BACLOFEN 10 MG/20 ML SOLUTION FOR INFUSION

Active substance: BACLOFEN

View full screen / Print PDF » Download PDF ⇩

Transcript
No information is available on co-administration with other medicines that are also delivered into the spinal
cord.
The following medicines may interact with Baclofen or Baclofen may interact with them:
- Medicines to relieve severe muscle spasms (antispastics).
- Medicines that have depressant effects on the functions of the central nervous system.
- Medicines to treat depression (tricyclic antidepressants).
- Medicines used to treat high blood pressure.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Baclofen 10 mg/20 ml solution for infusion
Baclofen

It may be necessary for the doctor to adjust the dose of Baclofen or one of your other medicines.

Please read this product information carefully before you or your child is given Baclofen since it
contains important information.
- 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 serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Baclofen is and what it is used for
2. Before you use Baclofen
3. How to use Baclofen
4. Possible side effects
5. How to store Baclofen
6. Further information

Important information about some of the ingredients of Baclofen
Baclofen 10 mg/20 ml solution for infusion contains less than 1 mmol sodium (23 mg) per maximum
dose of 4 ml (corresponding to 2 mg baclofen).

Evidence demonstrating the efficacy of Baclofen was obtained in clinical trials using the
SynchroMed Infusion System. This is an implantable drug delivery system with
refillable reservoirs, which is implanted in a subcutaneous pocket usually on the
abdominal wall. The device is connected to an intrathecal catheter that passes
subcutaneously to the subarachnoid space. Reliable experience with other implantable
pump systems is so far not available.

This is necessary because of the great variability between patients in the therapeutic
dose that is effective. During long-term treatment baclofen can be delivered
continuously into the cerebral spinal fluid using an implantable pump and Baclofen
10 mg/20 ml or Baclofen 10 mg/5 ml.

Baclofen is intended for administration in single bolus test doses (via spinal catheter or
lumbar puncture) and, for chronic use, in implantable pumps suitable for continuous
administration of intrathecal baclofen into the intrathecal space (EU certified pumps).
Establishment of the optimum dose schedule requires that each patient undergoes an
initial screening phase with intrathecal bolus, followed by a very careful individual dose
titration prior to maintenance therapy. Intrathecal administration of baclofen through an
implanted delivery system should only be undertaken by physicians with the necessary
knowledge and experience. Specific instructions for implantation, programming and/or
refilling of the implantable pump are given by the pump manufacturers, and must be
strictly adhered to.

The screening, implantation and dose titration phases of the intrathecal treatment
are to be carried out in hospital with very careful monitoring by appropriately
qualified specialist doctors and in centres with specific experience. In view of
possible life-threatening events or severe adverse reactions appropriate
resuscitative equipment should be on stand-by. (see also section 3 “How to Use
Baclofen”).

How is Baclofen prepared and administered?

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

No specific studies have been carried out on interactions with other medicines.
Experience so far does not allow any predictions to be made about combination of Baclofen with other
medications.

If treatment with Baclofen is interrupted
It is very important that you, and those caring for you, are able to recognise signs of Baclofen withdrawal.
These may appear suddenly or slowly for example because the pump is not working properly due to
battery problems, catheter problems or alarm dysfunction.
The signs of withdrawal are:
- increased spasticity, too much muscle tone
- difficulty with muscle movements
- increase in heart rate or pulse
- itching, tingling. burning sensation or numbness (paraesthesia) in your hands or feet
- palpitations
- anxiety
- high body temperature
- low blood pressure
- altered mental conditions for example agitation, confusion, hallucinations, abnormal thinking and
behaviour, convulsions
If you have any of the above signs, tell your doctor straight away. These signs may be followed by more
serious side effects unless you are treated immediately.
If you use more Baclofen than you should
It is very important that you, and those caring for you, are able to recognise the signs of overdose. These
may appear suddenly or slowly for example because the pump is not working properly.
The signs of overdose are:
- muscle weakness (too little muscle tone)
- sleepiness
- dizziness or light-headedness
- excessive salivation (hypersalivation)
- nausea or vomiting

In general in patients with spasticity of spinal origin the dose can be increased to a
maintenance dose of 300-800 µg/day, patients with spasticity of cerebral origin
usually require lower doses (see below).

Using Baclofen with other medicines
Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including
medicines obtained without a prescription.

If your muscle spasticity is not improving or if you start having spasms again, either gradually or
suddenly, contact your doctor immediately.

After the first day of treatment the dose can be adjusted slowly on a daily basis to
achieve the desired clinical effect. In patients with spasticity of spinal origin the daily
dosage increment should not exceed 10–30 % of the last dose and in patients with
spasticity of cerebral origin this should be limited to 5–15 %. With programmable
pumps, the dose should be increased only once every 24 hours. For nonprogrammable pumps with a 76 cm catheter delivering 1 mL solution per day,
intervals of 48 hours are suggested for evaluation of response to the dose
increment. If the daily dose has been significantly increased and no clinical effect is
achieved, check for proper pump function and catheter patency.

Elderly patients
Several patients over the age of 65 years have been treated with Baclofen during the clinical trials without
specific problems. Experience with Baclofen tablets shows however that this patient group may be more
susceptible to side effects. Elderly patients should therefore be carefully monitored for the occurrence of
side effects.

It is extremely important that you keep your appointments with the doctor to refill the pump, otherwise
spasms may recur because you are not getting a high enough dose of Baclofen. Your muscle spasms
may worsen as a result.

The initial total daily dose of Baclofen is calculated as follows:
if efficacy of the test dose is maintained for more than 12 hours this is administered
as the initial daily dose. If the efficacy of the test dose is maintained for less than
12 hours the dose should be doubled and given as the initial daily dose. No dose
increase should be administered in the first 24 hours.

Children and adolescents
Baclofen intrathecal formulation is intended for children of 4 years and above.
Children should be of sufficient body mass to accommodate the implantable pump. There is very limited
clinical data in children under the age of six.

Baclofen can be administered only by qualified specialist doctors by direct injection or infusion in the back
(spinal cord), for which special medical equipment is needed. For this reason hospitalisation will be
necessary at the beginning of therapy.

Implantation phase/Dose titration phases (under hospital conditions)
After confirmation that Baclofen has been effective in the screening phase,
intrathecal infusion is established using the above-mentioned implantable infusion
pump. The onset of the antispastic effect of baclofen is 6–8 hours after continuous
infusion is initiated and the maximum effect is achieved within 24–48 hours.

For patients with spasticity due to head injury, it is recommended not to proceed to long-term Baclofen
therapy until the symptoms of spasticity are stable and can be reliably assessed.

Intrathecal use.

Baclofen 10 mg/20 ml, solution for infusion
Baclofen 10 mg/5 ml, solution for infusion

Take special care with Baclofen
- if you have abnormal flow of cerebral spinal fluid (liquor) as a result of obstructed passage,
- epilepsy or other cerebral seizures,
- bulbar paralytic symptoms or partial paralysis (pareses) of the respiratory muscles (neurological
syndromes caused by damage to the motor cranial nerves in the elongated spine),
- acute or chronic confusional states,
- psychotic disorders, schizophrenia or Parkinson's disease,
- history of abnormal autonomic nervous system reflexes,
- inadequate blood flow in the brain and difficulty breathing (cerebrovascular and respiratory
insufficiency),
- pre-existing overactivity of the bladder sphincter muscle,
- cardiac problems,
- impaired renal function,
- stomach and intestinal ulcers (peptic ulcers),
- severely impaired hepatic function.

It may take several days to find out the optimal dose for you. Once the optimum treatment is established,
your doctor must check your progress and functioning of the pump at regular intervals.

Each ampoule is for single use only. The solution it contains is stable, isotonic, pyrogen
and antioxidant free and has a pH-value of 5.0–7.0.

2. BEFORE YOU USE BACLOFEN
Do not use Baclofen
- if you are allergic (hypersensitive) to baclofen or any of the other ingredients of Baclofen.
- if you have epilepsy that is untreatable.

At a first stage the doctor will find out by single injections of Baclofen 0.05 mg/l ml if this improves your
muscular spasms. If this is the case a special pump will be implanted under your skin, which permits
continuous delivery of small quantities of Baclofen.

Before using Baclofen each solution should be tested to make sure it is clear and
colourless; if particulate matter of discolorations are present, the solution must not be
used and should be discarded.

For this purpose a special infusion pump is implanted under your skin which allows continuous delivery of
small quantities of Baclofen 10 mg/20 ml solution for infusion or Baclofen 10 mg/5 ml solution for
infusion into the spinal cord.

3. HOW TO USE BACLOFEN
Always use Baclofen exactly as your doctor has told you.

Before using Baclofen in patients with posttraumatic spasticity the subarachnoid space
should be investigated using myelography. If this reveals signs of an arachnoiditis,
treatment with Baclofen must not be initiated.

Your doctor has decided that you or your child needs this medicine to help treat your condition.
Baclofen is intended for adults and children of 4 years and above and is used to reduce and relieve the
excessive tension in your muscles (spasms) occurring in various illnesses such as cerebral palsy, multiple
sclerosis, spinal cord diseases, cerebrovascular accidents, and other nervous system disorders.

Baclofen

Pregnancy and breast-feeding
There is no experience on the use of Baclofen during pregnancy or while breast-feeding. Baclofen should
not be used during pregnancy or while breast-feeding unless the potential benefit to the mother outweighs
the potential risk to the child. Baclofen passes into breast milk. As so far there are no adequate studies
available the concentration cannot be predicted.
Driving and using machines
During treatment with Baclofen your ability to drive or operate machines may be considerably impaired.
Do not drive, operate machines or participate in any other hazardous activities.
In particular it should be noted that drinking alcohol at the same time further intensifies this decreased
alertness.

1. WHAT BACLOFEN IS AND WHAT IT IS USED FOR
Baclofen is a medicine to relieve severe muscle spasms (antispastic).

Baclofen 10 mg/20 ml solution for infusion

Using Baclofen with food and drink
Drinking alcohol while using Baclofen should be avoided as this may lead to an undesirable intensification
or unpredictable change in the effect of the medicine.

-

difficulty in breathing (respiratory depression), respiratory arrest (apnoea)
convulsions
clouding or loss of consciousness (coma)
abnormal low body temperature

If you have any signs of an overdose of Baclofen, tell your doctor straight away.

For a description of the signs of withdrawal, see “If treatment with Baclofen is interrupted”.

If you stop using Baclofen
If this medicine must be stopped, this may only be done by your doctor who will reduce the dose
gradually to avoid side effects. Suddenly stopping Baclofen can cause withdrawal symptoms which in
some cases have proven fatal.

For a description of the signs of overdose, see “If you receive more Baclofen than you should”.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Baclofen can cause side effects, although not everybody gets them. These occur more
often at the start of treatment during your hospital stay, but they may also occur later. Many of these side
effects are also known to be associated with the specific medical condition for which you are being
treated.
The following categories are used as the frequency convention for side effects:

Storage conditions
This medicinal product does not require any special storage conditions.
The product should be used immediately after opening the ampoule and dilution (in the pump).
Chemical and physical in-use stability has been demonstrated for 2 months at 37°C.

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated from the available data

The solution must be clear and colourless. If particulate matter or discoloration are present the solution
must not be used and should be discarded.
Any unrequired fraction must be destroyed.

Metabolism and nutrition disorders
Common:
Decreased appetite.
Uncommon:
Dehydration.
Psychiatric disorders
Common:
Depression, Confusional state, Disorientation, Agitataion, Anxiety.
Uncommon:
Suicidal thoughts and attempt, Paranoia, Hallucinations, Disturbed
mood.
Nervous system disorders
Very common:
Drowsiness
Common:
Respiratory depression, Convulsion, Lethargy, Slurred quiet speech,
Headache, Numbness with tingling of the buttocks and feet,
Sleeplessness, Sedation, Dizziness.
Convulsion and headache occur more frequently in patients with
cerebral spasticity.
Uncommon:
Ataxia, Hypothermia, Dysphagia, Loss of memory / forgetfulness,
Nystagmus.
Eye disorders
Common:
Accommodation disorders with vision blurred or double vision.
Cardiac disorders
Uncommon:
Bradycardia.
Vascular disorders
Common:
Orthostatic hypotension.
Uncommon:
Deep vein thrombosis, Hypertension, Reddening of the skin, Pallor.
Respiratory, thoracic and mediastinal disorders
Common:
Aspiration pneumonia, Dyspnoea, Bradypnoea.
Gastrointestinal disorders
Common:
Vomiting, Constipation, Diarrhoea/bowl incontinence, Nausea, Dry mouth,
Increased salivation.
Nausea and vomiting occur more frequently in patients with cerebral spasticity.
Uncommon:
Ileus, Reduced taste perception.
Skin and subcutaneous tissue disorders
Common:
Urticaria, Pruritus.
Uncommon:
Alopecia, Excessive sweating.
Musculoskeletal and connective tissue disorders
Very common:
Hypotonia.
Common:
Hypertonia, Muscular weakness.
Renal and urinary disorders
Common:
Urinary retention, Urinary incontinence.
Urinary retention occurs more frequently in patients with cerebral spasticity.
Reproductive system and breast disorders
Common:
Sexual dysfunction.
General disorders and administration site conditions
Common:
Oedema peripheral, Face oedema, Pain, Fever, Shivering.

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 to protect the environment.
6. FURTHER INFORMATION
What Baclofen contains
The active substance is: baclofen.
Baclofen 10 mg/20 ml solution for infusion:
1 ml solution for infusion contains 0.5 mg baclofen.
1 ampoule with 20 ml solution for infusion contains 10 mg baclofen.
- The other ingredients are: sodium chloride and water for injections.
What Baclofen looks like and contents of the pack
Solution for infusion.
Baclofen is a clear, colourless solution in a clear, colourless ampoule.
Baclofen 10 mg/20 ml, solution for infusion is available in packs containing 1 and 5 ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sun Pharmaceuticals Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany:
Baclofen SUN 10 mg/20 ml Infusionslösung
Spain:
Baclofen SUN 10 mg/20 ml Solución para perfusion
France:
Baclofène SUN 10 mg/20 ml Solution pour perfusion
IT:
Baclofene SUN 10 mg/20 ml Soluzione per infusione
UK:
Baclofen 10 mg/20 ml Solution for Infusion
This leaflet was last approved in 03/2011.

Maintenance phase
The lowest dose that controls the spasticity well without inducing intolerable side
effects should be used. As the therapeutic effect can diminish during the course of
treatment or the severity of the spasticity can change, an adjustment of the dose
usually has to be carried out in the case of long-term treatment and this is done in
hospital.

Here too the daily dose in patients with spasticity of spinal origin may be increased
by 10–30 %, in patients with spasticity of cerebral origin by 5–20 % (upper limit) by
adjusting the dosing rate of the pump or by changing the concentration of baclofen
in the reservoir. The daily dose may also be reduced by 10–20 % if side effects are
experienced.

A sudden requirement for substantial dose escalation in order to elicit an adequate
response suggests a pump malfunction or a catheter kink, rupture (tear) or
dislodgement of the catheter.

Maintenance dosage for long-term continuous intrathecal infusion of Baclofen in
patients with spasticity of spinal origin is usually 300 µg to 800 µg baclofen/day.
During dose titration in individual patients the lowest daily dose used has
been12 µg/day, the maximum daily dose 2003 µg/day (US studies). Experience
with dosages higher than 1000 µg/day are limited. In the first months of treatment
the dosage has to be reviewed and adjusted especially often.

In patients with spasticity of cerebral origin the maintenance dosage for long-term
continuous intrathecal infusion of Baclofen was 22–1400 µg baclofen/day. The
mean daily dose after an observation period of 1 year was given as 276 µg/day,
after 2 years as 307 µg/day. Children under 12 years of age usually require lower
dosages, the daily dose was 24–1199 µg/day with a mean value of 274 µg/day.

After a constant daily dose has been achieved and the patient has stabilised with
regard to the antispastic effect, and provided the pump allows it, the mode of
delivery may be adjusted to control the spasticity at different times of the day. For
example, patients who have increased spasm at night may require a 20 % increase
in their hourly infusion rate. Changes in flow rate should be programmed to start
two hours before the onset of the desired clinical effect

Regular clinical review in the treatment centre, at least at monthly intervals, remains
a necessity throughout to assess tolerability of Baclofen and for evidence of
infection. The operational function of the infusion system must be checked on a
regular basis. A local infection or malfunction of the catheter can lead to an
interruption in the intrathecal delivery of baclofen with life-threatening consequences
(see section 2: “Take special care with Baclofen”).

The specific concentration of baclofen that should be used to fill the pump depends
upon the total daily dose required as well as the delivery rate of the pump. If
baclofen concentrations other than 0.05 mg/ml, 0.5 mg/ml or 2 mg/ml are required
Baclofen must be diluted under aseptic conditions with sterile, preservative-free
sodium chloride solution for injections. Please consult the manufacturer's manual
for specific recommendations.

During long-term treatment approximately 5 % of patients may require increasing
doses because of loss of effect (»development of tolerance«). As reported in the
literature a baclofen-free interval of 10 to 14 days in which intrathecal preservativefree morphine sulphate is administered, can counteract the »tolerance«. After this
interval sensitivity to treatment with Baclofen may be restored. Treatments should
be resumed at the initial continuous infusion dose. This should be followed by a
titration phase to avoid overdose accidents. This should also be carried out under
hospital conditions.

Paediatric population

Maintenance Therapy
The clinical goal is to maintain as normal a muscle tone as possible, and to minimise
the frequency and severity of spasms without inducing intolerable side effects. The
lowest dose producing an adequate response should be used. The retention of some
spasticity is desirable to avoid a sensation of "paralysis" on the part of the patient. In
addition, a degree of muscle tone and occasional spasms may help support circulatory
function and possibly prevent the formation of deep vein thrombosis.
In children aged 4 to <18 years with spasticity of cerebral and spinal origin, the initial
maintenance dosage for long-term continuous infusion of Baclofen ranges from 25 to
200 mcg/day (median dose: 100 mcg/day). The total daily dose tends to increase over
the first year of therapy, therefore the maintenance dose needs to be adjusted based on
individual clinical response. There is limited experience with doses greater than 1,000
micrograms/day.

Incompatibilities

If required, Baclofen 10 mg/20 ml and 10 mg/5 ml solutions for infusion may be diluted
under aseptic conditions with sterile, preservative-free sodium chloride solution for
injection (0.9% w/v = 9 mg/ml) only.

044BP1634B

Do not use Baclofen after the expiry date which is stated on the ampoule and the folding box. The expiry
date refers to the last day of that month.

044BP1634B

Very common:
Common:
Uncommon:
Rare:
Very rare:
Not known:

5. HOW TO STORE BACLOFEN
Keep out of the reach and sight of children.

Expand view ⇕

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.

Hide
(web1)