Clarithromycin Martindale Pharma 500 mg Powder for Concentrate for Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clarithromycin

Available from:

Martindale Pharmaceuticals Ltd

ATC code:

J01FA; J01FA09

INN (International Name):

Clarithromycin

Dosage:

500 milligram(s)

Pharmaceutical form:

Pdr/Conc/Soln for Infus

Prescription type:

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

Therapeutic area:

Macrolides; clarithromycin

Authorization status:

Not marketed

Authorization date:

2009-10-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE
USER
CLARITHROMYCIN 500MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Clarithromycin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
This medicine will be referred to as Clarithromycin in the rest of
this leaflet
WHAT IS IN THIS LEAFLET:
1.
What Clarithromycin is and what it is used for
2.
What you need to know before you are given Clarithromycin
3.
How Clarithromycin will be given
4.
Possible side effects
5.
How to store Clarithromycin
6.
Contents of the pack and other information
1.
WHAT CLARITHROMYCIN IS AND WHAT IT IS USED FOR
Clarithromycin contains the active substance clarithromycin, which
belongs to a group of
medicines called ‘macrolide antibiotics’. These are used to kill
bacteria or ‘germs’ that cause
infections.
Clarithromycin is used whenever an intravenous (injection into a vein)
antibiotic is required to
treat severe infections or alternatively if a patient is unable to
swallow clarithromycin tablets. It
is used to treat infections such as

Chest infections such as bronchitis and pneumonia

throat and sinus infections

skin and tissue infections caused by bacteria.
Clarithromycin is for use in adults and children 12 years and older.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CLARITHROMYCIN
YOU SHOULD NOT BE GIVEN CLARITHROMYCIN:

if you are allergic to clarithromycin or other macrolide antibiotics
such as erythromycin or azithromycin or to any of the other
ingredients of this
medicine, (listed in section 6)

if you are taking ergotamine or dihydroergotamine tablets or
ergotamine inhalers (used
to treat migraine

if you are taking oral midazolam (a sedative)

if you are taking terfenadine

Summary of Product characteristics

Health Products Regulatory Authority
13 December 2019
CRN008L8W
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clarithromycin Martindale Pharma 500 mg Powder for Concentrate for
Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg clarithromycin as clarithromycin
lactobionate.
When reconstituted and diluted, the final diluted solution contains
approximately 2 mg/ml of clarithromycin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for Concentrate for Solution for Infusion
A white to off-white caked powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clarithromycin is indicated when parenteral therapy is required for
treatment of infections caused by susceptible organisms in
the following conditions (see sections 4.4 and 5.1);

- Lower respiratory tract infections for example, acute and chronic
bronchitis, and pneumonia (see section 4.4 and
5.1 regarding Sensitivity Testing).- Upper respiratory tract
infections for example, sinusitis, pharyngitis and
tonsilitis.Skin and soft tissue infections (e.g. folliculitis,
cellulitis, erysipelas) (see section 4.4 and 5.1 regarding
Sensitivity Testing).
Consideration should be given to official guidance in the appropriate
use of antibacterial agents.
Clarithromycin is indicated in adults and children 12 years and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Intravenous therapy may be given for 2 to 5 days and should be changed
to oral clarithromycin therapy whenever possible as
determined by the physician.. The total duration of treatment should
not exceed more than 14 days. The usual duration of
treatment is 6 to 14 days.
Adults: The recommended dosage of Clarithromycin is 1gram daily,
divided into two 500 mg doses, appropriately diluted (see
section 6.6).
Paediatric population
Children older than 12 years: As for adults.
Children younger than 12 years: Use of clarithromycin IV is not
recommended for children younger than 12 years. Use
clarithromycin P