hovid-Griseofulvin Tablet 500 mg

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

GRISEOFULVIN

Tilgjengelig fra:

HOVID BERHAD

INN (International Name):

GRISEOFULVIN

Enheter i pakken:

20 Tablets; 100 Tablets; 100 Tablets; 500 Tablets; 1000 Tablets

Produsert av:

HOVID BERHAD

Informasjon til brukeren

Date
:
23 July 2020
Head of Generic Medicines Section
Centre of Product and Cosmetic Evaluation,
National Pharmaceutical Regulatory Agency,
Ministry of Health
Lot 36, Jalan Universiti,
46200 Petaling Jaya,
Selangor Darul Ehsan
_(melalui Quest 3+)_
ATTENTION: DATIN ZAHURA MOHAMED@ISMAIL
_Datin_,
COMMITMENT LETTER
PRODUCT NAME
: GRISEOFULVIN 500 TABLET
MAL NO.
: MAL19920513AZ
We hereby commit to submit of RiMUP to PKKK, upon request.
Thank you for your attention.
Your truly,
Chong Yen Leng (Ms)
Regulatory Affairs Manager
Hovid Berhad

Preparatomtale

HOVID-GRISEOFULVIN TABLET 500MG
VIGRI07-var (MY)_4
DESCRIPTION
Round,
white
film-coated
tablet,
bevel-edged,
shallow
convex faces, "HD" embossed and scored on the same face.
COMPOSITION
Each tablet contains:
Griseofulvin 500 mg.
PHARMACODYNAMICS
Griseofulvin inhibits fungal cell mitosis by causing disruption
of
the
mitotic
spindle
structure,
thereby
arresting
the
metaphase of cell division. It is deposited in the keratin
precursor cells of skin, hair, and nails rendering the keratin
resistant to fungal invasion. As the infected keratin is shed, it
is replaced with healthy tissue.
PHARMACOKINETICS
ABSORPTION
Irregularly
and
incompletely
absorbed
after
oral
administration;
absorption
of
griseofulvin
is
particle-size
dependent; its absorption is increased when administered
with fatty meals or milk and increased when administered
concomitantly with phenobarbitone.
BLOOD CONCENTRATION
After
an
oral
daily
dose
of
0.5
to
1.0g,
peak
plasma
concentrations of 1 to 3mg/ml are attained; after single oral
doses of 0.25 to 3g. Peak plasma concentrations of 0.3 to
1.7mg/ml are attained in 4 hours.
HALF-LIFE
Plasma half-life for the alpha-phase, about 1 hour and for the
beta-phase, 9 to 22 hours.
DISTRIBUTION
Localised in the skin, nails, and hair roots; secreted in the
sweat and crosses the placenta.
METABOLIC REACTIONS
O-Demethylation at the 4-and 6-positions and glucuronic
acid conjugation of the demathylated-metabolites.
EXCRETION
After an oral dose, about 35% is excreted in the urine as the
6-demethylated metabolite in 8 days; after an intravenous
dose about 65% is excreted in the urine as the same
metabolite in 72 hours; large amounts of an oral dose are
eliminated unchanged in the faeces but less than 1% is
excreted unchanged in the urine; the urinary excretion of
6-demethylgriseofulvin appears to be pH-dependent; small
amounts of the 4-demethylated metabolite are excreted in
the urine.
INDICATIONS
For treatment of dermatophytic infections of the skin, nails
and
hair
caused
by
species
of
Epidermophyton,
Microsporum and Tr