Zithromax Powder for Oral Suspension 200mg/5ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Azithromycin

Available from:

Pfizer Healthcare Ireland

ATC code:

J01FA; J01FA10

INN (International Name):

Azithromycin

Dosage:

200 mg/5ml

Pharmaceutical form:

Powder for oral suspension

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Macrolides; azithromycin

Authorization status:

Marketed

Authorization date:

1992-02-18

Patient Information leaflet

1. What Zithromax is and what it is used for
This medicine contains azithromycin, which is one of a group of
antibiotics called macrolides. It is used to treat infections caused
by certain bacteria and other micro-organisms, which include:
•
chest, throat or nasal infections (such as bronchitis,
pneumonia, tonsillitis, sore throat (pharyngitis) and sinusitis
•
ear infections
•
skin and soft tissue infections (such as an abscess or boil)
•
sexually transmitted diseases caused by organisms called
chlamydia or gonorrhoea.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. What you need to know before you take
Zithromax
Do not take Zithromax:
•
if you/your child are allergic to azithromycin or any other
macrolide antibiotic such as erythromycin or clarithromycin
or any of the ingredients listed in section 6. An allergic
reaction may cause skin rash or wheezing.
Warnings and precautions
Talk to your doctor or pharmacist before taking Zithromax if
you/your child have or have had any of the following:
•
kidney problems
•
heart conditions
•
diabetes
•
liver problems: your doctor may need to monitor your liver
function or stop the treatment
•
myasthenia gravis (localised muscle weakness)
•
if you/your child are taking any ergot derivatives such as
ergotamine (used to treat migraine) as these medicines
should not be taken together with Zithromax.
Tell your doctor immediately:
•
if you feel your heart beating in your chest or have an
abnormal heartbeat, or get dizzy or faint or suffer from any
muscle weakness when taking Zithromax.
•
if you develop diarrhoea or loose stools during or after
treatment, tell your doctor at once. Do not take any medicine
to treat your diarrhoea without first checking with your
doctor. If your diarrhoea continues, please inform your
doctor.
•
if you feel you are having an allergic reaction (e.g. difficulty
in breathing, dizziness, swelling of the face or throat, rash,
wheals, blistering). Stop taking this medicine and seek
urgent medical advi

Summary of Product characteristics

Health Products Regulatory Authority
22 June 2023
CRN00D8SD
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zithromax Powder for Oral Suspension 200mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Following reconstitution as directed, each 5 ml of suspension contains
200 mg azithromycin (as dihydrate).
Excipients with known effect
Also contains 3.87 g sucrose per 5 ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for Oral Suspension.
A dry white powder.
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
Zithromax should be given as a single daily dose.
Zithromax Suspension can be taken with 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.
THE ELDERLY:
The same dosage as in adult patients is used in the elderly. However,
since elderly patients can be patients with ongoing
proarrhythmi