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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 azithromycin, the following
should be considered:
Allergies—Tell your doctor if you have ever
had any unusual or allergic reaction to azithromycin or to any
related medicines such as erythromycin. Also tell your health care
professional if you are allergic to any other substances, such as
foods, preservatives, or dyes.
Pregnancy—Azithromycin has not been studied
in pregnant women. However, azithromycin has not been shown to
cause birth defects or other problems in animal studies.
Breast-feeding—It is not known whether
azithromycin passes into breast milk. Although most medicines pass
into breast milk in small amounts, many of them may be used safely
while breast-feeding. Mothers who are taking this medicine and who
wish to breast-feed should discuss this with their doctor.
Children—This medicine has been tested in a
limited number of children up to the age of 16. In effective
doses, the medicine has not been shown to cause different side
effects or problems than it does in adults.
Older adults—This medicine has been tested
in a limited number of elderly patients and has not been shown to
cause different side effects or problems in older people than it
does in younger adults.
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 taking azithromycin, it
is especially important that your health care professional know if
you are taking any of the following:
 | Antacids, aluminum- and magnesium-containing—Antacids may
decrease the amount of azithromycin in the blood, which may
decrease its effects. To avoid problems, azithromycin should
be taken at least 1 hour before or at least 2 hours after
antacids |
Other medical problems—The presence of other
medical problems may affect the use of azithromycin. Make sure you
tell your doctor if you have any other medical problems,
especially:
| Liver disease—Patients with severe liver disease may have
an increased chance of side effects |
Proper Use of This Medicine
Azithromycin capsules and pediatric oral suspension should be
taken at least 1 hour before or at least 2 hours after meals.
Azithromycin tablets and adult single dose oral suspension may be
taken with or without food.
To help clear up your infection completely, keep taking
azithromycin for the full time of treatment, even if you
begin to feel better after a few days. If you stop taking this
medicine too soon, your symptoms may return.
Dosing—
The dose of azithromycin 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 azithromycin. If your dose is different, do not
change it unless your doctor tells you to do so.
The number of capsules or tablets or the amount of suspension
that you take depends on the medical problem for which you are
taking azithromycin.
| For the capsule dosage form:
| For bronchitis, strep throat, pneumonia, and skin
infections:
| Adults and adolescents 16 years of age and
older—500 milligrams (mg) on the first day, then 250
mg once a day on days two through five.
| Children up to 16 years of age—Use and dose must
be determined by your doctor. |
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| For chlamydia infections:
| Adults and adolescents 16 years of age and
older—1000 mg taken once as a single dose.
| Children up to 16 years of age—Use and dose must
be determined by your doctor. |
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| For the oral suspension dosage form:
| For chancroid in men and chlamydia infections:
| Adults and adolescents—1 gram taken once as a
single dose.
| Children 6 months to 12 years of age—Use and dose
must be determined by your doctor. |
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| For gonococcal infections:
| Adults and adolescents—2 grams taken once as a
single dose.
| Children 6 months to 12 years of age—Use and dose
must be determined by your doctor. |
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| For otitis media and pneumonia:
| Children 6 months to 12 years of age—10 milligrams
(mg) per kilogram (kg) (4.5 mg per pound) of body
weight once a day on the first day, then 5 mg per kg
(2.2 mg per pound) of body weight once a day on days
two through five. |
| For strep throat:
| Adults and adolescents—The oral suspension is
usually not used. Refer to azithromycin capsules or
tablets.
| Children 2 to 12 years of age—12 mg per kg (5.4 mg
per pound) of body weight once a day for five days.
| Children up to 2 years of age—Use and dose must be
determined by your doctor. |
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| For the tablet dosage form:
| For bronchitis, strep throat, pneumonia, and skin
infections:
| Adults and adolescents 16 years of age and
older—500 milligrams (mg) on the first day, then 250
mg once a day on days two through five.
| Children up to 16 years of age—Use and dose must
be determined by your doctor. |
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| For chlamydia infections:
| Adults and adolescents 16 years of age and
older—1000 mg taken once as a single dose.
| Children up to 16 years of age—Use and dose must
be determined by your doctor. |
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| For prevention of Mycobacterium avium complex (MAC)
disease:
| Adults and adolescents 16 years of age and
older—1200 mg once a week.
| Children up to 16 years of age—Use and dose must
be determined by your doctor. |
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| For injection dosage form:
| For pelvic inflammatory disease:
| Adults and adolescents 16 years of age and
older—500 milligrams (mg) once a day for one or two
days, injected into a vein.
| Children up to 16 years of age—Use and dose must
be determined by your doctor. |
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| For pneumonia:
| Adults and adolescents 16 years of age and
older—500 mg once a day for at least two days,
injected into a vein.
| Children up to 16 years of age—Use and dose must
be determined by your doctor. |
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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—
To store this medicine:
| Keep out of the reach of children.
| Store away from heat and direct light.
| Store the pediatric suspension form of azithromycin in the
refrigerator.
| Do not store in the bathroom, near the kitchen sink, or in
other damp places. Heat or moisture may cause the medicine to
break down.
| Do not keep outdated medicine or medicine no longer needed.
Be sure that any discarded medicine is out of the reach of
children. |
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Precautions While Using This Medicine
If your symptoms do not improve within a few days, or if they
become worse, check with your doctor.
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.
Stop taking this medicine and get emergency help immediately
if any of the following side effects occur :
| More common (for injection form only)
| Pain, redness, and swelling at site of injection |
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| Rare
| Abdominal or stomach cramps or pain (severe);
abdominal tenderness; diarrhea (watery and severe,
which may be bloody); difficulty in breathing;
fever; joint pain; skin rash; swelling
of face, mouth, neck, hands, and feet |
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Other 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. However, check with your doctor if
any of the following side effects continue or are bothersome:
| Less common
| Diarrhea (mild); nausea; stomach pain or
discomfort |
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| Rare
| Dizziness; headache |
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Other side effects not listed above may also occur in some
patients. If you notice any other effects, check with your doctor.
Additional Information
Once a medicine has been approved for marketing for a certain
use, experience may show that it is also useful for other medical
problems. Although these uses are not included in product
labeling, azithromycin is used in certain patients with the
following medical condition:
| Trachoma (treatment) |
Other than the above information, there is no additional
information relating to proper use, precautions, or side effects
for this use.
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