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KLARICID IV 500 MG

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MKP-00709-2017

FPO
PATIENT INFORMATION LEAFLET ON
®

INFORMATION FOR THE HEALTHCARE
PROFESSIONAL
KLARICID® I.V. 500 mg
Powder for Concentrate for Solution for Infusion
Clarithromycin
Refer to the Summary of Product Characteristics
for the full prescribing information.
Method of administration
Refer to the summary of product characteristics for
posology information.
Clarithromycin should not be given as a bolus or
an intramuscular injection. Klaricid IV 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

STEP 2
10
ml

10 ml

Add 10 ml sterilised
Water for Injections into
the vial and shake
Use within 24 hours
May be stored from 5°C
up to room temperature

DO NOT USE
• Diluents containing
preservatives
• Diluents containing
inorganic salts

Add 10 ml from Step 1 to
250ml of a suitable diluent
(see below)
This provides a 2mg/ml
solution
Use within 6 hour (at room
temperature) or within 24
hours if stored at 5°C
DO NOT USE
• Solution strengths
greater than 2mg/ml
(0.2%)
• Rapid infusion rates
(<60 minutes)
• Failure to observe
these precautions
may result in pain
along the vein

Recommended Diluents
5% dextrose in Lactated Ringer’s Solution,
5% dextrose, Lactated Ringer’s solution, 5%
dextrose in 0.3% sodium chloride, Normosol-M
in 5% dextrose, Normosol-R in 5% dextrose,
5% dextrose in 0.45% sodium chloride, or 0.9%
sodium chloride. Compatibility with other IV
additives has not been established.
Storage
Do not store above 30°C. 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 Number: 46302/0018
Legal Category: POM
Marketing Authorisation Holder:
Mylan Products Ltd, 20 Station Close, Potters Bar,
Herts, EN6 1TL, UK
Revised: July 2017

MKP-00709-2017_d5

IV 500 mg

Powder for Concentrate for Solution for
Infusion
Clarithromycin
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or
your pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If you get any side effects talk to your doctor
or pharmacist. This includes any possible side
effects not listed in the leaflet. See section 4.
What is in this leaflet:
1. What Klaricid IV is and what it is used for
2. What you need to know before receiving Klaricid IV
3. How is Klaricid IV given?
4. Possible side effects
5. How to store Klaricid IV
6. Contents of the pack and other information

1. What Klaricid IV is and what it is used for
Klaricid IV contains the active ingredient
clarithromycin. Klaricid belongs to a group of
medicines called macrolide antibiotics. Antibiotics
stop the growth of bacteria (bugs) that cause
infections.
Klaricid IV is used whenever an intravenous (injection
into the vein) antibiotic is required to treat severe
infections or, alternatively, if a patient cannot swallow
Klaricid tablets.
It is used to treat infections such as:
1. Chest infections such as bronchitis and
pneumonia
2. Throat and sinus infections
3. Skin and tissue infections
Klaricid IV is indicated in adults and children 12 years
and older.

2. What you need to know before receiving
Klaricid IV















Do not receive Klaricid IV if you;
• know that you are allergic to
clarithromycin, other macrolide
antibiotics such as erythromycin
or azithromycin, or any of the other
ingredients in Klaricid IV.
are taking medicines called ergot alkaloid tablets
(e.g. ergotamine or dihydroergotamine) or use
ergotamine inhalers for migraine.
are taking medicines called terfenadine or
astemizole (widely taken for hay fever or allergies)
or cisapride (for stomach disorders) or pimozide
(for mental health problems) as combining
these drugs can sometimes cause serious
disturbances in heart rhythm. Consult your
doctor for advice on alternative medicines.
are taking other medicines which are known to
cause serious disturbances in heart rhythm.
are taking lovastatin or simvastatin (HMG-CoA
reductase inhibitors, commonly known as
statins, used to lower levels of cholesterol (a type
of fat) in the blood).
are taking oral midazolam (a sedative).
have abnormally low levels of potassium in your
blood (hypokalaemia).
have severe liver disease with kidney disease.
or someone in your family has a history of heart
rhythm disorders (ventricular cardiac arrhythmia,
including torsades de pointes) or abnormality of
electrocardiogram (ECG, electrical recording of
the heart) called “long QT syndrome”.
are taking medicines called ticagrelor or
ranolazine (for heart attack, chest pain or angina)
are taking colchicine (usually taken for gout)

Warnings and precautions
Talk to your doctor or pharmacist before being given
Klaricid IV;
• if you have heart problems (e.g. heart disease,
heart failure, an unusually slow heart rate, or
abnormally low levels of magnesium in the blood
(hypomagnesaemia))
• if you have any liver or kidney problems
• if you have, or are prone to, fungal infections (e.g.
thrush)

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if you are pregnant or breast feeding

Children
Klaricid IV is not suitable for use in children
under 12 years of age.
Other medicines and Klaricid IV
You should not be given Klaricid IV if you are taking
any of the medicines listed in the section above “Do
not receive Klaricid IV if you;”
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines as
your dose may need to be changed or you may need
to have regular tests performed:
• digoxin, quinidine or disopyramide (for heart
problems)
• warfarin, or any other anticoagulant (for blood
thinning)
• carbamazepine, valproate, phenobarbital or
phenytoin (for epilepsy)
• atorvastatin, rosuvastatin (HMG-CoA reductase
inhibitors, commonly known as statins, and used
to lower levels of cholesterol (a type of fat) in
the blood). Statins can cause rhabdomyolysis
(a condition which causes the breakdown of
muscle tissue which can result in kidney damage)
and signs of myopathy (muscle pain or muscle
weakness) should be monitored.
• nateglinide, pioglitazone, repaglinide,
rosiglitazone or insulin (used to lower blood
glucose levels)
• gliclazide or glimepiride (sulphonylureas used in
the treatment of type II diabetes)
• theophylline (used in patients with breathing
difficulties such as asthma)
• triazolam, alprazolam or intravenous or
oromucosal midazolam (sedatives)
• cilostazol (for poor circulation)
• methylprednisolone (a corticosteroid)
• vinblastine (for treatment of cancer)
• ciclosporin, sirolimus and tacrolimus (immune
suppressants)
• etravirine, efavirenz, nevirapine, ritonavir,
zidovudine, atazanavir, saquinavir (anti-viral
drugs used in the treatment of HIV)
• rifabutin, rifampicin, rifapentine, fluconazole,
itraconazole (used in the treatment of certain
bacterial infections)
• tolterodine (for overactive bladder)
• verapamil, amlodipine, diltiazem (for high blood
pressure)
• sildenafil, vardenafil and tadalafil (for impotence
in adult males or for use in pulmonary arterial
hypertension (high blood pressure in the blood
vessels of the lung))
• St John’s Wort (a herbal product used to treat
depression)
• quetiapine or other antipsychotic medicines.
• other macrolide medicines
• lincomycin and clindamycin (lincosamides – a
type of antibiotic)
Please tell your doctor if you are taking oral
contraceptive pills and diarrhoea or vomiting
occurs, as you may need to take extra contraceptive
precautions such as using a condom.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist before receiving the medicine
as the safety of clarithromycin in pregnancy or
breast-feeding is not known.
Driving and Using Machines:
Klaricid IV may make you feel dizzy or drowsy. If
they affect you in this way do not drive, operate
machinery or do anything that requires you to be
alert.

3. How is Klaricid IV given?
Klaricid IV is prepared by your doctor or nurse by
dissolving the powder in the vial in sterile water.
The solution obtained is added to a larger volume
of sterile liquid. Klaricid IV is given to you slowly
through a needle, into your vein over a period of at
least an hour.
The recommended dose of Klaricid IV for adults and
children over 12 years is 1.0g per day, split into 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 Klaricid
IV. Your doctor will prescribe another suitable
medicine for your child.

If a child accidentally swallows some of this
medicine, seek medical advice urgently.
If you are given more Klaricid IV than you should
have
As Klaricid IV is given to you by a doctor, an
overdose is unlikely but symptoms may include
vomiting and stomach pains.






4. Possible side effects
Like all medicines, Klaricid IV can
cause side effects although not
everybody gets them.
If you suffer from any of the following
at any time during your treatment
tell your doctor immediately as your
treatment may need to be stopped:
• severe or prolonged diarrhoea, which may have
blood or mucus in it. Diarrhoea may occur over
two months after treatment with clarithromycin,
in which case you should still contact your
doctor.
• a rash, difficulty breathing, fainting or swelling
of the face, tongue, lips, eyes and throat. This is
a sign that you may have developed an allergic
reaction.
• yellowing of the skin (jaundice), skin irritation,
pale stools, dark urine, tender abdomen or loss
of appetite. These are signs that your liver may
have inflammation and not be working properly.
• severe skin reactions such as painful blistering
of the skin, mouth, lips, eyes and genitals
(symptoms of a rare allergic reaction called
Stevens-Johnson syndrome/toxic epidermal
necrolysis)
• a red, scaly rash with bumps under the skin
and blisters (symptoms of exanthematous
pustulosis). The frequency of this side effect
is not known (cannot be estimated from the
available data).
• rare allergic skin reactions which cause severe
illness with ulceration of the mouth, lips and skin
which causes severe illness with rash, fever and
inflammation of internal organs (DRESS).
• muscle pain or weakness known as
rhabdomyolysis (a condition which causes the
breakdown of muscle tissue which can result in
kidney damage).
Other side effects
Common side effects (may affect up to 1 in 10
people) include;
• inflammation, tenderness or pain at the site of
the injection
• difficulty sleeping
• changes in sense of taste
• headache
• widening of blood vessels
• stomach problems such as feeling sick,
vomiting, stomach pain, indigestion, diarrhoea
• increased sweating
Uncommon side effects (may include up to 1 in 100
people) include:
• high temperature
• swelling, redness or itchiness of the skin
• oral or vaginal ‘thrush’ (a fungal infection)
• inflammation of the stomach and intestines
• decrease of the levels of blood platelets (blood
platelets help stop bleeding)
• decrease in white blood cells (leukopenia)
• decrease in neutrophils (neutropenia)
• stiffness
• chills
• increase of eosinophils (white blood cells
involved in immunity)
• exaggerated immune response to a foreign
agent
• lack or loss of appetite
• anxiety, nervousness
• drowsiness, tiredness, dizziness or shaking
• involuntary muscle movements
• vertigo
• ringing in the ears or hearing loss
• chest pain or changes in heart rhythm such as
palpitations or an irregular heartbeat
• asthma: lung disease associated with tightening
of air passages, making breathing difficult
• nose bleed
• blood clot that causes sudden blockage in a
lung artery (pulmonary embolism)
• inflammation of the lining of the gullet
(oesophagus) and lining of the stomach
• anal pain
• bloating, constipation, wind, burping

MKP-00709-2017_d5




dry mouth
situation where the bile (fluid made by the liver
and stored in the gallbladder) cannot flow from
the gallbladder to the duodenum (cholestasis)
inflammation of the skin characterized by the
presence of the bullae which are filled with fluid,
itchy and painful rash
muscle spasms, muscle pain or loss of muscle
tissue. If you suffer from myasthenia gravis (a
condition in which the muscles become weak
and tire easily), clarithromycin may worsen these
symptoms.
raised abnormal kidney and liver function blood
test and raised blood tests
feeling weak, tired and having no energy

Not known side effects (frequency cannot be
estimated from the available data):
• inflammation of the colon
• bacterial infection of the outer layers of the skin
• reduction in the level of certain blood cells (which
can make infections more likely or increase the
risk of bruising or bleeding)
• confusion, loss of bearings, hallucinations
(seeing things), change in sense of reality or
panicking, depression, abnormal dreams or
nightmares and mania (feeling of elation or overexcitement)
• convulsion (fits)
• paraesthesia, more commonly known as ‘pins
and needles’
• loss of taste or smell or inability to smell properly
• type of heart rhythm disorder (Torsade de
pointes, ventricular tachycardia)
• loss of blood (haemorrhage)
• inflammation of the pancreas
• discolouration of the tongue or teeth
• acne
• change in the levels of products produced by the
kidney, inflammation of the kidney or an inability
of the kidney to function properly (you may
notice tiredness, swelling or puffiness in the face,
abdomen, thighs or ankles or problems with
urination)
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 or search for MHRA
Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Klaricid IV
Keep out of the sight and reach of
children
Do not use after the expiry date on the
carton and vial.
Do not store above 30°C. Store in the
original container. The reconstituted
solution will be stored for either 6 hours
at room temperature or for 24 hours
at 5° C.

6. Contents of the pack and other
information
What Klaricid IV contains
Klaricid IV contains the active ingredient
clarithromycin.
The other ingredients are; lactobionic acid and
sodium hydroxide.
This medicinal product contains less than 23mg
sodium (1mmol) per 500mg i.e. essentially “sodiumfree”.
What Klaricid IV looks like and contents of the
pack
Klaricid IV is a white to off-white caked, lyophilized
powder available in vials containing 739.5 mg
clarithromycin lactobionate, corresponding to 500mg
of clarithromycin as the active ingredient. When
made up with Water for Injections, each millilitre (ml)
of solution contains 2mg of clarithromycin.
Marketing Authorisation Holder and
Manufacturer:
Marketing Authorisation Holder – Mylan Products
Ltd, 20 Station Close, Potters Bar, Herts, EN6 1TL, UK
Manufacturer - FAMAR L’Aigle Usine St Remy, Rue
de L’Isle, 28380 Saint Remy sur Avre, France.
This leaflet was last revised in February 2018.
MKP-00709-2017

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