Each sugar coated tablet contains: Eperisone hydrochloride 50 mg.
Generic name: Eperisone hydrochloride.
Chemical name: 4-Ethyl-2 methyl-3-piperidinopropiophenone hydrochloride.
Pharmacology: Skeletal muscle relaxation, relaxation of hypertonic skeletal muscles, improves intramuscular blood flow, suppression of spinal reflex potentials, reduction of muscle spindle sensitivity via motor neurons, vasodilatation and augmentation of blood flow, analgesic action and inhibition of the pain reflex in the spinal cord.
Efficacy: Data based on the assessment of 8660 clinical reports of Eperisone hydrochloride (Perispa) usage - Oct. 1982 to Sept, 1986.
Symptom Rate of Improvement (%): Rigidity 70.2, Stiffness 70.4, Dizziness 77.4, Headache 78.9, Tinnitus 65.9, Cervical pain 71.6, Stiff shoulder 82.1, Lumbago 74.8, Difficulty in going up & downstairs 55.2, Difficulty in walking 56.5.
Pharmacokinetics: The pharmacokinetic properties of Eperisone hydrochloride (Perispa) after a single dose of 150 mg/day orally for 14 consequent days to 8 healthy adult male volunteers: Tmax: 1.6 to 1.9 hr.
Cmax: 7.5 to 7.9 ng/ml.
Elimination half life: 1.6 to 1.8 hr.
Area under the plasma concentration time curve (AUC): 19.7 to 21.1 ng.hr/ml.
The plasma concentration profiles of Eperisone hydrochloride (Perispa) determined at day 8 and day 14 did not significantly vary from those of the first day.
Spastic paralysis in the following diseases: Cerebrovascular disease, spastic spinal paralysis, cervical spondylosis, postoperative sequelae (including cerebrospinal tumor), sequelae to trauma (spinal trauma, head injury), amyotrophic lateral sclerosis, cerebral palsy, spinocerebellar degeneration, spinal vascular diseases & other encephalomyelopathies.
Improvement of muscular hypertonic symptoms in the following diseases: Cervical syndrome, periarthritis of the shoulder, lumbago.
The usual adult dosage for oral use is one tablet three times a day after each meal or as directed by the physician. The dosage should be adjusted depending on the patient's age and severity of symptoms.
Patients with a history of hypersensitivity to any ingredients of the drug.
Careful administration (Eperisone HCl should be administered with care in the following patients): Patients with a history of drug hypersensitivity.
Patients with hepatic function disorder.
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.
Use in Children: Safe use of Eperisone hydrochloride (Perispa) in children has not been definitely established.
Use in Elderly: Since the elderly patients often have a psychological hypofunction, it is advisable to take measures, such as reduction in dosage under careful supervision.
Safety for use in pregnancy has not been established. Eperisone HCl (Perispa) should only be used in pregnant women or women suspected of being pregnant if therapeutic benefits are evaluated to outweigh the possible risk of treatment.
It is recommended that this drug not be used during lactation. If it must be used at such times, the patients should discontinue breast-feeding during treatment
The side effects of Eperisone HCl are very rare, only a few cases have been observed and none of them were of serious nature clinically. The observed side effects are excessive relaxation, stomachache, nausea, vertigo, anorexia, drowsiness, skin rashes, diarrhea, indigestion, GI disturbances, insomnia, headache, constipation etc.
There is a report that disturbances in ocular accommodation occurred after the concomitant use of tolperisone hydrochloride and methocarbamol.
Store at temperatures not exceeding 30°C in dry place. Protect from light.
M03BX09 - eperisone ; Belongs to the class of other centrally-acting muscle relaxants.