White circular shape tablet

1 tablet contains;
Baclofen----------------10mg

1. Multiple sclerosis, Stiffening of skeletal muscles caused by spinocerebellar degeneration
2. Stiffening caused by spindylopathy(inflammatory, external injury, newborn, unidentified, etc) (Ex: Spinal spastic paralysis, Amuotrophic lateral sclerosis, Syringomyelia, Transverse myelitis, Traumatic paraplegia, Metastatic spinal cord compression, other spinal diseases)
3. Stiffening caused by cerebrum: especially for the cases of cerebral palsy, cerebrovascular accident, newborn brain disease, degenerative brain disease.

Daily intake dosage should be 3 times a day, in case of child, 4 times a day.
Adult: Intake 5mg of Baclofen, 3 times a day. Increase by 5mg per intake, 3 times a day until the final dosage is determined

Precautions  baclofen

 

1.Do not take Baclofen tablets :

If you are allergic to baclofen or to any of the other ingredients of this medicine.

 

2. Before using this medicine:

1) psychotic disorders, schizophrenia, confusional states, or Parkinson's disease etc should be treated cautiously with this medication and kept under careful surveillance as exacerbations of these conditions have been observed with oral baclofen administration.

 2) Special attention should be given to patients known to suffer from epilepsy as seizures have been reported during overdose with, and withdrawal from, this medication, as well as in patients maintained on therapeutic doses of this medication.

 3) if you have or have ever had duodenal ulcers.

 4) acute renal failure patient.

 5) diseases of the cardiovascular system.

 6) cerebrovascular disorders.

 7) respiratory system diseases patient (skeletal muscle relaxants may cause respiratory depression).

 8) in patients with hepatic impairment.

 9) reduced kidney function patients (A particularly low dosage of baclofen should be used, i.e. 5 mg daily, in patients with impaired renal function or those undergoing haemodialysis.)

 10) Patients with neurogenic disturbances affecting emptying may show improvement. In patients with pre-existing sphincter hypertonia may experience acute urinary retention,  baclofen should be used with caution in such cases. 

11) children (especially in epileptic patients may occur convulsions.)

 

 

 

 

3. Side effects

Adverse effects occur mainly at the start of treatment (e.g. sedation, somnolence), if the dose is increased too rapidly, or if large doses are employed.

    

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.

 

 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.

 

Adverse reactions are ranked under heading of frequency, the most frequent first, using the following convention: very common (1/≥10); common (≥1/100, to < 1/10); uncommon (≥1/1,000, to <1/100); rare (≥1/10,000, to < 1/1,000); very rare (< 1/10,000).

 

 1) nervous system : The most common is sedation, drowsiness, common is dyspnea weak or shallow breathing, light-headedness, Malaise, tiredness, exhaustion , confusion, dizziness, headache, sleepiness, euphoria, depression, muscle weakness, incoordination, sedation, hallucinations, nightmares, muscle pain, nystagmus, Dry Mouth , and rarely paresthesia, dysarthria, Lowering of the convulsion threshold and convulsions may occur, particularly in epileptic patients.

 2) Special Senses : The common is abnormality of accommodation, Abnormal vision, and rarely strabismus, taste loss, tinnitus.

 3) Gastrointestinal : very common is nausea , The common is mild gastrointestinal disturbances, vomiting (retching), retching, anorexia, Gastro-intestinal disorder, abdominal distension, Dry Mouth, constipation, diarrhoea and rarely, generalized abdominal cramps, positive test for occult blood in stool.

 4) Cardiovascular: The common is low blood pressure , shallow heart beat, cardiovascular collapse, tachycardia , bradycardia, rarely, tachycardia, syncope, chest pain.

 5) Urogenital Svstem : The common is Urinary frequency, nocturia, Urination Impaired, rarely, urinary retention, erectile impotence, Hematuria.

 6) Abnormal liver: rarely, Disorders of hepatic functio, increased AST

 7) skin : The common is skin rash, excessive sweating.

 8) Other effects : there was a report that the spasticity had been increased by paradoxical reaction of this medicine .Side effects are noticed most particularly at the beginning of baclofen therapy. This medication might sometimes  cause oedema, Chest pain, sweating, dyspnea,  elevation of blood sugar, weight gain, nasal congestion etc.

 

4. GENERAL PRECAUTIONS 

1) Except in emergency cases associated with an overdose, treatment should be discontinued gradually with successive dose reductions(1-2weeks). This drug should not be abruptly discontinued. Sudden discontinuation of oral therapy is associated with confusion, hallucinations, confusional state, psychosis, Bipolar disorder, Epilepsy , Dyskinesia, tachycardia, hyperthermia etc, this medication can cause worsening muscle rigidity.

2) This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

 3) This drug may increase glucose levels, use with caution in diabeticsrarely, levels of AST, ALP, sugar in the blood. If you have liver disease or diabetics, should be monitored for any increases during therapy.

 

5. INTERACTIONS

 1) This medication such as alcohol, a narcotic (opioid) medication etc that depress the central nervous system may make some side effects of baclofen worse. also it could increased of  difficulty breathing events. if you have cardiopulmonary disease or respiratory muscle weakness affect breathing, should be monitored more closely than ever before.

 2) Tricyclic antidepressants can enhance the muscle relaxant effects of baclofen, resulting in profound muscle hypotonia so caution should be used if baclofen and tricyclic antidepressants are used concomitantly.

 3) With the simultaneous application of Baclofen increases the effects of antihypertensive drugs. Dosage adjustments of the antihypertensive medication may be required. have been reported in patients with low blood pressurehypotension who received morphine and baclofen into the spinal canal.

 4) Levodopa used to treat Parkinson's disease have been reported confusion , hallucinations, headach, nausea, indignation.

 

6.  Pregnancy and breast-feeding

 1) During administration of baclofen to animals during organogenesis at doses exceeding the maximum recommended human dose(approximately 13 times), there were increased incidences of omphaloceles (ventral hernias), Fetal structural abnormalities were not observed in mice or rabbits. 

2) The safety of baclofen has not been established during pregnancy. baclofen crosses the placenta. Baclofen should only be used during pregnancy when the potential benefit to the mother outweighs the potential risk to the fetus.

3) Baclofen can pass into the breast milk, but in quantities so small that no undesirable effects on the infant are to be expected. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation .

 

7. The elderly

 Elderly patients require lower initial doses and slow dose titration. Because it may occur muscle weakness, Malaise etc. Doses for seniors should generally be lower and increase more slowly than for other adults. Older adults may be more sensitive to the effects of this medicine.

 

8. OVERDOSE

 1) syndrome and reveal any unique signs : may include depression, drowsiness, Thinking Abnormal, coma, slowed breathing, confusional state, hallucinations, indignation, convulsion, coordination disorder, abnormality of accommodation, dilated or pinpoint pupils, muscular hypotonia, Myoclonus, convulsion, hyporeflexia or areflexia , peripheral vasodilation, hypotension, high blood pressure, Bradycardia, tachycardia, Hypothermia , nausea, vomiting, Diarrhea, increased salivation, elevated AST. The condition may be aggravated if various substances or drugs acting on the central nervous system (e.g. alcohol, diazepam, tricyclic antidepressants) were taken at the same time.

 

 2) Treatment:

             ①There is no specific antidote for treating overdoses of intrathecal baclofen.

            Elimination of the drug from the gastrointestinal tract (induction of vomiting, gastric lavage) administration of activated charcoal; if necessary, saline aperient; in respiratory depression, administration of artificial respiration, also measures in support of cardiovascular functions.

 ② Supportive measures and symptomatic treatment should be given for complications such as hypotension, hypertension, convulsions, gastrointestinal disturbances and respiratory or cardiovascular hypotension, hypertension, convulsions, gastrointestinal disturbances and respiratory or cardiovascular depression.

③ Activated charcoal is now being recommended for patients who have ingested potentially toxic amounts of a poison, Activated charcoal can help if baclofen was recently ingested. Gastric lavage may be considered if ingestion has occurred in ≤1 hour. Patients with respiratory depression should be intubated if necessary, until the drug is eliminated.(Coma or convulsion patients should be intubated prior to gastric lavage.)

 ④ Since the drug is excreted chiefly via the kidneys, generous quantities of fluid should be given, possibly together with a diuretic. Haemodialysis may be useful in severe poisoning associated with renal failure. 

⑤ In the event of convulsions, administer diazepam I.V. with caution.