Approved Drug Label (PDF)
5
Warnings and Precautions
5.8
Risk of Antibacterial Resistance in Sexually Transmitted Infections
Subsection
title revised
ZITHROMAX,
at the recommended dose, should not be relied upon to treat syphilis. Antibacterial
agents used to treat non-gonococcal urethritis may mask or delay the symptoms
of incubating syphilis. All patients with sexually transmitted urethritis or
cervicitis should have a serologic test for syphilis and appropriate testing
for gonorrhea performed at the time of diagnosis.
Appropriate
antibacterial therapy and follow-up tests for these diseases should be
initiated if infection is confirmed.
6
Adverse Reactions
6.1
Clinical Trials Experience
.
. .
Clinical
Trials Experience in Adults
Revised
subheading
Multiple-dose
regimens: Overall, the most common treatment-related adverse reactions in adult
patients receiving multiple-dose regimens of ZITHROMAX were related to the
gastrointestinal system with diarrhea/loose stools (4 to 5%), nausea (3%), and
abdominal pain (2 to 3%) being the most frequently reported.
.
. .
Clinical
Trials Experience in Pediatric Patients
Revised
subheading
Single
and Multiple-dose regimens: The types of adverse reactions in pediatric
patients were comparable to those seen in adults, with different incidence
rates for the dosage regimens recommended in pediatric patients.
.
. .
Addition
of Table 8. Incidence of Adverse Reactions in Pediatric Patients Treated for
Acute Otitis Media to the title section of table 8; please refer to label
for complete information.
.
. .
Addition
of Table 9. Incidence of Adverse Reactions in Pediatric Patients Treated for
Community-Acquired Pneumonia to the title section of table 9; please refer
to label for complete information.
.
. .
Addition
of Table 10. Incidence of Adverse Reactions in Pediatric Patients Treated for
Pharyngitis/Tonsillitis to the title section of table 10; please refer to
label for complete information.
.
. .
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
PATIENT
COUNSELING INFORMATION
Additions
and/or revisions underlined:
Advise
the patient to read the FDA-approved patient labeling (Patient Information).
Important
Administration Instructions
ZITHROMAX
tablets and oral suspension can be taken with or without food.
Concomitant
Administration with Aluminum and Magnesium Containing Antacids
Advise patients not to take aluminum and
magnesium containing antacids and azithromycin simultaneously.
Allergic
Reactions
Direct
patients to discontinue azithromycin immediately and contact a physician if any
signs of an allergic reaction occur [see
warnings and Precautions (5.1)].
Vomiting,
Irritability, Diarrhea or Rash with Feeding in Infants
Direct
parents or caregivers to contact their physician if vomiting, irritability, diarrhea
or rash with feeding occurs in the infant [see Warnings and Precautions (5.3) and Use in Specific Population
(8.2)].
Antibacterial
Resistance
Patients
should be counseled that antibacterial drugs including ZITHROMAX should only be
used to treat bacterial infections. They do not treat viral infections (e.g.,
the common cold). When ZITHROMAX is prescribed to treat a bacterial infection,
patients should be told that although it is common to feel better early in the
course of the therapy, the medication should be taken exactly as directed.
Skipping doses or not completing the full course of therapy may (1) decrease
the effectiveness of the immediate treatment and (2) increase the likelihood
that bacteria will develop resistance and will not be treatable by ZITHROMAX or
other antibacterial drugs in the future.
Diarrhea
Diarrhea
is a common problem caused by antibacterials, including ZITHROMAX which
usually ends when the antibacterial is discontinued. Sometimes after starting
treatment with antibacterials patients can develop watery and bloody stools
(with or without stomach cramps and fever) even as late as two or more months
after having taken the last dose of the antibacterial drug. If this occurs,
patients should contact their physician as soon as possible [see Warnings and Precautions (5.6)].
PATIENT INFORMATION
Additions and/or
revisions underlined:
. . .
What is ZITHROMAX?
ZITHROMAX is a macrolide antibiotic prescription
medicine used in adults 18 years of age or older to treat certain infections
caused by certain germs called bacteria. These bacterial infections include:
. . .
ZITHROMAX is used in children 6 months of age
and older to treat:
- ear
infections
- community-acquired
pneumonia
ZITHROMAX is used in children 2 years of age and
older to treat:
- infected
throat or tonsils
ZITHROMAX is not recommended for use
in people who cannot tolerate oral medicines because they are very ill or
have certain other risk factors including:
- have
cystic fibrosis
- have
hospital acquired infections
- have
known or suspected bacteria in the blood (bacterial infection in the blood)
. . .
What should I tell my healthcare provider before
taking ZITHROMAX?
Before you take ZITHROMAX, tell your healthcare
provider about all your medical conditions including if you:
. . .
- have heart
problems, including a slow or irregular heartbeat, a heart
problem called “QT prolongation”, or heart failure.
- have a
problem that causes muscle weakness (myasthenia gravis).
- are
pregnant or plan to become pregnant. It is not known if ZITHROMAX will harm
your unborn baby.
- are
breastfeeding or plan to breastfeed. ZITHROMAX can pass into breast
milk. Talk to your healthcare provider about the best way to feed your baby
while you take ZITHROMAX. Contact your healthcare provider immediately if you
are breastfeeding a young child (less than 6 weeks of age) and he or she
vomits, has diarrhea, develops a rash, or becomes irritable when fed.
Tell
your healthcare provider about all the medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
.
. .
What
are the possible side effects of ZITHROMAX?
ZITHROMAX
can cause serious side effects, including:
.
. .
Diarrhea.
Tell your
healthcare provider right away if you have watery diarrhea, diarrhea that does
not go away, or bloody stools. You may experience cramping and a fever. This
could happen as late as 2 or more months after you have finished your treatment
with ZITHROMAX.
. . .
Approved Drug Label (PDF)
5
Warnings and Precautions
5.5 Cardiovascular Death
Newly
added information:
Some
observational studies have shown an approximately two-fold increased shortterm potential
risk of acute cardiovascular death in adults exposed to azithromycin relative
to other antibacterial drugs, including amoxicillin. The five-day
cardiovascular mortality observed in these studies ranged from 20 to 400 per
million azithromycin treatment courses. This potential risk was noted to be
greater during the first five days
of
azithromycin use and does not appear to be limited to those patients with
preexisting cardiovascular diseases. The data in these observational studies
are insufficient to establish or exclude a causal relationship between acute
cardiovascular death and azithromycin use. Consider balancing this potential
risk with treatment benefits when prescribing ZITHROMAX.
6
Adverse Reactions
Newly
added information:
The
following clinically significant adverse reactions are described elsewhere in
labeling:
•
Hypersensitivity [see Warnings and Precautions (5.1)]
•
Hepatotoxicity [see Warnings and Precautions (5.2)]
•
Infantile Hypertrophic Pyloric Stenosis (IHPS) [see Warnings and Precautions
(5.3)]
•
QT Prolongation [see Warnings and Precautions (5.4)]
•
Cardiovascular Death [see Warnings and Precautions (5.5)]
•
Clostridioides difficile-Associated Diarrhea (CDAD) [see Warnings and
Precautions
(5.6)]
• Exacerbation of Myasthenia Gravis [see Warnings and
Precautions (5.7)]
6.2 Postmarketing Experience
Additions and/or revisions underlined:
Cardiovascular:
Arrhythmias
including ventricular tachycardia and hypotension. There
have
been reports of QT prolongation, and torsades de pointes, and
cardiovascular
death.
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Patient Information
Additions and/or revisions underlined:
What
are the possible side effects of ZITHROMAX?
Serious
heart rhythm changes that can be life-threatening, including heart
stopping
(cardiac arrest), QT prolongation, torsades de pointes, feeling that your
heart
is pounding or racing (palpitations), chest discomfort, or irregular
heartbeat.
Tell
your healthcare provider right away if you or your child feel a fast or
irregular
heartbeat, get dizzy or faint.
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