ACTONEL ONCE A MONTH 150 MG

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

RISEDRONIC ACID AS SODIUM

Tersedia dari:

ABIC MARKETING LTD, ISRAEL

Kode ATC:

M05BA07

Bentuk farmasi:

FILM COATED TABLETS

Komposisi:

RISEDRONIC ACID AS SODIUM 150 MG

Rute administrasi :

PER OS

Jenis Resep:

Required

Diproduksi oleh:

WARNER CHILCOTT DEUTSCHLAND GMBH, GERMANY

Kelompok Terapi:

RISEDRONIC ACID

Area terapi:

RISEDRONIC ACID

Indikasi Terapi:

Treatment of postmenopausal osteoporosis.Prevention of postmenopausal osteoporosis.

Tanggal Otorisasi:

2015-04-30

Selebaran informasi

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غلم ١٥٠ (مويدوص ـك) تانوردسير ضمح
.Risedronic Acid (as Sodium) 150 mg
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نكمم ماظعلا نادقف ،٣٥ ليج دعب
ةلباق نو

Karakteristik produk

_ _
_Page 1 _
THE FORMAT OF THIS INSERT WAS DETERMINED BY THE MINISTRY OF HEALTH AND
ITS CONTENT WAS
CHECKED AND APPROVED ON SEPTEMBER 2015
PRODUCT INFORMATION
ACTONEL
®
ONCE A MONTH 150 MG
NAME OF THE MEDICINE
ACTONEL ONCE A MONTH 150 MG
NON-PROPRIETARY NAME
Each Actonel tablet contains the equivalent of 150 mg of risedronate
sodium. The empirical formula for
risedronate sodium is C
7
H
10
NO
7
P
2
Na. The chemical name of risedronate sodium is [1-hydroxy-2-(3-
pyridinyl)ethylidene]bis(phosphonic acid) monosodium salt.
.
CHEMICAL STRUCTURE
The chemical structure of risedronate sodium is the following:
Molecular Weight: 305.10
The CAS registry number is 115436-72-1
DESCRIPTION
Risedronate sodium is a fine, white to off-white, odourless,
crystalline powder. It is soluble in water and in
aqueous solutions and essentially insoluble in common organic
solvents.
Each
Actonel
tablet
contains
risedronate
sodium
150
mg,
crospovidone,
magnesium
stearate,
microcrystalline cellulose, hydroxypropyl cellulose, hypromellose,
macrogol 400, macrogol 8000, colloidal
anhydrous silica, indigo carmine and titanium dioxide.
PHARMACOLOGY
Risedronate is a potent pyridinyl bisphosphonate that binds to bone
hydroxyapatite and inhibits osteoclast-
mediated
bone
resorption.
Risedronate
is
a
third
generation
bisphosphonate.
In
preclinical
studies
risedronate demonstrated potent anti-osteoclast and anti-resorptive
activity, increasing bone mass and
biomechanical strength dose-dependently. The activity of risedronate
was confirmed by bone marker
measurements during pharmacodynamic and clinical studies. With
risedronate 5 mg daily, decreases in
biochemical markers of bone turnover were observed within 1 month of
treatment and reached a maximum
decrease in 3-6 months, remaining stable during the course of therapy.
This data demonstrates that
risedronate causes a moderate reduction in bone resorption and bone
turnover. The new steady state
approximates the rate of bone turnover seen in pre-menopausal women.
Decreases in biochemical markers
of bo