美爾胰膜衣錠 1/250 毫克

País: Taiwan

Idioma: xinès

Font: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

ingredients actius:

GLIMEPIRIDE;;METFORMIN HCL (EQ TO METFORMIN HYDROCHLORIDE)

Disponible des:

賽諾菲股份有限公司 台北市信義區松仁路3號7樓 (97168356)

Codi ATC:

A10BD02

formulario farmacéutico:

膜衣錠

Composición:

METFORMIN HCL (EQ TO METFORMIN HYDROCHLORIDE) (6820400710) MG; GLIMEPIRIDE (6820601200) MG

Unidades en paquete:

鋁箔盒裝;;塑膠瓶裝

clase:

製　劑

tipo de receta:

須由醫師處方使用

Fabricat per:

HANDOK INC. 78, DAEPUNGSANDAN-RO, DAESO-MYEON, EUMSEONG-GUN, CHUNGCHEONGBUK-DO, KOREA KR

Área terapéutica:

metformin and sulfonylureas

indicaciones terapéuticas:

治療以glimepride或metformin單一藥物療法仍無法達到適當的血糖控制之第二型糖尿病患者，作為飲食和運動之外的輔助。不適合作第一線治療。

Resumen del producto:

註銷日期: 2018/08/21; 註銷理由: 自請註銷; 有效日期: 2018/11/03; 英文品名: Amaryl M Film-coated Tablets 1/250mg

Estat d'Autorització:

已註銷

Data d'autorització:

2008-11-03

Informació per a l'usuari

1
AMARYL M FILM-COATED TABLET 1/250MG
[Composition]
1 tablet contains;
Glimepiride (KPC) ….. 1 mg
Metformin HCl (EP) ….250 mg
[Indications]
For the treatment of NIDDM (type 2) patients who are having inadequate
glycemic
control with metformin or sulfonylurea monotherapy.
[Dosage and administration]
The dosage of anti-diabetic drugs should be individualized based on
the patient’s
blood glucose levels. Generally, it should be recommended to initiate
the lowest
effective dose and increase the dose depending on the patient’s
blood glucose
levels. Adequate monitoring of blood glucose levels should be
performed for this.
The maximum daily dose for glimepiride is 8mg and metformin is 2gm
(equivalent
8 tablets).
Metformin treatment should not start in patients older than 80 years
old.
Metformin treatment should be cautious when use in elderly patients
less than 80
years old.
To reduce the doses with a eGFR between 30-45ml/min/1.73m
2
It should be administered once or twice per day before or with the
meals. The
initial dose of Glimepiride/metformin 1/250mg is once per day.
[Precautions for use]
1. Warnings
1) Lactic acidosis
Metformin accumulation occurs at acute worsening of renal function and
increases the risk of lactic acidosis. When it occurs, it is fatal in
approximately
50% of cases. Lactic acidosis may also occur in association with a
number of
pathophysiologic conditions, including diabetes mellitus, and whenever
there is
significant tissue hypoperfusion and hypoxemia.
Lactic acidosis is characterized by elevated blood lactate levels
(>5mmol/L),
decreased blood pH, electrolyte disturbances with an increased anion
gap, and
increased lactate/pyruvate ratio. When metformin is implicated as the
cause of
lactic acidosis, metformin plasma levels > 5
µ
g/mL are generally found.
The reported incidence of lactic acidosis in patients receiving
metformin HCl is
very low (approximately 0.03 cases/1000 patients-years, with
approximately
0.015 fatal cases/1000 patients-years). Reported cases have occurred
primarily
in