Zithrocyn tablets film-coated

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

azithromycin (azithromycin dihydrate)

Disponibil de la:

A LAB PHARMACEUTICALS LLC

Codul ATC:

J01FA10

INN (nume internaţional):

azithromycin (azithromycin dihydrate)

Dozare:

250mg

Forma farmaceutică:

tablets film-coated

Unități în pachet:

(6/1x6/) in blister

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2022-04-12

Caracteristicilor produsului

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: ( [phone] Web: www.alab.am E-Mail: [e-mail]
C O N F I D E N T I A L
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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