CATAPRES AMPOULES 0.15MG/ML.

Active substance: CLONIDINE HYDROCHLORIDE

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Professional Leaflet


Catapres® Ampoules
150 micrograms in 1 ml
Solution for Injection

abcd

(clonidine hydrochloride)
Name of the medicinal product
CATAPRES Ampoules 150 micrograms in 1 ml Solution
for Injection

As with other antihypertensive drugs, treatment with
CATAPRES should be monitored particularly carefully in
patients with heart failure.

Qualitative and quantitative composition
Each 1 ml ampoule contains clonidine hydrochloride
150 micrograms. For excipients, see List of excipients.

In hypertension caused by phaeochromocytoma no
therapeutic effect of CATAPRES can be expected.

Pharmaceutical form
Solution for injection. Clear, colourless solution
Clinical particulars
Therapeutic indications
CATAPRES is indicated for the treatment of hypertensive
crises.
Posology and method of administration
Adults, including the elderly:
In hypertensive crises 150 to 300 micrograms (1 to 2
ampoules) should be given by slow intravenous
injection. This dose may be repeated up to a maximum
750 micrograms (5 ampoules) in a 24 hour period.
Patients undergoing anaesthesia should continue their
CATAPRES treatment before, during and after
anaesthesia using oral or intravenous administration
according to individual circumstances.
Intravenous injection of CATAPRES should be given slowly
over 10-15 minutes to avoid a possible transient pressor
effect. CATAPRES injection solution is compatible with 0.9%
sodium chloride solution and with 5% dextrose solution.
Paediatric Population:
There is insufficient evidence for the application of
clonidine in children and adolescents younger than 18
years. Therefore the use of clonidine is not recommended
in paediatric subjects under 18 years.
Renal insufficiency:
Dosage must be adjusted
• according to the individual antihypertensive response
which can show high variability in patients with renal
insufficiency
• according to the degree of renal impairment
Contraindications
CATAPRES should not be used in children (please refer to
Special warnings and precautions for use) or in patients
with known hypersensitivity to the active ingredient or
other components of the product, and in patients with
severe bradyarrhythmia resulting from either sick sinus
syndrome or AV block of 2nd or 3rd degree.
Special warnings and precautions for use
Clonidine should only be used with caution in patients
with depression or a history thereof, with Raynaud’s
disease, or other peripheral vascular occlusive disease.
The product should only be used with caution in patients
with cerebrovascular or coronary insufficiency.
CATAPRES should be used with caution in patients with
mild to moderate bradyarrhythmia such as low sinus
rhythm, and with polyneuropathy or constipation.

Clonidine, the active ingredient of CATAPRES, and its
metabolites are extensively excreted with the urine. Dosage
must be adjusted to the individual antihypertensive
response, which can show high variability in patients
with renal insufficiency (see Section Posology and
method of administration); careful monitoring is
required. Since only a minimal amount of clonidine is
removed during routine haemodialysis, there is no need
to give supplemental clonidine following dialysis.
Patients who wear contact lenses should be warned that
treatment with CATAPRES may cause decreased lacrimation.
The use and safety of clonidine in children and
adolescents has little supporting evidence in randomized
controlled trials and therefore cannot be recommended
for use in this population.
Serious adverse events, including sudden death, have
been reported in concomitant use with methylphenidate.
The safety of using methylphenidate in combination with
clonidine has not been systematically evaluated.
Interaction with other medicinal products and
other forms of interaction.
The reduction in blood pressure induced by clonidine
can be further potentiated by concurrent administration
of other hypotensive agents. This can be of therapeutic
use in the case of other antihypertensive agents such as
diuretics, vasodilators, beta-receptor blockers, calcium
antagonists and ACE-inhibitors, but the effect of
alpha1-blockers is unpredictable.
The antihypertensive effect of clonidine may be reduced
or abolished and orthostatic hypotension may be
provoked or aggravated by concomitant administration
of tricyclic antidepressants or neuroleptics with
alpha-receptor blocking properties.
Substances which raise blood pressure or induce a
sodium ion (Na+) and water retaining effect such as
non-steroidal anti-inflammatory agents can reduce the
therapeutic effect of clonidine.
Substances with alpha2-receptor blocking properties,
such as mirtazapine, may abolish the alpha2-receptor
mediated effects of clonidine in a dose-dependent manner.
Concomitant administration of substances with a
negative chronotropic or dromotropic effect such as
beta-receptor blockers or digitalis glycosides can cause
or potentiate bradycardic rhythm disturbances.
It cannot be ruled out that concomitant administration
of a beta-receptor blocker will cause or potentiate
peripheral vascular disorder.
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Based on observations in patients in a state of alcoholic
delirium it has been suggested that high intravenous doses
of clonidine may increase the arrhythmogenic potential
(QT-prolongation, ventricular fibrillation) of high
intravenous doses of haloperidol. Causal relationship
and relevance for antihypertensive treatment have not
been established.
The effect of centrally depressant substances or alcohol
can be potentiated by clonidine.
Fertility, pregnancy and lactation
Pregnancy
There are limited amount of data from the use of clonidine
in pregnant women. This product should only be used in
pregnancy if considered essential by the physician.
Careful monitoring of mother and child are recommended.
Clonidine passes the placental barrier and may lower the
heart rate of the foetus. Post partum a transient rise in
blood pressure in the newborn cannot be excluded.
Non-clinical studies do not indicate direct or indirect
harmful effects with respect to reproductive toxicity.
Lactation
Clonidine is excreted in human milk. However, there is
insufficient information on the effect on newborns. The
use of CATAPRES is therefore not recommended during
breast-feeding.
Fertility
No clinical studies on the effect on human fertility have
been conducted with clonidine. Non-clinical studies with
clonidine indicate no direct or indirect harmful effects
with respect to the fertility index.

Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use
machines have been performed.
However, patients should be advised that they may
experience undesirable effects such as dizziness,
sedation and accommodation disorder during treatment
with CATAPRES. If patients experience the above
mentioned side effects they should avoid potentially
hazardous tasks such as driving or operating machinery.
Undesirable effects
Most adverse effects are mild and tend to diminish with
continued therapy.
Adverse events have been ranked under headings of
frequency using the following convention:
Very common
≥ 1/10
Common
≥ 1/100, <1/10
Uncommon
≥ 1/1000, <1/100
Rare

≥ 1/10000, <1/1000
< 1/10000
Very rare
Not known
Cannot be estimated from


the available data
Endocrine disorders:
Gynaecomastia

rare
Psychiatric disorders:
Confusional state
Delusional perception
Depression
Hallucination
Libido decreased
Nightmare
Sleep disorder
2









not known
uncommon
common
uncommon
not known
uncommon
common

Nervous system disorders:
Dizziness

Headache

Paraesthesia

Sedation


very common
common
uncommon
very common

Eye disorders:
Accommodation disorder
Lacrimation decreased

not known
rare

Cardiac disorders:
Atrioventricular block
Bradyarrhythmia

Sinus bradycardia

rare
not known
uncommon

Vascular disorders:
Orthostatic hypotension
Raynaud’s phenomenon

very common
uncommon

Respiratory, thoracic and mediastinal disorders:
Nasal dryness

rare
Gastrointestinal disorders:
Colonic pseudo-obstruction
Constipation

Dry mouth

Nausea

Salivary gland pain

Vomiting


rare
common
very common
common
common
common

Skin and subcutaneous tissue disorders:
Alopecia

rare
Pruritus

uncommon
Rash


uncommon
Urticaria

uncommon
Reproductive system and breast disorders:
Erectile dysfunction
common
General disorders and administration site conditions:
Fatigue


common
Malaise

uncommon
Investigations:
Blood glucose increased
rare

Fluid retention and abnormal liver function tests have
been reported occasionally. Two cases of hepatitis have
also been reported.
Reporting suspected adverse reactions
Reporting suspected adverse reactions after
authorisation of the medicinal product is important. It
allows continued monitoring of the benefit / risk balance
of the medicinal product. Healthcare professionals are
asked to report any suspected adverse reactions via:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
FREEPOST, Pharmacovigilance Section
Irish Medicines Board, Kevin O’Malley House,
Earlsfort Centre, Earlsfort Terrace, Dublin 2, Ireland
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie

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Overdose
Symptoms:
Manifestations of intoxication are due to a generalised
sympathetic depression and include pupillary
constriction, lethargy, bradycardia, hypotension,
hypothermia, somnolence including coma and
respiratory depression including apnoea. Paradoxical
hypertension caused by stimulation of peripheral
alpha1-receptors may occur. Transient hypertension may
be seen if the total dose is over 10 mg.
Treatment:
There is no specific antidote for clonidine overdose.
Administration of activated charcoal should be
performed where appropriate.
Supportive care may include atropine sulfate for
symptomatic bradycardia, and intravenous fluids and/or
inotropic sympathomimetic agents for hypotension.
Severe persistent hypertension may require correction
with alpha-adrenoceptor blocking drugs.
Naloxone may be a useful adjunct for the management
of clonidine-induced respiratory depression.
Pharmacological properties
Pharmacodynamic properties
Clonidine acts primarily on the central nervous system,
resulting in reduced sympathetic outflow and a decrease
in peripheral resistance, renal vascular resistance, heart
rate and blood pressure. Renal blood flow and
glomerular filtration rate remain essentially unchanged.
Normal postural reflexes are intact and therefore
orthostatic symptoms are mild and infrequent. During
long-term therapy, cardiac output tends to return to
control values, while peripheral resistance remains
decreased. Slowing of the pulse rate has been observed
in most patients given clonidine, but the drug does not
alter normal haemodynamic response to exercise.
The efficacy of clonidine in the treatment of hypertension
has been investigated in five clinical studies in paediatric
patients. The efficacy data confirms the properties of
clonidine in reduction of systolic and diastolic blood
pressure. However, due to limited data and
methodological insufficiencies, no definitive conclusion
can be drawn on the use of clonidine for hypertensive
children.
The efficacy of clonidine has also been investigated in a
few clinical studies with paediatric patients with ADHD,
Tourette syndrome and stuttering. The efficacy of
clonidine in these conditions has not been demonstrated.
There were also two small paediatric studies in migraine,
neither of which demonstrated efficacy. In the paediatric
studies the most frequent adverse events were
drowsiness, dry mouth, headache, dizziness and
insomnia. These adverse events might have serious
impact on daily functioning in paediatric patients.
Overall, the safety and efficacy of clonidine in children
and adolescents have not been established (see posology
and method of administration).

Pharmacokinetic properties
The pharmacokinetics of clonidine is dose-
proportional in the range of 100-600 micrograms.
Clonidine, the active ingredient of CATAPRES, is well
absorbed and no first pass effect exists. It is rapidly and
extensively distributed into tissues and crosses the blood
brain barrier as well as the placental barrier. The plasma
protein binding is 30-40%.
The mean plasma half-life of clonidine is about 13 hours
ranging between 10 and 20 hours. The half-life does not
depend on the sex or race of the patient but can be
prolonged in patients with severely impaired renal
function up to 41 hours.
About 70% of the dose administered is excreted with the
urine mainly in the form of the unchanged parent drug
(40-60%). The main metabolite p-hydroxy-clonidine is
pharmacologically inactive. Approximately 20% of the
total amount is excreted with the faeces.
The antihypertensive effect is reached at plasma
concentrations between about 0.2 and 1.5 ng/ml in
patients with normal excretory function. A further rise in
the plasma levels will not enhance the antihypertensive
effect.
Pharmaceutical particulars
List of excipients
Sodium chloride
Water for injections
Hydrochloric acid

Incompatibilities
None known
Shelf life
Unopened: 5 years
Once opened, use immediately and discard any unused
contents.
Special precautions for storage
Do not store above 30°C
Keep the ampoules in the outer carton
Nature and contents of container
1 ml colourless glass (Ph. Eur. Type I) ampoules,
marketed in packs of 5.
Special precautions for disposal
For single use only. Discard any unused contents.
Marketing authorisation holder
Boehringer Ingelheim Limited,
Ellesfield Avenue, Bracknell, Berkshire,
RG12 8YS, United Kingdom.
Marketing authorisation number
PL 00015/5008R
PA 7/14/3
Manufacturer of the product
Boehringer Ingelheim España, S.A.
Prat de la Riba, 50, 08174 Sant Cugat del Vallès,
Barcelona, Spain
Legal category
POM
Date of revision of the text
This Professional Leaflet was revised in March 2014.

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© Boehringer Ingelheim Limited 2014

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Package Leaflet: Information for the user


Catapres® Ampoules
150 micrograms in 1 ml
Solution for Injection

abcd

(clonidine hydrochloride)
Read all of this leaflet carefully before you start
taking this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets troublesome or
serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What CATAPRES Ampoules are and what they
are used for
2. Before you receive CATAPRES Ampoules
3. How CATAPRES Ampoules will be given
4. Possible side effects
5. How to store CATAPRES Ampoules
6. Further information
1. WHAT CATAPRES AMPOULES ARE AND WHAT
THEY ARE USED FOR
The name of your medicine is CATAPRES
Ampoules 150 micrograms in 1 ml Solution for
Injection (called CATAPRES Ampoules in this
leaflet). Your medicine is a solution for injection.
CATAPRES Ampoules contain a medicine called
clonidine. This belongs to a group of medicines
called antihypertensives.
CATAPRES is used to lower high blood pressure in
cases of hypertensive crisis (a rapid rise in blood
pressure that needs treating straight away).
2. BEFORE YOU RECEIVE CATAPRES AMPOULES
You should not be given CATAPRES Ampoules if:
• You are pregnant, likely to get pregnant or are
breast-feeding
• You are allergic (hypersensitive) to clonidine
or any of the other ingredients of CATAPRES
(see section 6: Further information)
• You have a slow heart rate due to heart
problems
• You are under 18 years old
You should not receive this medicine if any of the
above apply to you. If you are not sure, talk to
your doctor or pharmacist before having
CATAPRES Ampoules.

Take special care with CATAPRES Ampoules
Check with your doctor or pharmacist before
having CATAPRES if:
• You have Raynaud’s disease (a problem with
circulation to the fingers and toes) or other
blood circulation problems, including
circulation to the brain
• You have heart or kidney problems
• You have or have ever had depression
• You have constipation
• You have a nerve disorder that causes your
hands and feet to feel different (‘altered
sensation’)
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
receiving CATAPRES Ampoules.
As you may get dry eyes whilst taking this
medicine, this may be a problem if you wear
contact lenses.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines. This includes medicines obtained
without a prescription and herbal medicines. This
is because CATAPRES Ampoules can affect the
way some other medicines work. Also some other
medicines can affect the way CATAPRES
Ampoules works.
In particular tell your doctor or pharmacist if you
are taking any of the following medicines:
• Other medicines that make you drowsy
• Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs) such as ibuprofen
• Medicines for depression such as imipramine
or mirtazapine
• Medicines for severe mental illness such as
schizophrenia. These are also known as
‘antipsychotics’ and include chlorpromazine
and haloperidol
Please also tell your doctor or pharmacist if you
are taking any of the following medicines for high
blood pressure or other heart problems:
• Beta blockers such as atenolol
• Water tablets (‘diuretics’) such as frusemide
• Alpha blockers such as prazosin or doxazosin.
These can also be used for prostate problems
in men.
• Vasodilators such as diazoxide or sodium
nitroprusside
• Calcium antagonists such as verapamil or
diltiazem hydrochloride
• ACE inhibitors such as captopril or lisinopril
• Digitalis glycosides such as digoxin
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
receiving CATAPRES Ampoules.

4

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Tests
If you are having any blood tests, tell the person
giving the test that you are taking this medicine.
This is because CATAPRES can affect results
relating to your liver.
Operations
If you are going to have an operation, you will
need to still receive CATAPRES Ampoules.
Having CATAPRES Ampoules with food and drink
You may feel drowsy while receiving CATAPRES
Ampoules. Drinking alcohol while receiving
CATAPRES Ampoules can make this worse.
Pregnancy and breast-feeding
You should not be given CATAPRES Ampoules if
you are pregnant, likely to get pregnant or are
breast-feeding.
Driving and using machines
You may feel drowsy, dizzy, or could have some
disturbances of vision. If affected, you should not
drive, operate machinery or take part in any
activities where these may put you or others at
risk.
Important information about some of the
ingredients of CATAPRES Ampoules
CATAPRES Ampoules contain sodium chloride,
the sodium content per 1 ml ampoule is less than
1 mmol (23 mg). The total sodium content if you
are given 5 ampoules in 24 hours is less than
1 mmol (23 mg). This means that CATAPRES
Ampoules are essentially sodium free.
3. HOW CATAPRES AMPOULES WILL BE GIVEN
CATAPRES Ampoules are usually given by a
doctor or nurse. You will normally be given 1 to 2
CATAPRES Ampoules but over 24 hours up to 5
ampoules may be given.
Your doctor will start you on a low dose but may
increase the dose if you need more medicine to
control your blood pressure.
Receiving the injection
• CATAPRES Ampoules are slowly injected into a
vein over 10-15 minutes
• CATAPRES Ampoules may be diluted with other
solutions if needed
CATAPRES Ampoules are not recommended for
children or adolescents under 18 years old.
If you have more CATAPRES Ampoules than you
should
It is unlikely that you will be given too much of
this medicine. However, tell the doctor or nurse if
you think that you have been given too much.
If you have any further questions on the use of
CATAPRES, ask your doctor or pharmacist.

5

4. POSSIBLE SIDE EFFECTS
Like all medicines, CATAPRES Ampoules can
cause side effects, although not everybody gets
them.
The side effects described below have been
experienced by people taking CATAPRES. They
are listed as either very common, common,
uncommon, rare or not known.
Very common (affects more than 1 in 10 people)
• Dizziness, feeling tired and more relaxed than
usual (sedation)
• Feeling dizzy when you stand up (because your
blood pressure has fallen sharply)
• Dry mouth
Common (affects less than 1 in 10 people, more
than 1 in 100 people)
• Depression, sleeping problems
• Headache
• Constipation, feeling sick (nausea), pain
below the ear (from the salivary gland), being
sick (vomiting)
• Erectile dysfunction
• Fatigue
Uncommon (affects less than 1 in 100 people,
more than 1 in 1,000 people)
• Problems with understanding what is
happening around you, hallucinations,
nightmares
• Your hands and feet feeling different (‘altered
sensation’)
• Regular unusually slow heart beat
• Raynaud’s phenomenon (a problem with
circulation to the fingers and toes)
• Itching, rash, urticaria (nettle rash)
• A feeling of discomfort and fatigue (‘malaise’)
Rare (affects less than 1 in 1,000 people, more
than 1 in 10,000 people)
• Breast growth (‘gynaecomastia’) in men
• Dry eyes
• Irregular heartbeat
• Drying out of the lining of the nose
• Pseudo-obstruction of the large bowel, which
causes colicky pain, vomiting and constipation.
Contact your doctor straight away if you have
all these side effects.
• Hair loss
• Increase in your blood sugar
Not known
• Confusion, loss of libido
• Blurred vision
• Abnormally slow heart beat
Two cases of hepatitis (inflammation of the liver)
have also been reported. This might show up in
some blood tests. Your body may also hold onto
more water than usual (fluid retention).

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Reporting of side effects
If you get 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 (see details below). By
reporting side effects you can help provide more
information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
FREEPOST, Pharmacovigilance Section,
Irish Medicines Board, Kevin O’Malley House,
Earlsfort Centre, Earlsfort Terrace,
Dublin 2, Ireland
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
5. HOW TO STORE CATAPRES AMPOULES
Keep out of the reach and sight of children.
The ampoules should not be stored above 30°C
and should be kept in the outer carton.
CATAPRES Ampoules should not be used after
the expiry date which is stated on the ampoule
label and carton. The expiry date refers to the last
day of that month.
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.
6. FURTHER INFORMATION
What CATAPRES Ampoules contain
• The active substance is clonidine hydrochloride.
Each 1 ml ampoule contains 150 micrograms of
clonidine hydrochloride
• The other ingredients in the injection are:
sodium chloride, water for injections and
hydrochloric acid
What CATAPRES Ampoules looks like and
contents of the pack
CATAPRES Ampoules are clear glass ampoules
containing a clear, colourless solution. CATAPRES
Ampoules are supplied in cartons of 5 ampoules.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisations for CATAPRES
Ampoules are held by:
Boehringer Ingelheim Limited, Ellesfield Avenue,
Bracknell, Berkshire, RG12 8YS, United Kingdom
and the ampoules are manufactured at
Boehringer Ingelheim España, S.A.
Prat de la Riba, 50, 08174 Sant Cugat del Vallès,
Barcelona, Spain
This leaflet was revised in March 2014.
©Boehringer Ingelheim Limited 2014
6

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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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