MYONAL Tablets / Granules (2009)

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1. Indications and Usage

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 ...

2. Dosage and Administration

Tablets 50 mg 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 patients age and ...

4. Contraindications

MYONAL is contraindicated in the following patients: Patients with a history of hypersensitivity to any ingredients of MYONAL.

5. Warnings and Precautions

Careful Administration MYONAL should be administered with care in the following patients: Patients with a history of drug hypersensitivity Patients with hepatic function disorder [MYONAL may aggravate ...

6. Adverse Reactions

Adverse reactions were reported in 416 of 12,315 patients (3.38%) (At the end of the reexamination period). Clinically significant adverse reactions (incidence unknown) Shock and anaphylactoid reactions ...

6.1. Clinical Trials Experience

Neck-shoulder-arm syndrome, scapulohumeral periarthritis and low back pain In open labeled clinical trials and a double blind controlled clinical trial undertaken to determine the effects of MYONAL on ...

8. Use in Specific Populations

Precautions concerning Use Caution in handing over drug (tablets): For drugs that are dispensed in a press-through package (PTP), instruct the patient to remove the drug from the package prior to use [It ...

8.1. 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 ...

8.3. Nursing Mothers

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 ...

8.4. Pediatric Use

Safety in children has not been established (insufficient clinical experience).

8.5. Geriatric Use

Since the elderly often have a physiological hypofunction, it is advisable to take measures, such as reduction in dosage under careful supervision.

11. Description

Tablets 50 mg Each white, sugar-coated tablet contains 50 mg of eperisone hydrochloride. It contains carnauba wax, carmellose, hydrated silicon dioxide, microcrystalline cellulose, titanium oxide, stearic ...

12. Clinical Pharmacology

Skeletal muscle relaxation Inhibition of experimentally-induced muscle rigidity Eperisone hydrochloride suppresses intercollicular section-induced decerebrate rigidity (γ-rigidity) and ischemic decerebrate ...

12.3. Pharmacokinetics

Blood concentration Eperisone hydrochloride was administered orally to 8 healthy adult male volunteers at a single dose of 150 mg/day<sup>note)</sup> for 14 consecutive days and the plasma concentration ...

15. References

1) Tanaka S. et al.: Clin. Report, 16, 6423, 1982. 2) Hanai K. et al.: Jap. J. Clin. Exp. Med., 60, 2049, 1983. 3) Tawara T. et al.: Prog. Med., 3, 1703, 1983. 4) Tsuyama N. et al.: Clin. Eval., 12, 231, ...

16.1. How Supplied

MYONAL Tablets 50 mg: Boxes of 100, 210 (21 Tabs. × 10), 1,000, 1,050 (21 Tabs. × 50), 3,000 and 3,150 (21 Tabs. × 150) in press-through packages, and bottles of 500. MYONAL Granules 10%: Cans of 100 g. ...