Rovista 10mg Film-Coated Tablet

Pajjiż: Filippini

Lingwa: Ingliż

Sors: FDA (Food And Drug Administration)

Ingredjent attiv:

Rosuvastatin (as calcium)

Disponibbli minn:

Getz Pharma (Phils.), Inc.

INN (Isem Internazzjonali):

Rosuvastatin (as calcium)

Dożaġġ:

10mg

Għamla farmaċewtika:

Film-Coated Tablet

Unitajiet fil-pakkett:

Alu/Alu Blister Pack x 10's (Box of 10's and 30's), Alu/Alu Blister Pack x 10's (Box of 10’s), Alu/Alu Blister pack x 10's (box of 10's)

Manifatturat minn:

Getz Pharma (Pvt.) Ltd., Pakistan

Data ta 'l-awtorizzazzjoni:

2024-01-16

Karatteristiċi tal-prodott

DESCRIPTION
Rosuvastatin (Rovista ), a synthetic lipid-lowering agent, is an
inhibitor
of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase.
Rosuvastatin calcium is bis[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-
[methyl(methylsulfonyl)amino]
pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-
6-enoic acid] calcium salt. The empirical formula for rosuvastatin
calcium
is (C
22
H
27
FN
3
O
6
S)
2
Ca. Its structural formula is:
FORMULATION
Rosuvastatin (Rovista
) is available for oral administration as:
1. Rosuvastatin (Rovista ) Tablets 5mg
Each film-coated tablet contains:
Rosuvastatin…5mg
(as calcium salt)
2. Rosuvastatin (Rovista ) Tablets 10mg
Each film-coated tablet contains:
Rosuvastatin…10mg
(as calcium salt)
3.
Rosuvastatin (Rovista ) Tablets 20mg
Each film-coated tablet contains:
Rosuvastatin…20mg
(as calcium salt)
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Rosuvastatin is a selective and competitive inhibitor of HMG-CoA
reductase,
the rate-limiting enzyme that converts 3-hydroxy-3-methylglutaryl
coenzyme
A to mevalonate, a precursor for cholesterol. The primary site of
action
of rosuvastatin is the liver, the target organ for cholesterol
lowering.
In _in vivo_ and _in vitro_ studies, rosuvastatin produces its
lipid-modifying
effects in two ways. First, it increases the number of hepatic LDL
receptors
on the cell-surface to enhance uptake and catabolism of LDL. Second,
rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the
total
number of VLDL and LDL particles.
PHARMACOKINETICS
_Absorption_
Maximum plasma concentration is achieved approximately in 5 hours
after oral administration. The absolute bioavailability is
approximately
20%. Both peak concentration (C
max
) and area under the plasma
concentration-time curve (AUC) increased in approximate proportion to
rosuvastatin dose.
Administration of rosuvastatin with food decreased the rate of drug
absorption by 20% as assessed by C
max
, but there was no effect on the
extent of absorption as assessed by AUC.
_Distribution_
Rosuvastatin is taken up