福善美錠７０公絲

Country: Taiwan

Bahasa: Cina

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

Bahan aktif:

ALENDRONATE (AS SODIUM)

Boleh didapati daripada:

美商默沙東藥廠股份有限公司台灣分公司 台北市信義區信義路五段106號12樓 (86683720)

Kod ATC:

M05BA04

Borang farmaseutikal:

錠劑

Komposisi:

ALENDRONATE (AS SODIUM) (9200036540) MG

Unit dalam pakej:

鋁箔盒裝

Kelas:

製　劑

Jenis preskripsi:

須由醫師處方使用

Dikeluarkan oleh:

MERCK SHARP & DOHME (ITALIA) SPA VIA EMILIA, 21 27100 PAVIA, ITALY IT

Kawasan terapeutik:

alendronic acid

Tanda-tanda terapeutik:

停經婦女骨質疏鬆症之治療。治療男性骨質疏鬆症，以增加骨密度。

Ringkasan produk:

註銷日期: 2016/07/22; 註銷理由: 屆期未申請展延; 有效日期: 2016/04/24; 英文品名: FOSAMAX TABLETS 70MG

Status kebenaran:

已註銷

Tarikh kebenaran:

2001-04-24

Risalah maklumat

MK0217-MF-052013
MK0217-TWN-2012-004080-V1
TABLETS
FOSAMAX
®
70 mg
(alendronate sodium)
ONCE WEEKLY
THERAPEUTIC CLASS
Bisphosphonates are synthetic analogs of pyrophosphate that bind to
the hydroxyapatite found in bone.
FOSAMAX® (alendronate sodium) is a bisphosphonate that acts as a
potent, specific inhibitor of
osteoclast-mediated bone resorption.
Inactive Ingredients: Microcrystalline cellulose, anhydrous lactose,
croscarmellose sodium, magnesium
stearate
INDICATIONS

In postmenopausal women with osteoporosis FOSAMAX is indicated for the
treatment of osteoporosis to
prevent fractures, including those of the hip and spine (vertebral
compression fractures).

FOSAMAX is indicated for the treatment of osteoporosis in men to
increase bone material density.
No available data in the pivotal studies indicated that the incidence
of bone fractures in men is reduced.
DOSAGE AND ADMINISTRATION
FOSAMAX must be taken at least one-half hour before the first food,
beverage, or medication of the day
with plain water only. Other beverages (including mineral water),
food, and some medications are likely to
reduce the absorption of FOSAMAX (see DRUG INTERACTIONS).
To facilitate delivery to the stomach and thus reduce the potential
for esophageal irritation, FOSAMAX
should only be swallowed upon arising for the day with a full glass of
water and patients should not lie
down for at least 30 minutes and until after their first food of the
day. FOSAMAX should not be taken at
bedtime or before arising for the day. Failure to follow these
instructions may increase the risk of
esophageal adverse experiences (see PRECAUTIONS).
Patients
should
receive
supplemental
calcium
and
vitamin
D,
if
dietary
intake
is
inadequate
(see
PRECAUTIONS).
No dosage adjustment is necessary for the elderly or for patients with
mild-to-moderate renal insufficiency
(creatinine clearance 35 to 60 mL/min). FOSAMAX is not recommended for
patients with more severe
renal insufficiency (creatinine clearance < 35 mL/min, or serum
creatinine > 1.6 mg/dL) due to