DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Zmax (Azithromycin) - Summary



Zmax (azithromycin extended release) for oral suspension contains the active ingredient azithromycin (as azithromycin dihydrate), an azalide, a subclass of macrolide antibiotics.

Zmax is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Please see DOSAGE AND ADMINISTRATION for specific dosing recommendations.


Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae.

Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae, in patients appropriate for oral therapy. (See CLINICAL STUDIES.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Zmax and other antibacterial drugs, Zmax should be used only to treat 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.

Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to Zmax. Therapy with Zmax may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly.

See all Zmax indications & dosage >>


Published Studies Related to Zmax (Azithromycin)

Azithromycin for prevention of exacerbations in non-cystic fibrosis bronchiectasis (EMBRACE): a randomised, double-blind, placebo-controlled trial. [2012]
bronchiectasis... INTERPRETATION: Azithromycin is a new option for prevention of exacerbations in

Lack of efficacy of long-term, low-dose azithromycin in chronic rhinosinusitis: a randomized controlled trial. [2011.11]
BACKGROUND: In persistent chronic rhinosinusitis (CRS), conventional treatment is often insufficient. Long-term, low-dose administration of macrolides has been suggested as a treatment option. The MACS (Macrolides in chronic rhinosinusitis) study is a randomized placebo-controlled trial evaluating the efficacy of azithromycin (AZM) in CRS... CONCLUSION: At the investigated dose of AZM over 3 months, no significant benefit was found over placebo. Possible reasons could be disease severity in the investigated group, under-dosage of AZM and under-powering of the study. Therefore, more research is urgently required. (c) 2011 John Wiley & Sons A/S.

Fluoroquinolones for treating typhoid and paratyphoid fever (enteric fever). [2011.10.05]
CONCLUSIONS: Generally, fluoroquinolones performed well in treating typhoid, and maybe superior to alternatives in some settings. However, we were unable to draw firm general conclusions on comparative contemporary effectiveness given that resistance changes over time, and many studies were small. Policy makers and clinicians need to consider local resistance patterns in choosing a fluoroquinolone or alternative.There is some evidence that the newest fluoroquinolone, gatifloxacin, remains effective in some regions where resistance to older fluoroquinolones has developed. However, the different fluoroquinolones have not been compared directly in trials in these settings.

Clinical and microbiological effects of azithromycin in the treatment of generalized chronic periodontitis: a randomized placebo-controlled clinical trial. [2011.09]
AIM: To evaluate the effects of systemic azithromycin (AZM) as an adjunct to scaling and root planing (SRP) in the treatment of generalized chronic periodontitis (ChP)... CONCLUSION: The data of the present study suggest no adjunctive benefit of AZM in the treatment of generalized ChP. (c) 2011 John Wiley & Sons A/S.

Azithromycin for prevention of exacerbations of COPD. [2011.08.25]
BACKGROUND: Acute exacerbations adversely affect patients with chronic obstructive pulmonary disease (COPD). Macrolide antibiotics benefit patients with a variety of inflammatory airway diseases... CONCLUSIONS: Among selected subjects with COPD, azithromycin taken daily for 1 year, when added to usual treatment, decreased the frequency of exacerbations and improved quality of life but caused hearing decrements in a small percentage of subjects. Although this intervention could change microbial resistance patterns, the effect of this change is not known. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00325897.).

more studies >>

Clinical Trials Related to Zmax (Azithromycin)

A Randomized, Open Label, Clinical Trial of the Pharmacokinetics of Azithromycin Following a Single Dose of Azithromycin Sustained Release (2 Gram) or Commercial Azithromycin Tablet (500 mg) to Cancer Patients That Require Lung Surgery [Completed]
The objective of this trial was to characterize the pharmacokinetics of the currently marketed azithromycin immediate release tablet formulation (AZ-IR) versus the azithromycin sustained release liquid formulation (AZ-SR) in lung tissue and bronchial washings, the latter consisting of the epithelial lining fluid (ELF) and cellular elements, mainly alveolar macrophages (AM).

A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults [Completed]
To determine if a single 2. 0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for both treatment regimens.

Comparative Study of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone to Treat Subjects With Blepharoconjunctivitis [Not yet recruiting]

Trial of Intravenous Azithromycin to Eradicate Ureaplasma Respiratory Tract Infection in Preterm Infants [Not yet recruiting]
The purpose of this study is to determine whether intravenous azithromycin is effective in eradicating Ureaplasma respiratory tract infection in preterm infants born at 24 to 28 weeks gestation.

Immunization With Plasmodium Falciparum Sporozoites Under Chloroquine or Chloroquine/Azithromycin Prophylaxis [Not yet recruiting]
This study will assess the superior protective immunity of the combination of chloroquine and azithromycin prophylaxis under Chemoprophylaxis Sporozoites (CPS) immunization versus a standard chloroquine prophylactic regimen.

more trials >>

Reports of Suspected Zmax (Azithromycin) Side Effects

Diarrhoea (5)Abdominal Pain Upper (2)Dizziness (2)Crying (2)Nervousness (2)Vomiting (2)Nausea (2)Tinnitus (1)Drug Ineffective (1)Deafness (1)more >>


Based on a total of 8 ratings/reviews, Zmax has an overall score of 7.25. The effectiveness score is 8.75 and the side effect score is 7.75. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Zmax review by 39 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   cold / flu
Dosage & duration:   250mg taken once per day for 5 days for the period of 5 days
Other conditions:   fever, chills, runny nose
Other drugs taken:   none
Reported Results
Benefits:   Quick relief of flu-like symptoms
Side effects:   I have never had any side effects from this medication. My husband and 13 year old daughter also take this without any side effects.
Comments:   The first day, you take 2 pills and then for the next four days you take 1 pill. The packaging is excellent and tells you exactly what pills to take and when to take them. As previously stated, no one in my family has experienced any side effects from taking this medication. We have taken both the Z-pak and the generic form. It works incredibly fast and has saved us from many vacation disasters!


Zmax review by 45 year old female patient

Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   bronchitis
Dosage & duration:   250 mg. taken once a day for the period of 5 days
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   The medicine kept the illness from getting worse, my cough loosened up immediately. The dose and length of treatment was very managable, it was easy to remember to take one dose each day. The packaging is very convenient - a blister pack so you know immediately how many you have taken.
Side effects:   I experienced some mild stomach upset a few hours after taking the first dose (a combined dose totalling 500 mg.)
Comments:   6 pills taken over 5 days - 2 pills first day, one each day after.


Zmax review by 32 year old female patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   Strep throat
Dosage & duration:   250 mg- 2 pills day 1 then 1 pill/day taken 2 pills on day 1 for the period of 2 pills on day 1 only
Other conditions:   n/a
Other drugs taken:   none
Reported Results
Benefits:   Antibiotic seemed to work quickly. My throat felt better within hours of taking the first pill.
Side effects:   Horrible, painful diarrhea after 4 hours of taking each pill I took on day one.
Comments:   Seems like a powerful antibiotic that works but it's just too powerful for my system and not worth the side effect.

See all Zmax reviews / ratings >>

Page last updated: 2013-02-10

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014