Reventa 70mg Tablet

Pays: Philippines

Langue: anglais

Source: FDA (Food And Drug Administration)

Ingrédients actifs:

Alendronic Acid

Disponible depuis:

Getz Pharma Phils., Inc.

DCI (Dénomination commune internationale):

Alendronic Acid

Dosage:

70mg

forme pharmaceutique:

Tablet

Unités en paquet:

Box of 1 Alu-Alu Blister pack x 4's, Alu-Alu Blister pack x 4's (box of 1's)

Fabriqué par:

Getz Pharma (Pvt.)., Ltd., Pakistan

Domaine thérapeutique:

Anti-Osteoporotic

indications thérapeutiques:

– In postmenopausal women for the treatment of osteoporosis to prevent fractures, including those of the hip and spine (vertebral compression fractures). – In postmenopausal women who are at risk of developing osteoporosis. – For the treatment of osteoporosis in men to prevent fractures. – For the treatment and prevention of glucocorticoid-induced osteoporosis in men and women. – For the treatment of Paget’s disease of bone in men and women.

Date de l'autorisation:

2017-06-05

Résumé des caractéristiques du produit

DESCRIPTION
Alendronic Acid (Reventa
®
) is an aminobisphosphonate that
acts as a potent inhibitor of bone resorption.
Alendronic Acid is chemically described as (4-amino-1-
hydroxybutylidene) bisphosphonic acid monosodium salt
trihydrate. The molecular formula is C
4
H
12
NNaO
7
P
2
•3H
2
O and
the structural formula is
FORMULATION
Alendronic Acid (Reventa
®
) is available for oral administration
as:
Alendronic Acid (Reventa
®
) Tablets 70mg
Each tablet contains:
Alendronic Acid (as Alendronate sodium trihydrate) ... 70mg
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
At the cellular level, alendronate shows preferential localization
to sites of bone resorption, specifically under osteoclasts. The
osteoclasts adhere normally to the bone surface but lack the
ruffled border that is indicative of active resorption. Alendronate
does not interfere with osteoclast recruitment or attachment,
but it does inhibit osteoclast activity. While incorporated in
bone matrix, alendronate is not pharmacologically active.
Thus, alendronate must be continuously administered to
suppress osteoclasts on newly formed resorption surfaces.
PHARMACOKINETICS
_Absorption_
Like other bisphosphonates, alendronate is poorly absorbed
following oral administration. Absorption is decreased by food,
especially by products containing calcium or other polyvalent
cations. Bioavailability is about 0.4% when administered half
an hour before food, reduced from 0.7% in the fasting state
absorption is negligible when taken up to 2 hours after a meal.
_Distribution_
The mean steady-state volume of distribution, exclusive of
bone, is at least 28L in humans. Concentrations of drug in
plasma following therapeutic oral doses are too low (less than
5ng/mL) for analytical detection. Protein binding in human
plasma is approximately 78%.
_Metabolism_
There is no evidence that alendronate is metabolized in animals
or humans.
_Elimination_
About half of the absorbed portion is excreted in the urine;
the remainder is sequestered to bone for a prolonged period.
The te