ACTONEL ONCE-A-MONTH

Pays: Indonésie

Langue: indonésien

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingrédients actifs:

RISEDRONATE SODIUM

Disponible depuis:

PYRIDAM FARMA TBK - Indonesia

DCI (Dénomination commune internationale):

RISEDRONATE SODIUM

Dosage:

150 MG

forme pharmaceutique:

TABLET SALUT SELAPUT

Unités en paquet:

DUS, 1 BLISTER @ 1 TABLET SALUT SELAPUT

Fabriqué par:

BALKANPHARMA-DUPNITSA AD - Bulgaria

Date de l'autorisation:

2021-03-28

Résumé des caractéristiques du produit

ACTONEL ONCE-A-MONTH
RISEDRONATE SODIUM
DESCRIPTION
Each Actonel 150 mg 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[phosponic acid] monosodium salt. The chemical structure
of risedronate sodium hemi-
pentahydrate is the following:
Molecular weight: 305.10
The CAS registry number is 115436-72-1
Risedronat sodium is a fine, white to off-white, odorless, crystalline
powder. It is soluble in water and in aqueous
solutions and essentially insoluble in common organic solvents.
Each Actonel 150 mg tablet contain risedronate sodium,crospovidone,
magnesium stearate, microcrystalline
cellulose, hydroxypropyl cellulose, hypromellose, macrogol 4000,
macrogol 8000, silicon dioxide, indigo carmine
and titanium dioxide.
CLINICAL PHARMACOLOGY
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
sodium demonstrated potent anti-osteoclast and antiresorptive
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 5 mg
risedronate 5 mg daily, decreases in
biochemical markers of bone turnover were observed withhin 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 were similar with risedronate 35 mg Once-a-Week and
risedronate 5 mg daily. In a study in
men with osteoporosis, decreases in biochemical markers of bone
turnover were observed at the earliest time
point of 3 months and continued to be observed at 24 months.
_COMP