Azithromycin tablets can be applied for the treatment of the following infections, when caused by microorganisms sensitive to azithromycin (see sections 4.4 and 5.1): - acute bacterial sinusitis (adequately diagnosed) - acute bacterial otitis media (adequately diagnosed) - pharyngitis, tonsillitis - acute exacerbation of chronic bronchitis (adequately diagnosed) - mild to moderately severe community acquired pneumonia - skin and soft tissue infections - uncomplicated Chlamydia trachomatis urethritis and cervicitis Considerations should be given to official guidance on the appropriate use of antibacterial agents. Adults In uncomplicated Chlamydia trachomatis urethritis and cervicitis the dose is 1000 mg as a single oral dose. For all other indications the dose is 1500 mg, to be administered as 500 mg per day for three consecutive days. As an alternative the same total dose (1500 mg) can also be administered over a period of five days with 500 mg on the first day and 250 mg on the second to the fifth day. Elderly people The same dose as in adult patients is used for elderly people. Since older people can be patients with ongoing proarrhythmic conditions a particular caution is recommended due to the risk of developing cardiac arrhythmia and torsades de pointes (see section 4.4). Paediatric population Azithromycin tablets should only be administered to children weighing more than 45 kg when normal adult dose should be used. Teva's generic medications are available in most pharmacies across the United States, though not all pharmacies carry the same Teva medications. To find out if your medication is available as a Teva generic, contact your local pharmacy. If the pharmacy doesn't regularly stock a certain medication from Teva, ask if it can be ordered for you at no additional cost. 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In addition to internal drug development and manufacture, we also offer contract manufacturing services with an emphasis on quality, customer satisfaction and low cost. We have a proven track record as we are the largest contract manufacturer in the United States for a large pharmaceutical company. operates a 110,000 square foot facility with approximately 200 employees. Our facility is a fully functional FDA approved manufacturing facility. We utilize state of the art machinery, technology, and techniques to bring our customers high quality products on time every time. Label it to indicate whether it is the monohydrate or the dihydrate. Where the quantity of azithromycin is indicated in the labeling of any preparation containing Azithromycin, this shall be understood to be in terms of anhydrous azithromycin (C Determine the percentage of volatile substances by thermogravimetric analysis in an appropriately calibrated instrument, using about 10 mg of Azithromycin, accurately weighed. Heat the specimen at the rate of 10 per minute between ambient temperature and 150 in an atmosphere of nitrogen at a constant flow rate of about 35 m L per minute. From the thermogram plot the derivatives of the loss on drying (percent loss per minute), identify the inflection points of the two weight loss steps at about 70 and 130: it loses not more than 4.5% of its weight between ambient temperature and the inflection point at about 70, and between 1.8% and 2.6% between the inflection point at about 70 and the inflection point at about 130. The liquid chromatograph is equipped with an amperometric electrochemical detector with dual glassy carbon electrodes operated in the oxidative screen mode with electrode 1 set at 0.70 ± 0.05 V and electrode 2 set at 0.85 ± 0.05 V , and the background current optimized to 95 ± 25 nanoamperes, a 4.6-mm × 5-cm guard column that contains 5-µm packing L29, and a 4.6-mm × 15-cm analytical column that contains 5-µm packing L29 or 3-µm packing L49 without the guard column. -demethylazithromycin, and 1.0 for azithromycin; the column efficiency is not less than 1500 theoretical plates for the azithromycin peak; the tailing factor for each of these compounds is not more than 1.5; and the relative standard deviation for replicate injections is not more than 5% for each of these compounds. Dissolve 5.8 g of monobasic potassium phosphate in 2130 m L of water, add 870 m L of acetonitrile, and mix. 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