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White, round, biconvex film coated tablet with engraved 50 on one side and plain on the other.
Each film coated tablet contains Eperisone hydrochloride 50 mg.
Pharmacology: Pharmacodynamics: Eperisone reduces alpha- and gamma-efferent activities and inhibits spinal cord activities by acting on the spinal cord and supraspinal structures.
In healthy volunteers, eperisone (150 and 300 mg/day) suppressed spontaneous contraction of muscle spindle, as well as static and dynamic responses to stretch.
In addition to its relaxant effect, eperisone exerts a vasodilatory activity, thus increasing muscle blood flow and is associated to antinociceptive effects by inhibiting the release of P substance. When eperisone hydrochloride is used in the treatment of spastic paralysis in patients with cerebral apoplexy, it improves the cybex torque curve and electromyogram and facilitates voluntary movements, such as extension and flexion of the extremities, without reducing the muscular force.
Pharmacokinetics: Half-life elimination: 1.6 to 1.8 hours.
Time to peak: 1.6 to 1.9 hours.
Muscle relaxant: Eperisone is indicated for improvement of myotonic symptoms such as in cervical syndrome, periarthritis of the shoulder, lumbago, etc.
Spastic paralysis: Eperisone is indicated for spastic paralysis caused by the following diseases: cerebrovascular disorders, spastic spinal paralysis, cervical spondylosis, sequela of trauma (spinal injury and head injury), spinal vascular disorders and other encephalomyelopathies.
Muscle relaxant: The usual adult dosage is 1 tablet 3 times a day (150 mg of eperisone hydrochloride) after meals. The dosage may be adjusted depending on the patient's age and symptoms.
Spastic paralysis: The usual adult dosage is 1-2 tablets 3 times a day (150-300 mg of eperisone hydrochloride) after meals. The dosage may be adjusted depending on the patient's age and severity.
Some adverse events, including skin eruptions and seizure, were previously reported in patients with eperisone intoxication. A case series of 13 patients who intentionally overdosed on eperisone were identified and the main symptoms were nausea in 6 patients, conscious disturbances in 4 patients, convulsions in 2 patients, and hypotension in 1 patient. Positive correlations between serum eperisone concentration and QTc interval in patients who overdosed on eperisone were demonstrated. Four patients developed QT prolongation following an overdose of eperisone, either alone or in combination with various other drugs. All patients were treated with gastric lavage and activated charcoal.
Patients with a history of hypersensitivity to eperisone or other components of the product.
The product contains the following components: Microcrystalline cellulose, Corn starch, Hydroxypropylcellulose, Povidone, Phosphoric acid, Croscarmellose sodium, Light anhydrous silicic acid, Talc, Stearic acid, Hypromellose, Macrogol, Isopropanol, Opadry AMB II, Titanium oxide, Simethicone, Copovidone.
Hypersensitivity reactions: Hypersensitivity reactions including rash and pruritus may occur. Cases of anaphylaxis have also been reported. Serious reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) may occur. Discontinue use if symptoms of fever, erythema, blistering, itching, ocular congestion, or stomatitis occur.
CNS depression: May cause CNS depression, which may impair physical or mental abilities. Patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
Special population: Use with caution in patients with hepatic impairment. May worsen hepatic function.
Use in the Elderly: Use with caution in elderly patients. Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy.
Pregnancy: The safety of eperisone in pregnant women has not been established. Eperisone should only be used in pregnant women or women suspected of being pregnant if the expected therapeutic benefits are evaluated to outweigh the possible risks of treatment.
Lactation: Avoid the administration of eperisone to nursing mothers. When eperisone must be used, breastfeeding should be discontinued during treatment.
Frequency 1% to 10%: Central nervous system: Fatigue (≤5%), headache (≤5%), insomnia (≤5%), numbness of extremities (≤5%).
Dermatologic: Skin rash (≤5%).
Endocrine & metabolic: Hot flash (≤5%), increased thirst (≤5%).
Gastrointestinal: Abdominal pain (≤5%), anorexia (≤5%), constipation (≤5%), diarrhea (≤5%), nausea (≤5%), stomach discomfort (≤5%), vomiting (≤5%).
Frequency <1%: Anaphylactoid reaction, anemia, diaphoresis, dizziness, drowsiness, edema, enlargement of abdomen, hiccups, increased blood urea nitrogen, increased post-void residual urine volume, increased serum alkaline phosphatase, increased serum ALT, increased serum AST, muscle hypotonia, muscle rigidity (body), palpitations, proteinuria, pruritus, shock, Stevens-Johnson syndrome, stomatitis, toxic epidermal necrolysis, tremor (extremities), urinary incontinence, urinary retention, weakness.
Avoid concomitant use: Avoid concomitant use of eperisone with: Azelastine (nasal), Orphenadrine, Oxomemazine, Paraldehyde, and Thalidomide.
Increased effect/toxicity: Eperisone may increase the levels/effects of: Alcohol (Ethyl), Analgesics (Opioid), Azelastine (nasal), Blonanserin, Buprenorphine, CNS Depressants, Flunitrazepam, Highest Risk QTc-Prolonging Agents, Hydrocodone, Methocarbamol, Methotrimeprazine, Metyrosine, Mirtazapine, Moderate Risk QTc-Prolonging Agents, Orphenadrine, Oxycodone, Paraldehyde, Piribedil, Pramipexole, Ropinirole, Rotigotine, Selective Serotonin Reuptake Inhibitors, Suvorexant, Thalidomide, Zolpidem.
The levels/effects of Eperisone may be increased by: Brimonidine (Topical), Cannabis, Chlormethiazole, Chlorphenesin Carbamate, Dimethindene (Topical), Doxylamine, Dronabinol, Droperidol, Hydroxyzine, Kava Kava, Lofexidine, Magnesium Sulfate, Methotrimeprazine, Mifepristone, Minocycline, Nabilone, Oxomemazine, Perampanel, Rufinamide, Sodium Oxybate, Tapentadol, Tetrahydrocannabinol, Trimeprazine.
M03BX09 - eperisone ; Belongs to the class of other centrally-acting muscle relaxants.
Emson 50 FC tab 50 mg
3 × 10's
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