AZITHROMYCIN (Systemic)
Some commonly used brand names are:
In the U.S.?
In Canada?
Category
Description
Azithromycin (az-ith-roe-MYE-sin) is used to treatbacterial infections in many different parts of the body. It is also usedto prevent Mycobacterium avium complex (MAC) diseasein patients infected with the human immunodeficiency virus (HIV). It worksby killing bacteria or preventing their growth. However, this medicine willnot work for colds, flu, or other viral infections. Azithromycin may be usedfor other problems as determined by your doctor.
Azithromycin is available only with your doctor's prescription, in thefollowing dosage forms:
Oral- Capsules (U.S. and Canada)
- Oral suspension (U.S. and Canada)
- Tablets (U.S. and Canada)
Parenteral- Injection (U.S.)
Before Using This Medicine
In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For azithromycin, thefollowing should be considered:
Allergies?Tell your doctor if you have ever had any unusual orallergic 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 problemsin animal studies.
Breast-feeding?It is not known whether azithromycin passes intobreast milk. Although most medicines pass into breast milk in small amounts,many of them may be used safely while breast-feeding. Mothers who are takingthis medicine and who wish to breast-feed should discuss this with their doctor.
Children?This medicine has been tested in a limited numberof children up to the age of 16. In effective doses, the medicine has notbeen shown to cause different side effects or problems than it does in adults.
Older adults?This medicine has been tested in a limited numberof elderly patients and has not been shown to cause different side effectsor problems in older people than it does in younger adults.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingazithromycin, it is especially important that your health care professionalknow if you are taking any of the following:
- Antacids, aluminum- and magnesium-containing?Antacids may decreasethe amount of azithromycin in the blood, which may decrease its effects. Toavoid problems, azithromycin should be taken at least 1 hour before or atleast 2 hours after antacids
Other medical problems?The presence of other medicalproblems may affect the use of azithromycin. Make sure you tell your doctorif you have any other medical problems, especially:
- Liver disease?Patients with severe liver disease may have anincreased chance of side effects
Proper Use of This Medicine
Azithromycincapsules and pediatric oral suspension should be taken at least 1 hour beforeor at least 2 hours after meals. Azithromycin tablets and adult single doseoral suspension may be taken with or without food.
To help clear up your infection completely, keep takingazithromycin for the full time of treatment, even if you begin to feelbetter after a few days. If you stop taking this medicine too soon, your symptomsmay return.
Dosing?The dose of azithromycin will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe 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 youtake depends on the medical problem for which you are taking azithromycin.
- 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 determinedby your doctor.
- 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 determinedby your doctor.
- For otitis media and pneumonia:
- Children 6 months to 12 years of age?10 milligrams (mg) perkilogram (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 twothrough 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 determinedby your doctor.
- 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 determinedby your doctor.
- For chlamydia infections:
- Adults and adolescents 16 years of age and older?1000 mg takenonce as a single dose.
- Children up to 16 years of age?Use and dose must be determinedby your doctor.
- For prevention of Mycobacterium avium complex(MAC) disease:
- Adults and adolescents 16 years of age and older?1200 mg oncea week.
- Children up to 16 years of age?Use and dose must be determinedby your doctor.
- For sinusitis:
- Adults and adolescents? 500 mg a day for 3 days
- Children up to 16 years of age?Use and dose must be determinedby your doctor.
- 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 determinedby your doctor.
- For pneumonia:
- Adults and adolescents 16 years of age and older?500 mg oncea day for at least two days, injected into a vein.
- Children up to 16 years of age?Use and dose must be determinedby your doctor.
Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is almost time for your next dose, skip themissed 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 otherdamp places. Heat or moisture may cause the medicine to break down.
- Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
If yoursymptoms do not improve within a few days, or if they become worse, checkwith your doctor.
Side Effects of This Medicine
Along with its needed effects,a medicine may cause some unwanted effects. Although not all of these sideeffects may occur, if they do occur they may need medical attention.
Stop taking this medicineand 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
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
Other side effects may occur that usually do not needmedical attention. These side effects may go away during treatment as yourbody adjusts to the medicine. However, check with your doctor if any of thefollowing side effects continue or are bothersome:
Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.
Additional Information
Once a medicine has been approved for marketingfor a certain use, experience may show that it is also useful for other medicalproblems. Although these uses are not included in product labeling, azithromycinis used in certain patients with the following medical condition:
Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for this use.
Revised: 08/17/2004
