ZENTHRO-500 Capsules

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Azithromycin Dihydrate

Available from:

Zenufa Laboratories (T) Limited, TANZANIA

ATC code:

Macrolides/ lincosamides and streptogramins

INN (International Name):

Azithromycin Dihydrate

Dosage:

500

Pharmaceutical form:

Capsules

Manufactured by:

Zenufa Laboratories Limited, TANZANIA

Product summary:

Physical description: Rosy red, size "0" capsules with "Zenthro-500" print on the cap and black "ZENUFA" print on the body; Local technical representative: Zenufa Laboratories (T) Limited (6759)

Authorization status:

Registered/Compliant

Authorization date:

2022-01-10

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Zenthro-500® Capsules 500 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Azithromycin dihydrate equivalent to 500 mg Azithromycin. Excipients
with known effect:
No excipient with known effect
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
White crystalline powder packed in a size ‘’0’’ Rosy red hard
gelatin Capsules.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Azithromycin is indicated for the treatment of the following
infections when known or likely to
be due to one or more susceptible microorganisms (see section 5.1):
Bronchitis community-acquired pneumonia sinusitis
Pharyngitis/tonsillitis (see section 4.4 regarding streptococcal
infections) otitis media skin and
soft tissue infections uncomplicated genital infections due to
Chlamydia trachomatis and
Neisseria gonorrhoeae.
Considerations
should
be
given
to
official
guidance
regarding
the
appropriate
use
of
antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Zenthro-500®should be given as a single daily dose.
In common with many other antibiotics Zenthro-500®Capsules should be
taken at least one
hour before or 2 hours after food.
Children over 45 kg body weight and adults, including elderly
patients:
The total dose of Azithromycin is 1500 mg which should be given over
three days (500 mg
once daily).
In uncomplicated genital infections due to Chlamydia trachomatis, the
dose is 1000 mg as a
single oral dose. For susceptible Neisseria gonorrhoeae the
recommended dose is 2000 mg
Azithromycin as a single oral dose together with 500 mg ceftriaxone
intramuscularly as a
single dose according to local clinical treatment guidelines. For
patients who are allergic to
penicillin and/or cephalosporins, prescribers should consult local
treatment guidelines.
PAEDIATRIC POPULATION
In children under 45 kg body weight:
Zenthro-500®Capsules are not suitable for children under 45 kg.
The Elderly
The same dosage as in adult patients is used in the e