Zmax (Azithromycin) - Summary

ZMAX 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.

Adults

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.

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NEWS HIGHLIGHTS

Published Studies Related to Zmax (Azithromycin)

Azithromycin plus artesunate versus artemether-lumefantrine for treatment of uncomplicated malaria in Tanzanian children: a randomized, controlled trial. [2009.10.15]
BACKGROUND: Acute febrile illness is the most common cause of outpatient attendance and mortality for children in Africa. Malaria and bacterial disease are difficult to differentiate with limited diagnostic facilities. Combinations of antibiotics and antimalarials are potentially attractive for treatment of the syndrome. Azithromycin plus artesunate (AT+AS) is an effective antimalarial combination for adults in Asia... CONCLUSIONS: This trial does not support the use of AZ+AS as treatment for malaria or acute febrile illness in children in areas of Africa with high levels of existing antimalarial drug resistance. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov NCT00694694.

Long-term daily high and low doses of azithromycin in children with cystic fibrosis: A randomized controlled trial. [2009.10.07]
BACKGROUND: Long-term administration of azithromycin (AZM) in children with cystic fibrosis (CF) has improved outcomes. However, the doses and schedule of administration are not very well studied in children with CF... CONCLUSION: In this randomized controlled trial, we did not find differences in the effect of 2 doses (5mg/kg/day or 15mg/kg/day) of AZM on change in percentage predicted FEV(1), clinical scores, Pseudomonas colonization rates, pulmonary exacerbations and need for antibiotics. There was increase in exacerbations after stopping azithromycin in both the groups. Our results also suggest that the decrease in the incidence of LRTI persists only till 6months after discontinuing azithromycin.

Effect of mass distribution of azithromycin for trachoma control on overall mortality in Ethiopian children: a randomized trial. [2009.09.02]
CONTEXT: Mass oral azithromycin distribution to affected communities is a cornerstone of the World Health Organization's trachoma elimination program. Antibiotics are provided to target the ocular strains of chlamydia that cause trachoma, but may also be efficacious against respiratory disease, diarrhea, and malaria--frequent causes of childhood mortality in trachoma-endemic areas. OBJECTIVE: To compare mortality rates of participants aged 1 to 9 years in treated communities with those in untreated communities... CONCLUSION: In a trachoma-endemic area, mass distribution of oral azithromycin was associated with reduced mortality in children. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00322972.

The effect of azithromycin and Chlamydophilia pneumonia infection on expansion of small abdominal aortic aneurysms--a prospective randomized double-blind trial. [2009.07]
OBJECTIVE: The aim of the study was to evaluate the effect of azithromycin on the expansion rate of small abdominal aortic aneurysms (AAAs), and to determine whether or not a correlation exists between serological markers for Chlamydophilia pneumonia (Cpn) infection and AAA expansion... CONCLUSION: Azithromycin did not have any effect on AAA expansion. No correlation was found between serological markers for Cpn and AAA expansion, indicating no clinical relevance for Cpn testing in AAA surveillance. However, a significant reduction in AAA expansion rate was found in patients treated with a combination of ASA and statins.

Pharmacokinetics of azithromycin in plasma and sinus mucosal tissue following administration of extended-release or immediate-release formulations in adult patients with chronic rhinosinusitis. [2009.07]
This study compared the pharmacokinetics of azithromycin (AZI) following administration of extended-release (ER) and immediate-release (IR) formulations in plasma and sinus mucosa in patients with chronic rhinosinusitis. Patients (n=71) were randomised 1:1 to receive a single dose of AZI-ER 2g or up to three doses of AZI-IR 500 mg daily...

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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.

Zithromax EV in Community-Acquired Pneumonia (CAP) [Completed]
The intravenous (IV) regimen containing azithromycin (Zithromax) plus ampicillin-sulbactam is consistent with current guidelines for the treatment of CAP. In fact the International guidelines for the treatment of CAP in hospitalised patients suggests the use of a combination between a b-lactam and a macrolide.

This trial will allow investigators to evaluate the efficacy of azithromycin plus ampicillin-sulbactam in the treatment of hospitalized subjects with community acquired pneumonia. In addition, this trial will allow investigators to evaluate the safety and toleration of combination therapy.

Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers [Completed]

Fed Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's azithromycin 600 mg tablets to Pfizer's Zithromax® 600 mg tablets following a single, oral 600 mg (1 x 600 mg) dose administered under fed conditions.

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PATIENT REVIEWS / RATINGS / COMMENTS

Zmax review by 39 year old female patient
		Rating
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 40 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		sinus infection
Dosage & duration:		one time dose (dosage frequency: once) for the period of once- one day
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		The sinus infection lessened but did not go away. I noticed that using a neti pot for a nasal flush worked much better.
Side effects:		none
Comments:		Zmax was administered in a single dose, orally.

Zmax review by 40 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		sinus infection
Dosage & duration:		one time dose (dosage frequency: once) for the period of once- one day
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		The sinus infection lessened but did not go away. I noticed that using a neti pot for a nasal flush worked much better.
Side effects:		none
Comments:		Zmax was administered in a single dose, orally.