or unusual drowsiness

sore mouth or tongue

stomach discomfort, upset, or pain

white patches in the mouth, tongue, or throat

Incidence not known

Attack, assault, or force

bad, unusual, or unpleasant (after) taste

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

change in taste

continuing ringing or buzzing or other unexplained noise in the ears

difficulty with moving

discoloration of the tongue

dizziness or lightheadedness

feeling of constant movement of self or surroundings

hearing loss

itching of the vagina or genital area

lack or loss of strength

loss of sense of smell

muscle pain or stiffness

pain during sexual intercourse

sensation of spinning

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

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.