Loading…
BACLOFEN is a brand name for Baclofen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Baclofen is indicated for the relief of spasticity of voluntary muscle resulting from such disorders as: multiple sclerosis, other spinal lesions, e.g. syringomyelia, motor neurone disease, transverse myelitis. Baclofen is also indicated in adults for the relief of spasticity of voluntary muscle arising from e.g.…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Baclofen is given orally in either tablet or liquid form. These two formulations are bioequivalent. The liquid may be particularly suitable for children or those adults who are unable to take tablets. Dosage titration can be more precisely managed with the liquid formulation.
g. bladder, central posture support. The lowest dose compatible with an optimal response is recommended. If no benefit is apparent within 6 to 8 weeks of achieving the maximum dosage, a decision should be taken whether to continue with Baclofen.
Treatment should always, (unless serious adverse effects occur), be gradually discontinued by successively reducing the dosage over a period of about 1-2 weeks. Discontinuation of the treatment should always be gradual by successively reducing the dosage over a period of approximately 1 to 2 weeks, except in overdose-related emergencies, or where serious adverse effects have occurred (see section
) which may impair the patient’s reaction. Patients experiencing these adverse reactions should be advised to refrain from driving or using machines. 2 posology and method of administration). 8 Undesirable effects Side-effects: Unwanted effects occur mainly at the start of treatment 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 Baclofen be ingested with food or a milk beverage.
Lowering of the convulsion threshold and convulsions may occur, particularly in epileptic patients. g. stroke) as well as in elderly patients, adverse reactions may assume a more serious form. Adverse reactions 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).
Nervous System Disorders:
Very common: Sedation, somnolence.
Common:
Respiratory depression, fatigue, confusional state, dizziness, headache, insomnia, euphoria mood, depression, muscular weakness, ataxia, tremor, hallucination, nightmare, myalgia, nystagmus, dry mouth.
Rare:
Paraesthesia, dysarthria, dysgeusia. Lowering of the convulsion threshold and convulsions may occur, particularly in epileptic patients.
Unknown:
). 5 ml (15 mg) daily, preferably in 2 to 4 divided doses. 5 ml (15 mg)/day increments at 3-day intervals until the requisite daily dosage has been attained. 4 Special warnings and precautions for use). The optimum dosage generally ranges from 15 to 40 ml (30 to 80 mg) daily.
Satisfactory control of symptoms is usually obtained with doses of up to 30 ml (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 50 ml (100mg) is not advised unless the patient is in hospital under careful medical supervision.
In such cases, 50 ml – 60 ml (100 mg-120 mg) may occasionally be necessary Small frequent dosage may prove better in some cases than larger spaced doses. Also some patients benefit from the use of Baclofen 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. Special populations Once the maximum recommended dose has been reached, if the therapeutic effect is not apparent within 6 weeks a decision whether to continue with baclofen should be taken.
Elderly Elderly patients may be more susceptible to side effects, particularly in the early stages of introducing Baclofen. 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. 3mg/kg a day), in 2-4 divided doses, (preferably in 4 divided doses). The dosage should be raised cautiously at about 1 to 2 week intervals, until it becomes sufficient for the child’s individual requirements.
75 and 2mg/kg body weight. e. approx. 5 ml (5mg) daily. Baclofen should be administered to end stage renal failure patients only if the expected benefit outweighs the potential risk. g. 9 Overdose).
Hypersensitivity to baclofen or to any of the excipients
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Baclofen in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Encephalopathy, Sleep, Apnoea syndrome* Eyes disorders: Common: Accommodation disorder, visual impairment.
Gastro-intestinal disorders:
Very common: Nausea.
Common:
Gastro-intestinal disorder, constipation, diarrhoea, retching, vomiting.
Rare:
Abdominal pain Cardiac Disorders: Common: Cardiac output decreased.
Not known:
Bradycardia Vascular disorders: Common: Hypotension Renal and urinary disorders: Common: Pollakiuria, enuresis, dysuria.
Rare:
Urinary retention Reproductive system and breast disorders: Rare: Erectile dysfunction Not known: Sexual dysfunction Hepatobiliary disorders: Rare: Hepatic function abnormal.
Immune system disorders:
Not known: Hypersensitivity Skin and subcutaneous tissue disorders: Common: Hyperhidrosis, skin rash. 4 special warnings and precautions for use).
Investigations Not known:
Blood glucose increased *Cases of central sleep apnoea syndrome have been observed with baclofen at high doses (≥ 100mg) in patients who are alcohol dependent. 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 (ie. by reducing the doses given during the day and possibly increasing the evening dose).
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Hepatic impairment:
No studies have been performed in patients with hepatic impairment receiving Baclofen therapy. 2 Clinical Pharmacology). However, Baclofen has the potential of elevating liver enzymes. 4 special warnings and precautions for use). Geriatric patients (aged 65 years or above) Since Unwanted effects are more likely to occur in elderly patients.
it is therefore recommended that a cautious dosage schedule be adopted and that the patient be kept under appropriate surveillance. Patients with spastic states of cerebral origin Since unwanted effects are more likely to occur in patients with spastic states of cerebral origin, it is recommended that a cautious dosage schedule be adopted in such cases and that the patient be kept under appropriate surveillance Method of administration Baclofen should be taken orally during meals with a little liquid.
Baclofen should be taken using the provided oral syringe. 4 Special warnings and precautions for use Psychiatric and nervous system disorders Porphyria, history of alcoholism, hypertension, Psychotic disorders, schizophrenia, depressive or manic disorders, confusional states or Parkinson’s disease may be exacerbated by treatment with Baclofen.
Patients suffering from these conditions should therefore be treated cautiously and kept under close surveillance. Suicide and suicide-related events have been reported in patients treated with baclofen. In most cases, the patients had additional risk factors associated with an increased risk of suicide including alcohol use disorder, depression and/or a history of previous suicide attempts.
Close supervision of patients with additional risk factors for suicide should accompany drug therapy. Patients (and caregivers of patients) should be alerted about the need to monitor for clinical worsening, suicidal behaviour or thoughts or unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Cases of misuse, abuse and dependence have been reported with baclofen. g. dose escalation, drug-seeking behaviour, development of tolerance. Epilepsy Baclofen should only be used with great caution in patients with a history of convulsions since exacerbation of such condition may occur and seizures have occasionally been reported in connection with the discontinuation of baclofen or with overdosage.
Adequate anticonvulsive therapy should be continued and the patient carefully monitored. Baclofen should be used with extreme care in patients already receiving antihypertensive therapy, (see Interactions). Others Baclofen should be used with caution in patients with a history of peptic ulcers […]