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Lioresal is also indicated in adults and children for the relief of spasticity of voluntary muscle arising from e.g. cerebrovascular accidents, cerebral palsy, meningitis, traumatic head injury.
Patient selection is important when initiating Lioresal 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 become stabilised.
Lioresal is indicated in patients 0 to <18 years for the symptomatic treatment of spasticity of cerebral origin, especially where due to infantile cerebral palsy, as well as following cerebrovascular accidents or in the presence of neoplastic or degenerative brain disease. Baclofen for sale online
Lioresal is also indicated for the symptomatic treatment of muscle spasms occurring in spinal cord diseases of infectious, degenerative, traumatic, neoplastic, or unknown origin such as multiple sclerosis, spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia or paraparesis, and compression of the spinal cord.
Treatment should be started with a dosage of 15 mg daily, preferably in divided doses. The following gradually increasing dosage regimen is suggested, but should be adjusted to suit individual patient requirements.
5mg three times a day for three days
10mg three times a day for three days
15mg three times a day for three days
20mg three times a day for three days
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Satisfactory control of symptoms is usually obtained with doses of up to 60mg daily, but a careful adjustment is often necessary to meet the requirements of each individual patient. The dose may be increased slowly if required, but a maximum daily dose of more than 100mg is not advised unless the patient is in hospital under careful medical supervision. Small frequent dosage may prove better in some cases than larger spaced doses. Also some patients benefit from the use of Lioresal only at night to counteract painful flexor spasm. Similarly a single dose given approximately 1 hour prior to performance of specific tasks such as washing, dressing, shaving, physiotherapy, will often improve mobility.
Elderly patients (aged 65 years or above):
Elderly patients may be more susceptible to side effects, particularly in the early stages of introducing Lioresal. Small doses should therefore be used at the start of treatment, the dose being titrated gradually against the response, under careful supervision. There is no evidence that the eventual average maximum dose differs from that in younger patients.
Paediatric population (0 to < 18 years):
Treatment should usually be started with a very low dose (corresponding to approximately 0.3 mg/kg a day), in 2-4 divided doses, preferably in 4 divided doses. The dosage should be cautiously raised at about 1 week intervals, until it becomes sufficient for the child’s individual requirements. The usual daily dosage for maintenance therapy ranges between 0.75 and 2mg/kg body weight. The total daily dose should not exceed a maximum of 40mg/day in children below 8 years of age. In children over 8 years of age, a maximum daily dosage of 60mg/day may be given.
Lioresal tablets are not suitable for use in children below 33 kg body weight.
Patients with impaired renal function:
In patients with impaired renal function or undergoing chronic haemodialysis, a particularly low dosage of Lioresal should be selected i.e. approx. 5mg daily.
Lioresal should be administered to end stage renal failure patients only if the expected benefit outweighs the potential risk. These patients should be closely monitored for prompt diagnosis of early signs and/or symptoms of toxicity (e.g. somnolence, lethargy) (see section 4.4 and section 4.9).
Patients with hepatic impairment:
No studies have been performed in patients with hepatic impairment receiving Lioresal therapy. The liver does not play a significant role in the metabolism of baclofen after oral administration of Lioresal (see section 5.2). However, Lioresal has the potential of elevating liver enzymes. Lioresal should be prescribed with caution in patients with hepatic impairment
Patients with spastic states of cerebral origin:
Unwanted effects are more likely to occur in these patients. It is therefore recommended that a cautious dosage schedule be adopted and that patients be kept under appropriate surveillance.
Method of administration
Lioresal should be taken during meals with a little liquid.
• Hypersensitivity to baclofen or to any of the excipients
• Peptic ulceration.
Psychiatric and nervous system disorders
Psychotic disorders, schizophrenia, depressive or manic disorders, confusional states or Parkinson’s disease may be exacerbated by treatment with Lioresal. Patients suffering from these conditions should therefore be treated cautiously and kept under close surveillance.
Lioresal may also exacerbate epileptic manifestations but can be employed provided appropriate supervision and adequate anticonvulsive therapy are maintained.
Lioresal should be used with extreme care in patients already receiving antihypertensive therapy, (see section 4.5).
Lioresal should be used with caution in patients suffering from cerebrovascular accidents or from respiratory or hepatic impairment.
Since unwanted effects are more likely to occur, a cautious dosage schedule should be adopted in elderly and patients with spasticity of cerebral origin (see section 4.2).
Drugs causing Central Nervous System (CNS) depression
Increased sedation may occur when Lioresal is taken concomitantly with other drugs causing CNS depression including other muscle relaxants (such as tizanidine), with synthetic opiates or with alcohol (see section 4.7).
The risk of respiratory depression is also increased. In addition, hypotension has been reported with concomitant use of morphine and intrathecal baclofen. Careful monitoring of respiratory and cardiovascular functions is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness.
During concomitant treatment with tricyclic antidepressants, the effect of Lioresal may be potentiated, resulting in pronounced muscular hypotonia.
Concomitant use of oral Lioresal and lithium resulted in aggravated hyperkinetic symptoms. Thus, caution should be exercised when Lioresal is used concomitantly with lithium.
Since concomitant treatment with Lioresal and anti-hypertensives is likely to increase the fall in blood pressure, the dosage of antihypertensive medication should be adjusted accordingly.
Agents reducing renal function
Drugs or medicinal products that can significantly affect renal function may reduce baclofen excretion leading to toxic effects (see section 4.4).
During pregnancy, especially in the first 3 months, Lioresal should only be employed if its use is of vital necessity. The benefits of the treatment for the mother must be carefully weighed against the possible risks for the child. Baclofen crosses the placental barrier.
Foetal/neonatal adverse reactions
Drug withdrawal reactions including postnatal convulsions in neonates have been reported after intra-uterine exposure to oral Lioresal (see section 4.4).
In mothers taking Lioresal at therapeutic doses, the active substance passes into the breast milk, but in quantities so small that no undesirable effects in the infant are to be expected.
Lioresal may be associated with adverse effects such as dizziness, sedation, somnolence and visual impairment (See section 4.8) which may impair the patient’s reaction. Patients experiencing these adverse reactions should be advised to refrain from driving or using machines.
Adverse effects occur mainly at the start of treatment (e.g. sedation, somnolence and nausea), if the dosage is raised too rapidly, if large doses are employed, or in elderly patients. They are often transitory and can be attenuated or eliminated by reducing the dosage; they are seldom severe enough to necessitate withdrawal of the medication.
Should nausea persist following a reduction in dosage, it is recommended that Lioresal be ingested with food or a milk beverage.
In patients with a history of psychiatric illness or with cerebrovascular disorders (e.g. stroke) as well as in elderly patients, adverse reactions may assume a more serious form. Buy Lioresal Baclofen 10mg
Lowering of the convulsion threshold and convulsions may occur, particularly in epileptic patients.
Certain patients have shown increased spasticity as a paradoxical reaction to the medication.
An undesirable degree of muscular hypotonia – making it more difficult for patients to walk or fend for themselves – may occur and can usually be relieved by re-adjusting the dosage (i.e. by reducing the doses given during the day and possibly increasing the evening dose).
Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000) very rare (< 1/10,000) and Not known (cannot be estimated from the available data).
Table 1 Tabulated summary of adverse drug reactions
|Nervous system disorders|
|Very common:||Sedation, somnolence|
|Common:||Respiratory depression, confusional state, dizziness, hallucination, depression, fatigue, insomnia, euphoric mood, muscular weakness, ataxia, tremor, nightmare, myalgia, headache, nystagmus, dry mouth|
|Rare:||Paraesthesia, dysarthria, dysgeusia|
|Unknown:||Sleep Apnoea syndrome*|
|Common:||Visual impairment, accommodation disorder|
|Common:||Cardiac output decreased|
|Common:||Gastrointestinal disorder, constipation, diarrhoea, retching, vomiting|
|Rare:||Abdominal pain Buy Lioresal Baclofen 10mg|
|Rare:||Hepatic function abnormal|
|Skin and subcutaneous tissue disorders|
|Renal and urinary disorders|
|Common:||Pollakiuria, enuresis, dysuria|
|Reproductive system and breast disorders|
|General disorders and administration site conditions|
|Not known||Drug withdrawal syndrome* (see section 4.4)|
|Not known:||Blood gluocse increased|
*Drug withdrawal syndrome including postnatal convulsions in neonates has also been reported after intra-uterine exposure to oral Lioresal.
* Cases of central sleep apnoea syndrome have been observed with baclofen at high doses (≥ 100 mg) in patients who are alcohol dependent. Buy Lioresal Baclofen 10mg
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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 Yellow Card Scheme (www.mhra.gov.uk/yellowcard). Baclofen for sale online
A deterioration in the condition may occur if various substances or drugs acting on the central nervous system (e.g. alcohol, diazepam, tricyclic antidepressants) have been taken at the same time.
Treatment: No specific antidote is known.
Supportive measures and symptomatic treatment should be given for complications such as hypotension, hypertension, convulsions, gastrointestinal disorders and respiratory or cardiovascular depression.
Since the drug is excreted chiefly via the kidneys, generous quantities of fluid should be given, possibly together with a diuretic. Haemodialysis (sometimes unscheduled) may be useful in severe poisoning associated with renal failure (see section 4.4).
Pharmacotherapeutic group: Antispastic with spinal site attack, ATC code: M03B X01
Lioresal is an antispastic agent acting at the spinal level. A gamma-aminobutyric acid (GABA) derivative, Lioresal is chemically unrelated to other antispastic agents.
Biotransformation: Baclofen is metabolised to only a minor extent. Deamination yields the main metabolite, β-(p-chlorophenyl)-4-hydroxybutyric acid, which is pharmacologically inactive.
Elimination/excretion: The plasma elimination half-life of baclofen averages 3 to 4 hours.
Baclofen is eliminated largely in unchanged form. Within 72 hours, approximately 75% of the dose is excreted via the kidneys with about 5% of this amount as metabolites.
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Elderly patients (aged 65 years or above)
The pharmacokinetics of baclofen in elderly patients are virtually the same as in patients below 65 years of age. Following a single oral dose, elderly patients have slower elimination but a similar systemic exposure of baclofen compared to adults below 65 years of age. Extrapolation of these results to multi-dose treatment suggests no significant pharmacokinetic difference between patients below 65 years of age and elderly patients.
5.3 Preclinical safety data
Baclofen increases the incidence of omphaloceles (ventral hernias) in the foetuses of rats given approximately 13 times the maximum oral dose (on a mg/kg basis) recommended for human use. This was not seen in mice or rabbits.
An apparently dose related increase in the incidence of ovarian cysts, and a less marked increase in enlarged and/or haemorrhagic adrenals have been observed in female rats treated for 2 years. The clinical relevance of these findings is not known.
Experimental evidence to date suggests that baclofen does not possess either carcinogenic or mutagenic properties. Baclofen for sale online
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Lioresal tablets should be protected from heat (store below 25°C) and moisture.
Tablets 10mg: circular, flat, white to faint yellowish tablets, uncoated, with bevelled edges, having the monogram CG on one side and the letters KJ and a break line on the other.
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