The patent for the omnipotent Zmax is set to expire for Pfizer on May 30, 2017. This is extremely relevant for research and development as a generic formulation of this cogent drug, specifically azithromycin, can now be produced. Azithromycin is indicated for mild to moderate infections including acute bacterial sinusitis in adults due to haemophilus influenzae, moraxella catarrhalis or streptococcus pneumonia; community-acquired pneumonia in adults and pediatric patients who are six months of age or older due to chlamydophila pneumonia; haemophilus influenza; mycoplasma pneumoniae and streptococcus pneumonia. LGM Pharma provides API Azithromycin cas number 83905-01-5, as well as the TEVA API Azithromycin for research and development.
With a unique one time dose of 2 grams, for all adult patients regardless of weight, this easy dose is simple and singular in nature. Pediatric patients six months of age and older are typically dosed a single dose of 60 mg/kg (equivalent to 27 mg/lb) body weight. The idea of one dose of antibiotic which provides complete therapy is appealing to patients and practitioners alike. Dr. Joseph Feczko, chief medical officer at Pfizer, states, “A single, high-dose antibiotic is an important advance in treating certain types of sinusitis and pneumonia in adults.” He also adds, “Results showed that one dose of Zmax was as effective as currently available treatments that must be taken for seven to ten days.” Side effects are mild, and may include diarrhea, nausea, abdominal pain and headache.
Azithromycin (Zmax) must be administered as a single dose of approximately 2 grams, at least one hour before or two hours after eating a meal. In the first 24 hours after a dose of azithromycin/Zmax the amount of drug that gets into the tissue is three times higher than a standard dose of immediate-release azithromycin. The immediate-release azithromycin is recognized as the brand name Zithromax, and it is effective by “front loading” or providing high drug levels earlier in the course of infection when the bacterial burden is believed to be highest. The innovation in the azithromycin/Zmax formulation is the microsphere technology which allows for the release of this medication in the small intestine, rather than in the stomach, lending to a more favorable side-effect profile. Additionally, the long half-life and high tissue penetration makes it conceivable for this form of azithromycin to deliver an entire course of therapy as a single dose.
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