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Zithromax®
(azithromycin tablets or oral suspension)
Drug Uses
Zithromax is used to treat many different types
of bacterial infections, such as bronchitis, pneumonia, tonsillitis, skin
infections, ear infections, and sexually transmitted diseases.
How Taken
Zithromax comes as a capsule, tablet, and liquid
to take it orally. It is usually taken once a day for 2-5 days. Take Zithromax
exactly as directed. Do not take more or less of it or take it more often than
prescribed by your doctor. Shake the liquid well before each use to mix the
medication evenly. The capsules and tablets should be taken with a full glass of
water. Continue to take Zithromax even if you feel well. Do not stop taking
Zithromax without talking to your doctor. Take Zithromax liquid at least 1 hour
before or 2 hours after meals. The capsule and tablet may be taken with or
without food. If it upsets your stomach, take it with food.
Warnings/Precautions
Before taking Zithromax, tell your doctor if you
have liver disease. You may not be able to take Zithromax, or you may require a
lower dose or special monitoring during treatment. Zithromax is in the FDA
pregnancy category B. This means that it is not expected to harm an unborn baby.
Do not take this medication without first talking to your doctor if you are
pregnant or could become pregnant during treatment. It is not known whether
Zithromax passes into breast milk. Do not take this medication without first
talking to your doctor if you are breast-feeding a baby
Missed Dose
Take the missed dose as soon as you remember.
However, if it is almost time for the next regularly scheduled dose, skip the
missed dose and take the next one as directed. Do not take a double dose of this
medication unless otherwise directed by your doctor.
Possible Side Effects
If you experience any of the following serious
side effects, stop taking Zithromax and seek emergency medical attention: an
allergic reaction (difficulty breathing; closing of the throat; swelling of the
lips, tongue, or face; or hives); or liver damage (yellowing of the skin or
eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe
fatigue). Other, less serious side effects may be more likely to occur. Continue
to take Zithromax and talk to your doctor if you experience nausea, vomiting,
diarrhea, or abdominal pain; unusual dizziness, fatigue, or headache; vaginal
yeast infection; a rash; or increased sensitivity to sunlight. Side effects
other than those listed here may also occur. Talk to your doctor about any side
effect that seems unusual or that is especially bothersome.
Storage
Zithromax tablets should be stored between 15° to
30° C (59° to 86°F). Store constituted suspension between 5° to 30°C (41° to
86°F) and discard when full dosing is completed or within 10 days. Shake well
before each use. Oversized bottle provides shake space. Keep tightly closed.
Overdose
Seek emergency medical attention. Symptoms of
Zithromax overdose include nausea, vomiting, diarrhea, and abdominal discomfort.
More Information
Avoid prolonged exposure to sunlight. Zithromax
may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear
protective clothing when exposure to the sun is unavoidable.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Zithromax® (azithromycin) and other bacterial drugs, Zithromax
(azithromycin) should be used only to treat or prevent infections that are
proven or strongly suspected to be caused by bacteria.
Zithromax (azithromycin tablets and azithromycin for oral suspension) contain
the active ingredient azithromycin, an azalide, a subclass of macrolide
antibiotics, for oral administration. Azithromycin has the chemical name
(2R,3S,4R,5R,8R,
10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)
oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-
(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.
Azithromycin is derived from erythromycin; however, it differs chemically from
erythromycin in that a methyl-substituted nitrogen atom is incorporated into the
lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is
749.00.
Azithromycin, as the dihydrate, is a white crystalline powder with a molecular
formula of C38H72N2O12•2H2O and a molecular weight of 785.0.
Zithromax is supplied for oral administration as film-coated, modified capsular
shaped tablets containing azithromycin dihydrate equivalent to either 250 mg or
500 mg azithromycin and the following inactive ingredients: dibasic calcium
phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium
stearate, sodium lauryl sulfate, hypromellose, lactose, titanium dioxide,
triacetin and D&C Red #30 aluminum lake.
Zithromax for oral suspension is supplied in bottles containing azithromycin
dihydrate powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin
per bottle and the following inactive ingredients: sucrose; sodium phosphate,
tribasic, anhydrous; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and
spray dried artificial cherry, creme de vanilla and banana flavors. After
constitution, each 5 mL of suspension contains 100 mg or 200 mg of azithromycin.
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