Baclofen Tablets 10mg – Summary of Product Characteristics (SmPC)

This information is intended for use by health professionals

Each tablet contains baclofen 10 mg.

Excipient with known effect: Each tablet contains 40 mg lactose monohydrate

For the full list of excipients, see section 6.1.

Tablet.

A 7 mm flat bevelled edge tablet marked “BN” breakline “10” on one side and “G” on the reverse.

Baclofen is indicated for the relief of spasticity of voluntary muscle resulting from such disorders as multiple sclerosis, other spinal lesions e.g. 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 e.g. cerebrovascular accidents, cerebral palsy, meningitis, traumatic head injury.

Patient selection is 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 become stabilized.

Paediatric population

Baclofen 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 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.

Dosage

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. The lowest dose compatible with an optimal response is recommended.

Posology

Before starting treatment with baclofen it is prudent to realistically assess the overall extent of the clinical improvement that the patient may be expected to achieve. Careful titration of dosage is essential (particularly in the elderly) until the patient is stabilised. If too high a dose is initiated or if the dosage is increased too rapidly side effects may occur. This is particularly relevant if the patient is ambulant in order to minimise muscle weakness in the unaffected limbs or where spasticity is necessary for support.

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.

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 4. 4).

Adults:

Treatment should be started with a dosage of 15 mg daily, preferably in divided doses. The following gradually increasing dosage regime is suggested, but should be adjusted to suit individual patient requirements.

Satisfactory control of symptoms is usually obtained with doses up to 60 mg 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 100 mg 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 baclofen only at night to counteract painful flexor spasm. Similarly a single dose given approximately 1 hour prior to the performance of specific tasks such as washing, dressing, shaving, physiotherapy, will often improve mobility.

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 the 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.

Patients with renal impairment:

In patients with impaired renal function or undergoing chronic haemodialysis, a particularly low dosage of baclofen should be selected i. e. approximately 5 mg daily.

Baclofen 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 sections 4.4 and 4.9).

Patients with hepatic impairment:

No studies have been performed in patients with hepatic impairment receiving baclofen therapy. The liver does not play a significant role in the metabolism of baclofen after oral administration of baclofen (see section 5.2). However, baclofen has the potential of elevating liver enzymes. Baclofen 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.

Paediatric population

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 raised cautiously, 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 2 mg/kg body weight. The total daily dose should not exceed a maximum of 40 mg/day in children below 8 years of age. In children over 8 years of age, a maximum daily dose of 60 mg/day may be given.

Baclofen tablets are not suitable for use in children below 33 kg body weight.

Method of administration

Baclofen should be taken during meals with a little liquid.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Peptic ulceration.

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. Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of baclofen misuse, abuse or dependence e.g. dose escalation, drug-seeking behaviour, development of tolerance.

Epilepsy

Baclofen may also exacerbate epileptic manifestations but can be employed provided appropriate supervision and adequate anticonvulsive therapy are maintained.

Others

Baclofen should be used with extreme care in patients already receiving antihypertensive therapy (see section 4.5).

Baclofen 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).

Renal impairment

Signs of overdose have been observed in patients with renal impairment taking baclofen at doses of more than 5 mg per day. Baclofen should be used with caution in patients with renal insufficiency and should only be administered to patients with end-stage renal failure (CKD stage 5, GFR < 15 ml/min) only if the expected benefit outweighs the potential risk (see section 4. 2 Posology and method of administration). Neurological signs and symptoms of overdose including clinical manifestations of toxic encephalopathy (e.g. confusion, disorientation, somnolence and depressed level of consciousness) have been observed in patients with renal impairment taking oral baclofen at doses of more than 5mg per day. Patients with impaired renal function should be closely monitored for prompt diagnosis of early symptoms of toxicity.

Cases of baclofen toxicity have been reported in patients with acute renal failure (see section 4.9).

Particular caution is required when combining baclofen with drugs or medicinal products that can significantly affect renal function. Renal function should be closely monitored and baclofen daily dosage adjusted accordingly to prevent baclofen toxicity.

Besides discontinuing treatment, unscheduled haemodialysis might be considered as a treatment alternative in patients with severe baclofen toxicity. Haemodialysis effectively removes baclofen from the body, alleviates clinical symptoms of overdose and shortens the recovery time in these patients.

Urinary disorders

Under treatment with baclofen, neurogenic disturbances affecting emptying of the bladder may show an improvement. In patients with pre-existing sphincter hypertonia, acute retention of urine may occur; the drug should be used with caution in such patients.

Abrupt withdrawal

Treatment should always, (unless serious adverse effects occur), be gradually discontinued by successively reducing the dosage over a period of about 1-2 weeks. Anxiety and confusional state, delirium, hallucination, psychotic disorder, mania or paranoia, convulsion (status epilepticus), dyskinesia, tachycardia, hyperthermia, rhabdomyolysis and temporary aggravation of spasticity as a rebound phenomenon have been reported with abrupt withdrawal of baclofen, especially after long term medication.

Neonatal convulsions have been reported after intrauterine exposure to oral baclofen (see section 4.6).

Treatment should always (unless serious adverse effects occur) therefore be gradually discontinued by successively reducing the dosage over a period of about 1-2 weeks.

Laboratory tests

In rare instances, elevated aspartate aminotransferase, alkaline phosphatase and glucose levels in serum have been recorded. Appropriate laboratory tests should be performed in patients with liver diseases or diabetes mellitus in order to ensure that no drug induced changes in these underlying diseases have occurred.

Posture and balance

Baclofen should be used with caution when spasticity is needed to sustain upright posture and balance in locomotion (see section 4.2).

Paediatric patients

There is very limited clinical data on the use of baclofen in children under the age of one year. Use in this patient population should be based on the physician’s consideration of individual benefit and risk of therapy.

Excipients

Baclofen Tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Drugs causing Central Nervous System (CNS) depression

Increased sedation may occur when baclofen 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 muscles weakness.

Pre-treatment with baclofen may prolong the duration of fentanyl induced anaesthesia.

Lithium

Concomitant use of oral baclofen and lithium resulted in aggravated hyperkinetic symptoms. Thus, caution should be exercised when baclofen is used concomitantly with lithium.

Antidepressants

During concomitant treatment with tricyclic antidepressants, the effect of baclofen may be potentiated, resulting in pronounced muscular hypotonia.

Antihypertensives

Since concomitant treatment with baclofen and anti-hypertensives is likely to increase the fall in blood pressure, the dosage of anti-hypertensive 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).

Levodopa/dopa decarboxylase (DDC) inhibitor (Carbidopa)

In patients with Parkinson’s disease receiving treatment with baclofen and levodopa (alone or in combination with DDC inhibitor, carbidopa), there have been reports of mental confusion, hallucinations, nausea and agitation. Worsening of the symptoms of Parkinsonism has also been reported. Hence, caution should be exercised during concomitant administration of baclofen and levodopa/carbidopa.

Pregnancy

During pregnancy, especially in the first 3 months, baclofen 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 syndrome including postnatal convulsions in neonates has also been reported after intra-uterine exposure to oral baclofen (see section 4.4).

In mothers taking baclofen in therapeutic doses, the active substance passes into the breast milk, but in quantities so small that no undesirable effects on the infant are to be expected.

Baclofen 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 operating machinery.

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 baclofen be ingested with food or a milk beverage.

Lowering of the convulsion threshold and convulsions may occur, particularly in epileptic patients.

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.

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 the heading of frequency, the most frequent first, using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000) and Not known (frequency cannot be estimated from the available data).

Table 1 Tabulated summary of adverse drug reactions

*Drug withdrawal syndrome including postnatal convulsions in neonates has also been reported after intra-uterine exposure to oral baclofen.

* Cases of central sleep apnoea syndrome have been observed with baclofen at high doses (≥ 100 mg) in patients who are alcohol dependent.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Symptoms: Prominent features are signs of central nervous depression: somnolence, depressed level of consciousness, respiratory depression, coma. Also liable to occur are: confusion, hallucinations, agitation, accommodation disorder, impaired pupillary reflex, generalised muscular hypotonia, myoclonus, hyporeflexia or areflexia, convulsions, abnormal electroencephalogram (burst suppression pattern and triphasic waves), peripheral vasodilation, hypotension or hypertension, bradycardia, tachycardia or cardiac arrhythmia, hypothermia, nausea, vomiting, diarrhoea, salivary hypersecretion, increased hepatic enzymes, SGOT and AP values, rhabdomyolysis. Patients with renal impairment can develop signs of overdose even on low doses of oral baclofen (see sections 4.2 and 4.4).

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

Baclofen is an antispastic agent acting at the spinal level. A gamma-aminobutyric acid (GABA) derivative, chemically unrelated to other antispastic agents.

Baclofen depresses monosynaptic and polysynaptic reflex transmission, probably by stimulating the GABA_B-receptors. This stimulation in turn inhibits the release of the excitatory amino acids glutamate and aspartate. Neuromuscular transmission is unaffected by baclofen.

The major benefits of baclofen stem from its ability to reduce painful flexor spasms and spontaneous clonus thereby facilitating the mobility of the patient, increasing their independence and helping rehabilitation.

Baclofen also exerts an antinociceptive effect. General well being is often improved and sedation is less often a problem than with centrally acting drugs.

Baclofen stimulates gastric acid secretion.

Absorption

Baclofen is rapidly and completely absorbed from the gastrointestinal tract. Following oral administration of single doses (10-30 mg) peak plasma concentrations are recorded after 0.5 to 1.5 hours and areas under the serum concentration curves are proportional to the dose.

Distribution

The volume of distribution of baclofen is 0.7 l/kg. The protein binding rate is approximately 30% and is constant in the concentration range of 10 nanogram/ml to 300 microgram/ml. In cerebrospinal fluid active substance concentrations are approximately 8.5 times lower than in the plasma.

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

The plasma elimination half-life of baclofen averages 3 to 4 hours.

Baclofen is eliminated largely in unchanged form. Within 72 hours, about 75% of the dose is excreted via the kidneys with about 5% of this amount as metabolites.

Special populations

Elderly (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.

Paediatric patients

Following oral administration of 2.5 mg Baclofen tablet in children (aged 2 to12 years), Cmax of 62.8±28.7 nanogram/ml, and Tmax in the range of 0.95-2h have been reported. Mean plasma clearance (Cl) of 315.9 ml/h/kg; volume of distribution (Vd) of 2.58 l/kg; and half-life (T1⁄2) of 5.10 h have been reported.

Hepatic impairment

No pharmacokinetic data are available in patients with hepatic impairment after administration of baclofen. However, as the liver does not play a significant role in the disposition of baclofen, it is unlikely that baclofen pharmacokinetics would be altered to a clinically significant level in patients with hepatic impairment.

Renal impairment

No controlled clinical pharmacokinetic study is available in patients with renal impairment after administration of baclofen. Baclofen is predominantly eliminated unchanged in urine. Sparse plasma concentration data collected only in female patients under chronic hemodialysis or compensated renal failure indicate significantly decreased clearance and increased half-life of baclofen in these patients. Dosage adjustment of baclofen based on its systemic levels should be considered in renal impairment patients, and prompt hemodialysis is an effective means of reversing excess baclofen in systemic circulation

Baclofen increases the incidence of omphaloceles (ventral hernias) in the foetuses of rats given approximately 13 times the maximum oral dose (on 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.

The tablet contains:

– microcrystalline cellulose

– lactose monohydrate

– anhydrous calcium hydrogen phosphate

– colloidal anhydrous silica

– magnesium stearate

– sodium starch glycollate (type A)

Store in a dry place below 25°C in order to protect from light.

Baclofen Tablets are available either in polypropylene containers with polyethylene caps (with optional polyethylene ullage filler, or in PVDC aluminium foil blisters. The pack sizes available in both pack types are 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, 180 and for the polypropylene containers pack sizes of 50, 250 and 500 are also available.

Not all pack sizes may be marketed.

No special requirements for disposal.

Generics [UK] Ltd t/a Mylan

Station Close

Potters Bar

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EN6 1TL

Date of first authorisation: 10/10/1986

Date of latest renewal: 05/10/2005

Baclofen Interactions – Drugs.com Interactions Checker

A total of 347 drugs are known to interact with
baclofen
categorized as 25 major, 321 moderate, and 1 minor interactions.

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Baclofen alcohol/food interactions

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Medical Disclaimer

Apo-Baclofen – Uses, Side Effects, Interactions

How does this medication work? What will it do for me?

Baclofen belongs to two groups of medications known as muscle relaxants and antispastics. It is used to treat spasticity (uncontrolled muscle movements) caused by multiple sclerosis, spinal cord injuries, or spinal cord diseases. It is believed to work mainly by relaxing the muscles.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

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What form(s) does this medication come in?

10 mg
Each oval, white, scored tablet, imprinted with “APO B10”, contains 10 mg of baclofen. Nonmedicinal ingredients: lactose, magnesium stearate, microcrystalline cellulose, and starch.

20 mg
Each capsule-shaped, white, scored tablet, imprinted with “APO B20”, contains 20 mg of baclofen. Nonmedicinal ingredients: lactose, magnesium stearate, microcrystalline cellulose, and starch.

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How should I use this medication?

The recommended adult dose of baclofen varies according to need. It is usually started at doses of 5 mg taken 3 times a day for 3 days, followed by 10 mg taken 3 times a day for 3 days, increasing each dose by 5 mg every 3 days until the best dose is reached. The maximum recommended dose of baclofen is 20 mg 4 times daily.

This medication can be taken with or without food.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

This medication should not be stopped suddenly. If you believe it is necessary to stop taking this medication, contact your doctor to discuss the best way for you to stop the medication without causing problems.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you are allergic to baclofen or any ingredients of the medication

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abdominal or stomach pain or discomfort
• constipation
• decreased sexual ability
• diarrhea
• difficulty sleeping
• dizziness
• drowsiness
• dry mouth
• fatigue
• frequent urination
• headache
• increased perspiration
• low blood pressure (e.g., fainting, dizziness, lightheadedness, blurred vision, nausea)
• nausea
• tiredness
• trouble sleeping
• vomiting
• weakness

Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• breathing problems
• confusion
• difficulty speaking
• false sense of well-being
• hallucinations (seeing or hearing things that aren’t there)
• loss of coordination
• muscle pain
• nightmares or vivid dreams
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of heart problems (e.g., tiredness, swelling in the legs, shortness of breath)
• signs of urinary tract problems (e.g., decreased urine production, difficulty urinating, bloody or dark urine)
• skin rash or hives
• slow heartbeat
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• tingling or numbness of the hands or feet
• trembling
• uncontrolled eye movements
• vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Drowsiness/reduced alertness: Baclofen may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how this medication affects you.

Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. This occurs because baclofen is primarily removed from the body by the kidneys. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Medical conditions: Certain medical conditions may make it more likely for you to experience serious side effects. People with certain types of bladder problems, stomach ulcers, breathing problems, and seniors with cerebrovascular problems (disorder of the blood vessels supplying the brain) should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Mental health: Baclofen may cause symptoms of psychosis or schizophrenia to get worse for people who have mental health problems. If you experience symptoms such as hallucinations, mania (feeling unusually over-excited or uninhibited), or delusional thinking, or notice them in a family member who is taking this medication, contact your doctor as soon as possible.

Seizures: Baclofen may cause a loss of seizure control, causing seizures to occur more often. If you have a history of epilepsy or medical conditions that increase your risk of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Withdrawal effects: If baclofen is suddenly stopped after regular use, withdrawal symptoms may occur, including:

• anxiety with racing heart and sweating
• confusion
• hallucinations (seeing and hearing things that aren’t there)
• insomnia (difficulty sleeping)
• involuntary movements
• psychotic, manic, or paranoid states
• seizures
• worsening of spasticity (loss of control of muscles)

Except when serious side effects occur, the dose should be reduced slowly when stopping the medication (over a period of approximately 1 to 2 weeks).

Pregnancy: The safe use of baclofen during pregnancy has not been established. Baclofen crosses the placental barrier and may affect the developing baby. Babies born to women who have taken baclofen during pregnancy may experience withdrawal symptoms after birth. If you are or may become pregnant, speak to your doctor. This medication should be taken during pregnancy only when the potential benefits outweigh the possible risks.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking baclofen, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safe use of baclofen by children under the age of 12 years has not been established and is not recommended.

Seniors: People over the age of 65 are more likely to experience side effects of taking baclofen. Doses for seniors should generally be lower and increased more slowly than for other adults.

What other drugs could interact with this medication?

There may be an interaction between baclofen and any of the following:

• alcohol
• antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
• antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• antidiabetes medications (e.g., glyburide, insulin)
• azelastine
• barbiturates (e.g., butalbital, phenobarbital)
• benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
• brimonidine
• buspirone
• chloral hydrate
• dimenhydrinate
• efavirenz
• entacapone
• general anesthetics (medications used to put people to sleep for surgery)
• guanfacine
• magnesium sulfate
• medications used to treat high blood pressure
• mirtazapine
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
• other muscle relaxants (e.g., cyclobenzaprine, methocarbamol, orphenadrine)
• nabilone
• narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
• pramipexole
• ropinirole
• rotigotine
• scopolamine
• seizure medications (e.g., carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid)
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
• tapentadol
• thalidomide
• tramadol
• tricyclic antidepressants (e.g., amitriptyline, imipramine)
• zolpidem
• zopiclone

If you are taking any medications containing this drug, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription) and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or illegal drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Apo-Baclofen

Lioresal, Gablofen (baclofen) dosing, indications, interactions, adverse effects, and more.

Drug – Baclof (10 mg) 10mg – 10 Tablets Tablet   (Baclofen) Price List or Cost of Medication

Drug information on Baclof (10 mg) (Baclofen) from Intas Pharmaceutical Ltd.

Drug Name : Baclofen

Baclofen(Lioresal Intrathecal) generic Baclof (10 mg) is a derivative of gamma-aminobutyric acid (GABA), prescribed for severe chronic spasticity. It also relieves pain and improves muscle movement.

More Info about Baclofen

Other Trade Names for Baclofen

India : 

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International : 

Lioresal Intrathecal

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Medical Condition(s) for which Baclof (10 mg) may be prescribed

•   Most Common :

Drowsiness.

•   Central Nervous System :

Sedation, unsteadiness, dizziness, headache, confusion and hallucinations.

•   Gastrointestinal :

Stomach upset, nausea, constipation, dry mouth, loss of appetite, taste disorder, abdominal pain, vomiting and diarrhea.

•   Heart :
Low blood pressure, difficulty in breathing, palpitation, chest pain and fainting.

•   Genitourinary : Urinary frequency and bedwetting.

•   Miscellaneous : Rash, itching, ankle swelling, excessive perspiration, weight gain and nasal congestion.

The recommended dose is 5 mg three times a day for 3 days 10 mg three times a day for 3 days 15 mg three times a day for 3 days 20 mg three times a day for 3 days. It may be increased if needed.

It comes as a tablet to take by mouth, with food.

Contraindicated in patients with peptic ulcer and hypersensitivity.

• Caution should be exercised in patients with history of kidney disease, epilepsy, ulcers, stroke, rheumatic disease, cerebral palsy, Parkinson’s disease, psychiatric condition, any allergy, who are taking other medications, elderly, children, pregnancy and breastfeeding.

•


It may cause drowsiness, do not drive a car or operate machinery while taking this medication.

Avoid alcohol consumption.



Avoid excess dosage.

Store it at room temperature (25°C), and in an airtight container.

Baclofen for chronic muscle spasm (Lyflex, Lioresal)

About baclofen

Long-term (chronic) muscle stiffness can occur in multiple sclerosis and in conditions where there has been damage to nerves that supply muscles. In these conditions, the muscles shorten (contract) tightly, and can then become stiff and harder to use. This is called muscle spasticity.

Baclofen works by relaxing the muscles, which reduces pain and discomfort.

Before taking baclofen

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking baclofen it is important that your doctor or pharmacist knows:

• If you are pregnant, trying for a baby or breastfeeding.
• If you have ever had a stomach ulcer.
• If you have kidney or liver problems, or an ‘overactive’ bladder.
• If you have ever had a stroke, or if the blood vessels to your brain are narrowed by cerebrovascular disease.
• If you have high blood pressure (hypertension).
• If you have epilepsy, Parkinson’s disease or diabetes.
• If you have any mental health problems.
• If you have problems with your breathing.
• If you have ever had problems with drug or alcohol misuse.
• If you are taking or using any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
• If you have ever had an allergic reaction to a medicine.

How to take baclofen

• Before you start this treatment, read the manufacturer’s printed information leaflet from inside your pack. The leaflet will give you more information about baclofen and a full list of side-effects which you may experience from taking it.
• When starting this treatment, your doctor will give you a small dose (usually half a tablet three times daily) and then gradually increase your dose every three days or so. This allows your doctor to make sure that you have the dose that helps your condition and avoids any unwanted symptoms.
• Take the tablets exactly as your doctor tells you to. Your dose will be on the label of the pack to remind you.
• When baclofen is prescribed for a child, it is likely that a liquid medicine will be supplied. Check the directions on the label carefully, as the dose will depend upon their body weight.
• Take baclofen with a snack or just after eating a meal.
• Try to take your doses at the same times of day each day, as this will help you to remember to take them. If you do forget to take a dose, skip the missed dose but remember to take your next dose when it is due. Do not take two doses together to make up for a forgotten dose. 

Getting the most from your treatment

• Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress.
• Baclofen may cause drowsiness and eyesight problems. If this happens, do not drive and do not use tools or machines until you feel better.
• If your muscle spasms increase or if you have difficulty doing things because you feel your muscles have become weak, let your doctor know about this, as your dose may need adjusting.
• It is recommended that you do not drink alcohol while you are on baclofen. This is because it increases the chance that you will experience side-effects such as feeling sleepy or dizzy.
• Treatment with baclofen is usually long-term, so keep taking these tablets unless your doctor tells you otherwise. Suddenly stopping treatment can cause problems, so your doctor is likely to want you to reduce your dose gradually if this is necessary.
• If you are having an operation or dental treatment, tell the person carrying out the treatment which medicines you are taking.
• If you buy any medicines, check with a pharmacist that they are safe to take with your other medicines.

Can baclofen cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with baclofen. You will find a full list in the manufacturer’s information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

If you experience any other symptoms which you think may be due to this medicine, speak with your doctor or pharmacist.

How to store baclofen

• Keep all medicines out of the reach and sight of children.
• Store in a cool, dry place, away from direct heat and light.

Important information about all medicines

Baclofen Tablets Muscle Relaxation, Packaging Size: 100 Pills Per Box, Rs 1000 /box

Baclofen, sold under the brand name Lioresal among others, is a medication used to treat muscle spasticity such as from a spinal cord injury or multiple sclerosis. It may also be used for hiccups and muscle spasms near the end of life. It is taken by mouth or by delivery into the spinal canal.

Liofen 10 Tablet is a muscle relaxer. It is used to treat muscle symptoms such as rigidity, tension, and stiffness that may occur due to various conditions such as cerebral palsy, multiple sclerosis, motor neuron disease, or injury to the head, brain or spine.

Liofen 10 Tablet can be taken with food. In general, you should try to use the smallest amount necessary to control your symptoms, for the shortest possible time. You should take this medicine regularly while you need it. Try not to miss doses as this will make the medicine less effective.

Some common side effects of this medicine include fatigue, weakness, drowsiness, and dizziness. If any of these side effects do not go away or get worse, you should let your doctor know. Your doctor may be able to suggest ways of preventing or reducing the symptoms.

To make sure it is safe for you, before taking this medicine, let your doctor know if you have any medical conditions or disorders. You should also tell your doctor all the other medicines you are using or taking. Pregnant and breastfeeding women should consult their doctors before using this medicine.USES OF LIOFEN TABLET

BENEFITS OF LIOFEN TABLETIn Muscle relaxationLiofen 10 Tablet is a muscle relaxant that is used to relieve rigidity, inflammation, and swelling in conditions that affects skeletal muscles. It works by blocking chemical messengers in the brain that are responsible for such symptoms. It effectively relieves muscle stiffness or spasm, thereby improving muscle movement.

Take it as it is prescribed to get the most benefit. Do not take more or for longer than needed as that can be dangerous. In general, you should take the lowest dose that works, for the shortest possible time. This will help you to go about your daily activities more easily and have a better, more active, quality of life.SIDE EFFECTS OF LIOFEN TABLETMost side effects do not require any medical attention and disappear as your body adjusts to the medicine. Consult your doctor if they persist or if you’re worried about themCommon side effects of Liofen

• Fatigue
• Weakness
• Drowsiness
• Dizziness

HOW TO USE LIOFEN TABLETTake this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Liofen 10 Tablet is to be taken with food.HOW LIOFEN TABLET WORKSLiofen 10 Tablet is a muscle relaxant. It works on the brain and spinal cord to relieve muscle stiffness or spasm maintaining the strength of the muscles. This relieves pain and improves movement of muscles.
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Additional Information

indications and contraindications, composition and dosage – Pharmacy Mos

Baclofen tablets – instructions for use and price

Introduction to instructions for use

Baclofen is an antispasmodic myotropic cholinomimetic drug. Its mechanism of action is based on stimulation of GABA group receptors, a decrease in the sensitivity of afferent fibers and inhibition of spinal reflexes.The result of this is the relief of pain sensitivity and a decrease in muscle tone. The indication for use is the clinic of spastic conditions of various origins associated with impaired conduction of the spinal cord in a patient. It is also prescribed for the relief of withdrawal symptoms in alcohol and drug addiction.

1. Pharmacological action

Drug group:

Centrally acting muscle relaxant.

Healing effects:

• Muscle relaxant.

Features:

• The drug does not affect the transmission of impulses in the neuromuscular synapses;
• Baclofen is able to cross the blood-brain barrier and into breast milk.

Binding to plasma blood proteins:

about 30%.

Excretion: kidneys.

2.Indications for use

The drug is used to eliminate increased skeletal muscle tone in:

• Cerebral circulation disorders, meningitis or cerebral palsy;
• Multiple sclerosis, traumatic brain injury or spinal cord injury.

3. Application method

Recommended dosage of Baclofen:

Application features:

• The drug should be taken with meals, drinking plenty of liquid;
• According to the instructions, the drug should be canceled within 1-2 weeks;
• The dosage and duration of use of Baclofen is individual and determined by a specialist.

4.Side effects

• Urinary system:

  various urinary disorders. including enuresis;

• Nervous system:

  drowsiness, weakness, fatigue, insomnia or nightmares, trembling of hands and feet, euphoria or depression, ataxia, hallucinations, dizziness, confusion. gait disturbance, depression;

• Digestive system:

  stool disorders, nausea, abdominal pain, liver dysfunction, dysgeusia, vomiting;

• Cardiovascular system:

  lowering blood pressure, lowering cardiac output;

• Reproductive system:

  impotence;

• Metabolic processes:

  increased sweating and decreased body temperature;

• Sensory organs:

  nystagmus, decreased visual acuity, impaired accommodation;

• Hypersensitivity reactions to Baclofen:

  skin rash, urticaria.

5. Contraindications

Use with caution:

6. During pregnancy and lactation

Pregnant women and nursing mothers are strictly contraindicated to use the drug.

7. Interaction with other medicinal products

Simultaneous use of the Drug with:

8. Overdose

Symptoms:

Specific Antidote: Does not exist.

Treatment of overdose with Baclofen:

• Drinking plenty of fluids and taking diuretics;
• Symptomatic treatment.

Hemodialysis: in rare cases.

9. Form of issue

Tablets, 10 mg or 25 mg – 50 pcs.

10. Storage conditions

• Lack of heat sources and access to children.

The recommended storage temperature for Baclofen

is between 15 and 25 degrees.

Recommended shelf life

– within 3 years.

11. Composition

1 tablet:

• baclofen – 10 mg;
• Excipients: lactose; potato starch; gelatin; talc; magnesium stearate; ethyl cellulose.

12. Conditions of dispensing from pharmacies

The drug is dispensed by prescription of the attending physician.

– Found a mistake? Select it and press Ctrl + Enter

* Instructions for medical use for Baclofen are published in free translation. THERE ARE CONTRAINDICATIONS. BEFORE USING IT IS NECESSARY TO CONSULT A SPECIALIST

Baklosan overdose: consequences and death

Practitioner.Graduated in 2012 with honors from Vitebsk State Medical University with a degree in General Medicine. She was awarded an honorary diploma for her achievements in work.

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An overdose of Baklosan is noted as a result of neglect of medical recommendations, independent “prescription” of the drug, use as a light drug. In case of severe intoxication, resuscitation of the patient is necessary, sometimes a lethal outcome is also stated.

Code according to ICD T36-T50.

Characteristic features of Baklosan

The drug belongs to muscle relaxants. The action is due to the elimination of muscle spasms. It is used to reduce the sensitivity of sensory fibers, but there is no negative effect on the transmission of impulses.

Often recommended for the treatment of pathologies of the musculoskeletal system, as it helps to improve the functionality of the joints, provides an analgesic effect. Indications for use also become:

1. Complications after a stroke.
2. Cerebral palsy.
3. Multiple sclerosis.
4. Spinal problems provoked by injuries, infections, oncology.
5. Inflammation of the lining of the brain.

The maximum concentration is observed 2.5 hours after taking Baklosan. In case of an overdose, uncontrolled chemical reactions between the ingredients of the drug, blood proteins and liver cells are characteristic, which leads to poisoning.

Mechanism of development of addiction

Previously, the drug was widely used for the treatment and prevention of epilepsy.But subsequently, the use of drugs as a seizure warning was abandoned. The reason is trivial – the drug affects the central nervous system, provoking the development of a habit.

Due to its psychotropic properties, Baklosan (Baclofen) relieves anxiety, improves mood, and causes euphoria. After taking the pills, the activity increases, the need for rest for several hours disappears. At the same time, the ability to self-esteem is lost, and a thirst for creativity is manifested.Depression develops as drug exposure decreases.

Prolonged use leads to overdose as well as psychological dependence. Often, at the end of the therapeutic course, patients take Baklosan as a light drug.

In some European countries, the drug was recommended for the treatment of alcoholism and drug addiction. As a result of such therapy, people continued to use the medicine after leaving the clinic, combining the intake with alcoholic beverages or heavy drugs.

Contraindications and side effects

Poisoning with Baklosan is likely if the instructions are ignored or the dosage is increased. There are several factors in which drug therapy is prohibited:

1. Mental disorders caused by the breakdown of the thinking process, a decrease in the emotional response.
2. Convulsive state.
3. Atherosclerosis.
4. Parkinson’s disease.
5. Pathology of the urinary organs.
6. Poor functionality of the respiratory system.
7. Ulcerative formations of the stomach and duodenum 12.
8. Problems of the gallbladder and liver.
9. Individual hypersensitivity.

Baclosan is contraindicated in pregnancy – prescribed with caution when there is a high risk to a woman’s life.

The therapy is sometimes accompanied by side effects:

1. Blood pressure drops.
2. The activity of the heart muscle and the vascular system deteriorates.
3. Intestinal motility is impaired.
4. Symptoms such as nausea, vomiting, flatulence, sour belching.
5. Appetite disappears, as a result the patient often loses weight.
6. Visual and auditory hallucinations are likely.
7. There is increased anxiety.
8. Emotionality is unstable.
9. Apathy is present.
10. Headaches develop.
11. Eyeballs twitch and the image becomes blurry.

Overdose may be accompanied by an allergic reaction with skin redness, swelling, rash. Numbness of parts of the body is possible. Ejaculation is impaired, erection problems occur, urine leaks.

The duration of Baklosan therapy does not exceed 5–7 days – this measure prevents the development of addiction.

Overdose symptoms

The clinical picture is characterized by the following symptoms:

1. Confusion of consciousness – the patient is not able to adequately assess what is happening.
2. Confused speech.
3. Poor orientation in both time and space.
4. Inability to concentrate.
5. Quick mood swings – from aggressiveness to euphoria.
6. Absence of muscle reflexes – the person cannot stand, falls.
7. Vertigo leading to fainting.
8. Skin pallor, fever.
9. Cold sweat comes out profusely.
10. Heart rate increases.
11. Decreases blood pressure, often up to 60 mm Hg.Art.

As a result of an overdose, oxygen starvation develops, which leads to edema of vascular tissues. The following symptoms appear:

• Shortness of breath is characteristic.
• When trying to inhale, a cough occurs.
• The condition becomes panic.
• The person loses consciousness.

The result is a coma that can last for several days. The clinical picture manifests itself depending on the stage:

1. The first is characterized by an inhibited state, inability to swallow.
2. In the second, the bladder and intestines empty spontaneously. The sensitivity of the skin is lost, the victim falls into a state of deep sleep.
3. On the third, body temperature and blood pressure decrease, breathing is rare. There is no reaction to light and pain.

If you do not provide qualified assistance, death occurs as a result of edema of the parenchyma of the lungs and brain tissue.

Lethal dose

The exact amount of Baklosan leading to poisoning has not been clarified.Depends on the individual condition of the person – the presence of chronic diseases, the duration of addiction, age. For example:

1. A few extra pills provoke a sharp increase in the concentration of hormones, which is dangerous in the presence of endocrine pathologies.
2. A minor overdose causes bleeding with gastric or duodenal ulcers. Perforation in this case can be fatal.

The maximum allowable amount of Baklosan per day for an adult is 100 mg.For a child, 20-30 mg, for a teenager, a single dose of 2.5 mg / kg, no more than 75 mg per day.

First aid

If baclosan poisoning occurs, call the ambulance. Before the arrival of doctors, the following procedures are recommended:

1. The person is laid on one side so as not to choke on vomit.
2. When the victim is conscious, wash the stomach with a warm solution of potassium permanganate.
3. Provides a plentiful drink – preferably sweet, strong tea.Tannins and tannins, which have an astringent effect, help remove toxic compounds.

Further therapy is carried out in the inpatient department.

Antidote

No specific antidote exists. Therefore, sorbents are used, for example, Activated carbon.

Methods of treatment

Therapy involves the following procedures:

1. Overdose leads to a decrease in heart rate, a drop in blood pressure.To normalize the condition, glucocorticoids or Adrenaline are used.
2. Respiratory failure is highly likely. Eliminate with artificial ventilation.
3. To cleanse the body of Baklosan, a solution of sodium chloride or Ringer is injected drip with the addition of diuretics.
4. Supports blood circulation.

If first aid is provided in a timely manner and the patient is taken to the hospital with the initial symptoms of an overdose, the prognosis in most cases is favorable.

Potential consequences

Exceeding the recommended amount of the drug leads to the development of such conditions of an irreversible nature:

1. Loss of feeling the reality of what is happening.
2. Manic-depressive syndrome.
3. Sociopathy.
4. Suicidal mood.

In addition to mental disorders, there are disorders of the gastrointestinal tract, cardiovascular system, and respiratory organs. If the pathology is not treated, chronic complications are likely.

Prophylaxis

When Baklosan therapy is needed, simple rules should be followed:

1. Do not prescribe the drug on your own.