Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
azithromycin (azithromycin dihydrate)
A LAB PHARMACEUTICALS LLC
J01FA10
azithromycin (azithromycin dihydrate)
250mg
tablets film-coated
(6/1x6/) in blister
Prescription
Registered
2022-04-12
A - L A B P H A R M A C E U P T I C A L S , L L C Address: Kochinyan 13/16 street Yerevan - Armenia Tell: ( +374)11 981000 Web: www.alab.am E-Mail: info@alab.am C O N F I D E N T I A L Page 13 of 64 SUMMARY PRODUCT CHARACTERISTICS 1. NAME OF THE PROPRIETARY PRODUCT: ZITHROCYN NAME OF THE NONPROPRIETARY INTERNATIONAL PRODUCT: Azithromycin Tablets 250 mg ROUTE OF ADMINISTRATION: Oral PROMOTIONAL CATEGORY: Prescription Only 2. QUALITATIVE AND QUANTITATIVE COMPOSITION : COMPOSITION: Each film-coated tablet contains: Azithromycin Dihydrate Eq. to Azithromycin (Anhydrous)...… 250.00 mg Excipients …………………………… q. s. Colour: Titanium Dioxide 3. PHARMACEUTICAL FORM: Oral film-coated tablet 4. CLINICAL PARTICULARS: 4.1 THERAPEUTIC INDICATIONS: Azithromycin tablets can be applied for the treatment of the following infections, when caused by microorganisms sensitive to azithromycin: − 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 − sexually transmitted diseases caused by organisms called Chlamydia trachomatis and Neisseria gonorrhoea. Considerations should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION: POSOLOGY ADULTS In uncomplicated Chlamydia trachomatis urethritis and cervicitis the dosage 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. OLDER PEOPLE The same dose range as in younger patients may be used in the elderly. IN THE ELDERLY: The same dosage as in adult patients is used in the elderly. Since elderly patients can be patients with ongoing proarrhythmic conditions a particular caution is recommended due to the risk of developing cardiac arrhythmia and torsades de pointes. CH Прочитать полный документ