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
Qualitative and quantitative composition
Each 1 ml ampoule contains clonidine hydrochloride
150 micrograms. For excipients, see List of excipients.
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.
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CATAPRES should be used with caution in patients
with mild to moderate bradyarrhythmia such as low
sinus rhythm, and with polyneuropathy or
constipation.
As with other antihypertensive drugs, treatment
with CATAPRES should be monitored particularly
carefully in patients with heart failure.
In hypertension caused by phaeochromocytoma no
therapeutic effect of CATAPRES can be expected.
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
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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.
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:
≥ 1/10
Very common
Common
≥ 1/100, <1/10
Uncommon
≥ 1/1000, <1/100
Rare

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

Endocrine disorders:
Gynaecomastia


rare

Psychiatric disorders:
Confusional state
Delusional perception
Depression

Hallucination

Libido decreased

Nightmare

Sleep disorder


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.

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.
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Treatment:
There is no specific antidote for clonidine overdose.
Administration of activated charcoal should be
performed where appropriate.
Supportive care may include atropine sulphate 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%.

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 April 2013

© Boehringer Ingelheim Limited 2013

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.
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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).
If any of the side effects gets troublesome or
serious, or if you notice any side effects not listed
in the leaflet, tell your doctor or pharmacist.

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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 April 2013.

20120123

©Boehringer Ingelheim Limited 2013

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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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