Baclofen Tablets BP 10mg

Spasmolen 10mg

Each tablet contains baclofen BP 10mg.

Tablets.

Baclofen is indicated for the relief of spasticity of voluntary muscle resulting from such disorders as: multiple sclerosis, other spinal lesions eg: tumours of the spinal cord, syringomyelia, motor neurone disease, transverse myelitis, traumatic partial section of the cord.

Baclofen is also indicated in adults and children for the relief of spasticity of voluntary muscle arising from eg: cerebrovascular accidents, cerebral palsy, meningitis, traumatic head injury.

Patient selection is most important when initiating baclofen therapy; it is likely to be of most benefit in patients whose spasticity constitutes a handicap to activities and/or physiotherapy. Treatment should not be commenced until the spastic state has been stabilised.

Oral administration.

The possible extent of clinical improvement to the patient should be assessed prior to the initiation of baclofen therapy. Titrated doses should be carefully administered in gradually increasing quantities until the patient's condition is stable (this is particularly important in elderly patients). If the dosage is too high or has been increased too quickly, side effects may ensue, especially in patients who are mobile to minimise muscle weakness in unaffected limbs or where some degree of spasticity is required.

Adults:

The following slowly increasing dosage regimen is suggested, but may be adjusted to suit the patient.

5mg 3 times a day for 3 days.

10mg 3 times a day for 3 days.

15mg 3 times a day for 3 days.

20mg 3 times a day for 3 days.

Doses up to 60mg a day usually provide satisfactory control of symptoms, though careful adjustment according to the requirements of each patient is frequently necessary. Small, more frequent doses of baclofen may prove better in some cases than larger, less frequent doses. If required, the dose may be increased slowly. A maximum daily dose of more than 100mg is not recommended, unless the patient is hospitalised and under close supervision. Once this maximum recommended dose is reached, if the therapeutic effects are not evident in 6 weeks, it may not be of benefit for the patient to continue on baclofen therapy.

Some patients may benefit from the use of baclofen just at night to oppose painful flexor spasm. Also, a single dose about an hour before carrying out tasks like dressing, washing, shaving and physiotherapy will often augment a patient's motility.

Elderly:

The elderly may be more susceptible to side effects, especially when first introducing baclofen. Initially, small doses are advised, with gradual adjustment under careful supervision. The eventual average maximum dose is as for adults, but caution should be exercised especially in patients with impaired renal function (see below).

Children:

Dosages in the range of 0.75 to 2mg/kg body weight should be used. In children over 10 years of age, a maximum daily dosage of 2.5mg/kg body weight may be given. Treatment usually commences with 2.5mg 4 times a day. Dosage should be cautiously raised at approximately 3 day intervals until the child's individual requirements are met.

Maintenance therapy:

Patients with Impaired Renal Function:

A low dosage of baclofen should be given, ie approximately 5mg a day, in patients with impaired renal function or who are undergoing chronic haemodialysis.

Patients with Spastic States of Cerebral Origin:

A very cautious dosage schedule should be adopted and patients should be carefully monitored as unwanted effects are more likely to occur in these patients.

Peptic ulceration and hypersensitivity to baclofen.

Psychotic disorders, confusional states, schizophrenia, depressive or manic disorders or Parkinson's disease may be worsened by treatment with baclofen. Therefore, patients with these conditions should be kept under close observation and treatment should be administered cautiously.

Epileptic manifestations may be exacerbated with baclofen treatment, but may be used if appropriate supervision and anticonvulsive therapy are maintained.

Baclofen should be used with extreme care in patients already receiving antihypertensive therapy.

Caution should be exercised with baclofen therapy in patients suffering from renal, hepatic or respiratory impairment or who have had a cerebrovascular accident.

Patients with neurogenic disturbances affecting emptying of the bladder may show improvement in their condition whilst taking baclofen. However, patients with pre-existing sphincter hypertonia may suffer with acute urine retention during treatment with baclofen; as a result it should be used cautiously in these patients.

Appropriate laboratory tests should be carried out on patients with hepatic dysfunction or diabetes mellitus to make sure that no drug-induced changes to the underlying diseases have resulted with concomitant baclofen therapy as, rarely, elevated SGOT, alkaline phosphatase and glucose levels in serum have been recorded.

Baclofen therapy should always be gradually discontinued, unless serious adverse effects have occurred, by reducing the dose over a period of 1-2 weeks. Anxiety, confusion, hallucinations, psychosis, mania, paranoia, convulsions, tachycardia, and, as a rebound phenomenon, temporary aggravation of spasticity, have all been reported on abrupt withdrawal.

There have been reports of hallucinations, agitation and mental confusion with the use of baclofen with levodopa and carbidopa in Parkinson's disease.

Use of tricyclic antidepressants and baclofen may result in the potentiation of the effect of baclofen, resulting in pronounced muscular hypotonia.

Baclofen excretion may be reduced by drugs which produce renal insufficiency, eg ibuprofen, resulting in toxic effects.

Concomitant use of drugs acting on the CNS or alcohol with baclofen may lead to increased sedation.

The risk of respiratory depression is also increased. Careful monitoring of respiratory and cardiovascular functions is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness.

Fentanyl induced analgesia may be extended by pretreatment with baclofen.

Hyperkinetic symptoms in patients receiving lithium may be exacerbated by baclofen.

Antihypertensive therapy may require adjustment as an increased fall in blood pressure may result with concomitant treatment with baclofen.

Not recommended in pregnancy as fetal malformations have been reported as having occurred in rats but not mice or rabbits. Where treatment is necessary, the benefits for the mother should be carefully considered against the possible risks to the child, particularly in the first trimester when baclofen should only be used if essential. Baclofen is not recommended whilst breast-feeding as it is known to be present in the milk.

Patients taking baclofen should not take charge of vehicles, other means of transport, or machinery where loss of attention may lead to accidents.

Undesirable effects occur predominately with initial treatment, with large doses, if the dose is increased too quickly or in the treatment of the elderly. These effects rarely necessitate withdrawal of the medication and are frequently of short duration. Modifying the dosage may lessen or eliminate the effects.

It may be difficult to distinguish between drug-induced undesirable effects and those caused by the diseases being treated.

Gastro-intestinal Tract: Mild gastro-intestinal disturbances such as constipation or diarrhoea may occasionally occur. Dry mouth, nausea and vomiting have also been reported. Should nausea continue despite reduced dosage, baclofen should be taken with food or a milk drink.

Genito-urinary Tract: Increased frequency of micturition, dysuria and enuresis have rarely been reported.

Cardio-respiratory System: Hypotension and cardiovascular or respiratory depression have been reported occasionally.

Central Nervous System: Especially at the beginning of treatment, effects including drowsiness and daytime sedation may occur with occasional reports of lassitude, exhaustion, light-headedness, confusion, dizziness, headache and insomnia.

A lower convulsion threshold and seizures may occur, particularly in patients with epilepsy.

Other neurological effects which have been reported include paraesthesiase, muscle weakness, myalgia, ataxia, tremor, nystagmus and accommodation disorders. Reported psychiatric effects include euphoria, hallucinations, nightmares and depressive states.

Other Unwanted Effects: There have been very rare reports of skin rash, hyperhidrosis, visual disturbance, changes in taste sensation and a deterioration in liver function tests.

Increased spasticity as a contradictory response to the medication has been reported in some patients.

Some patients may experience greater difficulty in walking or coping for themselves as a result of excessive hypotonia. This may be alleviated by altering the dosage schedule.

There have been rare reports of hypothermia.

Symptoms: Primarily, these are signs of central nervous depression: including drowsiness, consciousness impairment, respiratory depression, coma. Also likely are confusion, agitation, hallucinations, eye accommodation disorders, absent pupillary reflex, generalised muscular hypotonia, myoclonia, hyporeflexia or areflexia, convulsions, peripheral vasodilatation, hypotension, bradycardia, nausea, vomiting, diarrhoea, hypersalivation and elevated LDH, SGOT and AP values.

Deterioration in the condition may occur if various substances/drugs acting on the CNS, eg alcohol, tricyclic antidepressants or diazepam, have been taken at the same time.

Treatment: No specific antidote is known.

Removal of the drug from the gastro-intestinal tract should be attempted by inducing vomiting or gastric lavage. Comatose patients need to be intubated prior to gastric lavage. Activated charcoal or, if necessary, a saline aperient may be given. In respiratory depression, artificial respiration and measures to support cardiovascular functions should be applied. Large quantities of fluid should be given, possibly with a diuretic, since baclofen is excreted mainly through the kidneys. If convulsions occur, intravenous diazepam should be administered.

Baclofen is an analogue of aminobutyric acid. Its mode of action is not fully understood. It inhibits monosynaptic and polysynaptic transmission at the spinal level and also depresses the CNS.

The following mean values were obtained for Baclofen Tablets 10mg in healthy volunteers.

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Lactose, potato starch, microcrystalline cellulose, sodium starch glycollate and magnesium stearate.

Not known.

3 years.

Store in a cool dry place and protect from light.

Securitainer with polyethylene closure.

Pack sizes: 28, 84, 90 and 100.

Not applicable.

Sandoz Limited

Woolmer Way

Bordon

Hampshire

GU35 9QE

PL 04416/0160

27 September 1990 / 19 December 2000

27/02/2009