FIBID CAPSULE

Страна: Малайзия

Език: английски

Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активна съставка:

GEMFIBROZIL

Предлага се от:

Noripharma Sdn. Bhd.

INN (Международно Name):

GEMFIBROZIL

Броя в опаковка:

100 Capsule Capsules; 1000Capsule Capsules; 250Capsule Capsules; 500Capsule Capsules; 30 Capsule Capsules

Произведено от:

Noripharma Sdn. Bhd.

Данни за продукта

FIBID CAPSULE
DESCRIPTION:
Size ‘0’ scarlet/white coloured hard gelatin capsule containing
white to off white powder.
COMPOSITION:
Each capsule contains Gemfibrozil 300mg
ACTIONS & PHARMACOLOGY:
Gemfibrozil is a lipid regulating agent which reduces total
cholesterol, LDL cholesterol, VLDL and
triglycerides and increases HDL cholesterol. Gemfibrozil's mechanism
of action has not been definitely
established. In man, it inhibits peripheral lipolysis and decreases
the hepatic extraction of free fatty acids.
It also inhibits synthesis and increases clearance of apolipoprotein B
which is a carrier of VLDL. It
increases the HDL
2
and HDL
3
subfractions as well as apolipoprotein A-I and A-II. Animal studies
suggest
that the turnover and removal of cholesterol from the liver is
increased.
Gemfibrozil is well absorbed from the GIT after oral administration.
Peak plasma levels occur in 1-
2 hours with plasma half-life of 1.5 hours following single dose and
1.3 hours following multiple
doses. Plasma levels appear proportional to dose and do not
demonstrate accumulation across time
following multiple doses. It undergoes oxidation of a ring methyl
group to form successively a
hydroxymethyl and a carboxyl metabolite. Approximately 70% of
administered dose is excreted in
the urine as the glucuronide conjugate and as unchanged drug. About 6%
of the administered dose
is excreted in the faeces.
INDICATIONS:
Primary prevention of coronary heart disease in patients with
hypercholestrolemia, mixed dyslipidemia
and hypertriglyceridemia. Fredrickson's classification Types IIa, Ilb,
IV respectively who have not
responded adequately to diet and other appropriate measures. Treatment
of adult patients with elevated
levels of serum triglycerides (types IV and V hyperlipidemia) who
present a risk of pancreatitis and who
do not respond adequately to a determined dietary effort to control
them.
CONTRAINDICATIONS:
Contraindicated
in
patients
who
have
previously
exhibited
hypersensitivity
to
it.
Also
contraindicated in patients with primary b