Product Information
Prescription Medicines > Skeletal muscle relaxant
SAMSUNG Baclofen tab.
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.