Merislon betahistine mesylate tablets 12mg 100 tablets (Eisai dizziness)

Betahistine mesylate tablets are histamine-type drugs that relieve dizziness, tinnitus, and hearing loss caused by Meniere's disease and vertigo by improving inner ear circulation and regulating vestibular function.

I. Basic Drug Information

1. Generic name : betahistine mesylate tablets (Japanese Pharmacy Prescription Betahistine mesylate tablets)
2. English name : Betahistine Mesilate Tablets
3. Product Name : Merislon® Tablets, available in 6mg and 12mg strengths.
4. Dosage form : tablets, of which the 12mg strength is a secant tablet.
5. Indications : For the treatment of vertigo or dizziness associated with the following conditions, including Meniere's disease, Meniere's syndrome, and vertigo.
6. Element
   • Active ingredient : 6mg tablets contain 6mg of betahistine mesylate; 12mg tablets contain 12mg of betahistine mesylate.
   • Additives : Both specifications contain hydrated silica (hydrated silica diacid), crystalline cellulose (crystalline セルロース), calcium stearate (ステアリン acid カルシウム), Talc (タルク), low-substitution hydroxypropyl cellulose (low-substitution hydroxypropyl cellulose) Hydroxypropyl cellulose (Hydroxypropylcellulose)
7. Properties
   | Sales name (commercial name) | Miracle tablets 6mg | Miracle tablets 12mg |
   | ---- | ---- | ---- |
   | Dosage Form (Oil) | Plain Tablet | Plain Tablet (with cut line) |
   | Identification code (identification code) | 150 | 151 |
   | Shape (outer shape) - Surface (surface) | - | - |
   | Exterior (outer shape) - Side view (side view) | - | - |
   | Diameter (diameter, mm) | 6.1 | 7.1 |
   | Mass (mg) | 84 | 120 |
   | Thickness (thickness, mm) | 2.4 | 2.7 |
   | Color (hue) | White | White |
   | Other Physicochemical Properties | Betahistine mesylate is a white crystalline or crystalline powder, extremely soluble in water, readily soluble in acetic acid (100%), sparingly soluble in ethanol (99.5%), soluble in dilute hydrochloric acid, hygroscopic, and has a melting point of 110~114℃ after drying; its chemical name is N-Methyl-2-pyridin-2-ylethylamine dimethanesulfonate, with the molecular formula C₈H₁₂N₂・2CH₄O₃S and a molecular weight of 328.41.

II. Usage and Dosage

1. Methion tablets 6mg : The usual adult dosage is 1-2 tablets (6-12mg based on betahistine mesylate) three times daily, taken after meals. Dosage may be adjusted according to the patient's age and symptoms.
2. Melisron tablets 12mg : The usual adult dosage is one tablet (12mg betahistine mesylate) three times daily, taken after meals. The single dose range for betahistine mesylate is 6-12mg.

III. Taboos

IV. Precautions

1. Special populations
   • Patients with complications/previous medical history
     • Patients with a history of peptic ulcers or active peptic ulcers: This product has histamine-like effects and may cause increased gastric acid secretion through H₂ receptors, so it should be used with caution.
     • Patients with bronchial asthma: This product has histamine-like effects and may cause airway constriction through H₁ receptors, so it should be used with caution.
     • Patients with pheochromocytoma (brown cell tumor) or paraganglioma: This product has histamine-like effects and may cause high blood pressure due to excessive adrenaline secretion. It should be used with caution.
   • Pregnant women : This product should only be used on pregnant women or women who may become pregnant if the benefits of treatment outweigh the risks.
   • Breastfeeding women : The benefits of treatment and the nutritional benefits of breast milk should be considered comprehensively before deciding whether to continue or stop breastfeeding.
   • Children, etc .: No clinical studies have been conducted on children or other populations, and use should be carried out with extreme caution.
   • Elderly people : Since the physiological functions of the elderly usually decline, attention should be paid to reducing the dosage when using it.
2. Medication guidance
   • For medications packaged in PTP (PTP film), patients should be instructed to remove the medication from the PTP film before taking it. If the PTP film is accidentally swallowed, its sharp, hard edges may pierce the esophageal mucosa, even causing perforation and leading to serious complications such as mediastinitis.
   • The patient's condition should be closely monitored during medication. If any abnormalities occur, medication should be stopped immediately and appropriate measures should be taken.
3. Drug Preservation
   • Store at room temperature (Storage method: Store at room temperature).
   • Once opened, the bottle packaging (バル包) should be stored in a moisture-proof manner.
   • The shelf life of the medicine is 3 years (effective period: 3 years).

V. Adverse Reactions

1. Allergic reaction : Skin rash may occur (which is an allergic reaction, with an incidence rate of less than 0.1% to 5%).
2. Gastrointestinal reactions : Nausea and vomiting may occur (a digestive reaction, with an incidence rate of less than 0.1% to 5%).
3. Other tips : The patient's condition should be closely monitored during medication. If any abnormalities are found, medication should be stopped immediately and appropriate measures should be taken.

VI. Drug Interactions

VII. Pharmacological effects

1. Adjusting biomembrane function : No specific information available.
2. Improvement of metabolic abnormalities : No clear relevant information.
3. Regulating blood lipids : No clear relevant information.
4. Protect blood vessels
   • Effect on improving inner ear circulation disorders : In an experimental model of inner ear microcirculation disorders in guinea pigs, intraperitoneal administration of this product resulted in a 148% increase in blood flow compared to the control group after 30 minutes, and this phenomenon was specific under pathological conditions.
   • Effect on increasing cochlear blood flow : Oral administration of this product to guinea pigs with inner ear lymphedema significantly increased cochlear blood flow from 5.5 mL/min/100g to 8.1 mL/min/100g. This increase is presumably due to the product's relaxing effect on the smooth muscle of the radial arteries of the cochlea, thereby increasing blood flow.
   • Effect on improving cerebral blood flow : Experiments on rats showed that after intravenous administration of this product, cerebral blood flow increased from 70.4 mL/100 g/min to 81.4 mL/100 g/min, and cerebellar blood flow increased from 73.2 mL/100 g/min to 84.0 mL/100 g/min, thus improving cerebral blood flow.
5. Mechanism of action supplement : The mechanism of action of the active ingredient betahistine mesylate is currently unclear.

VIII. Pharmacokinetics

1. Absorption : No specific information on absorption is listed.
2. Excretion : No specific information about excretion is listed.

IX. Clinical Research

1. Domestic clinical results : In a clinical study (including double-blind trials) involving a total of 875 patients, this product has been shown to be effective for vertigo and dizziness associated with Meniere's disease, Meniere's syndrome, and vertigo.
2. References : Relevant clinical research results can be found in the following literature:
   • Watanabe: Otolaryngology, 1967; 39 (11): 1237-1250
   • Takeru Okamoto: Medical, 1968; 22 (5): 650-665
   • Kaoru Ishikawa: New clinical medicine, 1983; 32 (4): 631-635
   • Sato Matsuri: Drug therapy, 1980; 13 (4-5): 257-260
   • Michiko Nosue: 薬理とtherapy, 1978; 6 (1): 139-151
   • Saito et al.: Clinical Otolaryngology, 1967; 60 (12): 1112-1115
   • Kitano Jin: Clinical Otolaryngology, 1985; 78 (8): 1615-1626
   • Tomita M. et al.: Stroke, 1978;9(4):382-387

10. Packaging Specifications

XI. Production Information

Manufacturer: E-Zai Co., Ltd.