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CLARITHROMYCIN 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): CLARITHROMYCIN

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D03028

Clarithromycin 500 mg
Powder for Concentrate for Solution for Infusion
Clarithromycin
Read all this leaflet carefully before you are
given Clarithromycin.
• Keep this leaflet. You may need to read it
again
• If you have any further questions, please ask
your doctor or nurse
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm then,
even if their symptoms are the same as yours.
• If any of the side effects get serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or nurse

In this leaflet:
1. What Clarithromycin is and what it is used for
2. Before you are given Clarithromycin
3. How Clarithromycin is given
4. Possible side effects
5. How to store Clarithromycin
6. Further 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:
• a flare-up of chronic bronchitis caused by
bacteria
• infection of the lungs (pneumonia) caused by
bacteria
• infection of the sinuses (sinusitis) caused by
bacteria
• infection of the throat and tonsils (pharyngitis
and tonsillitis) caused by bacteria
• skin and tissue infections caused by bacteria.
Clarithromycin is for use in adults and children 12
years and older.

2. Before you are given
Clarithromycin
You should not be given Clarithromycin:
• if you are allergic (hypersensitive) to
clarithromycin or other macrolide antibiotics
such as erythromycin or azithromycin or to any
of the other ingredients in this medicine, listed
in section 6 of this leaflet
• if you are taking ergotamine or
dihydroergotamine tablets or ergotamine
inhalers (used to treat migraine)
• if you are taking terfenadine or astemizole
(widely used for hay fever or allergies) or
cisapride or pimozide tablets, as combining
these drugs whilst receiving Clarithromycin
sometimes can cause serious disturbances in
heart rhythm.
Take special care with Clarithromycin
• if you are taking colchicine (usually used to treat
gout), as this can cause serious side effects
• if you have a liver or kidney problem
• as prolonged or repeated use of clarithromycin
may result in the overgrowth of bacteria and
fungi
• if you develop severe or prolonged diarrhea
during or after receiving Clarithromycin.
You should inform your doctor immediately if
you are concerned about your treatment with
Clarithromycin.
Taking other medicines
Please tell your doctor or nurse if you are taking,
or have recently taken, any other medicines,
including those obtained without prescription and
herbal medicines.
Clarithromycin MUST NOT be used with the
following medicines:
• ergotamine or dihydroergotamine (used to
treat migraine) as there is an increased risk of
ergotism (fungal poisoning),
• pimozide (used in the treatment of
psychiatric conditions) as there is an
increased risk of ventricular arrhythmias
(abnormal heart rhythms).
If you are taking these medicines you
should tell your doctor before you are given
Clarithromycin

Tell your doctor if you are taking any of
the following medicines (listed below): clarithromycin increases the levels of the
medicinal products in the blood, which results in
the increased risk of side effects
• digoxin, quinidine or disopyramide (used to
treat heart conditions)
• carbamazepine, valproate or phenytoin (drugs
used to treat epilepsy)
• theophylline (used to treat breathing difficulties)
• terfenadine or astemizole (used to treat hay
fever or allergies)
• triazolam, alprazolam or midazolam (sedatives)
• cilostazol (used to treat poor circulation)
• cisapride (used to treat stomach disorders)
• methylprednisolone (a corticosteroid)
• vinblastine (used in the treatment of cancer)
• sildenafil (used to treat impotence)
• cyclosporine (immune suppressant drug)
• tacrolimus (used after organ transplants)

Also, tell your doctor or nurse if you are taking any
of the following medicinal products:
• warfarin or other drugs used to thin the blood use with clarithromycin will enhance the effect
of warfarin
• simvastatin or lovastatin (used to treat high
cholesterol) - use with clarithromycin, increases
the risk of myopathy (disease resulting in
muscle weakness), use with clarithromycin
should be avoided
• zidovudine (anti-viral agent) - use of
clarithromycin tablets reduces absorption of
zidovudine and can reduce its effectiveness in
treating your viral disease
• rifabutin (used in the treatment of some
infections) - clarithromycin increases the levels
of rifabutin in the blood, increased risk of uveitis
(inflammation of the eye).
Your doctor may reduce the dose of rifabutin.
• ritonavir (an anti-viral (anti-HIV) agent) ) clarithromycin increases the levels of ritonavir
in the blood, the dose of clarithromycin should
be reduced if the patient suffers from kidney
problems
• colchicine (used to treat gout) – clarithromycin
increases the risk of colchicine poisoning (side
effects include burning in the mouth and throat,
fever, vomiting, diarrhoea, abdominal pain and
kidney failure, death from respiratory failure can
follow)
Pregnancy and breast-feeding
Clarithromycin should not be given during
pregnancy or breast-feeding unless there is no
effective alternative treatment. In this situation the
doctor should assess the risk/benefit ratio.
You should ask your doctor for advice before
taking any medicine.
Driving and using machines
It is unlikely that after using Clarithromycin your
ability to drive and use machines will be affected.
However, if you feel unwell you must speak to
your doctor or nurse before driving or operating
machinery.

If you think you have been given too much
Clarithromycin
This medicine will be given to you by your doctor
so it is unlikely that you will receive too much. Your
doctor has information on how to recognise and
treat an overdose. If you are concerned about your
treatment please talk to your doctor.
If a child accidentally swallows some of this
medicine, seek medical advice urgently. An
overdose of Clarithromycin is likely to cause
vomiting and stomach pains.

4.Possible side effects
Like all medicines Clarithromycin can cause side
effects, although not everybody gets them.
If any of the following happens, tell your doctor
immediately:
• Swelling of the lips, face and neck (allergic
reaction) possibly with difficulty in swallowing
or breathing, wheezing, dizziness
• Severe or prolonged diarrhoea which may
contain blood or mucous
• Blistering of the skin, lining of the mouth or
genitals
Some side effects that have been reported
following treatment with clarithromycin are listed
below.
Frequency:
Very common side effects occur in more than 1
out of 10 patients
Common side effects occur in less than 1 out of 10
patients but in more than 1 out of 100 patients
Uncommon side effects occur in less than 1 out of
100 patients but in more than 1 out of 1,000
patients
Rare side effects occur in less than 1 out of 1,000
patients but in more than 1 out of 10,000 patients
Very rare side effects occur in less than 1 out of
10,000 patients
Common

Uncommon

Discuss with your doctor if you are unsure about
your treatment and its effects.
3. How Clarithromycin is given
Clarithromycin is prepared by dissolving the
powder in the vial in sterile water. The solution
prepared is then added to a larger volume of
sterile liquid, and this is then given into one of
your veins for at least an hour.
The usual dose of Clarithromycin for adults and
children over 12 years is 1.0 grams per day in two
doses, for 2 to 5 days. Your doctor will work out the
correct dose for you.
Children under 12 years should not be given
Clarithromycin. Your doctor will prescribe a more
suitable medicine for your child.
Length of treatment:
Treatment with intravenous clarithromycin should
be between 2 to 5 days. The patient should
then be switched to oral clarithromycin when
necessary.
The total treatment period should not exceed
more than 14 days. The usual duration of
treatment is 6 to 14 days.
Always use your medicine exactly as your doctor
has told you. You should check with your doctor or
nurse if you are not sure.

Rare

• oral candidiasis (fungal infection
of the mouth)
• headache
• altered sense of smell
• phlebitis (inflammation of vein)
• nausea (feeling sick)
• vomiting (being sick)
• diarrhoea
• dyspepsia (indigestion)
• abdominal pains
• discolouration of teeth and
tongue (reversible)
• glossitis (inflammation or
infection of tongue)
• stomatitis (inflammation of the
mouth)
• taste disorders
• tenderness or pain at site of
injection
• increased blood levels of
breakdown product of proteins
• leucopoenia (low levels of white
blood cells - detected during a
blood test)
• allergic reactions (ranging from
skin rash and hives to severe
anaphylactic reactions)
• hepatic dysfunction (liver
problems) usually reversible and
temporary
• hepatitis (liver inflammation)
• cholestasis (liver/gall bladder
disorders)
• jaundice
• joint pains
• muscle pain
• increased prothrombin time (the
time taken for blood to clot is
increased)
• increased plasma creatinine
levels (raised levels of proteins
excreted by the kidneys)
• increased liver transaminases
levels (raised levels of liver
enzymes - detected during a
blood test)
• thrombocytopenia (decreased
numbers of platelets - type of
blood cell)
• hypoglycaemia (low blood
glucose levels)
• convulsions
• tinnitus (‘ringing’ in the ears)
• hearing loss (normally reversible)
• extended QT interval (life
threatening irregular heartbeat)
• ventricular tachycardia (life
threatening irregular heartbeat)
• Torsades de Pointes (life
threatening irregular heartbeat)

Clarithromycin 500 mg
Powder for Concentrate for Solution for Infusion
Clarithromycin

Clarithromycin should not be given as a bolus or an
intramuscular injection.
Clarithromycin should be administered into one of
the larger proximal veins as an IV infusion over 60
minutes, using a solution concentration of about
2mg/ml.

STEP 1
• Add 10 ml sterilised Water
for Injections into the vial and
shake
• May be stored from 5°C up
to room temperature
DO NOT USE
• Diluents containing
preservatives
• Diluents containing inorganic
salts

STEP 2

• Add 10ml from Step 1 to
250ml of a suitable diluent
(see below)
• This provides a 2mg/ml
solution
DO NOT USE
• Solution strengths greater
than 2mg/ml (0.2%)
• Rapid infusion rates (< 60
minutes)

Recommended Diluents
• Dextrose 50 mg/ml (5%) solution for infusion in
Lactated Ringer’s Solution
• Dextrose 50 mg/ml (5%) solution for infusion
• Lactated Ringer’s Solution
• Dextrose 50 mg/ml (5%) in Sodium Chloride 3
mg/ml (0.3%) solution for infusion
Continued overleaf

5.Storing Clarithromycin
Keep out of the reach and sight of children.
Do not store above 30°C. The reconstituted
solution will be stored for up to 6 hours at 25°C.
Keep the vials in the outer carton in order to
protect from light.
The expiry date is stated on the end-flap of the
carton, please make sure this has not expired. The
doctor will also check that the product does not
show signs of visible damage or discoloration.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help protect the
environment.
This product should only be used in a hospital
environment and will be safely disposed of by
your doctor.

6.Further Information
What Clarithromycin contains:
The active substance is clarithromycin 500 mg.
When reconstituted and diluted, the final solution
has a concentration of 2 mg/ml of clarithromycin.
The other ingredient is lactobionic acid.
What Clarithromycin looks like and contents of
the pack:
Clarithromycin is a white to off-white powder and
when dissolved is a clear solution.
This medicinal product is presented in glass
containers called vials.
Each vial contains 500 mg of clarithromycin.
The product is supplied in cartons each containing
one vial.
Marketing
Authorisation
Holder:
Manufacturer:
Martindale
Laboratorios Alcala
Pharmaceuticals Ltd Farma, S.L.
Bampton Road,
Avenida de Madrid 82
Harold Hill, Romford, 28802 Alcalá de Henares,
Essex RM3 8UG
Madrid,
United Kingdom
Spain
Product licence numbers: PL 00156/0333

• Dextrose 50 mg/ml (5%) in Sodium Chloride 4.5
mg/ml (0.45%) solution for infusion
• Sodium Chloride 9 mg/ml (0.9%) solution for
infusion.
Compatibility with other IV additives has not been
established.
Recommended Dosage
Intravenous therapy may be given for 2 to 5 days
and should be changed to oral clarithromycin
therapy when appropriate. The total duration of
treatment should not exceed more than 14 days.
Adults: The recommended dosage of
Clarithromycin is 1.0 gram daily, divided into two
500 mg doses, appropriately diluted as described
below.
Children: At present, there are insufficient data
to recommend a dosage regime for routine use in
children.
Adolescents & Elderly: As for adults.
Renal Impairment: In patients with renal
impairment who have creatinine clearance less
than 30ml/min, the dosage of clarithromycin
should be reduced to one half of the normal
recommended dose.

Shelf life
4 years unopened.
Reconstituted/Diluted Solutions: Chemical and
physical in use stability has been demonstrated for
6 hours at 25oC.
From a microbiological point of view, the
reconstituted and diluted product should be
used immediately. If not used immediately,
in-use storage times and conditions prior to
use are the responsibility of the user and would
normally not be longer than 24 hours at 2 to 8oC,
unless reconstitution/dilution has taken place in
controlled and validated aseptic conditions.
Storage
As packaged for sale: Do not store above 30oC.
Store in the original container as the powder is
sensitive to light. See carton and vial for expiry
date. The product should not be used after this
date.
Product licence numbers:

PL 00156/0333

D03028

The following information is intended for medical
or healthcare professionals only:
Recommended Administration

If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor immediately.
Reporting of side effects
If you or your child gets any side effects, talk to
your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow
Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.

This leaflet was last approved in: April 2015
If you would like any more information, or
would like the leaflet in a different format,
please contact medical information at the
above address.

Continued overleaf

TECHNICAL PRESCRIBING INFORMATION D03028

Very rare
• anxiety
(inc. isolated • insomnia (difficulty sleeping)
• hallucinations (seeing things)
cases)
• psychoses (loss of contact with
reality)
• disorientation (loss of bearings)
• depersonalisation (changes in self
awareness)
• unpleasant dreams
• confusion
• muzziness (confused, muddled,
blurred state of mind)
• dizziness
• paresthesias (sensation of
tingling, pricking or numbness
of skin)
• pancreatitis (inflammation of the
pancreas)
• pseudomembranous colitis
(infection of the colon caused by
bacteria)
• fatal hepatic insufficiency
(particularly in patients with
existing liver disease or patients
who are currently using
medicinal products for liver
problems)
• Steven-Johnson’s disease (severe
illness with ulceration of the
mouth, lip and skin)
• toxic epidermal necrolysis (severe
illness with sloughing of the skin)
• interstitial nephritis (inflammation
within the kidneys)
• renal insufficiency (reduced
function of the kidneys with
buildup of waste products in the
blood)

D03028

PACKAGE LEAFLET: INFORMATION FOR THE USER

100mm Measurement Verification Bar
2970-E

DEVELOPMENT ARTWORK
Component Code: D03028
Prod: CLARITHROMYCIN 500MG
UK
Trim size: 130 x 420 mm
Version Control Date

By

Version A Created 28/04/15 AC
Version B

29/04/15 AC

Version C

30/04/15 AC

Version D

05/05/15 AC

Version E

12/05/15 AC

Version F
Version G
Version H
Version I
Version J
Version K
Version L
Version M
Version N
Grand Fromage Creative Limited
1 Blighs Road, Sevenoaks,
Kent, TN13 1DA, UK
t: 01732 749 749
e: alan@grand-fromage.co.uk
www.grand-fromage.co.uk

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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