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July 12, 2004

Rapid Disintegration Tablet for Hypotension "Metligine"
"Metligine D Tablets 2mg" to be Launched




Taisho Pharmaceutical Co., Ltd. (President: Akira Uehara) will launch the world's first rapid disintegration tablet for hypotension, "Metligine D Tablets 2mg" (generic name: midodrine hydrochloride), on July 12. The approval for manufacturing was obtained on February 10, 2004 and the NHI Price was listed on July 9 of the same year; the product will be distributed by Taisho Toyama Pharmaceutical Co., Ltd.

"Metligine D Tablets 2mg" is a new formulation of "Metligine Tablets 2mg," which was launched by Taisho Pharmaceutical Co., Ltd. in June 1989 with indications for essential hypotension and orthostatic hypotension. As it dissolves in the mouth instantly, it can be taken without water, thus bringing advantages to many patients, including those who have difficulty swallowing tablets and capsules.

Midodrine hydrochloride, the chief ingredient of the product, is a prodrug in which sympathetic nerve exciting amine DMAE* is modulated by glycine. DMAE was synthesized by Zölss Gerhard et al. (Austria) in 1962.
We introduced this to Japan from Chemie Linz (currently Nycomed Pharma) in Austria in 1982. By selectively stimulating sympathetic nerve α1 receptors and constricting peripheral blood vessels, it increases blood pressure, and, in an upright position, inhibits a decrease in blood pressure. Moreover, it is a safe drug without direct influence on the heart and the central nervous system.

Midodrine hydrochloride preparations have been sold in over 30 countries including the US, Austria, Germany, France, and Italy. In Japan, it is sold solely as "Metligine" by Taisho Toyama Pharmaceutical Co., Ltd.

* DMAE:2-amino-1-(2,5-dimethoxyphenyl)ethanol

Product specification
Product name Metligine D Tablets 2mg
Generic name Midodrine hydrochloride
Classification Designated drug
Indications Essential hypotension, orthostatic hypotension
Dosage and administration  For adults, administer 4mg of midodrine hydrochloride orally in two separate doses daily. The dosage may be adjusted according to the symptoms, and in severe cases it can be increased up to 8mg daily. 
For children, administer 4mg of midodrine hydrochloride orally in two separate doses daily. The dosage may be adjusted according to the symptoms, and in severe cases it can be increased up to 6mg daily.
Precautions related to dosage and administration:
Although this drug dissolves in the mouth, it needs to be swallowed with the aid of saliva or water, as it cannot be absorbed through oral mucosa.
Price ¥56.70 per tablet
Package  PTP 100 tablets, PTP 500 tablets
Approval date for manufacturing  February 10, 2004
Listed date in the NHI List July 9, 2004
Launch date July 12, 2004
Manufacturer Taisho Pharmaceutical Co., Ltd.
Distributor Taisho Toyama Pharmaceutical Co., Ltd.