Zithromax
Description
Zithromax is in a class of drugs called macrolide antibiotics. Zithromax fights bacteria in the body.
Zithromax is used to treat many different types of bacterial infections, such as bronchitis, pneumonia, tonsillitis, skin infections, ear infections, and sexually transmitted diseases.
Zithromax may also be used for purposes other than those listed here.
Recommendations
Follow the directions for using this medicine provided by your doctor. This medicine may be taken on an empty stomach or with food. DO NOT TAKE THIS MEDICINE within 1 hour before or 2 hours after aluminum- or magnesium-containing antacids.
STORE THIS MEDICINE at room temperature, away from heat and light.
TO CLEAR UP YOUR INFECTION COMPLETELY, continue taking this medicine for the full course of treatment even if you feel better in a few days. Do not miss any doses. Taking this medicine at the same time each day will make it easier to remember.
IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
If your symptoms do not improve within a few days or if they become worse, check with your doctor. IF MODERATE TO SEVERE DIARRHEA OCCURS during or after treatment with this medicine, check with your doctor or pharmacist. Do not treat it with non-prescription (over-the-counter) medicines.
IF YOU EXPERIENCE difficulty breathing; tightness of chest; swelling of eyelids, face, or lips; or if you develop a rash or hives, tell your doctor immediately. Do not take any more doses of this medicine unless your doctor tells you to do so.
BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist.
FOR WOMEN TAKING BIRTH CONTROL PILLS: this medicine may decrease the effectiveness of your birth control pill. To prevent pregnancy, you may want to use an additional form of birth control. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby.
Stephen Freiman, CO:
I originally found your website because I had a bad sore throat and I just didn't feel right, but couldn't put my finger on the reason. After two visits to the doctor it wasn't getting any better. He gave me a nasal spray and the sore throat seemed to disappear for about a week. Then it came back just as bad. The second time he gave me a Zithromax prescription. After a couple of days on the Zithromax it went away - and it has not come back. Thanks for your help with delivering the drug to me. I will keep in touch.
Susan, Washington:
I am very happy with Zithromax. I was suffering from a very strong vaginal yeast infection that was unaffected by 3 doses of diflucan, and several doses of the over the counter drugs available. I took Zithromax and the yeast infection went away in a matter of days.
Methew Hotard, NY, 32:
I would like to thank you for the excellent service that you have given me. I ordered Zithromax on the 12th and recieved it today the 18th. I am impressed and will refer your company to others. Again thank you so very much. I hope I spell this right but Mucho Gracias!
ZITHROMAX (azithromycin) is indicated for the treatment of patients with mild to moderate
infections (pneumonia: see WARNINGS) caused by susceptible strains of the designated
microorganisms in the specific conditions listed below. As recommended dosages, durations of
therapy and applicable patient populations vary among these infections, please see DOSAGE
AND ADMINISTRATION for specific dosing recommendations.
Adults:
Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus
influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.
Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or
Streptococcus pneumoniae.
Community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae,
Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy.
NOTE: Azithromycin should not be used in patients with pneumonia who are judged to be
inappropriate for oral therapy because of moderate to severe illness or risk factors such as
any of the following:
patients with cystic fibrosis,
patients with nosocomially acquired infections,
patients with known or suspected bacteremia,
patients requiring hospitalization,
elderly or debilitated patients, or
patients with significant underlying health problems that may compromise their
ability to respond to their illness (including immunodeficiency or functional asplenia).
Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in
individuals who cannot use first-line therapy.
NOTE: Penicillin by the intramuscular route is the usual drug of choice in the
treatment of Streptococcus pyogenes infection and the prophylaxis of rheumatic fever.
ZITHROMAX is often effective in the eradication of susceptible strains of
Streptococcus pyogenes from the nasopharynx. Because some strains are resistant to
ZITHROMAX, susceptibility tests should be performed when patients are treated
with ZITHROMAX. Data establishing efficacy of azithromycin in subsequent
prevention of rheumatic fever are not available.
Uncomplicated skin and skin structure infections due to Staphylococcus aureus,
Streptococcus pyogenes, or Streptococcus agalactiae. Abscesses usually require surgical
drainage.
Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae.
Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number
of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in
women has not been established.
ZITHROMAX, at the recommended dose, should not be relied upon to treat syphilis.
Antimicrobial agents used in high doses for short periods of time 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 cultures for gonorrhea performed at the time of diagnosis. Appropriate antimicrobial
therapy and follow-up tests for these diseases should be initiated if infection is confirmed.
Appropriate culture and susceptibility tests should be performed before treatment to determine
the causative organism and its susceptibility to azithromycin. Therapy with ZITHROMAX may
be initiated before results of these tests are known; once the results become available,
antimicrobial therapy should be adjusted accordingly.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
ZITHROMAX (azithromycin) and other antibacterial drugs, ZITHROMAX (azithromycin)
should be used only to treat or prevent infections that are proven or strongly suspected to be
caused by susceptible bacteria. When culture and susceptibility information are available, they
should be considered in selecting or modifying antibacterial therapy. In the absence of such data,
local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Acute otitis media caused by Haemophilus influenzae, Moraxella catarrhalis or Streptococcus
pneumoniae.
Community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae,
Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy.
NOTE: Azithromycin should not be used in pediatric patients with pneumonia who are
judged to be inappropriate for oral therapy because of moderate to severe illness or risk
factors such as any of the following:
patients with cystic fibrosis,
patients with nosocomially acquired infections,
patients with known or suspected bacteremia,
patients requiring hospitalization, or
patients with significant underlying health problems that may compromise their
ability to respond to their illness (including immunodeficiency or functional
asplenia).
Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in
individuals who cannot use first-line therapy.
NOTE: Penicillin by the intramuscular route is the usual drug of choice in the
treatment of Streptococcus pyogenes infection and the prophylaxis of rheumatic fever.
ZITHROMAX is often effective in the eradication of susceptible strains of
Streptococcus pyogenes from the nasopharynx. Because some strains are resistant to
ZITHROMAX, susceptibility tests should be performed when patients are treated
with ZITHROMAX. Data establishing efficacy of azithromycin in subsequent
prevention of rheumatic fever are not available.
Appropriate culture and susceptibility tests should be performed before treatment to determine
the causative organism and its susceptibility to azithromycin. Therapy with ZITHROMAX may
be initiated before results of these tests are known; once the results become available,
antimicrobial therapy should be adjusted accordingly.
Precautions
If your symptoms do not improve within a few days or if they become worse, check with your doctor. IF MODERATE TO SEVERE DIARRHEA OCCURS during or after treatment with this medicine, check with your doctor or pharmacist. Do not treat it with non-prescription (over-the-counter) medicines.
IF YOU EXPERIENCE difficulty breathing; tightness of chest; swelling of eyelids, face, or lips; or if you develop a rash or hives, tell your doctor immediately. Do not take any more doses of this medicine unless your doctor tells you to do so.
BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist.
FOR WOMEN TAKING BIRTH CONTROL PILLS: this medicine may decrease the effectiveness of your birth control pill. To prevent pregnancy, you may want to use an additional form of birth control. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby.
Stephen Freiman, CO:
I originally found your website because I had a bad sore throat and I just didn't feel right, but couldn't put my finger on the reason. After two visits to the doctor it wasn't getting any better. He gave me a nasal spray and the sore throat seemed to disappear for about a week. Then it came back just as bad. The second time he gave me a Zithromax prescription. After a couple of days on the Zithromax it went away - and it has not come back. Thanks for your help with delivering the drug to me. I will keep in touch.
Susan, Washington:
I am very happy with Zithromax. I was suffering from a very strong vaginal yeast infection that was unaffected by 3 doses of diflucan, and several doses of the over the counter drugs available. I took Zithromax and the yeast infection went away in a matter of days.
Methew Hotard, NY, 32:
I would like to thank you for the excellent service that you have given me. I ordered Zithromax on the 12th and recieved it today the 18th. I am impressed and will refer your company to others. Again thank you so very much. I hope I spell this right but Mucho Gracias!
ZITHROMAX (azithromycin) is indicated for the treatment of patients with mild to moderate
infections (pneumonia: see WARNINGS) caused by susceptible strains of the designated
microorganisms in the specific conditions listed below. As recommended dosages, durations of
therapy and applicable patient populations vary among these infections, please see DOSAGE
AND ADMINISTRATION for specific dosing recommendations.
Adults:
Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus
influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.
Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or
Streptococcus pneumoniae.
Community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae,
Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy.
NOTE: Azithromycin should not be used in patients with pneumonia who are judged to be
inappropriate for oral therapy because of moderate to severe illness or risk factors such as
any of the following:
patients with cystic fibrosis,
patients with nosocomially acquired infections,
patients with known or suspected bacteremia,
patients requiring hospitalization,
elderly or debilitated patients, or
patients with significant underlying health problems that may compromise their
ability to respond to their illness (including immunodeficiency or functional asplenia).
Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in
individuals who cannot use first-line therapy.
NOTE: Penicillin by the intramuscular route is the usual drug of choice in the
treatment of Streptococcus pyogenes infection and the prophylaxis of rheumatic fever.
ZITHROMAX is often effective in the eradication of susceptible strains of
Streptococcus pyogenes from the nasopharynx. Because some strains are resistant to
ZITHROMAX, susceptibility tests should be performed when patients are treated
with ZITHROMAX. Data establishing efficacy of azithromycin in subsequent
prevention of rheumatic fever are not available.
Uncomplicated skin and skin structure infections due to Staphylococcus aureus,
Streptococcus pyogenes, or Streptococcus agalactiae. Abscesses usually require surgical
drainage.
Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae.
Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number
of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in
women has not been established.
ZITHROMAX, at the recommended dose, should not be relied upon to treat syphilis.
Antimicrobial agents used in high doses for short periods of time 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 cultures for gonorrhea performed at the time of diagnosis. Appropriate antimicrobial
therapy and follow-up tests for these diseases should be initiated if infection is confirmed.
Appropriate culture and susceptibility tests should be performed before treatment to determine
the causative organism and its susceptibility to azithromycin. Therapy with ZITHROMAX may
be initiated before results of these tests are known; once the results become available,
antimicrobial therapy should be adjusted accordingly.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
ZITHROMAX (azithromycin) and other antibacterial drugs, ZITHROMAX (azithromycin)
should be used only to treat or prevent infections that are proven or strongly suspected to be
caused by susceptible bacteria. When culture and susceptibility information are available, they
should be considered in selecting or modifying antibacterial therapy. In the absence of such data,
local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Acute otitis media caused by Haemophilus influenzae, Moraxella catarrhalis or Streptococcus
pneumoniae.
Community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae,
Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy.
NOTE: Azithromycin should not be used in pediatric patients with pneumonia who are
judged to be inappropriate for oral therapy because of moderate to severe illness or risk
factors such as any of the following:
patients with cystic fibrosis,
patients with nosocomially acquired infections,
patients with known or suspected bacteremia,
patients requiring hospitalization, or
patients with significant underlying health problems that may compromise their
ability to respond to their illness (including immunodeficiency or functional
asplenia).
Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in
individuals who cannot use first-line therapy.
NOTE: Penicillin by the intramuscular route is the usual drug of choice in the
treatment of Streptococcus pyogenes infection and the prophylaxis of rheumatic fever.
ZITHROMAX is often effective in the eradication of susceptible strains of
Streptococcus pyogenes from the nasopharynx. Because some strains are resistant to
ZITHROMAX, susceptibility tests should be performed when patients are treated
with ZITHROMAX. Data establishing efficacy of azithromycin in subsequent
prevention of rheumatic fever are not available.
Appropriate culture and susceptibility tests should be performed before treatment to determine
the causative organism and its susceptibility to azithromycin. Therapy with ZITHROMAX may
be initiated before results of these tests are known; once the results become available,
antimicrobial therapy should be adjusted accordingly.
Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions
including Stevens Johnson Syndrome and toxic epidermal necrolysis have been reported rarely in
patients on azithromycin therapy. Although rare, fatalities have been reported. (See
CONTRAINDICATIONS.) Despite initially successful symptomatic treatment of the allergic
symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon
thereafter in some patients without further azithromycin exposure. These patients required
prolonged periods of observation and symptomatic treatment. The relationship of these episodes
to the long tissue half-life of azithromycin and subsequent prolonged exposure to antigen is
unknown at present.
If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be
instituted. Physicians should be aware that reappearance of the allergic symptoms may occur
when symptomatic therapy is discontinued.
In the treatment of pneumonia, azithromycin has only been shown to be safe and effective
in the treatment of community-acquired pneumonia due to Chlamydia pneumoniae,
Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients
appropriate for oral therapy. Azithromycin should not be used in patients with pneumonia
who are judged to be inappropriate for oral therapy because of moderate to severe illness
or risk factors such as any of the following: patients with cystic fibrosis, patients with
nosocomially acquired infections, patients with known or suspected bacteremia, patients
requiring hospitalization, elderly or debilitated patients, or patients with significant
underlying health problems that may compromise their ability to respond to their illness
(including immunodeficiency or functional asplenia).
Pseudomembranous colitis has been reported with nearly all antibacterial agents and may
range in severity from mild to life-threatening. Therefore, it is important to consider this
diagnosis in patients who present with diarrhea subsequent to the administration of
antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit
overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a
primary cause of “antibiotic-associated colitis.”
After the diagnosis of pseudomembranous colitis has been established, therapeutic measures
should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation
of the drug alone. In moderate to severe cases, consideration should be given to management
with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug
clinically effective against Clostridium difficile colitis.
Ingredients
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-?-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)-?-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.
