Nazione: Singapore
Lingua: inglese
Fonte: HSA (Health Sciences Authority)
EPERISONE HCl
DKSH SINGAPORE PTE. LTD.
M03BX09
50 mg
TABLET, SUGAR COATED
EPERISONE HCl 50 mg
ORAL
Prescription Only
BUSHU PHARMACEUTICALS LTD.
ACTIVE
1991-06-21
Caution : Use only as directed by a physician. 【COMPOSITION】 Each white, sugar-coated tablet contains 50 mg of eperisone hydrochloride. 【PRODUCT DESCRIPTION】 Brand name Dosage form and identification code Appearance Description Face Reverse Lateral MYONAL Tablets 50mg Sugar –coated tablets White Diameter Weight Thickness (mm) (mg) (mm) 7.5 162 4.2 【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 Leggi il documento completo
CAUTION: USE ONLY AS DIRECTED BY A PHYSICIAN. 【COMPOSITION】 - For improvement of myotonic symptoms - _MYONAL_ ® 50 mg _TABLETS _2. USE DURING LACTATION It is advisable to avoid the administration of MYONAL to nursing mothers. 【PHARMACOKINETICS】 BLOOD CONCENTRATION Eperisone hydrochloride was administered orally to 8 healthy adult male volunteers at a single dose of 150 mg/day note ) for 14 consecutive days and the plasma concentration was determined at days 1, 8 and 14. The time to reach the peak plasma concentration (t max ) ranged from 1.6 to 1.9 hr, the peak plasma concentration (c max ) was 7.5 to 7.9 ng/mL, elimination half-life (t 1/2 ) was 1.6 to 1.8 hr, and the area under the plasma concentration- time curve (AUC) was 19.7 to 21.1 ng ・ hr/mL. The plasma concentration profiles of eperisone hydrochloride determined at days 8 and 14 did not significantly vary from those of the first day. 【EXCIPIENTS】 It contains carnauba wax, carmellose, micro crystalline cellulose, titanium oxide, stearic acid, calcium stearate, sucrose, talc, precipitated calcium carbonate, corn starch, white shellac, hydroxypropylcellulose, pullulan, povidone K30, macrogol 6000 and hydrated silicon dioxide as inactive ingredients. 【EXPIRATION DATE】 MYONAL should be used before the expiration date indicated on the package or label. 【STORAGE】 MYONAL should be stored below 30°C. Each white, sugar-coated tablet contains 50 mg of eperisone hydrochloride. 【PRODUCT DESCRIPTION】 【INDICA TIONS】 ・ 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 vascu Leggi il documento completo