Azasite

Azithromycin is a prescription medication used to treat many bacterial infections such as those of the lungs and airways, eyes, ears, sinuses, skin, throat, and infections from sexually transmitted diseases. Azithromycin belongs to a group of drugs called macrolide antibiotics, which stop the growth of bacteria.

This medication comes in tablet, oral (by mouth) suspension, eye drops, and injection forms. The tablets and regular suspensions are taken once a day, with or without food. The extended release suspension is taken once only on an empty stomach. The eye drops are used in the affected eye twice a day. The injection is given by a healthcare professional.

Common side effects of azithromycin include nausea, vomiting, diarrhea, stomach pain, and headache. Eye irritation is the common side effect of the eye drop form.

Azithromycin is a prescription medication used to treat many bacterial infections such as those of the lungs and airways, eyes, ears, sinuses, skin, throat, and infections from sexually transmitted diseases.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

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Serious side effects have been reported with azithromycin. See “Drug Precautions” section.

Common side effects of azithromycin in the tablet, oral solution, and injection forms include:

• nausea
• vomiting
• diarrhea
• stomach pain
• heartburn
• headache

Common side effects of azithromycin in the eye drop form include:

• eye burning, stinging and irritation
• dry eye
• discharge coming from your eye
• changes to the surface of your eye
• blurred vision

This is not a complete list of azithromycin side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• drugs that can cause QT prolongation such as selegiline (Emsam, Eldepryl), amitriptyline (Elavil), and nortriptyline (Aventyl)
• antacids containing aluminum or magnesium (Maalox, Mylanta, Rolaids, others)
• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Tegretol XR)
• cyclosporine (Gengraf, Neoral, Sandimmune)
• digoxin (Lanoxin)
• dihydroergotamine (D.H.E. 45, Migranal)
• ergotamine (Ergostat, Ergomar)
• corticosteroids such as hydrocortisone (Cortef, Cortril, Hydrocortone), methylprednisolone (Medrol), and prednisone (Cortan, Prednisone Intensol)
• nelfinavir (Viracept)
• phenytoin (Dilantin)
• tacrolimus (Prograf, Protopic)
• triazolam (Halcion)

This is not a complete list of azithromycin drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with azithromycin including:

• Hypersensitivity reaction: An allergic reaction to azithromycin is possible. Tell your healthcare provider right away if you have some or all of the following symptoms of an allergic reaction:
  • hives or rash
  • difficulty breathing or swallowing
  • swelling
  • hoarseness
• Azithromycin should not be used for extended periods of time. Prolonged use can lead to the growth of dangerous organisms that are resistant to azithromycin. Take azithromycin for the duration prescribed by your doctor.

• Clostridium difficile associated diarrhea: Azithromycin and other antibiotics can kill the “good” bacteria in the colon leading to a growth of C. difficile bacteria. C. difficile is “bad” bacteria that can cause diarrhea.
• Heart rhythm changes: Azithromycin can cause abnormal changes in the electrical activity of the heart that may lead to a potentially life-threatening irregular heart rhythm. Tell your doctor if you have a history of any of the following:
  • existing heart rhythm problems called QT prolongation
  • low blood levels of potassium or magnesium
  • slower than normal heart rate
  • use of drugs for the treatment of abnormal heart rhythms or arrhythmias
• Muscle problems: Azithromycin can worsen the symptoms of a muscle disease called myasthenia gravis. In addition, azithromycin can cause muscle weakness. Alert your doctor if you have a history of myasthenia gravis or experience the new muscle weakness.

Do not take azithromycin if you:

• are allergic to azithromycin, erythromycin, or any other macrolide antibiotic

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of azithromycin, there are no specific foods that you must exclude from your diet when receiving azithromycin.

Before taking azithromycin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have a history of heart problems (especially QT prolongation, Torsades de Pointes)
• have a history of liver or kidney problems
• have a history of myasthenia gravis
• have cystic fibrosis or human immunodeficiency virus (HIV)
• are allergic to azithromycin, erythromycin, or any other macrolide antibiotic
• use contacts and are taking the eye drops
• are pregnant or breastfeeding

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Azithromycin falls into category B. Studies in animals have failed to demonstrate a risk to the unborn baby and there are no well-controlled studies in pregnant women. Azithromycin should be used during pregnancy only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if azithromycin is excreted in human breast milk or if it will harm your nursing baby.

The injectable form of azithromycin is given directly into the vein (IV) by a healthcare professional.

Take all other forms of azithromycin exactly as prescribed.

For the tablets and regular suspensions (liquid):

• Take once a day, with a glass of water and with or without food.
• Take with food if azithromycin upsets your stomach.

For the extended release suspension (liquid):

• Take one dose only on an empty stomach (at least 1 hour before or 2 hours following a meal).

For the eye drops:

• One drop is instilled in the affected eye twice a day for the first 2 days.
• One drop is instilled in the affected eye once a day for the next 5 days.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of azithromycin at the same time.

The injectable form of azithromycin is given directly in the vein (IV) by a healthcare professional.

Take all other forms of azithromycin exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Your doctor will determine the best dose for you or your child based on the type of infection and the patient's age.

For the tablets and regular suspension:

• Adults: The recommended azithromycin dosage for most infections is 250, 500, and 600 mg once daily in this dosage form. Azithromycin is usually taken for 3 to 5 days, or longer for more serious infections. For some infections a single 1 or 2 g dose is prescribed.

• Children: The recommended azithromycin dose in this dosage form in children is based on weight and ranges from 5 mg to 20 mg per kilogram of body weight per day. Azithromycin is usually taken for 3 to 5 days.

For the extended release suspensions:

• Adults: Azithromycin in this form should be taken as a single 2 g dose.

• Children: For children 6 months and older, azithromycin in this form should be taken as a single dose of 60 mg/kg (equivalent to 27 mg/lb) body weight. Children weighing 75 lb (34 kg) or more should receive the adult dose of 2 grams.

For the eye drops:

• The recommended azithromycin eye drop dosage is one drop in the affected eye(s) twice daily, eight to twelve hours apart, for the first two days. Then, instill one drop in the affected eye(s) once daily for the next five days.

If you take too much azithromycin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

For the eye drops:

• Before you open your eye drops, store it in the refrigerator between 36°F to 46°F (2°C to 8°C).
• After you open your eye drops, store it at room temperature or the refrigerator between 36°F to 77°F (2°C to 25°C). After opening the bottle, throw away this medication after 14 days.
• Safely throw away medicine that is out of date or no longer needed.

For the extended release suspension:

• After mixing with water, extended release suspensions should be used within 12 hours. For adult patients, the entire bottle should be consumed. For pediatric patients, any suspension remaining after dosing MUST be discarded.
• Do not refrigerate or freeze. Store at room temperature.
• Store azithromycin suspensions and tablets at room temperature.

Keep this and all medicines out of the reach of children.