Baclofen 10 mg/5 ml solution for infusion

Baclofen

The following information is intended for medical or healthcare professionals only: tfow is Baclofen prepared and administered?

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 “Howto Use Baclofen”).

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.

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.

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.

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.

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.

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.

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

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 24^18 hours.

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.

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.

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

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