AzaSite

Name: AzaSite

Azasite Overview

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.

Azasite and Lactation

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.

Azasite Dosage

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.

Other Requirements

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.

What should I avoid while taking azithromycin ophthalmic?

Do not use this medication while wearing contact lenses. Azithromycin ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using azithromycin ophthalmic before putting your contact lenses in.

You should not wear contact lenses while you still have active symptoms of the eye infection you are treating (eye redness, irritation, or drainage).

Commonly used brand name(s)

In the U.S.

  • AzaSite

Available Dosage Forms:

  • Solution

Therapeutic Class: Antibiotic

Chemical Class: Macrolide

Before Using AzaSite

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Azasite® in children. However, safety and efficacy have not been established in children younger than 1 year of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Azasite® in the elderly.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Proper Use of AzaSite

Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to. This medicine is not for long-term use.

To use the eye drops:

  • First, wash your hands. Then turn the closed bottle upside down and shake it one time before putting the medicine in your eye. Remove the cap with the bottle still being held upside down.
  • Tilt your head back and pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eye. Do not blink. Keep the eye closed for 1 or 2 minutes to allow the medicine to be absorbed.
  • If you think you did not get the drop of medicine into your eye properly, repeat the directions with another drop.
  • Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
  • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

To help clear up your eye infection completely, keep using this medicine for the full treatment time, even if your symptoms disappeared and even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon. Do not miss any doses.

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 ophthalmic dosage form (eye drops):
    • For bacterial conjunctivitis:
      • Adults, teenagers, and children 1 year of age and older—Put one drop in the affected eye(s) two times a day for 2 days, with each dose being at least 8 to 12 hours apart. Then, put one drop in the affected eye(s) once a day for the next 5 days.
      • Children younger than 1 year of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the unopened bottle in the refrigerator. Do not freeze. Once the medicine is opened, you may store it in the refrigerator or in a closed container at room temperature, away from heat, moisture, and direct light for up to 14 days.

Ask your doctor how you should dispose of any medicine you do not use. Throw away any unused medicine after 14 days.

What are some other side effects of AzaSite?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Eye irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How do I store and/or throw out AzaSite?

  • Store unopened containers in a refrigerator. Do not freeze.
  • After opening, store at room temperature or in a refrigerator. Throw away after 14 days.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Use in specific populations

Pregnancy

Pregnancy Category B. Reproduction studies have been performed in rats and mice at doses up to 200 mg/kg/day. The highest dose was associated with moderate maternal toxicity. These doses are estimated to be approximately 5,000 times the maximum human ocular daily dose of 2 mg. In the animal studies, no evidence of harm to the fetus due to azithromycin was found. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azithromycin is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of AzaSite solution in pediatric patients below 1 year of age have not been established. The efficacy of AzaSite in treating bacterial conjunctivitis in pediatric patients one year or older has been demonstrated in controlled clinical trials [see Clinical Studies (14)].

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

What should i discuss with my health care provider before taking azithromycin ophthalmic (azasite)?

You should not use this medication if you are allergic to azithromycin (Zithromax).

FDA pregnancy category B. Azithromycin ophthalmic is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether azithromycin ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

What should i avoid while taking azithromycin ophthalmic (azasite)?

Do not use this medication while wearing contact lenses. Azithromycin ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using azithromycin ophthalmic before putting your contact lenses in.

You should not wear contact lenses while you still have active symptoms of the eye infection you are treating.

Where can i get more information?

Your doctor or pharmacist can provide more information about azithromycin ophthalmic.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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What other drugs will affect AzaSite?

It is not likely that other drugs you take orally or inject will have an effect on AzaSite used in the eyes. But many drugs can interact with each other. Tell your doctor about all medicines you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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