ACTONEL ONCE-A-WEEK

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

RISEDRONATE SODIUM

Tersedia dari:

PYRIDAM FARMA TBK - Indonesia

INN (Nama Internasional):

RISEDRONATE SODIUM

Dosis:

35 MG

Bentuk farmasi:

TABLET SALUT SELAPUT

Unit dalam paket:

DUS, 1 BLISTER @ 4 TABLET SALUT SELAPUT

Diproduksi oleh:

BALKANPHARMA-DUPNITSA AD - Bulgaria

Tanggal Otorisasi:

2021-03-28

Karakteristik produk

Actonel Once-a-Week
Risedronate sodium
DESCRIPTION
ACTONEL (risedronate sodium tablets) is a pyridinyl bisphosphonate
that inhibits osteoclast mediated bone
resorption and modulates bone metabolism. Each ACTONEL tablet for oral
administration contains the equivalent
of 5 mg or 25 mg of anhydrous risedronate sodium in the form of the
hemi-pentahydrate with small amounts of
monohydrate. The empirical formula for risedronate sodium
hemi-pentahydarte is C7H10NO7P2Na●2.5H2O. The
chemical name of risedronate sodium is [1-hydroxy-2-(-3-pyrudinyl)
ethyli-dene]bis[phosponic acid] monosodium
salt. The chemical structure of risedronate sodium hemi-pentahydrate
is the following:
Molecular Weight:
Anhydrous: 305.10
Hemi-pentahydrate: 350.13
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.
Inactive Ingredients:
Crospovidone, ferric oxide red (35 mg tablets only), ferric oxide
yellow (5 & 35 mg tablets
only),
hydroxypropyl
cellulose,
hydroxypropyl
methylcellulose,
lactose
monohydrate,
magnesium
stearate,
microcrystalline cellulose, polyethylene glycol, silicon dioxide,
titanium dioxide.
CLINICAL PHARMACOLOGY
Mechanism of Action:
ACTONEL has affinity for hydroxyapatite crystals in bone and acts as
an antiresorptive
agent. At the cellular level, ACTONEL inhibits osteoclasts. The
osteoclasts adhere normally to the bone surface,
but show evidence of reduced active resorption (e.g., lack of ruffled
border). Histomorphometry in rats, dogs, and
minipigs showed that ACTONEL treatment reduces bone turnover
(activation frequency, i.e., the rate at which
bone remodeling sites are activated) and bone resorption at remodeling
sites.
Pharmacokinetics:
Absorption:
Absorption after an oral dose is relatively rapid (tmax ̴
1 hour) and occurs throughout the upper
gastrointestinal tract. The fraction of the dose absorbed is
independent of dose over the range studied (single
dose, 2.5 to 30 mg; multiple dose, 2.5 t