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 Myonal®
Eperisone hydrochloride
COMPOSITION
Each white, sugar-coated tablet contains 50 mg of eperisone hydrochloride.
[PRODUCT DESCRIPTION]
INDICATIONS
• Improvement of myotonic conditions caused by the following diseases
:
Neck-shoulder-arm syndrome, scapulohumeral periarthritis and low back pain
• Spastic paralysis caused by the following diseases
:
Cerebrovascular disorders, spastic spinal paralysis, cervical spondylosis, sequelae of surgical trauma (including cerebrospinal tumor), sequelae of trauma (spinal injury and head injury), amyotrophic lateral sclerosis, infantile cerebral palsy, spinocerebellar degeneration, spinal vascular disorder, subacute myelo-optico neuropathy (SMON) and other encephalomyelopathies
DOSAGE AND ADMINISTRATION
The usual adult dosage for oral use is 3 tablets (150 mg of eperisone hydrochloride) daily in three divided doses after meals. The dosage may be adjusted depending on the patient's age and symptoms.
CONTRAINDICATIONS
(MYONAL is contraindicated in the following patients.)
Patients with a history of hypersensitivity to any ingredients of MYONAL.
PRECAUTIONS
1. Careful Administration (MYONAL should be administered with care in the following patients.)
(1) Patients with a history of drug hypersensitivity
(2) Patients with hepatic function disorder
[MYONAL may aggravate hepatic function.]
2. Important Precautions
Weakness, light-headedness, sleepiness or other symptoms may occur. In the event of such symptoms, the dosage should be reduced or treatment discontinued. Patients should be cautioned against engaging in potentially hazardous activities requiring alertness, such as operating machinery or driving a car.
[DRUG INTERACTIONS]
Precautions for coadministration (MYONAL should be administered with care when coadministered with the following drugs.)
[USE IN THE ELDERLY]
Since the elderly often have a physiological hypofunction, it is advisable to take measures, such as reduction in dosage under careful supervision.
[PREGNANCY AND LACTATION]
1. Use During Pregnancy MYONAL should only be used in pregnant women or women suspected of being pregnant, if the expected therapeutic benefits are evaluated to outweigh the possible risk of treatment.
[The safety of MYONAL in pregnant women has not been established.]
2. Use During Lactation
It is advisable to avoid the administration of MYONAL to nursing mothers. When MYONAL must be used, breast feeding should be discontinued during treatment. [It has been reported that MYONAL is excreted in breast milk in an animal study (in rats).]
[PEDIATRIC USE]
Safety in children has not been established (insufficient clinical experience).
[ADVERSE REACTIONS]
Adverse reactions were reported in 416 of 12,315 patients (3.38%).
(At the end of the reexamination period)
(1) Clinically significant
adverse reactions (incidence unknown)
1) Shock and anaphylactoid reactions
Since shock and anaphylactoid reactions may occur, patients should be carefully observed. In the event of symptoms such as redness, itching, urticaria, edema of the face or other parts and dyspnea etc., treatment should be discontinued and appropriate measures taken.
2) Oculo-muco-cutaneous syndrome (Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell syndrome)
Serious dermatopathy such as oculo-muco-cutaneous syndrome (Stevens-Johnson syndrome) or toxic epidermal necrolysis (Lyell syndrome) may occur. Patients should be carefully observed, treatment discontinued and appropriate measures taken, in the event of symptoms such as fever, erythema, blistering, itching, ocular congestion or stomatitis, etc.
(2) Other adverse reactions
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5%>
≥0.1% |
<0.1% |
Incidence unknown |
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Hepatic |
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Elevation of AST
(GOT), ALT(GPT)
and Al-P, etc. |
|
|
Renal |
|
Proteinuria and
Elevation of BUN etc.
|
|
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Hematologic |
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Anemia |
|
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Hypersensitivity |
Rash |
Pruritus |
erythema exudativum
multiforme |
|
Psychoneurologic |
Sleepiness, insomnia,
headache and numbness
in the extremities
|
Stiffness and tremor
in the extremities |
|
|
Gastrointestinal |
Nausea/vomiting,
anorexia, stomach discomfort,
abdominal pain, diarrhea,
constipation and thirst |
Stomatitis and tremor
in the extremities |
|
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Urinary |
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Urinary retention,
urinary incontinence and
feeling of residual urine |
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